NCIt Code NCIt PT Subset PT Subset SY NCIt Definition Subset Definition NCIt Code of First Parent First Parent NCIt Code of Second Parent Second Parent NCIt Code of Subset PT of NICHD Subset Subset Antiquated PT Subset Antiquated SY Target Term Relationship to Target Target Term Type Target Code Target Terminology C78161 Abdominal Distention Abdominal Distention Abdominal Bloating Swelling of the abdomen resulting from excessive food intake, malnutrition, liver disease, primary abdominal tumors, and tumors metastatic to the abdominal cavity. Protrusion of the abdomen. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Abdominal distension Has Synonym LLT 10000060 MedDRA C113482 Abdominal Migraine Abdominal Migraine Paroxysmal episodes of intense, acute periumbilical pain that lasts for one or more hours with intervening periods of usual health lasting weeks to months, with no evidence of an inflammatory, anatomic, metabolic, or neoplastic process that explains the symptoms. The pain interferes with normal activities and is associated with at least two of the following symptoms: anorexia, nausea, vomiting, headache, photophobia, and/or pallor. Paroxysmal episodes of intense, acute periumbilical pain that lasts for one or more hours with intervening periods of usual health lasting weeks to months, with no evidence of an inflammatory, anatomic, metabolic, or neoplastic process that explains the symptoms. The pain interferes with normal activities and is associated with at least two of the following symptoms: anorexia, nausea, vomiting, headache, photophobia, and/or pallor. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Abdominal migraine Has Synonym LLT 10049714 MedDRA C26682 Abdominal Pain Abdominal Pain Painful sensation in the abdominal region. Discomfort in the central region of the body located between the chest and the groin. C3368 Gastrointestinal System Signs and Symptoms C3303 Pain C118464 Pediatric Adverse Events Terminology Abdominal pain Has Synonym LLT 10000081 MedDRA C122430 Abnormal Behavior Abnormal Behavior Behavioral Disturbance|Not Acting Normal|Not Acting Self Conduct that is unusual for the individual. Conduct that is unusual for the individual. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Behavior abnormal Has Synonym LLT 10004203 MedDRA C122516 Abnormal Liver Function Test Abnormal Liver Function Test Atypical results found on serum liver enzyme testing, which may indicate significant disease and/or disease progression. Atypical results found on serum liver enzyme testing, which may indicate significant disease and/or disease progression. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Liver function test abnormal Has Synonym LLT 10024690 MedDRA C50449 Abrasion Abrasion Superficial damage to the skin caused by rubbing or scraping. Superficial damage to the skin caused by rubbing or scraping. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Abrasion NOS Has Synonym LLT 10000245 MedDRA C26686 Abscess Abscess An inflammatory process characterized by the accumulation of pus within a newly formed tissue cavity which is the result of a bacterial, fungal, or parasitic infection or the presence of a foreign body. The accumulation of pus and necrotic material that is separated from the surrounding tissue by a fibrous capsule. C26726 Infectious Disorder C118464 Pediatric Adverse Events Terminology Abscess Has Synonym LLT 10000269 MedDRA C122410 Absence of Bowel Movement Absence of Bowel Movement The lack of any bowel movements. The lack of any bowel movements. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Absent bowel movement Has Synonym LLT 10077302 MedDRA C111756 Absent Fetal Heart Rate Variability Absent Baseline Variability A baseline fetal heart rate with an undetectable amplitude range. A baseline fetal heart rate with an undetectable amplitude range. C92790 Fetal Heart Rate Variability C118464 Pediatric Adverse Events Terminology Absent baseline fetal heart rate variability Has Synonym LLT 10074644 MedDRA C26687 Acanthosis Nigricans Acanthosis Nigricans A melanotic cutaneous lesion that develops in the axilla and other body folds. It may be idiopathic, drug-induced, or it may be associated with the presence of an endocrine disorder or malignancy. Abnormal darkening of the skin in body folds and creases characterized by a velvet texture and appearance. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Acanthosis nigricans Has Synonym LLT 10000350 MedDRA C122722 Accidental Drug Ingestion Accidental Medicine Ingestion The unintentional consumption of a drug. The unintentional consumption of a drug. C3367 Finding C118464 Pediatric Adverse Events Terminology Accidental ingestion of drug Has Synonym LLT 10073319 MedDRA C27195 Acne Acne Acne Vulgaris An inflammatory process of the sebaceous glands which is characterized by comedones, nodules, papules and/or pustules on the skin. An inflammatory process of the sebaceous glands which is characterized by comedones, nodules, papules and/or pustules on the skin. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Acne Has Synonym LLT 10000496 MedDRA C118186 Acoria Acoria Akoria Absence of satiety after eating. Absence of satiety after eating. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Lack of satiety Has Synonym LLT 10064720 MedDRA C118712 Acquired Color Blindness Acquired Color Blindness Non-heritable difficulty in distinguishing colors. Non-heritable difficulty in distinguishing colors. C3891 Color Blindness C118464 Pediatric Adverse Events Terminology Color blindness acquired Has Synonym LLT 10055513 MedDRA C122426 Acquired Cytomegaloviral Infection Acquired Cytomegaloviral Infection An infection with the Cytomegalovirus that is not present from birth. An infection with the Cytomegalovirus that is not present from birth. C3439 Viral Infection C118464 Pediatric Adverse Events Terminology CMV infection Narrower Than LLT 10009703 MedDRA C98803 Acquired Hydrocephalus Acquired Hydrocephalus Hydrocephalus that results from head trauma, brain tumors, intracranial hemorrhage, or meningitis. An abnormal accumulation of cerebrospinal fluid within the ventricles of the brain that is acquired after birth. C3111 Hydrocephalus C118464 Pediatric Adverse Events Terminology Hydrocephalus acquired Has Synonym LLT 10020510 MedDRA C112831 Ichthyosis Acquisita Acquired Ichthyosis A non-hereditary form of ichthyosis characterized by plate-like scales on the legs, arms and occasionally the torso. A non-hereditary form of ichthyosis characterized by plate-like scales on the legs, arms and occasionally the torso. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Acquired ichthyosis Has Synonym LLT 10000561 MedDRA C2851 Acquired Immunodeficiency Syndrome Acquired Immunodeficiency Disease AIDS|Acquired Immunodeficiency Syndrome A syndrome resulting from the acquired deficiency of cellular immunity caused by the human immunodeficiency virus (HIV). It is characterized by the reduction of the Helper T-lymphocytes in the peripheral blood and the lymph nodes. Symptoms include generalized lymphadenopathy, fever, weight loss, and chronic diarrhea. Patients with AIDS are especially susceptible to opportunistic infections (usually pneumocystis carinii pneumonia, cytomegalovirus (CMV) infections, tuberculosis, candida infections, and cryptococcosis), and the development of malignant neoplasms (usually non-Hodgkin lymphoma and Kaposi sarcoma). The human immunodeficiency virus is transmitted through sexual contact, sharing of contaminated needles, or transfusion of contaminated blood. A chronic, potentially life threatening condition that is caused by human immunodeficiency virus (HIV) infection, and is characterized by increased susceptibility to opportunistic infections, certain cancers and neurologic disorders. C9229 Systemic Disorder C118464 Pediatric Adverse Events Terminology Acquired immune deficiency syndrome Has Synonym LLT 10000563 MedDRA C112180 Acral Erythema Acral Erythema Reddening of the palmar and plantar regions of the body with occasional involvement of the distal extremities. Reddening of the palmar and plantar regions of the body with occasional involvement of the distal extremities. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Acral erythema Has Synonym LLT 10070580 MedDRA C84533 Acromegaly Acromegaly A syndrome characterized by enlargement of the hands, feet, ears, nose, lips, and tongue, skin thickening and swelling of internal organs. It is caused by overproduction of growth hormone in the pituitary gland, usually by a pituitary adenoma. Excessive growth of body tissues due to overproduction of growth hormone in an individual who has completed linear growth. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Acromegaly Has Synonym LLT 10000599 MedDRA C114839 Acute Cellular Allograft Nephropathy Acute Cellular Kidney Allograft Nephropathy A sudden onset of T-cell mediated immune response occurring after transplantation, directed against donor kidney alloantigens. A sudden onset of T-cell mediated immune response occurring after transplantation, directed against donor kidney alloantigens. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Acute cellular allograft nephropathy Has Synonym LLT 10076691 MedDRA C34578 Acute Disseminated Encephalomyelitis Acute Disseminated Encephalomyelitis ADEM An inflammatory process affecting the central nervous system. It is characterized by perivascular demyelination. Symptoms usually follow an acute viral infection or immunization and include fever, confusion, somnolence and involuntary movements. It may lead to coma and death. Transitory inflammation of the brain and spinal cord that is associated with demyelination with or without neuronal damage. C34580 Encephalomyelitis C118464 Pediatric Adverse Events Terminology Acute disseminated encephalomyelitis Has Synonym LLT 10000709 MedDRA C112122 Acute Generalized Exanthematous Pustulosis Acute Generalized Exanthematous Pustulosis A widespread acute rash characterized by fever and multiple small pustules on a reddish background. A widespread acute rash characterized by fever and multiple small pustules on a reddish background. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Acute generalized exanthematous pustulosis Has Synonym LLT 10062372 MedDRA C4980 Acute Graft Versus Host Disease Acute Graft Versus Host Disease A syndrome of immunologically mediated tissue damage that may occur following an allogeneic transplant, usually affecting the skin, liver, and GI tract. The onset is usually within one hundred days of transplantation or immunologic manipulation. A complication of allogeneic bone marrow or blood cell transplantation, occurring within the first three months of transplantation, in which donor lymphoid cells damage the host tissue. C3063 Graft Versus Host Disease C118464 Pediatric Adverse Events Terminology Acute graft versus host disease Has Synonym LLT 10066260 MedDRA C113749 Acute Hemorrhagic Edema of Infancy Acute Hemorrhagic Edema of Infancy A self-limiting cutaneous vasculitis that typically presents as a clinical triad of purpura, edema, and fever in children between the ages of four months and two years old. It is usually associated with a recent history of upper respiratory infection and/or antibiotic therapy. A self-limiting cutaneous vasculitis that typically presents as a clinical triad of purpura, edema, and fever in children between the ages of four months and two years old. It is usually associated with a recent history of upper respiratory infection and/or antibiotic therapy. C26323 Hematologic Disorder C118464 Pediatric Adverse Events Terminology Acute hemorrhagic edema of infancy Has Synonym LLT 10070601 MedDRA C114841 Acute Humoral Allograft Nephropathy Acute Humoral Kidney Allograft Nephropathy A sudden onset of B-cell mediated immune response occurring after transplantation, directed against donor kidney alloantigens. A sudden onset of B-cell mediated immune response occurring after transplantation, directed against donor kidney alloantigens. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Acute humoral allograft nephropathy Has Synonym LLT 10076679 MedDRA C116926 Acute Inflammatory Demyelinating Polyradiculoneuropathy Acute Inflammatory Demyelinating Polyradiculoneuropathy Acute Inflammatory Demyelinating Polyradiculopathy A subtype of Guillain-Barre syndrome that targets the myelin sheath, and is characterized by progressive weakness, distal paresthesia and autonomic dysfunction. A subtype of Guillain-Barre Syndrome that targets the myelin sheath, and is characterized by progressive weakness, distal paresthesia and autonomic dysfunction. C116345 Guillain-Barre Syndrome C118464 Pediatric Adverse Events Terminology Acute inflammatory demyelinating polyradiculoneuropathy Has Synonym LLT 10067898 MedDRA C114838 Acute Allograft Nephropathy Acute Kidney Allograft Nephropathy Kidney Transplant Rejection A sudden immune response occurring after transplantation, directed against donor kidney alloantigens. A sudden immune response occurring after transplantation, directed against donor kidney alloantigens. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Acute allograft nephropathy Has Synonym LLT 10076656 MedDRA C26808 Acute Renal Failure Acute Kidney Injury Acute Renal Failure Sudden and sustained deterioration of the kidney function characterized by decreased glomerular filtration rate, increased serum creatinine or oliguria. Deterioration of renal function, occurring within a time frame of hours to weeks, that results in failure to maintain normal fluid, electrolyte, waste products, and/or acid-base balance. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Acute kidney injury Has Synonym LLT 10069339 MedDRA C84396 Acute Liver Failure Acute Liver Failure Rapid deterioration of liver function causing encephalopathy and coagulopathy. It results from damage to the liver parenchyma usually secondary to acetaminophen overdose or viral infections. Evidence of acute hepatic dysfunction in the absence of chronic liver disease with coagulopathy unresponsive to Vitamin K. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Acute liver failure Has Synonym LLT 10049844 MedDRA C3167 Acute Lymphoblastic Leukemia Acute Lymphoblastic Leukemia Acute Lymphocytic Leukemia Leukemia with an acute onset, characterized by the presence of lymphoblasts in the bone marrow and the peripheral blood. It includes the acute B lymphoblastic leukemia and acute T lymphoblastic leukemia. A rapidly progressive cancer of the blood and bone marrow consisting of the proliferation of lymphoblasts, which are immature, dysfunctional white blood cells. C3161 Leukemia C118464 Pediatric Adverse Events Terminology Acute lymphoblastic leukemia Has Synonym LLT 10000845 MedDRA C116927 Acute Motor and Sensory Axonal Neuropathy Acute Motor And Sensory Axonal Neuropathy Acute Motor-Sensory Axonal Neuropathy A subtype of Guillain-Barre syndrome that targets sensory motor axons, and is characterized by acute onset of quadriparesis, distal sensory loss, areflexia, and respiratory insufficiency. A subtype of Guillain-Barre Syndrome that targets sensory motor axons, and is characterized by acute onset of quadriparesis, distal sensory loss, areflexia, and respiratory insufficiency. C116345 Guillain-Barre Syndrome C118464 Pediatric Adverse Events Terminology Acute motor-sensory axonal neuropathy Has Synonym LLT 10076657 MedDRA C116929 Acute Motor Axonal Neuropathy Acute Motor Axonal Neuropathy A subtype of Guillain-Barre syndrome that targets motor axons, and is characterized by symmetric limb weakness, diffuse areflexia, facial and oropharyngeal muscle weakness, and respiratory insufficiency. A subtype of Guillain-Barre Syndrome that targets motor axons, and is characterized by symmetric limb weakness, diffuse areflexia, facial and oropharyngeal muscle weakness, and respiratory insufficiency. C116345 Guillain-Barre Syndrome C118464 Pediatric Adverse Events Terminology Acute motor axonal neuropathy Has Synonym LLT 10076658 MedDRA C3171 Acute Myeloid Leukemia Acute Myeloid Leukemia AML|Acute Granulocytic Leukemia|Acute Myelocytic Leukemia|Acute Myelogenous Leukemia A clonal expansion of myeloid blasts in the bone marrow, blood or other tissues. The classification of acute myeloid leukemias (AMLs) encompasses four major categories: 1) AML with recurrent genetic abnormalities; 2) AML with multilineage dysplasia; 3) Therapy-related AML; 4) AML not otherwise specified. The required bone marrow or peripheral blood blast percentage for the diagnosis of AML is 20% (WHO classification). A rapidly progressive cancer of the blood and bone marrow consisting of the proliferation of abnormal myeloblasts, which are immature, dysfunctional white blood cells. C3161 Leukemia C118464 Pediatric Adverse Events Terminology Acute myeloid leukemia Has Synonym LLT 10000886 MedDRA C34749 Acute Tubular Necrosis Acute Tubular Necrosis Acute renal failure caused by the cell death of the renal tubules. Causes include nephrotoxins, cytotoxic drugs, and antibiotics. Damage to the renal tubular epithelial cells resulting in acute kidney injury. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Acute tubular necrosis Has Synonym LLT 10001099 MedDRA C115149 Adenovirus Infection Adenovirus Infection An infectious process caused by adenovirus. The virus may cause respiratory illness, conjunctivitis, gastroenteritis, and cystitis. An infectious process caused by adenovirus. The virus may cause respiratory illness, conjunctivitis, gastroenteritis, and cystitis. C3439 Viral Infection C118464 Pediatric Adverse Events Terminology Adenovirus infection Has Synonym LLT 10060931 MedDRA C113303 Adipose Tissue Deposition Adipose Tissue Deposition The deposition of lipids in tissue. The deposition of lipids in tissue. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Fat tissue increased Related To LLT 10016251 MedDRA C113203 Adrenal Androgen Deficiency Adrenal Androgen Deficiency Adrenal Hypoandrogenism Abnormally low or absent secretion of the androgen precursor hormones dehydroepiandrosterone (DHEA), DHEA sulfate, and androstenedione, from the adrenal gland. Reduced concentrations of the adrenal androgens dehydroepiandrosterone (DHEA), DHEA sulfate, and androstenedione. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Adrenal androgen deficiency Has Synonym LLT 10075902 MedDRA C113209 Adrenal Androgen Excess Adrenal Androgen Excess Adrenal Hyperandrogenism Excessive secretion of the androgen hormones dehydroepiandrosterone (DHEA), DHEA sulfate, and androstenedione, from the adrenal gland. Clinical manifestations may include virilization. Excessive secretion of the androgen hormones dehydroepiandrosterone (DHEA), DHEA sulfate, and androstenedione, from the adrenal gland. Clinical manifestations may include virilization. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Adrenal androgen excess Has Synonym LLT 10075903 MedDRA C112840 Adrenal Crisis Adrenal Crisis A life threatening condition due to inadequate levels of glucocorticoids in an individual with adrenal insufficiency. A life threatening condition due to inadequate concentration of glucocorticoids characterized by loss of vascular tone leading to hypotension, tachycardia, and eventual cardiovascular collapse. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Adrenal crisis Has Synonym LLT 10001346 MedDRA C26691 Adrenocortical Insufficiency Adrenal Insufficiency Adrenal Cortical Hypofunction|Adrenocortical Insufficiency|Hypocortisolemia|Hypocortisolism An endocrine or hormonal disorder that occurs when the adrenal cortex does not produce enough of the hormone cortisol and in some cases, the hormone aldosterone. It may be due to a disorder of the adrenal cortex (Addison's disease or primary adrenal insufficiency) or to inadequate secretion of ACTH by the pituitary gland (secondary adrenal insufficiency). Subnormal concentration of cortisol, with or without mineralocorticoid insufficiency. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Adrenal insufficiency Has Synonym LLT 10001367 MedDRA C116374 Ageusia Ageusia Inability to taste. Inability to taste. C28246 Dysesthesia C118464 Pediatric Adverse Events Terminology Ageusia Has Synonym LLT 10001480 MedDRA C117262 Aggression Aggression A verbal or physical act of hostility. A verbal or physical act of hostility. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Aggression Has Synonym LLT 10001488 MedDRA C79530 Agitation Agitation A state of restlessness associated with unpleasant feelings of irritability and tension. Causes include pain, stress, fever, alcohol and nicotine withdrawal, cocaine and hallucinogenic drugs use, depression, bipolar disorders, and schizophrenia. Irritability associated with physical and psychological restlessness. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Agitation Has Synonym LLT 10001497 MedDRA C121624 Agonal Respiration Agonal Respiration Gasping An abnormal breathing pattern originating from lower brainstem neurons and characterized by labored breaths, gasping, and, often, myoclonus and grunting. An abnormal breathing pattern originating from lower brainstem neurons and characterized by labored breaths, gasping, and, often, myoclonus and grunting. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Agonal death struggle Has Synonym LLT 10048664 MedDRA C107102 Agranulocytosis Agranulocytosis A marked decrease in the number of mature granulocytes (most often neutrophils) in the peripheral blood. Severely low level of granulocytic white blood cells, particularly neutrophils, in the blood due to destruction of circulating cells or failed production by the bone marrow. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Agranulocytosis Has Synonym LLT 10001507 MedDRA C50455 Air Embolism Air Embolism The presence of bubbles of air in the vascular system; occurrence is related to the entry of air into the venous circulation following trauma or surgery. An obstruction of a blood vessel due to the introduction of air. C26759 Embolism C118464 Pediatric Adverse Events Terminology Air embolism Has Synonym LLT 10001526 MedDRA C121626 Airway Compromise Airway Compromise The inhibition of normal respiration by physical obstruction(s) to the airway. The inhibition of normal respiration by physical obstruction(s) to the airway. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Airway compromise Has Synonym LLT 10077277 MedDRA C78163 Akathisia Akathisia An uncomfortable feeling of inner restlessness and inability to stay still. It can be a side effect of psychotropic medications. An uncomfortable feeling of physical restlessness associated with the urge to move. C87124 Central Nervous System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Akathisia Has Synonym LLT 10001540 MedDRA C116923 Akinesia Akinesia Lack of movement. Lack of movement. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Akinesia Has Synonym LLT 10001541 MedDRA C113206 Hypoaldosteronemia Aldosterone Deficiency Hypoaldosteronemia|Hypoaldosteronism|Mineralocorticoid Deficiency Abnormally low levels of aldosterone in the blood. Reduced or absent secretion of mineralocorticoids, primarily aldosterone. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hypoaldosteronemia Has Synonym LLT 10075907 MedDRA C116362 Alice in Wonderland Syndrome Alice in Wonderland Syndrome A neurological syndrome characterized by distorted perceptions of shape, loss of sense of time, and visual, auditory, and tactile hallucinations. A neurological syndrome characterized by distorted perceptions of shape, loss of sense of time, and visual, auditory, and tactile hallucinations. C2934 Central Nervous System Disorder C118464 Pediatric Adverse Events Terminology Alice in wonderland syndrome Has Synonym LLT 10001666 MedDRA C114476 Allergic Reaction Allergic Reaction An immune response that occurs following re-exposure to an innocuous antigen, and that requires the presence of existing antibodies against that antigen. This response involves the binding of IgE to mast cells, and may worsen with repeated exposures. A hypersensitivity reaction triggered by exposure to a previously encountered foreign substance to which the individual has formed antibodies. C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Allergic reaction Has Synonym LLT 10001718 MedDRA C79532 Allergic Rhinitis Allergic Rhinitis Inflammation of the nasal mucous membranes caused by an IgE-mediated response to external allergens. The inflammation may also involve the mucous membranes of the sinuses, eyes, middle ear, and pharynx. Symptoms include sneezing, nasal congestion, rhinorrhea, and itching. It may lead to fatigue, drowsiness, and malaise thus causing impairment of the quality of life. Inflammation of the mucous membrane lining the nose due to allergy. C114476 Allergic Reaction C118464 Pediatric Adverse Events Terminology Allergic rhinitis Has Synonym LLT 10001723 MedDRA C6527 Alloimmunization Alloimmunization Alloimmunisation An immune response to foreign (donor) antigens. An immune system response to foreign human substances. C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Alloimmunization Has Synonym LLT 10054308 MedDRA C50575 Alopecia Alopecia Hair loss usually from the scalp. It may result in bald spots or spread to the entire scalp or the entire epidermis. It may be androgenetic or caused by chemotherapeutic agents, compulsive hair pulling, autoimmune disorders or congenital conditions. Hair loss usually from the scalp. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Alopecia Has Synonym LLT 10001760 MedDRA C35257 Alper Syndrome Alpers Disease Alpers Huttenlocher Disease|Alpers Huttenlocher Syndrome|Alpers Syndrome A rare genetic syndrome with an autosomal recessive pattern of inheritance. It is caused by a mutation in the gene for the mitochondrial DNA polymerase POLG. Clinical signs are usually not present at birth but develop within the first two years of life and include hypoglycemia from underlying liver dysfunction, failure to thrive, spasticity, myoclonus and seizures. The clinical course follows a progression of neurologic disability and hepatic failure. The prognosis is poor with survival outside the first decade unlikely. A neurodegenerative disorder with autosomal recessive inheritance that presents in childhood and is characterized by spasticity, seizures, dementia, and liver disease. C3101 Genetic Disorder C118464 Pediatric Adverse Events Terminology Alpers' disease Has Synonym LLT 10062943 MedDRA C121627 Altered Level of Consciousness Altered Level of Consciousness A level of awareness and arousal other than normal. A level of awareness and arousal other than normal. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Altered state of consciousness Has Synonym LLT 10001854 MedDRA C121628 Altered Mental Status Altered Mental Status A change to an individual's judgment, orientation (to place, time, and self), intellectual functioning, or mood from their baseline. A change to an individual's judgment, orientation (to place, time, and self), intellectual functioning, or mood from their baseline. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Mental status changes Has Synonym LLT 10048294 MedDRA C118459 Amastia Amastia Absence of one or both mammary glands. Absence of one or both mammary glands. C89337 Congenital Musculoskeletal Defect C118464 Pediatric Adverse Events Terminology Amastia Has Synonym LLT 10072717 MedDRA C84550 Amaurosis Fugax Amaurosis Fugax Transient, monocular loss of vision. Transient, monocular loss of vision. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Amaurosis fugax Has Synonym LLT 10001903 MedDRA C118764 Amblyopia Amblyopia Lazy Eye Decreased vision that results from abnormal visual development. Decreased vision that results from abnormal visual development. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Amblyopia Has Synonym LLT 10001906 MedDRA C50458 Ambulation Difficulty Ambulation Difficulty Any persistent problem with walking. Any persistent problem with walking. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Walking difficulty Has Synonym LLT 10047810 MedDRA C61443 Amenorrhea Amenorrhea The absence of menses in a woman who has achieved reproductive age. The absence of menses in a female individual who has achieved reproductive age. C27020 Female Reproductive System Disorder C118464 Pediatric Adverse Events Terminology Amenorrhea Has Synonym LLT 10001927 MedDRA C2867 Amnesia Amnesia Systematic and extensive loss of memory caused by organic or psychological factors. The loss may be temporary or permanent, and may involve old or recent memories. Loss of memory. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Amnesia Has Synonym LLT 10001949 MedDRA C117286 Amotivation Amotivation Lack of drive to participate in social activities or goal oriented behavior. Lack of drive to participate in social activities or goal oriented behavior. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Lack of motivation Has Synonym LLT 10023614 MedDRA C107101 Anaphylaxis Anaphylaxis An acute hypersensitive immune response that occurs from exposure to an allergen. It results from the release of histamine and histamine-like substances from mast cells, and can present with breathing difficulty due to narrowed airways, dizziness and hypotension, skin rash, weak pulse, nausea and vomiting. An acute, severe multi-systemic allergic reaction that may include itching, hives, angioedema, abdominal pain, vomiting, diarrhea, breathing and swallowing difficulties, and hypotension which may progress to shock and death. C9229 Systemic Disorder C118464 Pediatric Adverse Events Terminology Anaphylaxis Has Synonym LLT 10002218 MedDRA C98811 Anasarca Anasarca A condition that is characterized by the presence of generalized edema. Causes include congestive heart failure, liver failure, renal failure, and severe malnutrition. Profound accumulation of an excessive amount of fluid throughout the body. C3002 Edema C118464 Pediatric Adverse Events Terminology Anasarca Has Synonym LLT 10002241 MedDRA C2869 Anemia Anemia A reduction in the number of red blood cells, the amount of hemoglobin, and/or the volume of packed red blood cells. Clinically, anemia represents a reduction in the oxygen-transporting capacity of a designated volume of blood, resulting from an imbalance between blood loss (through hemorrhage or hemolysis) and blood production. Signs and symptoms of anemia may include pallor of the skin and mucous membranes, shortness of breath, palpitations of the heart, soft systolic murmurs, lethargy, and fatigability. Abnormally low level of hemoglobin in the blood. C26323 Hematologic Disorder C118464 Pediatric Adverse Events Terminology Anemia Has Synonym LLT 10002272 MedDRA C73506 Anger Anger An emotional state characterized by marked annoyance or hostility. An emotional state characterized by marked annoyance or hostility. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Anger Has Synonym LLT 10002368 MedDRA C51221 Angina Angina Paroxysms of chest pain due to reduced oxygen to the heart. Chest pain secondary to decreased blood flow to cardiac muscle. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Anginal pain Has Synonym LLT 10002391 MedDRA C112175 Angioedema Angioedema Rapid swelling of the deep layers of the skin due to transient vascular leakage of serous fluid. Rapid swelling of the deep layers of the skin due to transient vascular leakage of serous fluid. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Angioedema Has Synonym LLT 10002424 MedDRA C111908 Angiotensin Converting Enzyme Inhibitor Fetopathy Angiotensin Converting Enzyme Inhibitor Fetopathy ACE Fetopathy|ACE Inhibitor Fetopathy Fetal embryopathy associated with maternal angiotensis converting enzyme (ACE) inhibitor use during pregnancy that may include fetal acute renal failure, growth restriction, oligohydramnios, calvaria abnormalities, preterm birth, and pulmonary hypoplasia with respiratory distress. Fetal embryopathy associated with maternal ACE inhibitor use that may include growth restriction, oligohydramnios, calvaria abnormalities, preterm birth, pulmonary hypoplasia and acute kidney injury. C92719 Fetal Disorder C118464 Pediatric Adverse Events Terminology Angiotensin converting enzyme inhibitor fetopathy Has Synonym LLT 10060516 MedDRA C112198 Angular Cheilitis Angular Cheilitis Cheilosis|Perleche Inflammation of the skin at the corners of the mouth characterized by redness, fissures or crusts. Inflammation of the skin at the corners of the mouth characterized by redness, fissures or crusts. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology C3673 Anhedonia Anhedonia An inability to experience pleasure. Reduced ability to experience pleasure. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Anhedonia Has Synonym LLT 10002511 MedDRA C111971 Annular Lesion Annular Lesion A ring-shaped skin finding with clear central area. A ring-shaped skin finding with clear central area. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Skin lesion Narrower Than LLT 10040882 MedDRA C2875 Anorexia Anorexia Loss of appetite. Loss of appetite. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Anorexia Has Synonym LLT 10002646 MedDRA C116369 Anosmia Anosmia Inability to smell. Inability to smell. C28246 Dysesthesia C118464 Pediatric Adverse Events Terminology Anosmia Has Synonym LLT 10002653 MedDRA C34388 Anovulation Anovulation The absence of ovulation. The absence of ovulation. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Anovulation Has Synonym LLT 10002658 MedDRA C2876 Anoxia Anoxia Absence or reduction of oxygen in body tissue. The absence of oxygen delivery to body tissue. C45233 Respiratory System Finding C118464 Pediatric Adverse Events Terminology Anoxia Has Synonym LLT 10002660 MedDRA C113381 Antepartum Stillbirth Antepartum Stillbirth Fetal death greater than or equal to 20 weeks of gestation prior to labor with Apgar scores of 0 at 1 minute, 5 minutes and beyond. Fetal death greater than or equal to 20 weeks of gestation prior to labor with Apgar scores of 0 at 1 minute, 5 minutes and beyond. C34941 Pregnancy Complication C118464 Pediatric Adverse Events Terminology Stillbirth Narrower Than LLT 10042062 MedDRA C118861 Anterior Segment Ischemia Anterior Segment Ischemia Compromise of blood supply to the anterior segment of the eye. Compromise of blood supply to anterior segment of eye. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Anterior segment ischemia Has Synonym LLT 10076698 MedDRA C35109 Anterior Uveitis Anterior Uveitis Inflammation of the iris and anterior chamber of the eye. Inflammation of the anterior uveal tract. C26909 Uveitis C118464 Pediatric Adverse Events Terminology Anterior uveitis Has Synonym LLT 10002709 MedDRA C112209 Anticonvulsant Hypersensitivity Syndrome Anti-Convulsant Hypersensitivity Syndrome A form of drug hypersensitivity syndrome caused by anti-convulsants. A form of drug hypersensitivity syndrome caused by anti-convulsants. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Drug-induced hypersensitivity syndrome Narrower Than LLT 10059724 MedDRA C114699 Anuria Anuria Absence of urine output. Absence of urine output. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Anuria Has Synonym LLT 10002847 MedDRA C26696 Anxiety Anxiety Apprehension of danger and dread accompanied by restlessness, tension, tachycardia, and dyspnea unattached to a clearly identifiable stimulus. An emotional state characterized by excessive worried thoughts that may be accompanied by restlessness, tension, tachycardia, increased blood pressure, and/or dyspnea. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Anxiety Has Synonym LLT 10002855 MedDRA C50461 Aortic Dissection Aortic Dissection A progressive tear in the tissue lining the aorta, characterized by the passage of blood from the tunica intima into, and partially through, the tunica media. A progressive tear in the aorta characterized by a separation of the medial layer from the outer-most layer. C35117 Vascular Disorder C118464 Pediatric Adverse Events Terminology Aortic dissection Has Synonym LLT 10002895 MedDRA C117197 Apathy Apathy Emotional Indifference An emotional state of indifference characterized by a lack of interest or concern. An emotional state of indifference characterized by a lack of interest or concern. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Apathy Has Synonym LLT 10002942 MedDRA C121623 Aphagia Aphagia The inability or refusal to swallow. The inability or refusal to swallow. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Aphagia Has Synonym LLT 10049866 MedDRA C34393 Aphasia Aphasia Impairment of the expression or comprehension of verbal and written language. Impairment of the expression or comprehension of verbal and written language. C87124 Central Nervous System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Aphasia Has Synonym LLT 10002948 MedDRA C79539 Aphonia Aphonia A term referring to the inability to speak. It may result from injuries to the vocal cords or may be functional (psychogenic). The inability to produce speech sounds. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Aphonia Has Synonym LLT 10002953 MedDRA C2870 Aplastic Anemia Aplastic Anemia Anemia resulting from bone marrow failure (aplastic or hypoplastic bone marrow). The production of erythroblasts and red cells is markedly decreased, and it may be associated with decreased production of granulocytes (granulocytopenia) and platelets (thrombocytopenia) as well. Aplastic anemia may be idiopathic or secondary due to bone marrow damage by toxins, radiation, or immunologic factors. A syndrome of bone marrow failure characterized by peripheral pancytopenia and marrow hypoplasia. C2869 Anemia C118464 Pediatric Adverse Events Terminology Aplastic anemia Has Synonym LLT 10002969 MedDRA C26698 Apnea Apnea Transient cessation of respiration. Cessation of air flow. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Apnea Has Synonym LLT 10002972 MedDRA C118381 Apophysitis Apophysitis Inflammation of a bony outgrowth located near the attachment site for muscles. Inflammation of a bony outgrowth located near the attachment site for muscles. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Apophysitis Has Synonym LLT 10071511 MedDRA C116310 Apparent Life Threatening Event Apparent Life Threatening Event ALTE An episode during which the patient, usually a child less than one year, experiences a combination of apnea, color change, alteration in muscle tone, choking or gagging. This event can be frightening to the observer. An episode in an infant that is frightening to the observer, and that is characterized by some combination of apnea (central or occasionally obstructive), color change, marked change in muscle tone, choking or gagging. (NIH, 1987) C89328 Pediatric Disorder C118464 Pediatric Adverse Events Terminology Apparent life threatening event Has Synonym LLT 10065044 MedDRA C35145 Appendicitis Appendicitis Acute inflammation of the vermiform appendix. Inflammation of the vermiform appendix. C26726 Infectious Disorder C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Appendicitis Has Synonym LLT 10003011 MedDRA C37913 Arachnoiditis Arachnoiditis Inflammation of the arachnoid membrane and adjacent subarachnoid space. Inflammation of the arachnoid membrane and adjacent subarachnoid space. C27582 Central Nervous System Infectious Disease C118464 Pediatric Adverse Events Terminology Arachnoiditis Has Synonym LLT 10003074 MedDRA C2881 Arrhythmia Arrhythmia Cardiac Arrhythmia Any variation from the normal rate or rhythm (which may include the origin of the impulse and/or its subsequent propagation) in the heart. Any variation from the normal rate or rhythm (which may include the origin of the impulse and/or its subsequent propagation) in the heart. C78245 Cardiac Conduction Disorder C118464 Pediatric Adverse Events Terminology Arrhythmia Has Synonym LLT 10003119 MedDRA C111117 Arterial Embolus Arterial Embolism The passage of an embolus from its site of formation in the arterial system to another location within the circulatory system. The passage of an embolus from its site of formation in the arterial system to another location within in the circulatory system C26759 Embolism C118464 Pediatric Adverse Events Terminology Embolism arterial Has Synonym LLT 10014513 MedDRA C95802 Ischemic Cerebrovascular Accident Arterial Ischemic Stroke An acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of brain tissue. Acute onset of neurological deficits resulting from a loss of blood supply to brain tissue in an area of arterial distribution. C3390 Cerebrovascular Accident C118464 Pediatric Adverse Events Terminology Ischemic stroke Has Synonym LLT 10055221 MedDRA C34399 Arteritis Arteritis An inflammatory process affecting an artery. Inflammation of an artery. C35117 Vascular Disorder C118464 Pediatric Adverse Events Terminology Arteritis Has Synonym LLT 10003230 MedDRA C50464 Arthralgia Arthralgia Joint Pain Pain in a joint. Pain in a joint. C3303 Pain C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Arthralgia Has Synonym LLT 10003239 MedDRA C2883 Arthritis Arthritis An inflammatory process affecting a joint. Causes include infection, autoimmune processes, degenerative processes, and trauma. Signs and symptoms may include swelling around the affected joint and pain. Inflammation of the joint tissues of any etiology. Signs and symptoms may include pain, swelling, warmth, guarding, limited range of motion or overlying erythema. C107377 Musculoskeletal System Disorder C118464 Pediatric Adverse Events Terminology Arthritis Has Synonym LLT 10003246 MedDRA C35760 Arthropathy Arthropathy Any disorder of the joints. A disease or disorder that affects a joint. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Arthropathy Has Synonym LLT 10003285 MedDRA C2885 Ascites Ascites The accumulation of fluid in the peritoneal cavity, which may be serous, hemorrhagic, or the result of tumor metastasis to the peritoneum. The accumulation of fluid in the peritoneal cavity, which may be serous, hemorrhagic, or the result of tumor metastasis to the peritoneum. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Ascites Has Synonym LLT 10003445 MedDRA C118299 Aseptic Meningitis Aseptic Meningitis Inflammation of the membranes surrounding the brain and spinal cord without a bacterial pathogen. Inflammation of the membranes surrounding the brain and spinal cord without a bacterial pathogen. C26828 Meningitis C118464 Pediatric Adverse Events Terminology Aseptic meningitis Has Synonym LLT 10003458 MedDRA C50465 Asphyxia Asphyxia A state of general hypoxia and hypercapnea, resulting in acidosis, which affects all tissues in the body. A state of hypoxia and hypercapnea, resulting in acidosis, which affects all tissues in the body. C45233 Respiratory System Finding C118464 Pediatric Adverse Events Terminology Asphyxia Has Synonym LLT 10003497 MedDRA C83507 Respiratory Tract Aspiration Aspiration Respiratory Tract Aspiration Accidental inhalation of a foreign material into the lungs. The entry of foreign material past the larynx, and into the lower respiratory tract. C45233 Respiratory System Finding C118464 Pediatric Adverse Events Terminology Aspiration Has Synonym LLT 10003504 MedDRA C28397 Asthma Asthma A chronic respiratory disease manifested as difficulty breathing due to the narrowing of bronchial passageways. A chronic respiratory disease caused by obstruction of the bronchi and small airways, and characterized by wheezing and shortness of breath. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Asthma Has Synonym LLT 10003553 MedDRA C60781 Astrocytoma Astrocytoma A tumor of the brain or spinal cord showing astrocytic differentiation. It includes the following clinicopathological entities: pilocytic astrocytoma, diffuse astrocytoma, anaplastic astrocytoma, pleomorphic xanthoastrocytoma, and subependymal giant cell astrocytoma. A malignant neoplasm of the central nervous system that arises from astrocytes. C3268 Nervous System Neoplasm C118464 Pediatric Adverse Events Terminology Astrocytoma Has Synonym LLT 10003571 MedDRA C26702 Ataxia Ataxia Lack of coordination of muscle movements resulting in the impairment or inability to perform voluntary activities. Causes include peripheral nerve disorders, posterior column injuries, cerebral and cerebellar disorders, basal ganglia disorders, and thalamic disorders. A movement disorder characterized by a lack of coordination of muscle movements resulting in the impaired performance of voluntary activities. C116757 Movement Disorders C118464 Pediatric Adverse Events Terminology Ataxia Has Synonym LLT 10003591 MedDRA C2888 Atelectasis Atelectasis The collapse of part or the entire lung due to airway obstruction, infection, tumor, or general anesthesia. The collapse of alveoli and small airways. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Atelectasis Has Synonym LLT 10003598 MedDRA C116574 Athetosis Athetosis Slow, involuntary, and nonpurposeful writhing movements that usually affect the upper limbs. A movement disorder consisting of slow, involuntary, and nonpurposeful writhing movements that usually affect the upper limbs. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Athetosis Has Synonym LLT 10003620 MedDRA C50466 Atrial Fibrillation Atrial Fibrillation A disorder characterized by an electrocardiographic finding of a supraventricular arrhythmia characterized by the replacement of consistent P waves by rapid oscillations or fibrillatory waves that vary in size, shape and timing and are accompanied by an irregular ventricular response. (CDISC) An irregular heart rhythm, usually associated with a rapid rate, that is caused by abnormal electrical activity within the atria. C27158 Supraventricular Arrhythmia C118464 Pediatric Adverse Events Terminology Atrial fibrillation Has Synonym LLT 10003658 MedDRA C51224 Atrial Flutter Atrial Flutter A disorder characterized by an electrocardiographic finding of an organized, regular atrial rhythm with atrial rate of 240-340 beats per minute. Multiple P waves typically appear in the inferior leads in a saw tooth-like pattern between the QRS complexes. (CDISC) A rapid heart rate, associated with a regular rhythm, that is caused by abnormal electrical activity within the atria. C27158 Supraventricular Arrhythmia C118464 Pediatric Adverse Events Terminology Atrial flutter Has Synonym LLT 10003662 MedDRA C84473 Atrial Septal Defect Atrial Septal Defect The presence of a defect (opening) in the septum that separates the two atria of the heart. It can be congenital or acquired. C84482 Congenital Septal Defect C118464 Pediatric Adverse Events Terminology Atrial septal defect Has Synonym LLT 10003664 MedDRA C111118 Atrial Thrombus Atrial Thrombus Presence of a blood clot in the atria of the heart. Presence of a thrombus within a cardiac atrium. C27083 Thrombus C118464 Pediatric Adverse Events Terminology Atrial thrombosis Has Synonym LLT 10048632 MedDRA C62015 AV Block First Degree Atrioventricular Block, First Degree AV Block First Degree A disorder characterized by an electrocardiographic finding of prolonged PR interval for a specific population. For adults one common threshold is a PR interval greater than 0.20 seconds. Abnormally slow conduction of atrial electrical impulses to the ventricles. C2881 Arrhythmia C118464 Pediatric Adverse Events Terminology Atrioventricular block first degree Has Synonym LLT 10003674 MedDRA C111119 AV Block Second Degree Atrioventricular Block, Second Degree AV Block Second Degree Intermittent failure of atrial electrical impulse conduction to the ventricles. Intermittent failure of atrial electrical impulse conduction to the ventricles. C2881 Arrhythmia C118464 Pediatric Adverse Events Terminology Atrioventricular block second degree Has Synonym LLT 10003677 MedDRA C50501 Complete Atrioventricular Block Atrioventricular Block, Third Degree AV Block Third Degree|Complete Atrioventricular Block|Non-Congenital Complete Atrioventricular Block A disorder characterized by an electrocardiographic finding of complete failure of atrial electrical impulse conduction to the ventricles. This is manifested on the ECG by disassociation of atrial and ventricular rhythms. The atrial rate must be faster than the ventricular rate. (CDISC) Complete disassociation of the atrial electrical impulse conduction to the ventricles. C2881 Arrhythmia C118464 Pediatric Adverse Events Terminology Atrioventricular block third degree Has Synonym LLT 10065659 MedDRA C97160 Attention Deficit Hyperactivity Disorder Attention Deficit/Hyperactivity Disorder Attention Deficit Hyperactivity Disorder A disorder characterized by a marked pattern of inattention and/or hyperactivity-impulsivity that is inconsistent with developmental level and clearly interferes with functioning in at least two settings (e.g. at home and at school). At least some of the symptoms must be present before the age of 7 years. A neurodevelopmental disorder presenting in early childhood that is characterized by chronic and excessive inattention, overactivity, and/or impulsivity. C35470 Behavioral Disorder C118464 Pediatric Adverse Events Terminology Attention deficit/hyperactivity disorder Has Synonym LLT 10003736 MedDRA C98810 Ambiguous Genitalia Atypical Genitalia A rare congenital abnormality in which the infant's external genitalia do not have the typical appearance of a male's or female's genitalia. External genitalia that are neither typically male nor typically female in appearance. C103185 Congenital Reproductive System Abnormality C118464 Pediatric Adverse Events Terminology Ambiguous Genitalia Ambiguous external genitalia Has Synonym LLT 10001904 MedDRA C118174 Auditory Hallucination Auditory Hallucination Perception of sound in the absence of a corresponding stimulus. Perception of sound in the absence of a corresponding stimulus. C37961 Hallucination C118464 Pediatric Adverse Events Terminology Hallucination auditory Has Synonym LLT 10019064 MedDRA C116364 Auditory Neuropathy Spectrum Disorder Auditory Neuropathy Spectrum Disorder ANSD|Auditory Dys-synchrony|Auditory Neuropathy A hearing disorder characterized by impaired transmission of signals through the auditory nerve, resulting in mild to severe hearing loss and poor speech perception. A group of hearing disorders characterized by impaired transmission of signal through the auditory nerve with abnormal or absent auditory brainstem response with hearing loss and poor speech perception. C63711 Sensory Disorder C118464 Pediatric Adverse Events Terminology Auditory neuropathy spectrum disorder Has Synonym LLT 10072198 MedDRA C97161 Autism Autism Autistic Disorder A disorder characterized by marked impairments in social interaction and communication accompanied by a pattern of repetitive, stereotyped behaviors and activities. Developmental delays in social interaction and language surface prior to age 3 years. A neurodevelopmental disorder presenting in early childhood that is characterized by impaired communication, difficulty in social interactions, stereotypic behaviors, and a limited range of interests and activities. C88412 Autism Spectrum Disorder C118464 Pediatric Adverse Events Terminology Autism Has Synonym LLT 10003805 MedDRA C88412 Autism Spectrum Disorder Autism Spectrum Disorder Pervasive Developmental Disorders A spectrum of developmental disorders that includes autism, Asperger syndrome, and Rett syndrome. Signs and symptoms include poor communication skills, defective social interactions, and repetitive behaviors. Neurodevelopmental disorders presenting in childhood with classic symptoms of impairment in verbal and nonverbal communication, social interactions, and/or imaginative play. C97179 Pervasive Developmental Disorder C118464 Pediatric Adverse Events Terminology Autism spectrum disorder Has Synonym LLT 10063844 MedDRA C113814 Autoimmune Primary Adrenal Insufficiency Autoimmune Adrenalitis Diminished production of adrenocortical hormones due to autoimmune destruction of the adrenal glands. Addison disease due to autoimmune destruction of the adrenal glands. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Addison's disease Has Synonym LLT 10001130 MedDRA C122414 Autoimmune Encephalitis Autoimmune Encephalitis Inflammation of the brain secondary to an immune response triggered by the body itself. Inflammation of the brain secondary to an immune response triggered by the body itself. C2934 Central Nervous System Disorder C118464 Pediatric Adverse Events Terminology Encephalitis autoimmune Has Synonym LLT 10072378 MedDRA C119050 Autoinflammatory Syndrome Autoinflammatory Syndrome A group of disorders of the innate immune system characterized by attacks of seemingly unprovoked inflammation without significant levels of either autoantibodies or autoreactive T cells more characteristic of autoimmune disease. A group of disorders of the innate immune system characterized by attacks of seemingly unprovoked inflammation without significant levels of either autoantibodies or autoreactive T cells more characteristic of autoimmune disease. C2889 Autoimmune Disease C118464 Pediatric Adverse Events Terminology Autoinflammatory disease Has Synonym LLT 10072220 MedDRA C114753 AV Fistula Aneurysm AV Fistula Aneurysm Arteriovenous Fistula Aneurysm A bulge in a weakened vessel wall segment of an arteriovenous fistula. A bulge in a weakened vessel wall segment of a therapeutic arteriovenous fistula. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Arteriovenous fistula aneurysm Has Synonym LLT 10066916 MedDRA C114780 AV Fistula Maturation Failure AV Fistula Maturation Failure Arteriovenous Fistula Maturation Failure Inadequate development of an arteriovenous fistula within three months of creation. Inadequate development of an therapeutic arteriovenous fistula within three months of creation. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology AV fistula maturation failure Has Synonym LLT 10076699 MedDRA C114754 AV Fistula Stenosis AV Fistula Stenosis Arteriovenous Fistula Stenosis Narrowing of the lumen of an arteriovenous fistula. Narrowing of the lumen of an therapeutic arteriovenous fistula. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Arteriovenous fistula site stenosis Has Synonym LLT 10055136 MedDRA C114756 AV Fistula Thrombosis AV Fistula Thrombosis Arteriovenous Fistula Thrombosis Partial or complete occlusion of the lumen within an arteriovenous fistula by a thrombus. Partial or complete occlusion of the lumen within an therapeutic arteriovenous fistula by a thrombus. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Arteriovenous fistula thrombosis Has Synonym LLT 10003192 MedDRA C114758 AV Graft Aneurysm AV Graft Aneurysm Arteriovenous Graft Aneurysm A bulge in a weakened wall segment of an arteriovenous graft. A bulge in a weakened wall segment of an arteriovenous graft. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Arteriovenous graft aneurysm Has Synonym LLT 10064775 MedDRA C114762 AV Graft Stenosis AV Graft Stenosis Arteriovenous Graft Stenosis Narrowing of the lumen of an arteriovenous graft. Narrowing of the lumen of an arteriovenous graft. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Arteriovenous graft site stenosis Has Synonym LLT 10055147 MedDRA C114763 AV Graft Thrombosis AV Graft Thrombosis Arteriovenous Graft Thrombosis Partial or complete occlusion of the lumen of an arteriovenous graft by a thrombus. Partial or complete occlusion of the lumen of an arteriovenous graft by a thrombus. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Arteriovenous graft thrombosis Has Synonym LLT 10053182 MedDRA C118385 Avascular Necrosis Avascular Necrosis Tissue death resulting from an interruption to the blood supply. Tissue death resulting from an interruption to the blood supply. C35552 Cardiovascular System Finding C118464 Pediatric Adverse Events Terminology Avascular necrosis Has Synonym LLT 10066480 MedDRA C121556 Back Arching Back Arching A convex curvature of the spine that occurs when an individual thrusts forward the shoulders and pulls back the abdomen. A convex curvature of the spine that occurs when an individual thrusts forward the shoulders and pulls back the abdomen. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Infantile back arching Broader Than LLT 10077276 MedDRA C41830 Back Pain Back Pain Painful sensation in the back region. Pain localized to the back. C3303 Pain C118464 Pediatric Adverse Events Terminology Back pain Has Synonym LLT 10003988 MedDRA C102993 Bacteremia Bacteremia A laboratory test result that indicates the presence of bacteria in the blood. The presence of bacteria in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Bacteremia Has Synonym LLT 10003999 MedDRA C118297 Bacterial Meningitis Bacterial Meningitis Inflammation of the membranes surrounding the brain and spinal cord due to a bacterial infection. Inflammation of the membranes surrounding the brain and spinal cord due to a bacterial infection. C26828 Meningitis C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Bacterial meningitis Has Synonym LLT 10004049 MedDRA C118765 Band Keratopathy Band Keratopathy The deposition of calcium on the cornea, resulting in pain and decreased visual acuity. Calcific degeneration of the superficial cornea. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Band keratopathy Has Synonym LLT 10004086 MedDRA C117013 Basilar-Type Migraine Basilar-type Migraine A migraine disorder characterized by episodes that are preceded by focal neurological symptoms originating in the brainstem. A migraine disorder characterized by episodes that are preceded by focal neurological symptoms originating in the brainstem. C89715 Migraine C118464 Pediatric Adverse Events Terminology Basilar migraine Has Synonym LLT 10050258 MedDRA C34414 Basophilia Basophilia Abnormally high level of basophils in the blood. Abnormally high level of basophils in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Basophilia Has Synonym LLT 10004173 MedDRA C113713 Basophilopenia Basophilopenia Abnormally low level of basophils in the blood. Abnormally low level of basophils in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Basophilopenia Has Synonym LLT 10075813 MedDRA C112814 Horizontal Nail Ridging Beau's Lines Horizontal Nail Ridging Linear transverse/horizontal groove of one or more nail plates that migrate distally from the proximal nail fold with nail growth, usually secondary to illness, trauma or malnutrition. Linear transverse/horizontal groove of one or more nail plates that migrate distally from the proximal nail fold with nail growth, usually secondary to illness, trauma or malnutrition. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Beau's lines Has Synonym LLT 10074981 MedDRA C118172 Nocturnal Enuresis Bedwetting Nocturnal Enuresis|Sleep Enuresis Urination during sleep. Urination during sleep. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Bed wetting Has Synonym LLT 10004197 MedDRA C116361 Behavioral Insomnia of Childhood Behavioral Insomnia of Childhood A childhood disorder characterized by difficulty initiating and maintaining sleep due to negative sleep associations, refusal to go to bed, and/or repeated attempts to delay bedtime. A childhood disorder characterized by difficulty initiating and maintaining sleep due to negative sleep associations, refusal to go to bed, and/or repeated attempts to delay bedtime. C28286 Insomnia C118464 Pediatric Adverse Events Terminology Behavioral insomnia of childhood Has Synonym LLT 10072101 MedDRA C4781 Benign Brain Neoplasm Benign Brain Tumor A primary, slow growing, noninvasive neoplasm of the brain. In children, astrocytomas of the cerebellum represent relatively common benign brain neoplasms. In adults meningiomas, neurilemomas and pituitary tumors comprise the majority of benign tumors. An abnormal intracranial solid mass or growth arising within the brain without histologic features suggesting the potential to metastasize. C2907 Brain Tumor C118464 Pediatric Adverse Events Terminology Benign neoplasm of brain Has Synonym LLT 10004306 MedDRA C116538 Benign Rolandic Epilepsy Benign Rolandic Epilepsy Benign Childhood Epilepsy With Centrotemporal Spikes A neurological disorder of childhood characterized by partial seizures consisting of twitching, numbness, or tingling of the face or tongue that often progress to secondary generalized seizures. A neurological disorder of childhood characterized by partial seizures consisting of twitching, numbness, or tingling of the face or tongue that often progress to secondary generalized seizures. C3020 Epilepsy C118464 Pediatric Adverse Events Terminology Benign rolandic epilepsy Has Synonym LLT 10070530 MedDRA C97162 Binge Eating Binge Eating Recurrent episodes of over-eating. Binge eating with or without purging. C89332 Eating Disorder C118464 Pediatric Adverse Events Terminology Binge eating Has Synonym LLT 10004716 MedDRA C118718 Binocular Diplopia Binocular Diplopia Perception of two images secondary to misalignment of the eyes. Perception of two images secondary to misalignment of the eyes. C37941 Diplopia C118464 Pediatric Adverse Events Terminology Binocular diplopia Has Synonym LLT 10076680 MedDRA C79541 Bladder Obstruction Bladder Outlet Obstruction Blockage of the opening between the bladder and the urethra resulting in the reduction or prevention of the urine flow from the bladder into the urethra. An impediment of urine flow at the outlet of the bladder. C2900 Bladder Disorder C118464 Pediatric Adverse Events Terminology Bladder outlet obstruction Has Synonym LLT 10071445 MedDRA C78208 Bladder Perforation Bladder Perforation A rupture in the bladder wall due to traumatic or pathologic processes. A rupture in the bladder wall. C2900 Bladder Disorder C118464 Pediatric Adverse Events Terminology Bladder perforation Has Synonym LLT 10063575 MedDRA C112176 Blanching Blanching Transient pallor of the skin caused by reduced blood flow to the affected region. Transient pallor of the skin caused by reduced blood flow to the affected region. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Blanching Has Synonym LLT 10052142 MedDRA C112183 Blepharitis Blepharitis Inflammation of the eyelids near the eyelashes. Inflammation of the eyelids near the eyelashes. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Blepharitis Has Synonym LLT 10005148 MedDRA C118723 Blepharospasm Blepharospasm Involuntary twitching of the eyelid. Involuntary twitching of the eyelid and/or eyebrow. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Blepharospasm Has Synonym LLT 10005159 MedDRA C97109 Blindness Blindness The lack of vision. It is caused by neurological or physiological factors. Profound visual impairment despite optimal refractive correction. C35126 Vision Disorder C118464 Pediatric Adverse Events Terminology Blindness Has Synonym LLT 10005169 MedDRA C75564 Blister Blister An intraepidermal/subepidermal cavity filled with clear, serosanguineous or cloudy fluid. An intraepidermal/subepidermal cavity filled with clear, serosanguineous or turbid fluid. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Blister Has Synonym LLT 10005191 MedDRA C113391 Blood in Stool Blood in Stool A finding indicating the presence of blood in stool. It is the result of gastrointestinal hemorrhage and it may be easily seen in stool or may be identified microscopically. The presence of blood in fecal matter; usually as a result of gastrointestinal tract hemorrhage. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Blood in stool Has Synonym LLT 10005603 MedDRA C122438 Blood Urea Nitrogen Increased Blood Urea Nitrogen Increased Elevated Blood Urea Nitrogen Laboratory results demonstrating an increase in the concentration of urea nitrogen in a blood sample. Laboratory results demonstrating an increase in the concentration of urea nitrogen in a blood sample. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Blood urea nitrogen increased Has Synonym LLT 10005855 MedDRA C121557 Bloody Discharge Bloody Discharge Bloody Drainage The leaking of serosanguinous fluids from an orifice or wound. The leaking of serosanguinous fluids from an orifice or wound. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Bloody discharge Has Synonym LLT 10057687 MedDRA C118460 Blount's Disease Blount's Disease A growth disorder of the tibia in children and adolescents that presents as progressive bowing of one or both legs. A growth disorder of the tibia in children and adolescents that presents as progressive bowing of one or both legs. C89330 Developmental Disorder C118464 Pediatric Adverse Events Terminology Blount's disease Has Synonym LLT 10072255 MedDRA C117195 Blunted Affect Blunted Affect Restricted Range of Emotion Restricted range of emotional expressiveness. Restricted range of emotional expressiveness. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Blunted affect Has Synonym LLT 10005885 MedDRA C27123 Blurred Vision Blurred Vision Blurred vision is the loss of visual acuity (sharpness of vision) resulting in a loss of ability to see small details. (from MedlinePlus Medical Encyclopedia) Unclear or indistinct sight. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Blurred vision Has Synonym LLT 10005886 MedDRA C50437 Body Substance Discharge Body Substance Discharge The leakage of a substance from an orifice or wound. The leakage of a substance from an orifice or wound. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Secretion discharge Has Synonym LLT 10053459 MedDRA C4016 Malignant Bone Neoplasm Bone Cancer A primary or metastatic malignant neoplasm affecting the bone or articular cartilage. A solid malignant neoplasm that develops or arises in the bone. C9305 Cancer C118464 Pediatric Adverse Events Terminology Bone cancer Has Synonym LLT 10005949 MedDRA C9175 Bowel Obstruction Bowel Obstruction Intestinal Obstruction Blockage of the normal flow of the intestinal contents within the bowel. A blockage of the passage of the intestinal contents. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Bowel obstruction Has Synonym LLT 10006055 MedDRA C27194 Brachial Plexopathy Brachial Plexopathy A brachial plexus disorder characterized by regional paresthesia, pain and muscle weakness, and limited movement in the arm or hand. A brachial plexus disorder characterized by regional paresthesia, pain and muscle weakness, and limited movement in the arm or hand. C103231 Brachial Plexus Injury C118464 Pediatric Adverse Events Terminology Brachial plexopathy Has Synonym LLT 10065417 MedDRA C37920 Bradycardia Bradycardia An abnormally slow heart rate. Thresholds for different age, gender, and patient populations exist. An abnormally low heart rate for age. C2881 Arrhythmia C118464 Pediatric Adverse Events Terminology Bradycardia Has Synonym LLT 10006093 MedDRA C116707 Bradykinesia Bradykinesia Slow movement. Slow movement. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Bradykinesia Has Synonym LLT 10006100 MedDRA C118187 Bradyphagia Bradyphagia Abnormally slow eating. Abnormally slow eating. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Bradyphagia Has Synonym LLT 10076659 MedDRA C116340 Brain Death Brain Death Irreversible absence of cortical and brain stem functioning. Irreversible absence of cortical and brain stem functioning. C28554 Death C118464 Pediatric Adverse Events Terminology Brain death Has Synonym PT 10049054 MedDRA C2907 Brain Neoplasm Brain Tumor A benign or malignant neoplasm that arises from or metastasizes to the brain. An abnormal intracranial solid mass or growth. C3268 Nervous System Neoplasm C118464 Pediatric Adverse Events Terminology Brain tumor Has Synonym LLT 10006153 MedDRA C4872 Breast Carcinoma Breast Cancer A carcinoma arising from the breast, most commonly the terminal ductal-lobular unit. It is the most common malignant tumor in females. Risk factors include country of birth, family history, menstrual and reproductive history, fibrocystic disease and epithelial hyperplasia, exogenous estrogens, contraceptive agents, and ionizing radiation. The vast majority of breast carcinomas are adenocarcinomas (ductal or lobular). Breast carcinoma spreads by direct invasion, by the lymphatic route, and by the blood vessel route. The most common site of lymph node involvement is the axilla. A malignant neoplasm that develops or arises in breast tissue. C9305 Cancer C118464 Pediatric Adverse Events Terminology Breast cancer Has Synonym LLT 10006187 MedDRA C78223 Breast Pain Breast Pain Painful sensation in the breast region. Pain localized to the breast. C3303 Pain C118464 Pediatric Adverse Events Terminology Breast pain Has Synonym LLT 10006298 MedDRA C121558 Breath Holding Breath Holding Episodic apnea, which is more common in young children and usually resolves by age six. Episodic apnea, which is more common in young children and usually resolves by age six. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Breath holding Has Synonym LLT 10006322 MedDRA C39658 Bronchiolitis Bronchiolitis Wheezy Bronchitis Inflammation of the bronchioles characterized by swelling of the bronchioles and mucus accumulation. It is usually caused by the respiratory syncytial virus and affects children. Signs and symptoms include coughing, wheezing, and shortness of breath. Inflammation of the bronchioles. C3198 Lung Disorder C118464 Pediatric Adverse Events Terminology Bronchiolitis Has Synonym LLT 10006448 MedDRA C2911 Bronchitis Bronchitis An acute or chronic inflammatory process affecting the bronchi. Inflammation of the bronchi. C3198 Lung Disorder C118464 Pediatric Adverse Events Terminology Bronchitis Has Synonym LLT 10006451 MedDRA C98847 Bronchomalacia Bronchomalacia A congenital or acquired abnormality of the wall of the bronchi. In congenital cases, there is lack of rigidity in the cartilage of the bronchial wall. In acquired cases, the cartilage of the bronchial wall is degenerated, secondary to tracheostomy or presence of a breathing tube. Symptoms include noisy breathing and wheezing. Increased bronchial collapsibility. C98541 Chronic Lung Disease C118464 Pediatric Adverse Events Terminology Bronchomalacia Has Synonym LLT 10053421 MedDRA C90599 Bronchopulmonary Dysplasia Bronchopulmonary Dysplasia BPD Chronic lung disease requiring treatment with oxygen for at least 28 days and with a spectrum of severity from mild to severe, that predominantly affects premature infants. While the radiologic pattern is typical in the closer to term patient, the pattern in the small preterm infant is very non-discrete and variable. A chronic lung disorder associated with pulmonary maldevelopment, scarring, and/or inflammation that develops in preterm neonates. The condition is defined based on treatment with supplemental oxygen for at least 28 days adjusted for the degree of prematurity. C97173 Congenital Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Bronchopulmonary dysplasia Has Synonym LLT 10006475 MedDRA C34439 Bronchospasm Bronchospasm Sudden contraction of the smooth muscles of the bronchial wall. A pathologic contraction of the smooth muscle of the bronchial wall. C45233 Respiratory System Finding C118464 Pediatric Adverse Events Terminology Bronchospasm Has Synonym LLT 10006482 MedDRA C37921 Bruise Bruise Injury of the soft tissues or bone without breaking the skin that is characterized by blood leakage into the surrounding area. Extravasation of blood into the surrounding tissues. C3671 Injury C118464 Pediatric Adverse Events Terminology Bruise Has Synonym LLT 10006502 MedDRA C73511 Bruxism Bruxism Teeth Grinding Excessive clenching of the jaw and grinding of the teeth. Excessive clenching of the jaw and grinding of the teeth. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Bruxism Has Synonym LLT 10006514 MedDRA C34440 Bulimia Nervosa Bulimia Nervosa Bulimia A disorder characterized by recurrent episodes of binge-eating over which the individual feels a lack of control; these episodes of binge-eating are followed by recurrent compensatory behavior to prevent weight gain, usually self-induced vomiting. In addition, self-evaluation is unduly influenced by body image. Recurrent episodes of over-eating. C89332 Eating Disorder C118464 Pediatric Adverse Events Terminology Bulimia Narrower Than LLT 10006549 MedDRA C111970 Bulla Bulla A large (greater than 5-10 mm) intraepidermal/subepidermal cavity filled with clear, serosanguineous or cloudy fluid. A large (greater than 5 - 10 mm) intraepidermal/subepidermal cavity filled with clear, serosanguineous or turbid fluid. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Bullae Has Synonym LLT 10006554 MedDRA C34441 Burn Burn A traumatic injury involving interruption of tissue cohesiveness that results from exposure to caustic chemicals, extreme heat, extreme cold or excessive radiation. A traumatic injury involving interruption of tissue cohesiveness that results from exposure to caustic chemicals, extreme heat, extreme cold or excessive radiation. C3671 Injury C118464 Pediatric Adverse Events Terminology Burn Has Synonym LLT 10006634 MedDRA C62545 Burning Mouth Syndrome Burning Mouth Syndrome A condition characterized by a burning or tingling sensation on the lips, tongue, or entire mouth. Pain in the mouth, not attributed to another disorder, that presents daily and persists for most of the day. C63711 Sensory Disorder C118464 Pediatric Adverse Events Terminology Burning mouth syndrome Has Synonym LLT 10068065 MedDRA C116371 Cacosmia Cacosmia A hallucination of an unpleasant odor. A hallucination of an unpleasant odor. C28246 Dysesthesia C118464 Pediatric Adverse Events Terminology Cacosmia Has Synonym LLT 10049878 MedDRA C114585 Calcineurin Nephrotoxicity Calcineurin Nephrotoxicity Calcineurin Inhibitor Nephrotoxicity Kidney injury caused by calcineurin inhibitor immunosuppressive therapy which may lead to diminished kidney function. Kidney injury caused by calcineurin inhibitor immunosuppressive therapy which may lead to diminished kidney function. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Nephrotoxicity Narrower Than LLT 10067571 MedDRA C84607 Calciphylaxis Calciphylaxis A rare syndrome characterized by vascular calcification and skin necrosis. It seen in patients with end stage renal disease. A syndrome of vascular calcification and thrombosis with cutaneous necrosis that is usually associated with severe chronic kidney disease. C27120 Electrolyte Disorder C118464 Pediatric Adverse Events Terminology Calciphylaxis Has Synonym LLT 10051714 MedDRA C9305 Malignant Neoplasm Cancer Malignancy|Malignant Growth|Malignant Neoplasm|Malignant Neoplastic Disease A tumor composed of atypical neoplastic, often pleomorphic cells that invade other tissues. Malignant neoplasms often metastasize to distant anatomic sites and may recur after excision. The most common malignant neoplasms are carcinomas (adenocarcinomas or squamous cell carcinomas), Hodgkin and non-Hodgkin lymphomas, leukemias, melanomas, and sarcomas. Uncontrolled growth of abnormal cells with potential for metastatic spread. C3262 Neoplasm C118464 Pediatric Adverse Events Terminology Cancer Has Synonym LLT 10007050 MedDRA C111887 Candida Diaper Dermatitis Candida Diaper Dermatitis Candida Diaper Rash|Candida Nappy Rash An inflammatory skin condition in the diaper area superimposed with Candida infection, characterized by a bright red rash with a sharply demarcated edge and satellite lesions. Skin folds are often involved. An inflammatory skin condition in the diaper area superimposed with Candida infection, characterized by a bright red rash with a sharply demarcated edge and satellite lesions. Skin folds are often involved. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Candida diaper rash Has Synonym LLT 10007132 MedDRA C50479 Cardiac Arrest Cardiac Arrest The sudden cessation of cardiac activity in an individual who becomes unresponsive, without normal breathing and no signs of circulation. Cardiac arrest may be reversed by CPR, and/or defibrillation, cardioversion or cardiac pacing. Cessation of cardiac function. C50483 Cardiopulmonary Arrest C118464 Pediatric Adverse Events Terminology Cardiac arrest Has Synonym LLT 10007515 MedDRA C73502 Cardiac Perforation Cardiac Perforation The presence of an acquired hole in the heart. Cardiac perforation may or may not be symptomatic and may or may not be self sealing. (ACC) The presence of an acquired hole in the heart. C3079 Heart Disorder C118464 Pediatric Adverse Events Terminology Cardiac perforation Has Synonym LLT 10058039 MedDRA C50481 Cardiac Tamponade Cardiac Tamponade Pericardial Tamponade Acute compression of the heart caused by increased intrapericardial pressure due to the collection of blood or fluid in the pericardium from rupture of the heart, penetrating trauma, or progressive effusion. Acute compression of the heart caused by increased intrapericardial pressure due to the collection of blood or fluid in the pericardium. C101327 Pericardial Anomaly C118464 Pediatric Adverse Events Terminology Cardiac tamponade Has Synonym LLT 10007610 MedDRA C34830 Cardiomyopathy Cardiomyopathy A disease of the heart muscle or myocardium proper. Cardiomyopathies may be classified as either primary or secondary, on the basis of etiology, or on the pathophysiology of the lesion: hypertrophic, dilated, or restrictive. A disease of the heart muscle. C3079 Heart Disorder C101216 Myopathy C118464 Pediatric Adverse Events Terminology Cardiomyopathy Has Synonym LLT 10007636 MedDRA C50483 Cardiopulmonary Arrest Cardiopulmonary Arrest Cessation of breathing and/or cardiac function. Cessation of breathing and/or cardiac function. C3079 Heart Disorder C118464 Pediatric Adverse Events Terminology Cardiopulmonary arrest Has Synonym LLT 10007644 MedDRA C27894 Carotenosis Cutis Carotenoderma Orange or yellow discoloration of the skin caused by excessive deposits of carotene. Orange or yellow discoloration of the skin caused by excessive deposits of carotene. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Carotenoderma Has Synonym LLT 10070630 MedDRA C121560 Cat Bite Cat Bite A wound received from the teeth of a cat. A wound received from the teeth of a cat. C3671 Injury C118464 Pediatric Adverse Events Terminology Cat bite Has Synonym LLT 10007723 MedDRA C26713 Cataract Cataract Partial or complete opacity of the crystalline lens of one or both eyes that decreases visual acuity and eventually results in blindness. Some cataracts appear in infancy or in childhood, but most develop in older individuals. (Sternberg Diagnostic Surgical Pathology, 3rd ed.) Opacity of the crystalline lens. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Cataract Has Synonym LLT 10007739 MedDRA C121604 Catheter-Related Inflammation Catheter-Related Inflammation Inflammation associated with the use of a catheter. Inflammation associated with the use of a catheter. C78254 Device Complication C118464 Pediatric Adverse Events Terminology Catheter related complication Narrower Than LLT 10052253 MedDRA C26715 Cellulitis Cellulitis Inflammation of the dermis and subcutaneous tissues caused by a bacterial infection. Symptoms include erythema, edema, and pain to the affected area. An infection of the skin and subcutaneous tissues with induration and erythema. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Cellulitis Has Synonym LLT 10007882 MedDRA C62602 Secondary Adrenal Insufficiency Central Adrenal Insufficiency Central Hypoadrenalism A hormonal disorder that occurs when lack of corticotropin-releasing hormone (CRH) secretion from the hypothalamus or adrenocorticotropic hormone (ACTH) secretion from the pituitary is responsible for hypofunction of the adrenal cortex. Diminished production of adrenocortical hormones due to a condition originating in the hypothalamus and/or pituitary gland. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Secondary adrenal insufficiency Has Synonym LLT 10052382 MedDRA C116335 Central Apnea Central Apnea Cessation of air flow due to abnormal central nervous system control. Cessation of air flow due to abnormal central nervous system control. C26698 Apnea C118464 Pediatric Adverse Events Terminology Central sleep apnea syndrome Has Synonym LLT 10055576 MedDRA C84933 Neurogenic Diabetes Insipidus Central Diabetes Insipidus ADH Deficiency|AVP deficiency|Antidiuretic Hormone Deficiency|Arginine Vasopressin Deficiency|Neurogenic Diabetes Insipidus|Vasopressin Deficiency Diabetes insipidus caused by decreased secretion of antidiuretic hormone from the pituitary gland. Diabetes insipidus caused by a decrease in the secretion of antidiuretic hormone (vasopressin) from the posterior pituitary gland; causes include autoimmune and/or inflammatory conditions, congenital anomalies of the central nervous system and pituitary gland, mutation(s) of the AVP gene, irradiation to the region, neoplasia, surgery, and trauma. C43263 Diabetes Insipidus C118464 Pediatric Adverse Events Terminology Central diabetes insipidus Has Synonym LLT 10068587 MedDRA C34662 Central Hearing Loss Central Hearing Loss Hearing loss resulting from disorders of the central nervous system auditory pathways. Hearing loss resulting from disorders of the central nervous system auditory pathways. C35731 Hearing Loss C118464 Pediatric Adverse Events Terminology Central hearing loss Has Synonym LLT 10007933 MedDRA C113146 Central Hyperthyroidism Central Hyperthyroidism Overproduction of thyroid hormones due to a disorder originating within the hypothalamic-pituitary axis. Hyperthyroidism due to a condition originating within the hypothalamic-pituitary axis. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Secondary hyperthyroidism Has Synonym LLT 10053260 MedDRA C113144 Central Hypothyroidism Central Hypothyroidism Hypothalamic-Pituitary Hypothyroidism|TSH Deficiency|Thyroid Stimulating Hormone Deficiency|Thyrotropin Deficiency Abnormally low levels of thyroid hormones due to a disorder originating within the hypothalamic-pituitary axis. Subnormal concentrations of thyroid hormone(s) caused by hypothalamic-pituitary dysfunction. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Secondary Hypothyroidism Hypothyroidism Narrower Than LLT 10021114 MedDRA C121589 Central Line Complication Central Line Complication A problem with a central venous access catheter or site of insertion. A problem with a central venous access catheter or site of insertion. C78254 Device Complication C118464 Pediatric Adverse Events Terminology Central line complication Has Synonym LLT 10059063 MedDRA C121607 Central Line Infection Central Line Infection An infectious process related to a central venous catheter. An infectious process related to a central venous catheter. C26726 Infectious Disorder C118464 Pediatric Adverse Events Terminology Central line infection Has Synonym LLT 10054192 MedDRA C34456 Central Retinal Artery Occlusion Central Retinal Artery Occlusion Blockage of the central retinal artery. Occlusion of central retinal artery. C26875 Retinal Disorder C118464 Pediatric Adverse Events Terminology Central retinal artery occlusion Has Synonym LLT 10007971 MedDRA C118859 Central Retinal Vein Occlusion Central Retinal Venous Occlusion Blockage of the central retinal vein. Occlusion of central retinal vein. C26875 Retinal Disorder C118464 Pediatric Adverse Events Terminology Central retinal vein occlusion Has Synonym LLT 10007972 MedDRA C116046 Central Sleep Apnea Central Sleep Apnea The periodic cessation of breathing while asleep that occurs secondary to the decreased responsiveness of the respiratory center of the brain to carbon dioxide, resulting in alternating cycles of apnea and hyperpnea. Cessation of air flow during sleep due to abnormal central nervous system control. C26884 Sleep Apnea C118464 Pediatric Adverse Events Terminology Central sleep apnoea syndrome Has Synonym LLT 10007975 MedDRA C118728 Central Visual Field Defect Central Visual Field Defect Reduced or abnormal sight in the central visual field. Reduced or abnormal sight in the central visual field. C118727 Visual Field Defect C118464 Pediatric Adverse Events Terminology Vision central defective Has Synonym LLT 10047514 MedDRA C116379 Cerebellar Mutism Cerebellar Mutism A syndrome, usually presenting after midline posterior fossa tumor resection, which is characterized by abnormalities of speech, behavioral or affective disturbances, and diffuse cerebellar dysfunction. A syndrome, usually presenting after midline posterior fossa tumor resection, which is characterized by abnormalities of speech, behavioral or affective disturbances, and diffuse cerebellar dysfunction. C2934 Central Nervous System Disorder C118464 Pediatric Adverse Events Terminology Cerebellar mutism Has Synonym LLT 10070563 MedDRA C4909 Cerebral Edema Cerebral Edema Swelling due to an excessive accumulation of fluid in the brain. Excessive accumulation of fluid in the intracellular and/or extracellular spaces of the brain. C3002 Edema C118464 Pediatric Adverse Events Terminology Cerebral edema Has Synonym LLT 10008107 MedDRA C50485 Cerebral Hemorrhage Cerebral Hemorrhage Intracerebral Hemorrhage Bleeding within the cerebrum. Bleeding within the brain tissue. C3390 Cerebrovascular Accident C26791 Hemorrhage C118464 Pediatric Adverse Events Terminology Cerebral hemorrhage Has Synonym LLT 10008114 MedDRA C34460 Cerebral Palsy Cerebral Palsy A group of disorders affecting the development of movement and posture, often accompanied by disturbances of sensation, perception, cognition, and behavior. It results from damage to the fetal or infant brain. A non-progressive, neurological syndrome presenting in infancy or early childhood that is caused by brain injury or malformation and is characterized by permanent impairment of muscle coordination and various movement disorders. C26835 Nervous System Disorder C89328 Pediatric Disorder C118464 Pediatric Adverse Events Terminology Cerebral palsy Has Synonym LLT 10008129 MedDRA C118710 Cerebral Visual Impairment Cerebral Visual Impairment Central Visual Impairment Visual impairment due to central nervous system dysfunction. Visual impairment due to central nervous system dysfunction. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Visual pathway disorder Related To LLT 10061411 MedDRA C50487 Cerebrospinal Fluid Leakage Cerebrospinal Fluid Leakage The loss of cerebrospinal fluid into the surrounding tissues. The loss of cerebrospinal fluid into the surrounding tissues. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Cerebrospinal fluid leakage Has Synonym LLT 10008164 MedDRA C3390 Cerebrovascular Accident Cerebrovascular Accident Cerebral Infarction|Stroke A sudden loss of neurological function secondary to hemorrhage or ischemia in the brain parenchyma due to a vascular event. Brain tissue necrosis due to a disturbance in the blood flow or hemorrhage. C50438 Intracranial Hemorrhage C118464 Pediatric Adverse Events Terminology Cerebrovascular accident Has Synonym LLT 10008190 MedDRA C26716 Cervicitis Cervicitis An acute or chronic inflammatory process that affects the cervix. Causes include sexually transmitted diseases and bacterial infections. Clinical manifestations include abnormal vaginal bleeding and vaginal discharge. Inflammation of the uterine cervix. C27020 Female Reproductive System Disorder C118464 Pediatric Adverse Events Terminology Cervicitis Has Synonym LLT 10008323 MedDRA C26717 Chalazion Chalazion An eyelid cyst caused by the blockage of a meibomian gland. An eyelid cyst caused by the blockage of a meibomian gland. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Chalazion Has Synonym LLT 10008388 MedDRA C79545 Cheilitis Cheilitis An inflammatory process affecting the lip. Inflammation of the lips characterized by redness, fissures or crusts. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Cheilitis Has Synonym LLT 10008417 MedDRA C118458 Cheiromegaly Cheiromegaly Chiromegaly Abnormal enlargement of one or both hands, along with hyperhydrosis. Abnormal enlargement of one or both hands. C89330 Developmental Disorder C118464 Pediatric Adverse Events Terminology Cheiromegaly Has Synonym LLT 10067705 MedDRA C118709 Chemical Burn of Eye Chemical Burn of Eye Injury to the eye secondary to a chemical substance. Injury to the eye secondary to a chemical substance. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Chemical burns of eye Has Synonym LLT 10008422 MedDRA C114752 Chemical Peritonitis Chemical Peritonitis A non-infectious inflammation of the peritoneum. A non-infectious inflammation of the peritoneum. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Chemical peritonitis Has Synonym LLT 10070419 MedDRA C38665 Chest Pain Chest Pain Pain in the chest. Pain in the chest, not otherwise specified. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Chest pain Has Synonym LLT 10008479 MedDRA C97164 Childhood Disintegrative Disorder Childhood Disintegrative Disorder A pediatric disorder characterized by normal development for at least the first two years of life followed by a severe regression in language, social interaction, bowel or bladder control, and/or motor skills. The affected individual may also exhibit repetitive and stereotyped patterns of behavior similar to autism. A neurodevelopmental disorder that presents between the ages of two and ten, and is characterized by severe regression of communication, social interactions, bowel or bladder control, and/or motor skills that has previously developed normally. C97179 Pervasive Developmental Disorder C92190 Pediatric Psychiatric Disorder C118464 Pediatric Adverse Events Terminology Childhood disintegrative disorder Has Synonym LLT 10008522 MedDRA C118233 Childhood Linear IgA Disease Childhood Linear IgA Disease Chronic Bullous Disease of Childhood A blistering disorder characterized by linear deposition of IgA at the dermoepidermal junction. A blistering disorder characterized by linear deposition of IgA at the dermoepidermal junction. C2889 Autoimmune Disease C118464 Pediatric Adverse Events Terminology Linear IgA bullous disease of childhood Has Synonym LLT 10024514 MedDRA C35143 Chills Chills Shivering or moderate tremors of the body often accompanied by a cold sensation. Shivering or moderate tremors of the body, this is often accompanied by a cold sensation. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Chills Has Synonym LLT 10008531 MedDRA C50494 Choking Choking Interference with respiration by compression or obstruction of the larynx or trachea. Interference with respiration by compression or obstruction of the larynx or trachea. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Choking Has Synonym LLT 10008589 MedDRA C122822 Cholelithiasis Cholelithiasis Gallstones The presence of calculi in the gallbladder. The presence of calculi in the gallbladder. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Cholelithiasis Has Synonym LLT 10008629 MedDRA C83006 Cholestasis Cholestasis Impairment of the bile flow caused by obstruction within the liver, or outside the liver in the bile duct system. Diminished or obstructed bile flow. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Cholestasis Has Synonym LLT 10008635 MedDRA C84633 Chorea Chorea A neurological condition affecting the involuntary movements. It is characterized by brief, non-repetitive irregular muscle contractions. It is seen in patients with Huntington's disease. A movement disorder affecting the limbs, trunk, and facial muscles that is characterized by involuntary, unpredictable jerking movements. C116757 Movement Disorders C118464 Pediatric Adverse Events Terminology Chorea Has Synonym LLT 10008748 MedDRA C116730 Choreoathetosis Choreoathetosis Abnormal movement characterized by involuntary jerking and writhing affecting the limbs, trunk, and facial muscles. A movement disorder affecting the limbs, trunk, and facial muscles that is characterized by involuntary jerking and writhing. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Choreoathetosis Has Synonym LLT 10008754 MedDRA C26720 Chorioamnionitis Chorioamnionitis A morphologic finding indicating inflammation of the fetal sac membranes. It is characterized by neutrophilic infiltration of the amnion and chorion. Inflammation of the fetal sac membranes. C35169 Pregnancy Disorder C118464 Pediatric Adverse Events Terminology Chorioamnionitis Has Synonym LLT 10008755 MedDRA C110923 Chorioretinitis Chorioretinitis Inflammation of the distal posterior uveal tract (choroid) and its structural and vascular attachments to the retina. It is usually caused by infection and though rare, it is clinically significant due to its most serious sequela: loss of vision. A form of posterior uveitis in which the choroid and retina are inflamed. C115993 Retinitis C118464 Pediatric Adverse Events Terminology Chorioretinitis Has Synonym LLT 10008769 MedDRA C112115 Chronic Decubitus Chronic Decubitus Chronic Decubitus Ulcer|Chronic Pressure Sore|Chronic Pressure Ulcer A longstanding lesion caused by death of tissue due to external pressure. A longstanding lesion caused by death of tissue due to external pressure. C50706 Decubitus C118464 Pediatric Adverse Events Terminology Decubitus ulcer Narrower Than LLT 10011985 MedDRA C4981 Chronic Graft Versus Host Disease Chronic Graft Versus Host Disease A syndrome of immunologically mediated tissue damage that may occur following an allogeneic transplant, and may affect multiple organs with manifestations similar to autoimmune diseases. The onset is usually within three years of transplantation or immunologic manipulation. A complication of allogeneic bone marrow or blood cell transplantation, usually occurring more than three months after transplantation, in which donor lymphoid cells damage the host tissue. C3063 Graft Versus Host Disease C118464 Pediatric Adverse Events Terminology Chronic graft versus host disease Has Synonym LLT 10066261 MedDRA C38145 Chronic Allograft Nephropathy Chronic Kidney Allograft Nephropathy Gradual loss of donor kidney function occurring months to years after transplantation. It is characterized by renal tubular atrophy, interstitial fibrosis, and arterial wall thickening. Gradual loss of donor kidney function occurring months to years after transplantation. It is characterized by renal tubular atrophy, interstitial fibrosis, and arterial wall thickening. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Chronic allograft nephropathy Has Synonym LLT 10063209 MedDRA C80078 Chronic Kidney Disease Chronic Kidney Disease Chronic Renal Failure|Chronic Renal Insufficiency Impairment of the renal function secondary to chronic kidney damage persisting for three or more months. Impairment of the renal function secondary to chronic kidney damage persisting for three or more months. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Chronic kidney disease Has Synonym LLT 10064848 MedDRA C113609 Chronic Liver Disease Chronic Liver Disease Hepatic necrosis, inflammation, or scarring due to any cause that persists for more than 6 months. Manifestations may include signs and symptoms of cholestasis, portal hypertension, and/or abnormal liver function tests. Hepatic necrosis, inflammation, or scarring due to any cause that persists for more than 6 months. Manifestations may include signs and symptoms of cholestasis, portal hypertension, and/or abnormal liver function tests. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Chronic liver disease Has Synonym LLT 10008953 MedDRA C117015 Chronic Migraine Chronic Migraine Episodes of migraine occurring on 15 or more days per month, for more than three months. Episodes of migraine occurring on 15 or more days per month, for more than three months. C89715 Migraine C118464 Pediatric Adverse Events Terminology Chronic migraine Has Synonym LLT 10066636 MedDRA C26940 Chronic Pain Chronic Pain Ongoing or recurrent pain that persists beyond that which is expected following acute injury, usually 3 months or more. A longstanding unpleasant sensation. C3303 Pain C118464 Pediatric Adverse Events Terminology Chronic pain Has Synonym PT 10049475 MedDRA C9438 Chronic Renal Failure Chronic Renal Failure Impairment of the renal function due to chronic kidney damage. Impairment of the renal function due to chronic kidney damage. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Chronic renal failure Has Synonym LLT 10009119 MedDRA C116768 Chronic Tic Disorder Chronic Tic Disorder A neurological disorder presenting in childhood that is characterized by either motor or phonic tics, but not both, that occur daily or nearly daily for at least a year and are not attributed to an identifiable cause. A neurological disorder presenting in childhood that is characterized by either motor or phonic tics, but not both, that occur daily or nearly daily for at least a year and are not attributed to an identifiable cause. C116757 Movement Disorders C118464 Pediatric Adverse Events Terminology Chronic tic disorder Has Synonym LLT 10076661 MedDRA C79546 Chylothorax Chylothorax A milky pleural effusion resulting from accumulation of lymph fluid in the pleural cavity. Causes include malignancies (usually lymphoma), trauma to the thoracic duct, tuberculosis, sarcoidosis, and congenital causes. A pleural effusion resulting from the accumulation of lymph in the pleural cavity. C3331 Pleural Effusion C118464 Pediatric Adverse Events Terminology Chylothorax Has Synonym LLT 10051228 MedDRA C2951 Cirrhosis Cirrhosis Liver Cirrhosis A disorder characterized by replacement of the liver parenchyma with fibrous tissue and regenerative nodules. It is usually caused by alcoholism, hepatitis B, and hepatitis C. Complications include the development of ascites, esophageal varices, bleeding, and hepatic encephalopathy. A chronic degenerative disease of the liver characterized by parenchymal nodularity and fibrosis. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Cirrhosis of liver Has Synonym LLT 10009213 MedDRA C34639 Angle Closure Glaucoma Closed Angle Glaucoma Angle Closure Glaucoma The sudden increase of intraocular pressure, resulting in pain and an abrupt decrease in visual acuity. Optic nerve damage secondary to appositional closure of the angle of the eye. C26782 Glaucoma C118464 Pediatric Adverse Events Terminology Angle glaucoma closed Has Synonym LLT 10002502 MedDRA C34623 Closed Fracture Closed Fracture A traumatic break to the bone in which the continuity of the bone has not broken through the skin. A traumatic break to the bone in which the continuity of the bone has not broken through the skin. C3046 Fracture C118464 Pediatric Adverse Events Terminology Closed fracture Has Synonym LLT 10076681 MedDRA C118747 Closed Globe Injury Closed Globe Injury Traumatic injury to one or more intraocular structures without full thickness wound of the eyewall (sclera and cornea). (adapted from the Birmingham Eye Trauma Terminology System (BETTS)) Traumatic injury to one or more intraocular structures without full thickness wound of the eyewall (sclera and/or cornea). (Birmingham Eye Trauma Terminology System (BETTS)) C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Closed globe injury Has Synonym LLT 10076662 MedDRA C35286 Clostridium Difficile Colitis Clostridium difficile Infection C. diff Colitis|C. diff Infection|Clostridium difficile Colitis|Clostridium difficile Infection A bacterial infection of the colon secondary to infection with Clostridium difficile bacteria. This infection generally results from the loss of normal gut flora secondary to recent antibiotic use, and manifests as copious watery stools, with associated abdominal pain and myalgia. C. difficile is the most common cause of pseudomembranous colitis, and can progress to toxic megacolon if left untreated. An infection of the large intestine by the bacterium Clostridium difficile. C26723 Colitis C118464 Pediatric Adverse Events Terminology Clostridium difficile infection Has Synonym LLT 10054236 MedDRA C122818 Closure Patent Ductus Arteriosus Closure Patent Ductus Arteriosus The closing of the ductus arteriosus; this can occur naturally or as a result of a therapeutic procedure. The closing of the ductus arteriosus; this can occur naturally or as a result of a therapeutic procedure. C35552 Cardiovascular System Finding C118464 Pediatric Adverse Events Terminology Patent ductus arteriosus repair Has Synonym LLT 10034131 MedDRA C117077 Cluster Headache Cluster Headache A headache disorder that is characterized by periodic severe, unilateral orbital, supraorbital, and/or temporal pain, and is associated with ipsilateral cranial autonomic symptoms. A headache disorder that is characterized by periodic severe, unilateral orbital, supraorbital, and/or temporal pain, and is associated with ipsilateral cranial autonomic symptoms. C34661 Headache C118464 Pediatric Adverse Events Terminology Cluster headache Has Synonym LLT 10059133 MedDRA C2902 Coagulation Disorder Coagulation Disorder Coagulation Defect|Coagulopathy A condition in which there is a deviation from or interruption of the normal coagulation properties of the blood. A condition of abnormal blood clotting or bleeding. C2931 Cardiovascular Disorder C26323 Hematologic Disorder C118464 Pediatric Adverse Events Terminology Coagulopathy Has Synonym LLT 10009802 MedDRA C116921 Cognitive Impairment Cognitive Impairment Diminished mental function. Diminished mental function. C87124 Central Nervous System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Cognitive impairment Has Synonym LLT 10009846 MedDRA C113481 Infantile Colic Colic Infant Colic|Infantile Colic Paroxysms of irritability, fussing or crying that starts and stops without obvious cause in an infant up to four months of age without failure to thrive. Episodes last three or more hours per day for at least three days per week for at least on week. Consistent pattern of crying in a healthy infant between 3 weeks and 3 months of age. Often defined as lasting 3 hours a day more than 3 days a week for at least 3 weeks in a row. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Infantile colic Has Synonym LLT 10021746 MedDRA C26723 Colitis Colitis Inflammation of the colon. Inflammation of the colon. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Colitis Has Synonym LLT 10009887 MedDRA C3891 Color Blindness Color Blindness Color Vision Defects The absence of or defect in the perception of colors. Impaired ability to distinguish colors on the spectrum. C97109 Blindness C118464 Pediatric Adverse Events Terminology Color blindness Has Synonym LLT 10010016 MedDRA C122640 Colostomy Site Colostomy Site A surgically created external opening into the colon. A surgically created external opening into the colon. C122645 Enterostomy Site C118464 Pediatric Adverse Events Terminology C34497 Coma Coma A state of profound unconsciousness associated with markedly depressed cerebral activity. Causes include central nervous system damage, intoxication, and metabolic abnormalities. Prolonged unconsciousness. C87124 Central Nervous System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Coma Has Synonym LLT 10010071 MedDRA C34501 Communicating Hydrocephalus Communicating Hydrocephalus Non-Obstructive Hydrocephalus An abnormal accumulation of cerebrospinal fluid within the ventricles of the brain that occurs as a consequence of impaired cerebrospinal fluid reabsorption by the arachnoid granulations. An abnormal accumulation of cerebrospinal fluid within the ventricles of the brain that occurs as a consequence of impaired cerebrospinal fluid reabsorption by the arachnoid granulations. C3111 Hydrocephalus C118464 Pediatric Adverse Events Terminology Communicating hydrocephalus Has Synonym LLT 10010116 MedDRA C115163 Community-Acquired Pneumonia Community-acquired Pneumonia Pneumonia that is not acquired in a hospital or long-term care facility setting. Pneumonia that is not acquired in a hospital or long-term care facility setting. C3333 Pneumonia C118464 Pediatric Adverse Events Terminology Community acquired pneumonia Has Synonym LLT 10010120 MedDRA C118422 Compartment Syndrome Compartment Syndrome Elevated pressure in a confined space enclosed by fascia or eschar, which may lead to vascular compromise and subsequent ischemic injury to the tissue within the space. Elevated pressure in a confined space enclosed by fascia or eschar, which may lead to vascular compromise and subsequent ischemic injury to the tissue within the space. C107377 Musculoskeletal System Disorder C118464 Pediatric Adverse Events Terminology Compartment syndrome Has Synonym LLT 10010121 MedDRA C116762 Complex Tic Complex Tic A tic that involves multiple muscles or muscle groups, or words or sentences. A tic that involves multiple muscles or muscle groups, or words or sentences. C116758 Tic C118464 Pediatric Adverse Events Terminology Complex tic Has Synonym LLT 10076663 MedDRA C94241 Compulsion Compulsive Behavior A series of actions or ritualistic behavior that is difficult to suppress and is performed to relieve or prevent anxiety. A series of actions or ritualistic physical or mental behavior that is difficult to suppress and is performed to relieve or prevent anxiety. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Compulsive reaction Has Synonym LLT 10010224 MedDRA C50502 Concussion Concussion A violent jar or shock, or the condition which results from such an injury. Traumatic brain injury that results in temporary disturbance of cerebral function without radiographic changes. C3671 Injury C118464 Pediatric Adverse Events Terminology Concussion Has Synonym LLT 10010254 MedDRA C27645 Conductive Hearing Loss Conductive Hearing Loss Hearing loss caused by impaired transmission of signals from the external auditory canal or middle ear to the cochlea. Hearing loss caused by impaired transmission of signals from the external auditory canal or middle ear to the cochlea. C35731 Hearing Loss C118464 Pediatric Adverse Events Terminology Conductive hearing loss Has Synonym LLT 10010282 MedDRA C37928 Confusion Confusion Disorientation A mental state characterized by a lack of clear and orderly thought and behavior. Impaired orientation to person, place or time. C87124 Central Nervous System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Confusion Has Synonym LLT 10010300 MedDRA C118170 Confusional Arousal Confusional Arousal Excessive Sleep Inertia|Sleep Drunkeness Disorganized thinking, disorientation, or inappropriate responsiveness to external stimuli that occurs during and after awakening. Disorganized thinking, disorientation, or inappropriate responsiveness to external stimuli that occurs during and after awakening. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Confusional arousal Has Synonym LLT 10067494 MedDRA C122427 Congenital Cytomegaloviral Infection Congenital Cytomegaloviral Infection An infection with the Cytomegalovirus that is present from birth. An infection with the Cytomegalovirus that is present from birth. C96411 Pediatric Viral Infection C118464 Pediatric Adverse Events Terminology Congenital cytomegalovirus infection Has Synonym LLT 10010430 MedDRA C118729 Congruent Visual Field Defect Congruent Visual Field Defect Identically shaped visual field defect in the same location in both eyes. Identically shaped visual field defect in the same location in both eyes. C118727 Visual Field Defect C118464 Pediatric Adverse Events Terminology Visual field defect Narrower Than LLT 10047555 MedDRA C113768 Direct Hyperbilirubinemia Conjugated Hyperbilirubinemia Direct Hyperbilirubinemia Abnormally high level of conjugated bilirubin in the blood. Abnormally high level of conjugated bilirubin in the blood. C27088 Hyperbilirubinemia C118464 Pediatric Adverse Events Terminology Conjugated bilirubinemia Has Synonym LLT 10075815 MedDRA C118740 Conjunctival Foreign Body Conjunctival Foreign Body External material in or on the conjunctiva. External material in or on the conjunctiva. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Foreign body in conjunctival sac Has Synonym LLT 10017008 MedDRA C34504 Conjunctivitis Conjunctivitis Pink Eye Inflammation of the conjunctiva of the eye. Inflammation of the mucous membrane that covers the front of the eye and lines the inside of the eyelids. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Conjunctivitis Has Synonym LLT 10010741 MedDRA C37930 Constipation Constipation Irregular and infrequent or difficult evacuation of the bowels. Irregular and infrequent or difficult evacuation of the bowels. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Constipation Has Synonym LLT 10010774 MedDRA C26743 Contact Dermatitis Contact Dermatitis An inflammatory skin condition caused by direct contact between the skin and either an irritating substance or an allergen. An inflammatory skin condition caused by direct contact between the skin and either an irritating substance or an allergen. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Contact dermatitis Has Synonym LLT 10010790 MedDRA C50441 Contusion Contusion A bruise due to trauma. A bruise due to trauma. C3671 Injury C118464 Pediatric Adverse Events Terminology Contusion Has Synonym LLT 10050584 MedDRA C122443 Coombs Test Positive Coombs Test Positive Positive Coombs Test A laboratory test result demonstrating the presence of antibodies that act against red blood cells. A laboratory test result demonstrating the presence of antibodies that act against red blood cells. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Coombs test positive Has Synonym LLT 10061090 MedDRA C116763 Corprolalia Coprolalia Involuntary and repetitive utterances of obscene or socially inappropriate words or statements. Involuntarily and repetitive utterances of obscene or socially inappropriate words or statements. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Coprolalia Has Synonym LLT 10010964 MedDRA C26730 Corneal Abrasion Corneal Abrasion Injury to the epithelium of the cornea. Injury to the epithelium of the cornea. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Corneal abrasion Has Synonym LLT 10010984 MedDRA C118862 Corneal Delle Corneal Dellen Delle Corneal thinning just anterior to the limbus secondary to abnormal and/or irregular bulbar conjunctival contour. Corneal thinning just anterior to the limbus secondary to abnormal and/or irregular bulbar conjunctival contour. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Dellen Has Synonym LLT 10052122 MedDRA C118741 Corneal Foreign Body Corneal Foreign Body External material in or on the cornea. External material in or on the cornea. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Corneal foreign body Has Synonym LLT 10011015 MedDRA C118707 Cortical Blindness Cortical Blindness Visual impairment due to visual cortex dysfunction. Visual impairment due to visual cortex dysfunction. C97109 Blindness C118464 Pediatric Adverse Events Terminology Cortical blindness Has Synonym LLT 10011165 MedDRA C37935 Cough Cough A sudden, often repetitive, spasmodic contraction of the thoracic cavity, resulting in violent release of air from the lungs, and usually accompanied by a distinctive sound. A sudden, often repetitive, spasmodic release of air from the lungs accompanied by a distinctive sound. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Cough Has Synonym LLT 10011224 MedDRA C2965 Crohn Disease Crohn's Disease A gastrointestinal disorder characterized by chronic inflammation involving all layers of the intestinal wall, noncaseating granulomas affecting the intestinal wall and regional lymph nodes, and transmural fibrosis. Crohn disease most commonly involves the terminal ileum; the colon is the second most common site of involvement. A chronic, transmural inflammation that can affect any location along the gastrointestinal tract. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Crohn's disease Has Synonym LLT 10011401 MedDRA C26735 Croup Croup Laryngotracheitis|Laryngotracheobronchitis Acute upper respiratory airways infection that results in the swelling of the larynx. It is usually caused by parainfluenza viruses. Signs include a characteristic barking cough and stridor. Swelling and narrowing of the trachea, vocal cords, and bronchi usually due to a viral infection and which typically manifests with stridor and barking cough. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Croup Has Synonym LLT 10011415 MedDRA C77963 Crying Crying The shedding of tears associated with emotions, usually sadness but also joy or frustration. The shedding of tears associated with emotions, usually sadness, but also joy or frustration. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Crying Has Synonym LLT 10011469 MedDRA C118864 Crystalline Lens Dislocation Crystalline Lens Dislocation Displacement of the crystalline lens from the visual axis. Displacement of the crystalline lens from the visual axis. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Lens dislocation Has Synonym LLT 10024203 MedDRA C113210 Cushing Disease Cushing Disease ACTH Producing Pituitary Adenoma|Cushing's Disease Cushing's syndrome due to abnormally high secretion of adrenocorticotropic hormone (ACTH) from the pituitary gland. Cushing syndrome due to an adrenocorticotropic hormone-producing adenoma in the pituitary gland. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Cushing's disease Has Synonym LLT 10011651 MedDRA C2969 Cushing Syndrome Cushing Syndrome Cortisol Excess|Cushing's Syndrome|Hypercortisolism A syndrome caused by high levels of cortisol in the blood either due to excessive production and secretion of corticosteroids secondary to pituitary or adrenocortical neoplasms, or intake of glucocorticoid drugs. Signs and symptoms include a round face, upper body obesity, fragile and thin skin, purple stretch marks in the skin, fatigue, muscle weakness, hypertension, diabetes mellitus, hypertrichosis and amenorrhea in women, impotence in men, and osteoporosis. A clinical condition characterized by variable degrees of central obesity, rounding of the face ("moon" face), hypertension, striae, and a number of other physical findings, as a result of prolonged exposure to supranormal cortisol concentration of any etiology. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Cushing's syndrome Has Synonym LLT 10011652 MedDRA C37938 Cushingoid Cushingoid A constellation of signs and symptoms caused by an excess of glucocorticoids. Classic features include moon facies, buffalo hump, obesity, striae and adiposity. A constellation of signs and symptoms caused by an excess of glucocorticoids. Classic features include moon facies, buffalo hump, obesity, striae and adiposity. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Cushingoid Has Synonym LLT 10011655 MedDRA C112210 Cutaneous Vasculitis Cutaneous Vasculitis Inflammation of the blood vessel wall characterized by palpable purpura. Inflammation of the blood vessel wall characterized by palpable purpura. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Cutaneous vasculitis Has Synonym LLT 10011686 MedDRA C118201 Cutting Behavior Cutting Behavior Self-injury caused by making cuts into the skin. Self-injury caused by making cuts into the skin. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Self inflicted laceration Has Synonym LLT 10067875 MedDRA C26737 Cyanosis Cyanosis Blue Spells A bluish or purplish discoloration of the skin and mucous membranes resulting from a reduced concentration of oxygenated hemoglobin in the blood. A bluish or purplish discoloration of the skin and mucous membranes resulting from a reduced concentration of oxygenated hemoglobin in the blood. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Cyanosis Has Synonym LLT 10011703 MedDRA C117014 Cyclical Vomiting Cyclical Vomiting A condition characterized by recurrent, self-limiting episodes of vomiting associated with intense nausea, pallor, and lethargy. It is commonly a migraine precursor. A periodic syndrome that is commonly a migraine precursor and is characterized by recurrent, self-limiting episodes of vomiting associated with intense nausea, pallor, and lethargy. C3442 Vomiting C118464 Pediatric Adverse Events Terminology Cyclic vomiting syndrome Has Synonym LLT 10062937 MedDRA C2975 Cystic Fibrosis Cystic Fibrosis A congenital, autosomal, metabolic disorder affecting the exocrine glands. The secretions of exocrine glands are abnormal, resulting in excessively viscid mucus production that causes obstruction of passageways, including pancreatic and bile ducts, intestines, and bronchi. Symptoms usually appear in childhood, and include meconium ileus, poor growth despite good appetite, malabsorption and foul bulky stools, chronic bronchitis with cough, recurrent pneumonia, bronchiectasis, emphysema, clubbing of the fingers, and salt depletion in hot weather secondary to increased sodium and chloride concentration in sweat. A congenital, autosomal, metabolic disorder affecting the exocrine glands. The secretions of exocrine glands are abnormal, resulting in excessively viscid mucus production that causes obstruction of passageways, including pancreatic and bile ducts, intestines, and bronchi. Symptoms usually appear in childhood, and include meconium ileus, poor growth despite good appetite, malabsorption and foul bulky stools, chronic bronchitis with cough, recurrent pneumonia, bronchiectasis, emphysema, clubbing of the fingers, and salt depletion in hot weather secondary to increased sodium and chloride concentration in sweat. C34816 Congenital Metabolic Disorder C118464 Pediatric Adverse Events Terminology Cystic fibrosis Has Synonym LLT 10011762 MedDRA C121562 Cystic Fibrosis Pulmonary Exacerbation Cystic Fibrosis Pulmonary Exacerbation An acute episode of worsening pulmonary symptoms related to cystic fibrosis. An acute episode of worsening pulmonary symptoms related to cystic fibrosis. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Cystic fibrosis pulmonary exacerbation Has Synonym LLT 10068288 MedDRA C26738 Cystitis Cystitis Inflammation of the urinary bladder. Inflammation of the urinary bladder. C3430 Urinary System Disorder C118464 Pediatric Adverse Events Terminology Cystitis Has Synonym LLT 10011781 MedDRA C34794 Cystoid Macular Edema Cystoid Macular Edema An accumulation of fluid in the outer plexiform layer, secondary to an increase in permeability of perifoveal retinal capillaries. An accumulation of fluid in the outer plexiform layer, secondary to an increase in permeability of perifoveal retinal capillaries. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Cystoid macular edema Has Synonym LLT 10051240 MedDRA C122641 Cystostomy Site Cystostomy Site A surgically created external opening into the anterior wall of the bladder. A surgically created external opening into the anterior wall of the bladder. C122638 Ostomy Site C118464 Pediatric Adverse Events Terminology C78251 Cytokine Release Syndrome Cytokine Release Syndrome A syndrome that occurs after therapeutic infusion of antibodies into the blood and is characterized by nausea, headache, tachycardia, hypotension, rash, and shortness of breath. It is caused by the release of cytokines from the cells that are targeted by the antibodies. Most patients experience a mild to moderate reaction; however, the reaction may be severe and life-threatening. A systemic inflammatory reaction caused by the release of an excessive amount of cytokines into the circulation by activated T-cells. C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Cytokine release syndrome Has Synonym LLT 10052015 MedDRA C27644 Deafness Deafness An inherited or acquired condition characterized by the inability to hear in one or both ears. Inability to hear. C35731 Hearing Loss C118464 Pediatric Adverse Events Terminology Deafness Has Synonym LLT 10011878 MedDRA C28554 Dead Death The cessation of life. The cessation of life. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Death Has Synonym LLT 10011906 MedDRA C117245 Decreased Attention Decreased Attention Impaired ability to focus on a subject or idea. Impaired ability to focus on a subject or idea. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Attention impaired Has Synonym LLT 10003738 MedDRA C118715 Decreased Best Corrected Visual Acuity Decreased Best Corrected Visual Acuity Diminished clarity of vision despite optimal optical correction (glasses and/or contacts). Diminished clarity of vision despite optimal optical correction (glasses and/or contacts). C118714 Decreased Visual Acuity C118464 Pediatric Adverse Events Terminology Best-corrected distance visual acuity decreased Has Synonym LLT 10070552 MedDRA C117246 Decreased Concentration Decreased Concentration Reduced ability to sustain attention. Impaired ability to sustain attention. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Mental concentration decreased Has Synonym LLT 10027346 MedDRA C78432 Decreased Libido Decreased Libido Decreased sexual desire. A decrease in overall desire for sexual activity. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Libido decreased Has Synonym LLT 10024419 MedDRA C122444 Decreased Physical Activity Decreased Physical Activity A reduction in the normal physical activity for an individual. A reduction in the normal physical activity for an individual. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Decreased activity Has Synonym LLT 10011953 MedDRA C118716 Decreased Uncorrected Visual Acuity Decreased Uncorrected Visual Acuity Diminished clarity of vision without optical correction (glasses and/or contacts). Diminished clarity of vision without optical correction (glasses and/or contacts). C118714 Decreased Visual Acuity C118464 Pediatric Adverse Events Terminology Visual acuity reduced Narrower Than LLT 10047531 MedDRA C118714 Decreased Visual Acuity Decreased Visual Acuity Visual Acuity Decreased Diminished clarity of vision. Diminished clarity of vision. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Visual acuity decreased Has Synonym PT 10049061 MedDRA C118717 Decreased Visual Acuity with Current Correction Decreased Visual Acuity with Current Correction Diminished clarity of vision with current correction (glasses and/or contacts). Diminished clarity of vision with current correction (glasses and/or contacts). C118714 Decreased Visual Acuity C118464 Pediatric Adverse Events Terminology Visual acuity reduced Narrower Than LLT 10047531 MedDRA C50706 Pressure Sore Decubitus Bedsore|Decubiti|Decubitus Ulcer|Pressure Sore|Pressure Ulcer Death of tissue due to external pressure. Skin damage generally present over a bony prominence that is associated with uninterrupted external pressure. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Decubitus Has Synonym LLT 10011983 MedDRA C49343 Deep Vein Thrombosis Deep Venous Thrombosis Deep Vein Thrombosis A blood clot in a deep vein, predominantly in the lower extremity, but may include the pelvis or upper extremity. Formation of a blood clot within a deep vein. C99107 Venous Thrombosis C118464 Pediatric Adverse Events Terminology Deep vein thrombosis Has Synonym LLT 10051055 MedDRA C26740 Dehydration Dehydration A condition resulting from the excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or diaphoresis. A state characterized by lower than normal levels of water in the body. C9229 Systemic Disorder C118464 Pediatric Adverse Events Terminology Dehydration Has Synonym LLT 10012174 MedDRA C78267 Delayed Epiphyseal Fusion Delayed Epiphyseal Fusion Abnormally late fusion of the bone growth plate. Abnormally late fusion of the bone growth plate. C89330 Developmental Disorder C118464 Pediatric Adverse Events Terminology Epiphyses delayed fusion Has Synonym LLT 10015077 MedDRA C114853 Delayed Graft Function Delayed Graft Function The need for dialysis within a week of kidney transplant. The need for dialysis within a week of transplant. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Delayed graft function Has Synonym LLT 10076664 MedDRA C62587 Delayed Puberty Delayed Puberty Constitutional Growth Delay|Pubertal Delay Unusually late sexual maturity. Lack of onset of breast development by the age of 13 years in girls and the absence of testicular enlargement by the age of 13-14 years in boys. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Delayed puberty Has Synonym LLT 10012205 MedDRA C2981 Delirium Delirium A usually reversible condition characterized by the acute and sudden development of confusion, illusions, movement changes, inattentiveness, agitation, and hallucinations. Causes include drug abuse, poisoning, infectious processes, and fluid and electrolyte imbalance. A mental state, characterized by fluctuations in orientation, concentration and ability to think clearly. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Delirium Has Synonym LLT 10012218 MedDRA C26741 Delusion Delusion False personal beliefs held contrary to reality, despite contradictory evidence and common sense. Firmly held, illogical belief that is unsupported by evidence, and not shared by a sub-cultural group, with which a person is preoccupied . C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Delusion Has Synonym LLT 10012239 MedDRA C52593 Caries Dental Caries Caries|Cavities|Tooth Decay The decay of a tooth, in which it becomes softened, discolored, and/or porous. Demineralization and breakdown of tooth enamel due to bacterial infection. C35077 Dental Disorder C118464 Pediatric Adverse Events Terminology Dental caries Has Synonym LLT 10012318 MedDRA C85059 Dental Fluorosis Dental Fluorosis A condition that results from excessive fluoride ingestion during tooth development, resulting in tooth discoloration ranging from white streaks to brown stains and cracks or pits in the tooth enamel. A condition resulting from excessive fluoride ingestion during tooth development resulting in tooth discoloration ranging from white streaks to brown stains, and possible cracks or pits in the enamel. C35077 Dental Disorder C118464 Pediatric Adverse Events Terminology Fluorosis dental Has Synonym LLT 10016819 MedDRA C112817 Depigmentation Depigmentation Loss of all color from the skin. Loss of all color from the skin. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Depigmentation skin Has Synonym LLT 10012362 MedDRA C78253 Depressed Level Of Consciousness Depressed Level Of Consciousness A neurologic state characterized by decreased ability to perceive and respond. A neurologic state characterized by decreased ability to perceive and respond. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Depressed level of consciousness Has Synonym LLT 10012373 MedDRA C117199 Depressed Mood Depressed Mood Decreased Mood|Depressed|Low Mood An emotional state characterized by feelings of sadness, emptiness, and/or tearfulness. An emotional state characterized by feelings of sadness, emptiness, and/or tearfulness. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Depressed mood Has Synonym LLT 10012374 MedDRA C111885 Dermatographism Dermatographism A raised, inflamed skin reaction to pressure from rubbing or scratching. A raised, inflamed skin reaction to pressure from rubbing or scratching. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Dermographism Has Synonym LLT 10012521 MedDRA C111657 Desquamation Desquamation Shedding of the outer layer of skin or mucosal tissue. Mild, superficial peeling or shedding of skin. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Desquamation Has Synonym LLT 10012528 MedDRA C116942 Developmental Delay Developmental Delay Failure to meet, or late achievement of developmental milestones. Failure to meet, or late achievement of developmental milestones. C89330 Developmental Disorder C118464 Pediatric Adverse Events Terminology Developmental delay Has Synonym LLT 10012559 MedDRA C92561 Developmental Coordination Disorder Developmental Dyspraxia Development Coordination Disorder|Developmental Coordination Disorder A disorder characterized by an impairment in the development of an individual's motor coordination skills; this impairment in motor development is not due to a medical condition. A developmental disorder characterized by voluntary motor skill impairment. C89338 Neurodevelopmental Disorder C118464 Pediatric Adverse Events Terminology Clumsy Child Syndrome Developmental coordination disorder Narrower Than LLT 10012557 MedDRA C78254 Device Complication Device Complication Any problem arising from the use of a medical device. Any problem arising from the use of a medical device. C2959 Complication C118464 Pediatric Adverse Events Terminology Device complication Has Synonym LLT 10056488 MedDRA C111642 Device Embolization Device Embolization Movement of a medical device to an unintended location within the body with resulting obstruction of an organ or vessel. Migration of a medical device to an unintended location with or without obstruction. C26759 Embolism C118464 Pediatric Adverse Events Terminology Device embolization Has Synonym LLT 10074897 MedDRA C62814 Unintended Movement Device Migration Movement of the device to an unintended location within the body. Movement of a medical device to an unintended location within the body. C2959 Complication C118464 Pediatric Adverse Events Terminology Device migration Has Synonym LLT 10012588 MedDRA C43263 Diabetes Insipidus Diabetes Insipidus A disorder characterized by excretion of large amounts of urine, accompanied by excessive thirst. Causes include deficiency of antidiuretic hormone or failure of the kidneys to respond to antidiuretic hormone. It may also be drug-related. A condition characterized by excretion of large amounts of dilute urine, accompanied by excessive thirst. Causes include deficiency of antidiuretic hormone or failure of the kidneys to respond to antidiuretic hormone. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Diabetes insipidus Has Synonym LLT 10012599 MedDRA C50530 Diabetic Ketoacidosis Diabetic Ketoacidosis DKA The metabolic condition resulted from uncontrolled diabetes mellitus, in which the shift of acid-base status of the body toward the acid side because of loss of base or retention of acids other than carbonic acid is accompanied by the accumulation of ketone bodies in body tissues and fluids. A metabolic derangement characterized by ketosis, acidosis, and often hyperglycemia, as a consequence of absolute or relative insulin deficiency. C3235 Metabolic Disease C118464 Pediatric Adverse Events Terminology Diabetic ketoacidosis Has Synonym LLT 10012671 MedDRA C34538 Diabetic Retinopathy Diabetic Retinopathy A chronic, pathological complication associated with diabetes mellitus, where retinal damages are incurred due to microaneurysms in the vasculature of the retina, progressively leading to abnormal blood vessel growth, and swelling and leaking of fluid from blood vessels, resulting in vision loss or blindness. Disorder of the retina due to diabetes. C62601 Retinopathy C118464 Pediatric Adverse Events Terminology Diabetic retinopathy Has Synonym LLT 10012689 MedDRA C114722 Dialysis Catheter Embolism Dialysis Catheter Embolism An obstruction of a vessel caused by a detached fragment of an indwelling dialysis catheter. An obstruction of a vessel caused by a detached fragment of an indwelling dialysis catheter. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Device embolization Narrower Than LLT 10074897 MedDRA C114727 Dialysis Catheter Exit Site Infection Dialysis Catheter Exit Site Infection Local infection at the dialysis catheter exit site. Local infection at the dialysis catheter exit site. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Catheter infection Narrower Than LLT 10051387 MedDRA C114717 Dialysis Catheter Fracture Dialysis Catheter Fracture A crack or break in a dialysis catheter caused by material weakness or mechanical compression. A crack or break in a dialysis catheter caused by material weakness or mechanical compression. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Catheter breakage Narrower Than LLT 10073971 MedDRA C114723 Dialysis Catheter Infection Dialysis Catheter Infection A local or systemic infection associated with the use of a dialysis catheter. A local or systemic infection associated with the use of a dialysis catheter. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Catheter infection Narrower Than LLT 10051387 MedDRA C114764 Dialysis Catheter Obstruction Dialysis Catheter Obstruction Blockage of a dialysis catheter by a thrombus or other substance. Blockage of a dialysis catheter by a thrombus or other substance. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Catheter blockage Narrower Than LLT 10052255 MedDRA C114726 Dialysis Catheter Tunnel Infection Dialysis Catheter Tunnel Infection Tunnel Infection Associated with Dialysis Access Local infection involving the subcutaneously tunneled portion of a dialysis catheter. Local infection involving the subcutaneously tunneled portion of a dialysis catheter. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Catheter infection Narrower Than LLT 10051387 MedDRA C114714 Dialysis Membrane Reaction Dialysis Membrane Reaction Dialyzer Reaction A severe hypersensitivity-like reaction occurring during dialysis due to exposure to the dialysis membrane. A severe hypersensitivity-like reaction occurring during dialysis due to exposure to the dialysis membrane. C3114 Hypersensitivity Reaction C118464 Pediatric Adverse Events Terminology Dialysis membrane reaction Has Synonym LLT 10076665 MedDRA C114776 Dialyzer Blood Leakage Dialyzer Blood Leak Leakage of blood into the dialysate during hemodialysis due to apparatus malfunction. Leakage of blood into the dialysate during hemodialysis due to apparatus malfunction. C2959 Complication C118464 Pediatric Adverse Events Terminology Blood leak in dialyzer Has Synonym LLT 10052260 MedDRA C111886 Diaper Dermatitis Diaper Dermatitis Diaper Rash|Nappy Rash An inflammatory skin condition in the diaper area that may be caused by irritation or infection. An inflammatory skin condition in the diaper area that may be caused by irritation or infection. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Dermatitis diaper Has Synonym LLT 10012444 MedDRA C35051 Diaphoresis Diaphoresis Profuse sweating. Profuse sweating. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Diaphoresis Has Synonym LLT 10012703 MedDRA C2987 Diarrhea Diarrhea Frequent Stools|Loose Stools Watery bowel movements. Watery bowel movements. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Diarrhea Has Synonym LLT 10012727 MedDRA C116955 Diencephalic Syndrome of Infancy Diencephalic Syndrome of Infancy Diencephalic Syndrome Emaciation in the setting of normal linear growth and intellectual development, which is usually associated with neoplasms involving the anterior hypothalamus in infancy or early childhood. Emaciation in the setting of normal linear growth and intellectual development, which is usually associated with neoplasms involving the anterior hypothalamus in infancy or early childhood. C98996 Neonatal Disorder C118464 Pediatric Adverse Events Terminology Diencephalic syndrome of infancy Has Synonym LLT 10012774 MedDRA C116599 Diplegia Diplegia Paralysis affecting corresponding parts on both sides of the body. Paralysis affecting corresponding parts on both sides of the body. C26835 Nervous System Disorder C118464 Pediatric Adverse Events Terminology Diplegia Has Synonym LLT 10013033 MedDRA C37941 Diplopia Diplopia Double Vision The condition in which a single object appears as two objects. Also called "double vision." (from medterms.com) Perception of a single object as two images. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Diplopia Has Synonym LLT 10013036 MedDRA C34691 Direct Inguinal Hernia Direct Inguinal Hernia A protrusion of the abdominal cavity contents into the inguinal canal through the superficial inguinal ring. The protrusion of abdominal cavity contents into the inguinal canal, medial to the inferior epigastric vessels. C34690 Inguinal Hernia C118464 Pediatric Adverse Events Terminology Direct inguinal hernia Has Synonym LLT 10013046 MedDRA C117253 Disinhibition Disinhibited Disinhibition Unrestrained behavior, often at odds with social norms. Unrestrained behavior, often at odds with social norms. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Disinhibition Has Synonym LLT 10013142 MedDRA C122439 Dislodged Catheter Dislodged Catheter A catheter that has moved from its intended location. A catheter that has moved from its intended location. C122712 Medical Device Dislodged C118464 Pediatric Adverse Events Terminology Catheter dislodgment Has Synonym LLT 10073974 MedDRA C115161 Dislodged Peritoneal Dialysis Catheter Dislodged Peritoneal Dialysis Catheter Malposition of a peritoneal dialysis catheter. Malposition of a peritoneal dialysis catheter. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Catheter dislodgment Narrower Than LLT 10073974 MedDRA C121669 Disordered Eating Disordered Eating Abnormal eating behaviors, including binge eating, compulsive eating, emotional eating, night eating, and self-induced vomiting, though not at a level that rises to the diagnosis of eating disorder. Abnormal eating behaviors, including binge eating, compulsive eating, emotional eating, night eating, and self-induced vomiting, though not at a level that rises to the diagnosis of eating disorder. C35470 Behavioral Disorder C118464 Pediatric Adverse Events Terminology Eating disorder Narrower Than LLT 10014062 MedDRA C117264 Disordered Thinking Disordered Thinking Disordered Thoughts|Thought Disorganization Incoherent, disorganized or illogical thought processes. Incoherent, disorganized or illogical thought processes. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Abnormal thinking Related To LLT 10000182 MedDRA C115162 Displaced Peritoneal Dialysis Catheter Displaced Peritoneal Dialysis Catheter Malposition and dysfunction of a peritoneal dialysis catheter. Malposition and dysfunction of a peritoneal dialysis catheter. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Catheter dislodgment Narrower Than LLT 10073974 MedDRA C122527 Disrupted Suture Disrupted Suture Stitches Coming Loose The loss of tension or continuity of sutures. The loss of tension or continuity of sutures. C78254 Device Complication C118464 Pediatric Adverse Events Terminology Ruptured suture Has Synonym LLT 10039334 MedDRA C113669 Disseminated Bacillus Calmette-Guerin Infection Disseminated Bacillus Calmette-Guérin Infection BCGosis|Disseminated BCGitis|Disseminated Bacillus Calmette-Guerin Infection A rare systemic and life-threatening infection associated with vaccination with the live attenuated strain of Mycobacterium bovis, bacillus Calmette-Guerin. A systemic and life-threatening infection associated with vaccination with the live attenuated strain of Mycobacterium bovis, Bacillus Calmette-Guerin. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Disseminated Bacillus Calmette-Guerin infection Has Synonym LLT 10076666 MedDRA C2992 Disseminated Intravascular Coagulation Disseminated Intravascular Coagulation DIC A pathological process where the blood starts to coagulate throughout the whole body. This depletes the body of its platelets and coagulation factors, and there is an increased risk of hemorrhage. Excessive activation of the body's coagulation system resulting in systemic microvascular thrombi formation. C131658 Consumptive Coagulopathy C2902 Coagulation Disorder C118464 Pediatric Adverse Events Terminology Disseminated intravascular coagulation Has Synonym LLT 10013442 MedDRA C113672 Disseminated Oka Varicella Zoster Virus Infection Disseminated Varicella Zoster Vaccine Virus Infection A rare systemic and life-threatening infection associated with vaccination with the live attenuated strain of the Varicella-zoster virus, Oka. A systemic and life-threatening infection associated with vaccination with the live attenuated strain of the Varicella zoster virus. C96407 Varicella Zoster Infection C118464 Pediatric Adverse Events Terminology Disseminated varicella zoster vaccine virus infection Has Synonym LLT 10076667 MedDRA C121629 Disturbance of Temperature Regulation Disturbance of Temperature Regulation Any condition characterized by an inability to regulate body temperature. Any condition characterized by an inability to regulate body temperature. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Temperature regulation disorder Has Synonym LLT 10061376 MedDRA C37943 Dizziness Dizziness Lightheadedness A sensation of lightheadedness, unsteadiness, turning, spinning or rocking. A sensation of lightheadedness, unsteadiness, turning, spinning or rocking. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Dizziness Has Synonym LLT 10013573 MedDRA C122419 Dog Bite Dog Bite A wound received from the teeth of a dog. A wound received from the teeth of a dog. C3671 Injury C118464 Pediatric Adverse Events Terminology Dog bite Has Synonym LLT 10013589 MedDRA C116933 Double Cortex Syndrome Double Cortex Syndrome Subcortical Band Heterotopia A developmental brain abnormality characterized by atypical migration of neurons during cortical development. A developmental brain abnormality characterized by abnormal migration of neurons during cortical development. C96412 Brain Development Abnormality C118464 Pediatric Adverse Events Terminology Double cortex syndrome Has Synonym LLT 10073490 MedDRA C116573 Dravet Syndrome Dravet Syndrome Severe Myoclonic Epilepsy of Infancy A severe form of epilepsy that presents in early childhood and is characterized by frequent, prolonged febrile or myoclonic seizures that may progress to status epilepticus and poor development of language, motor, and socialization skills. A severe form of epilepsy that presents in early childhood and is characterized by frequent, prolonged febrile or myoclonic seizures that may progress to status epilepticus and poor development of language, motor, and socialization skills. C3020 Epilepsy C118464 Pediatric Adverse Events Terminology Dravet syndrome Has Synonym LLT 10073682 MedDRA C121582 Drooling Drooling Saliva spilling out of the mouth. Saliva spilling from the mouth. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Drooling Has Synonym LLT 10013642 MedDRA C112203 Drug Induced Cutaneous Lupus Erythematosus Drug Induced Cutaneous Lupus Erythematosus A reaction to a drug characterized by skin findings common to lupus including photosensitivity and butterfly rash; typically it resolves after drug discontinuation. A reaction to a drug characterized by skin findings common to lupus including photosensitivity and malar rash; typically it resolves after drug discontinuation. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Drug-induced cutaneous lupus erythematosus Has Synonym LLT 10074893 MedDRA C112204 Drug Induced Cutaneous Vasculitis Drug Induced Cutaneous Vasculitis Drug Induced Vasculitis A skin hypersensitivity reaction due to exposure to a pharmacologic substance that is characterized by raised purpuric lesions, red macules, hemorrhagic blisters and ulcerations. A skin hypersensitivity reaction due to exposure to a pharmacologic substance that is characterized by raised purpuric lesions, red macules, hemorrhagic blisters and ulcerations. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Cutaneous vasculitis Narrower Than LLT 10011686 MedDRA C114354 Drug Induced Lupus Erythematosus Drug Induced Lupus Erythematosus Drug Induced Lupus|Drug-Induced Lupus An autoimmune disorder, similar to systemic lupus erythematosus, that is caused by certain drugs. A lupus-like condition which occurs after exposure to a specific pharmacologic agent and typically resolves after discontinuation of the agent. C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Drug-induced lupus erythematosus Has Synonym LLT 10013706 MedDRA C114280 Drug Skin Rash Drug Rash An eruption in the skin due to exposure to a pharmacologic substance. An eruption in the skin due to exposure to a pharmacologic substance. C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Drug rash Has Synonym LLT 10062948 MedDRA C112208 Drug Hypersensitivity Syndrome Drug Reaction with Eosinophilia and Systemic Symptoms DRESS|Drug Hypersensitivity Syndrome A potentially life-threatening hypersensitivity reaction to a pharmacologic substance that is characterized by rash, lymphadenopathy, fever, hematologic abnormalities and involvement of one or more internal organs. A potentially life-threatening hypersensitivity reaction to a pharmacologic substance that is characterized by rash, lymphadenopathy, fever, hematologic abnormalities and involvement of one or more internal organs. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Drug reaction with eosinophilia and systemic symptoms Has Synonym LLT 10073508 MedDRA C114583 Drug-Induced Nephropathy Drug-Induced Kidney Injury Drug-Induced Renal Failure|Toxic Nephropathy Kidney damage resulting from exposure to drugs. Kidney damage resulting from exposure to drugs. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Toxic nephropathy Narrower Than LLT 10044238 MedDRA C99110 Drug Induced Thrombocytopenia Drug-Induced Thrombocytopenia Drug Induced Thrombocytopenia|Drug-Induced Immune Thrombocytopenia Thrombocytopenia caused by ingested or injected drugs. It may be the result of decreased platelet production due to bone marrow suppression or increased rate of platelet destruction. Thrombocytopenia caused by medications, which can be the result of decreased platelet production due to bone marrow suppression or increased rate of platelet destruction. C131634 Platelet Abnormality C3408 Thrombocytopenia C118464 Pediatric Adverse Events Terminology Thrombocytopenia Narrower Than PT 10043554 MedDRA C34553 Dry Eye Syndrome Dry Eye A syndrome characterized by dryness of the cornea and conjunctiva. It is usually caused by a deficiency in tear production. Symptoms include a feeling of burning eyes and a possible foreign body presence in the eye. Breakdown of the tear film, resulting in decreased lubrication of the cornea and/or conjunctiva. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Dry eye Has Synonym LLT 10013774 MedDRA C122639 Duodenostomy Site Duodenostomy Site A surgically created external opening into the duodenum. A surgically created external opening into the duodenum. C122645 Enterostomy Site C118464 Pediatric Adverse Events Terminology C114781 Dysequilibrium Syndrome Dysequilibrium Syndrome Dialysis Dysequilibrium Syndrome A complication occurring during hemodialysis that is thought to be due to a rapid decrease in blood urea nitrogen, and is characterized by an increase in intracranial pressure resulting in nausea, headache, vomiting, restlessness, and/or a decreased level of consciousness. A complication occurring during hemodialysis that is thought to be due to a rapid decrease in blood urea nitrogen, and is characterized by an increase in intracranial pressure resulting in nausea, headache, vomiting, restlessness, and/or a decreased level of consciousness. C2959 Complication C118464 Pediatric Adverse Events Terminology Dysequilibrium syndrome Has Synonym LLT 10013140 MedDRA C28246 Dysesthesia Dysesthesia Distortion of a sense resulting in an abnormal and unpleasant sensation, usually described as burning, tingling, or numbness. Causes include lesions of the nervous system. Distortion of any sense. C3367 Finding C118464 Pediatric Adverse Events Terminology Dysesthesia Has Synonym LLT 10062872 MedDRA C28145 Dysgeusia Dysgeusia Persistence of unpleasant taste. Distortion of taste. C28246 Dysesthesia C118464 Pediatric Adverse Events Terminology Dysgeusia Has Synonym LLT 10013911 MedDRA C50539 Dyskinesia Dyskinesia Abnormality or impairment of voluntary movement. Impairment of voluntary muscle control, characterized by spasmodic or repetitive motions or lack of coordination. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Dyskinesia Has Synonym LLT 10013916 MedDRA C34559 Dysmenorrhea Dysmenorrhea Abnormally painful abdominal cramps during menstruation. Pain with menstruation. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Dysmenorrhea Has Synonym LLT 10013934 MedDRA C117277 Demyelination Dysmyelination Breakdown, or abnormal development, of a nerve fiber myelin sheath. Breakdown, or abnormal development, of a nerve fiber myelin sheath. C87124 Central Nervous System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Dysmyelination Has Synonym LLT 10067601 MedDRA C116370 Dysosmia Dysosmia Abnormal sense of smell. Abnormal sense of smell. C28246 Dysesthesia C118464 Pediatric Adverse Events Terminology Dysosmia Has Synonym LLT 10013939 MedDRA C26756 Dyspepsia Dyspepsia Indigestion An uncomfortable, often painful feeling in the stomach, resulting from impaired digestion. Symptoms include burning stomach pain, bloating, heartburn, nausea, and vomiting. Causes include gastritis, gastric ulcer, gastroesophageal reflux disease, pancreatic disease, and gallbladder disease. Upper abdominal discomfort associated with food intake characterized by post prandial fullness, early satiety and/or epigastric pain or burning. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Dyspepsia Has Synonym LLT 10013946 MedDRA C2980 Dysphagia Dysphagia Difficulty Swallowing A symptom referring to difficulty in swallowing. It may be observed in patients with stroke, motor neuron disorders, cancer of the throat or mouth, head and neck injuries, Parkinson disease, and multiple sclerosis. Difficulty in swallowing. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Dysphagia Has Synonym LLT 10013950 MedDRA C35546 Dysphasia Dysphasia Impairment of verbal communication skills, often resulting from brain damage. Impairment of verbal communication skills. C87124 Central Nervous System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Dysphasia Has Synonym LLT 10013951 MedDRA C47813 Hoarseness Dysphonia Hoarseness Harsh and raspy voice secondary to laryngeal infection, voice overuse, irritants inhalation, vocal cord paralysis, vocal cord polyps, and malignant neoplasms arising from or spreading to the larynx. The alteration of voice to a harsh and raspy tone. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Dysphonia Has Synonym LLT 10013952 MedDRA C2998 Dyspnea Dyspnea An uncomfortable sensation of difficulty breathing. It may present as an acute or chronic sign of an underlying respiratory or heart disorder. A sensation of discomfort with breathing. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Dyspnea Has Synonym LLT 10013963 MedDRA C34563 Dystonia Dystonia A movement disorder characterized by sustained or intermittent muscle contractions, resulting in abnormal movements and/or postures. A movement disorder characterized by sustained or intermittent muscle contractions, resulting in abnormal movements and/or postures. C116757 Movement Disorders C118464 Pediatric Adverse Events Terminology Dystonia Has Synonym LLT 10013983 MedDRA C2999 Dysuria Dysuria Pain or discomfort during urination. Pain or discomfort during urination. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Dysuria Has Synonym LLT 10013990 MedDRA C112862 Early Fetal Death Early Fetal Death Death of a fetus at 10 weeks, 0 days to 15 weeks, 6 days of gestation. Death of a fetus at 10 weeks, 0 days to 15 weeks, 6 days of gestation. C50620 Fetal Death C118464 Pediatric Adverse Events Terminology Early fetal death Has Synonym LLT 10076682 MedDRA C92770 Early Deceleration Early Fetal Heart Rate Deceleration Early Deceleration|Early Fetal Heart Deceleration A gradual decrease in the fetal heart rate and return to baseline that is associated with a uterine contraction. The nadir of the deceleration occurs at the same time as the peak of the uterine contraction, and the time from onset to nadir of the deceleration is greater than or equal to 30 seconds. A gradual decrease in the fetal heart rate and return to baseline that is associated with a uterine contraction. The nadir of the deceleration occurs at the same time as the peak of the uterine contraction, and the time from onset to nadir of the deceleration is greater than or equal to 30 seconds. C92789 Fetal Heart Deceleration C118464 Pediatric Adverse Events Terminology Early deceleration Has Synonym LLT 10058344 MedDRA C116552 Early Infantile Epileptic Encephalopathy with Burst-Suppression Early Infantile Epileptic Encephalopathy with Burst-Suppression EIEE with Burst-Suppression|Ohtahara Syndrome A neurological disorder characterized by recurring seizures presenting within the first three months of life, progressive cerebral dysfunction, and an EEG pattern of periods of low electrical brain activity interspersed with bursts of high spiky activity. A neurological disorder characterized by recurring seizures presenting within the first three months of life, progressive cerebral dysfunction, and an EEG pattern of periods of low electrical brain activity interspersed with bursts of high spiky activity. C26920 Encephalopathy C118464 Pediatric Adverse Events Terminology Early infantile epileptic encephalopathy with burst-suppression Has Synonym LLT 10071545 MedDRA C116593 Early Myoclonic Encephalopathy Early Myoclonic Encephalopathy A neurologic disorder characterized by frequently recurring myoclonic seizures and other seizure types presenting within the first months of life. A neurological disorder characterized by recurring seizures presenting within the first months of life, characterized by frequently recurring myoclonic seizures and other seizure types. C26920 Encephalopathy C118464 Pediatric Adverse Events Terminology Myoclonic encephalopathy of infants Has Synonym LLT 10053856 MedDRA C116772 Early Neonatal Death Early Neonatal Mortality Death of a live newborn during the first 7 days of life. Death of live-born infants less than 7 days of age. C80082 Neonatal Death C118464 Pediatric Adverse Events Terminology Early neonatal death Has Synonym LLT 10076742 MedDRA C116718 Early Onset Primary Dystonia Early Onset Primary Dystonia Early Onset Torsion Dystonia|Oppenheim's Dystonia A genetic disorder that usually presents in early childhood and is characterized by muscle contractions in a foot, leg, or arm that gradually spreads to other body regions. A genetic disorder that usually presents in early childhood and is characterized by muscle contractions in a foot, leg, or arm that gradually spreads to other body regions. C26835 Nervous System Disorder C3101 Genetic Disorder C118464 Pediatric Adverse Events Terminology Early onset primary dystonia Has Synonym LLT 10076668 MedDRA C112858 Early Pregnancy Loss Early Pregnancy Loss Pregnancy loss before 10th week of gestation with documentation of a confirmed pregnancy. Pregnancy loss before 10th week of gestation. C90491 Pregnancy Outcome C118464 Pediatric Adverse Events Terminology Abortion early Has Synonym LLT 10052846 MedDRA C112174 Skin Bruise Ecchymosis Bruise Extravasation of blood into the subcutaneous space. Extravasation of blood into the subcutaneous space. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Ecchymosis Has Synonym LLT 10014080 MedDRA C97166 Echolalia Echolalia A symptom of neurologic or psychiatric dysfunction in which the individual involuntarily and meaninglessly repeats a recently heard word, series of words, or a song. Involuntarily repeating of other peoples words. C97170 Central Auditory Processing Disorder C118464 Pediatric Adverse Events Terminology Echolalia Has Synonym LLT 10014127 MedDRA C3001 Eczema Eczema Atopic Dermatitis|Eczematous Dermatitis A form of dermatitis characterized by red, itchy, scaly, or crusty patches that can be chronic or intermittent. A form of dermatitis characterized by red, itchy, scaly, or crusty patches that can be chronic or intermittent. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Eczema Has Synonym LLT 10014184 MedDRA C3002 Edema Edema Accumulation of an excessive amount of fluid in cells or intercellular tissues. Accumulation of an excessive amount of fluid in cells or intercellular tissues. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Edema Has Synonym LLT 10014210 MedDRA C3003 Effusion Effusion A collection of fluid in a body cavity, which may be the result of a non-neoplastic disorder (e.g. heart failure) or a tumor (e.g. carcinoma of the lung). A collection of fluid in a body cavity, which may be the result of a non-neoplastic disorder (e.g. heart failure) or a tumor (e.g. carcinoma of the lung). C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Effusion Has Synonym LLT 10063045 MedDRA C78264 Ejaculation Disorder Ejaculatory Dysfunction A disorder referring to problems related to ejaculation. This category includes premature, delayed, retrograde, and painful ejaculation. Any disturbance in the ejection of semen, which causes distress to the affected individual. C27019 Male Reproductive System Disorder C118464 Pediatric Adverse Events Terminology Ejaculation disorder Has Synonym LLT 10014326 MedDRA C114798 Elevated Blood Pressure Measurement Elevated Blood Pressure Measurement An abnormally high blood pressure reading. An abnormally high blood pressure reading. C35552 Cardiovascular System Finding C118464 Pediatric Adverse Events Terminology Blood pressure reading high Has Synonym LLT 10067049 MedDRA C35607 Blood Alkaline Phosphatase Increased Elevated Serum Alkaline Phosphatase A laboratory test result which indicates an increased level of alkaline phosphatase in a biological specimen. An elevated concentration of alkaline phosphatase in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Alkaline phosphatase increased Has Synonym LLT 10001675 MedDRA C34572 Empyema Empyema An accumulation of pus in a body cavity, usually the pleural space. An accumulation of pus in a body cavity, usually the pleural space. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Empyema Has Synonym LLT 10014568 MedDRA C112197 Enanthem Enanthem An acute eruption of ulcerative lesions on the mucous membrane of the oropharynx. An acute eruption of ulcerative lesions on the mucous membrane of the oropharynx. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Enanthema Has Synonym LLT 10014579 MedDRA C26760 Encephalitis Encephalitis An inflammatory process affecting the brain parenchyma. Causes include viral infections and less frequently bacterial infections, toxins, and immune-mediated processes. Inflammation of the brain. C96413 Brain Disorder C118464 Pediatric Adverse Events Terminology Encephalitis Has Synonym LLT 10014581 MedDRA C34580 Encephalomyelitis Encephalomyelitis Inflammation of the brain and the spinal cord. Inflammation of the brain and spinal cord. C2934 Central Nervous System Disorder C118464 Pediatric Adverse Events Terminology Encephalomyelitis Has Synonym LLT 10014619 MedDRA C26920 Encephalopathy Encephalopathy A functional and/or structural disorder of the brain caused by diseases (e.g. liver disease, kidney disease), medications, chemicals, and injuries. Diffuse disease of the brain that alters function and/or structure of the brain and is characterized by an altered mental state. C96413 Brain Disorder C118464 Pediatric Adverse Events Terminology Encephalopathy Has Synonym LLT 10014625 MedDRA C92568 Encopresis Encopresis An elimination disorder characterized by fecal incontinence, whether involuntary or intentional, which is not due to a medical condition and which occurs in someone who is toilet trained. The leakage of stool in an individual who is toilet trained. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Encopresis Has Synonym LLT 10014643 MedDRA C34582 Endocarditis Endocarditis Inflammation of the endocardium. Inflammation of the endocardium. C3079 Heart Disorder C118464 Pediatric Adverse Events Terminology Endocarditis Has Synonym LLT 10014665 MedDRA C34586 Endophthalmitis Endophthalmitis An infectious process affecting the internal structures of the eye. Inflammation of the intraocular space, usually due to infection. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Endophthalmitis Has Synonym LLT 10014801 MedDRA C84428 End Stage Liver Disease End-Stage Liver Disease Chronic Liver Failure A disorder characterized by irreversible damage to the liver tissue, leading to complete liver failure. Causes include cirrhosis, viral hepatitis, metastases to the liver, genetic disorders, toxins, and drugs. A progressive systemic illness occurring in the setting of cirrhosis, characterized by coagulopathy not corrected by vitamin K, cholestasis, portal hypertension, and variable encephalopathy. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology End stage liver disease Has Synonym LLT 10050060 MedDRA C79552 Enophthalmos Enophthalmos Abnormal recession of the eyeball within the eye socket. The posterior displacement of the eye within the orbit. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Enophthalmos Has Synonym LLT 10014853 MedDRA C26765 Enteritis Enteritis Inflammation of the small intestine. Inflammation of the small intestine. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Enteritis Has Synonym LLT 10014866 MedDRA C79573 Enterocolitis Enterocolitis An inflammatory process affecting the small intestine and colon. Causes include viruses, bacteria, radiation, and antibiotics use. Inflammation of the small and large intestines. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Enterocolitis Has Synonym LLT 10014893 MedDRA C78570 Intestinal Stoma Prolapse Enterostomy Prolapse An intestinal stoma complication characterized by protrusion of the intestine above the abdominal surface. Protrusion of the intestine through the stoma opening. C36173 Prolapse C118464 Pediatric Adverse Events Terminology Prolapse of intestinal stoma Has Synonym LLT 10065745 MedDRA C122645 Enterostomy Site Enterostomy Site A surgically created external opening into the intestine. A surgically created external opening into the intestine. C122638 Ostomy Site C118464 Pediatric Adverse Events Terminology C114470 Enthesitis Enthesitis Inflammation at the site of insertion of ligaments, tendons, and other fibrous structures into bone. Inflammation where ligaments, tendons, and other fibrous structures attach to bone. C107377 Musculoskeletal System Disorder C118464 Pediatric Adverse Events Terminology Enthesitis Has Synonym LLT 10058497 MedDRA C3015 Eosinophilia Eosinophilia Abnormal high level of eosinophils in the blood. Abnormally high level of eosinophils in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Eosinophilia Has Synonym LLT 10014950 MedDRA C112116 Eosinophilic Fasciitis Eosinophilic Fasciitis Shulman Syndrome Inflammation and induration of the fascia related to an accumulation of white blood cells, including eosinophils. An inflammatory disease of the fascia caused by infiltration of eosinophils, which manifests as progressive thickening of the tissues, often with accompanying erythema, pain, and induration. A classic finding is eosinophilia in the peripheral blood. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Eosinophilic fasciitis Has Synonym LLT 10014954 MedDRA C113712 Eosinophilopenia Eosinophilopenia Abnormally low level of eosinophils in the blood. Abnormally low level of eosinophils in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Eosinopenia Has Synonym LLT 10014940 MedDRA C3017 Ependymoma Ependymoma A WHO grade II, slow growing tumor of children and young adults, usually located intraventricularly. It is the most common ependymal neoplasm. It often causes clinical symptoms by blocking cerebrospinal fluid pathways. Key histological features include perivascular pseudorosettes and ependymal rosettes. (WHO) A malignant neoplasm arising from ependymal cells that line the ventricles of the brain and the central canal of the spinal cord. C3268 Nervous System Neoplasm C118464 Pediatric Adverse Events Terminology Ependymoma Has Synonym LLT 10014967 MedDRA C84690 Epidermolysis Bullosa Acquisita Epidermolysis Bullosa Aquisita A chronic autoimmune inflammatory disorder characterized by the formation of subepidermal blisters in the skin and the mucous membranes. An acquired blistering disease of the skin that has the clinical and pathologic findings similar to the group of inherited disorders called "Epidermolysis Bullosa", which are characterized by recurrent blisters from abnormal or absent essential components of the basement membrane zone or epidermal cell layer. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Epidermolysis bullosa aquisita Has Synonym LLT 10074980 MedDRA C116588 Epidural Hematoma Epidural Hematoma A collection of blood into the space between the dura mater and the skull. A collection of blood into the space between the dura mater and the skull. C50579 Hematoma C118464 Pediatric Adverse Events Terminology Epidural hematoma Has Synonym LLT 10015013 MedDRA C118374 Epigastric Hernia Epigastric Hernia Protrusion of abdominal cavity contents or pre-peritoneal fat through the abdominal wall between the umbilicus and the xiphoid process. Protrusion of abdominal cavity contents or pre-peritoneal fat through the abdominal wall between the umbilicus and the xiphoid process. C34685 Hernia C118464 Pediatric Adverse Events Terminology Epigastric hernia Has Synonym LLT 10015019 MedDRA C116007 Epiglottitis Epiglottitis Supraglottitis Inflammation of the epiglottis. Inflammation of the epiglottis. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Epiglottitis Has Synonym LLT 10015030 MedDRA C3020 Seizure Disorder Epilepsy Seizure Disorder A brain disorder characterized by episodes of abnormally increased neuronal discharge resulting in transient episodes of sensory or motor neurological dysfunction, or psychic dysfunction. These episodes may or may not be associated with loss of consciousness or convulsions. A neurological disorder characterized by recurring seizures. C96413 Brain Disorder C118464 Pediatric Adverse Events Terminology Epilepsy Has Synonym LLT 10015037 MedDRA C118382 Epiphysiolysis Epiphysiolysis Abnormal separation of an epiphysis from the shaft of a bone. Abnormal separation of an epiphysis from the shaft of a bone. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Epiphysiolysis Has Synonym LLT 10015079 MedDRA C112189 Bulbar Conjunctivitis Episcleritis Bulbar Conjunctivitis Inflammation of the thin layer of tissue lining the sclera of the eye characterized by redness in the white portion of the eye. Inflammation of the episclera, the thin layer of tissue between the conjunctiva and the sclera. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Episcleritis Has Synonym LLT 10015084 MedDRA C26766 Epistaxis Epistaxis Nose Bleed Bleeding from the nose. Bleeding from the nose. C45233 Respiratory System Finding C118464 Pediatric Adverse Events Terminology Epistaxis Has Synonym LLT 10015090 MedDRA C116723 Erb's Palsy Erb's Palsy Erb-Duchenne Palsy Weakness or paralysis of muscles in the arm due to damage in the upper brachial plexus. A condition characterized by reduced or absent movement of the ipsilateral shoulder or arm as a consequence of an injury to cervical roots 5, 6 and sometimes 7, also known as the upper brachial plexus. C103231 Brachial Plexus Injury C118464 Pediatric Adverse Events Terminology Erb's palsy Has Synonym LLT 10015113 MedDRA C34801 Male Erectile Disorder Erectile Dysfunction A disorder characterized by the persistent or recurrent inability to achieve or to maintain an erection during sexual activity. The inability to attain or maintain an erection for satisfactory sexual intercourse. C27019 Male Reproductive System Disorder C118464 Pediatric Adverse Events Terminology Erectile dysfunction Has Synonym LLT 10061461 MedDRA C50845 Skin Erosion Erosion Skin Breakdown|Skin Erosion Tearing or wearing off of skin. Tearing or wearing off of skin. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Skin erosion Related To LLT 10040840 MedDRA C26901 Erythema Erythema Redness Red discoloration of the skin caused by infectious agents, inflammation, drug hypersensitivity, or underlying disease. Red discoloration of the skin caused by infectious agents, inflammation, drug hypersensitivity, or underlying disease. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Erythema Has Synonym LLT 10015150 MedDRA C3024 Erythema Multiforme Erythema Multiforme A hypersensitivity reaction characterized by the sudden appearance of symmetrical cutaneous and mucocutaneous macular or papular lesions which evolve into lesions with bright red borders (target lesions). The lesions usually appear in the hands, feet, extremities, and face. Symptoms include fever, malaise, sore throat, cough, vomiting, diarrhea, arthralgia, and myalgia. Causes include infections (most commonly herpes simplex virus), drugs (e.g., sulfonamides, anticonvulsants, and antibiotics), malignancies, and collagen vascular disorders. A hypersensitivity reaction characterized by fixed, rapidly evolving lesions that develop from papules or papulovesicles in a sequential manner to a round target-like appearance. The lesions are usually symmetric, may involve palms, soles, and mucous membranes, and may have secondary bullous or purpuric variants. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Erythema multiforme Has Synonym LLT 10015218 MedDRA C113711 Erythrocytosis Erythrocytosis Abnormally high level of red blood cells in the blood. Abnormally high level of red blood cells in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Erythrocytosis Has Synonym LLT 10015276 MedDRA C113469 Esophageal Dysphagia Esophageal Dysphagia Difficulty in swallowing due to an abnormality in the esophagus. Difficulty in swallowing due to an abnormality in the esophagus. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Esophageal dysphagia Has Synonym LLT 10075767 MedDRA C9224 Esophagitis Esophagitis An acute or chronic inflammatory process affecting the esophageal wall. Inflammation of the esophagus as confirmed by histology. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Esophagitis Has Synonym LLT 10015461 MedDRA C34598 Euphoria Euphoria An exaggerated feeling of well-being which is disproportionate to events and stimuli. It may result from psychological causes, organic brain syndromes, or toxic states. Abnormally excessive and unfounded elevation in mood. C87124 Central Nervous System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Euphoria Has Synonym LLT 10015533 MedDRA C4817 Ewing Sarcoma Ewing Sarcoma A small round cell tumor that lacks morphologic, immunohistochemical, and electron microscopic evidence of neuroectodermal differentiation. It represents one of the two ends of the spectrum called Ewing sarcoma/peripheral neuroectodermal tumor. It affects mostly males under age 20, and it can occur in soft tissue or bone. Pain and the presence of a mass are the most common clinical symptoms. A malignant neoplasm of the bone, or the soft tissue adjacent to bone, that is comprised of primitive neuroectodermal cells. C9118 Sarcoma C118464 Pediatric Adverse Events Terminology Ewing's sarcoma Has Synonym LLT 10015560 MedDRA C111884 Exanthem Exanthem A widespread, acute rash. A widespread, acute rash. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Exanthem Has Synonym LLT 10015585 MedDRA C113742 Excessive Bleeding Excessive Bleeding Abnormally heavy or prolonged loss of blood. Abnormally heavy or prolonged loss of blood. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Aggravated bleeding tendency Has Synonym LLT 10066486 MedDRA C113743 Excessive Bruising Excessive Bruising Bruising that is disproportionately high to the amount of trauma received or reported. Bruising that is disproportionally high for the associated trauma. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Bruising Narrower Than LLT 10006504 MedDRA C34599 Excoriation Excoriation Excoriation of Skin Self-inflicted tearing or wearing off of skin. Self-inflicted tearing or wearing off of skin. C36281 Integumentary System Finding C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Excoriation Has Synonym LLT 10049796 MedDRA C39646 Erythroderma Exfoliative Dermatitis Erythroderma A generalized inflammatory cutaneous disorder characterized by erythema and desquamation. A generalized inflammatory cutaneous disorder characterized by erythema and desquamation. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Exfoliative dermatitis Has Synonym LLT 10015665 MedDRA C118763 Exophthalmos Exophthalmos The anterior displacement of the eye within the orbit, giving a bulging appearance. The anterior displacement of the eye within the orbit. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Exophthalmos Has Synonym LLT 10015683 MedDRA C50856 Exsanguination Exsanguination Extensive loss of blood due to internal or external hemorrhage. The extreme loss of blood, which may result in death. C113742 Excessive Bleeding C118464 Pediatric Adverse Events Terminology Exsanguination Has Synonym LLT 10015719 MedDRA C117083 External Compression Headache External Compression Headache Headache resulting from pressure applied to the cutaneous nerves of the head. Headache resulting from pressure applied to the cutaneous nerves of the head. C34661 Headache C118464 Pediatric Adverse Events Terminology External compression headache Has Synonym LLT 10076669 MedDRA C116382 External Hydrocephalus External Hydrocephalus Abnormal increase of cerebrospinal fluid in the subdural space of the brain. Abnormal increase of cerebrospinal fluid in the subdural space of the brain. C3111 Hydrocephalus C118464 Pediatric Adverse Events Terminology External hydrocephalus Has Synonym LLT 10076670 MedDRA C114772 Extracorporeal Circuit Clot Extracorporeal Circuit Clot Thrombus formation within an apparatus that carries blood outside of the body, such as pheresis, dialysis or extracorporeal membrane oxygenation (ECMO). Thrombus formation within an apparatus that carries blood outside of the body, such as pheresis, dialysis or extracorporeal membrane oxygenation (ECMO). C2959 Complication C118464 Pediatric Adverse Events Terminology Clotting of extracorporeal circuit Has Synonym LLT 10052261 MedDRA C3918 Extragonadal Germ Cell Tumor Extragonadal Germ Cell Tumor A germ cell tumor arising in an anatomic site other than the testis or ovary (e.g., central nervous system, lung, mediastinum, and retroperitoneum). A neoplasm arising from gonadal tissue outside the ovary or testes. C3708 Germ Cell Tumor C118464 Pediatric Adverse Events Terminology Extragonadal primary germ cell tumor Broader Than LLT 10073060 MedDRA C114845 Extraosseous Calcification Extraosseous Calcification Deposition of calcium in tissues outside of bone. Deposition of calcium in tissues outside of bone. C9229 Systemic Disorder C118464 Pediatric Adverse Events Terminology Calcinosis Narrower Than LLT 10006938 MedDRA C114939 Extremely Preterm Infant Extremely Preterm Infant Extreme Immaturity A newborn infant less than 28 weeks, 0 days gestational age. A newborn infant less than 28 weeks, 0 days gestational age. C16731 Newborn C118464 Pediatric Adverse Events Terminology Premature baby Has Synonym LLT 10036590 MedDRA C35448 Eye Discharge Eye Discharge Liquid exudate from the eye. Liquid exudate from the eye. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Eye discharge Has Synonym LLT 10015915 MedDRA C118724 Eye Redness Eye Redness The prominence of the superficial vessels of the sclera or conjunctiva resulting in a red or pink appearance. The prominence of the superficial vessels of the sclera or conjunctiva resulting in a red or pink appearance. C99208 Eye Finding C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Eye redness Has Synonym LLT 10015963 MedDRA C26692 Factor I Deficiency Factor I Deficiency Fibrinogen Deficiency|Hypofibrinogenemia A usually inherited blood coagulation disorder characterized by the partial or complete absence of fibrinogen in the blood, resulting in bleeding. A coagulation disorder characterized by the partial or complete absence of fibrinogen (factor I) activity in the blood. C27215 Coagulation Factor Deficiency C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hypofibrinogenemia Has Synonym LLT 10020978 MedDRA C50558 Fall Fall A sudden movement downward, usually resulting in injury. An event which results in an individual coming to rest inadvertently on the ground or lower object. (WHO) C3367 Finding C118464 Pediatric Adverse Events Terminology Fall Has Synonym LLT 10016173 MedDRA C117009 Familial Hemiplegic Migraine Familial Hemiplegic Migraine A migraine disorder characterized by individual and family history of aura that includes motor weakness. A migraine disorder characterized by individual and family history of aura that includes motor weakness. C89715 Migraine C118464 Pediatric Adverse Events Terminology Familial hemiplegic migraine Has Synonym LLT 10067039 MedDRA C3034 Fanconi Syndrome Fanconi Syndrome A genetic or acquired disorder characterized by impairment of the function of the proximal tubules of the kidney. It results in decreased reabsorption of electrolytes, glucose, amino acids, and other nutrients. A constellation of functional abnormalities including aminoaciduria, glycosuria, phosphaturia, renal tubular acidosis, and hypophosphatemia, resulting from decreased reabsorption caused by proximal renal tubule dysfunction. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Fanconi syndrome Has Synonym LLT 10016219 MedDRA C34606 Fasciculation Fasciculation Muscle Twitching The involuntary trembling of one or more muscles. The involuntary trembling of one or more muscles. C36280 Nervous System Finding C118464 Pediatric Adverse Events Terminology Fasciculation Has Synonym LLT 10016225 MedDRA C118860 Fat Adherence Syndrome Fat Adherence Syndrome Violation of Tenon's capsule with prolapse of orbital fat into the sub-Tenon's space. Violation of Tenon's capsule with prolapse of orbital fat into the sub-Tenon's space. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Fat adherence syndrome Has Synonym LLT 10076671 MedDRA C3036 Fatigue Fatigue Overall tiredness and lack of energy. Overall tiredness and lack of energy. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Fatigue Has Synonym LLT 10016256 MedDRA C116503 Febrile Seizure Febrile Seizure A seizure occurring in infants and young children that occurs in the setting of fever. A seizure occurring in infants and young children that occurs in the setting of fever. C2962 Seizure C118464 Pediatric Adverse Events Terminology Febrile seizure Has Synonym LLT 10016290 MedDRA C78498 Fecal Incontinence Fecal Incontinence Involuntary passage of stool from the rectum. Involuntary passage of stool from the rectum. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Fecal incontinence Has Synonym LLT 10016296 MedDRA C113395 Feeding Intolerance Feeding Intolerance Inability to achieve a full feeding volume. Inability to achieve a full feeding volume. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Feeding intolerance Has Synonym LLT 10076042 MedDRA C122445 Feeding Tube Complication Feeding Tube Complication Any problem with a feeding tube or its site of insertion. Any problem with a feeding tube or its site of insertion. C78254 Device Complication C118464 Pediatric Adverse Events Terminology Feeding tube complication Has Synonym LLT 10056661 MedDRA C111766 Fetal Arrhythmia Fetal Arrhythmia A variation from the normal heart rhythm in a fetus. A variation from the normal heart rhythm in a fetus. C92715 Fetal Heart Finding C118464 Pediatric Adverse Events Terminology Fetal arrhythmia Has Synonym LLT 10054723 MedDRA C92782 Fetal Bradycardia Fetal Bradycardia Baseline Fetal Bradycardia|Bradycardia Fetal A fetal heart rate below 110 bpm that is sustained for longer than 10 minutes. A fetal heart rate below 110 bpm that is sustained for longer than 10 minutes. C92715 Fetal Heart Finding C118464 Pediatric Adverse Events Terminology Fetal bradycardia Has Synonym LLT 10054724 MedDRA C50620 Intrauterine Fetal Death Fetal Death Fetal Demise Death of a fetus after 10 weeks gestation. Death of a fetus after 10 weeks gestation. C90491 Pregnancy Outcome C118464 Pediatric Adverse Events Terminology Fetal death Has Synonym LLT 10076683 MedDRA C92789 Fetal Heart Deceleration Fetal Heart Deceleration Fetal Heart Rate Deceleration A decrease in the fetal heart rate that has a duration of less than 10 minutes. A decrease from the baseline fetal heart rate that has a duration of less than 10 minutes. C92715 Fetal Heart Finding C118464 Pediatric Adverse Events Terminology Fetal heart rate deceleration Has Synonym LLT 10058335 MedDRA C92796 Fetal Tachycardia Fetal Tachycardia Baseline Fetal Tachycardia|Tachycardia Fetal A fetal heart rate above 160 bpm that is sustained for longer than 10 minutes. A fetal heart rate above 160 bpm that is sustained for longer than 10 minutes. C92715 Fetal Heart Finding C92719 Fetal Disorder C118464 Pediatric Adverse Events Terminology Fetal tachycardia Has Synonym LLT 10054725 MedDRA C111910 Fetal Virilization Fetal Virilization Fetal Virilism Inappropriate secondary sex characteristics in the neonate usually due to in utero androgen exposure. The development of male secondary sexual characteristics in a biologically female fetus that is most often due to in utero exposure to androgens. C92711 Fetal Finding C79859 Virilization C118464 Pediatric Adverse Events Terminology Virilism fetal Has Synonym LLT 10054731 MedDRA C114875 Fetus Small for Gestational Age Fetus Small for Gestational Age Fetal Growth Restriction|Fetal SGA|Fetal Small for Gestational Age|IUGR|Intrauterine Growth Restriction A fetus that does not grow beyond the 10th percentile of conventionally accepted weight for gestational age. A fetus that does not grow beyond the 10th percentile of conventionally accepted weight for gestational age. C92711 Fetal Finding C118464 Pediatric Adverse Events Terminology Small for gestational age Narrower Than LLT 10041093 MedDRA C3038 Fever Fever Pyrexia Elevation of body temperature above normal due to inflammatory or immune responses. Elevation of body temperature above normal due to the production of more heat than the body is able to dissipate. C50589 Hyperthermia C118464 Pediatric Adverse Events Terminology Fever Has Synonym LLT 10016558 MedDRA C116602 Fine Motor Delay Fine Motor Delay Delayed acquisition of age appropriate motor milestones that produce small and precise movements. Failure to meet, or late achievement of milestones pertaining to small and precise movements. C89330 Developmental Disorder C118464 Pediatric Adverse Events Terminology Fine motor delay Has Synonym LLT 10066088 MedDRA C76130 First-Degree Burn First Degree Burn A painful injury to the epidermis due to chemical, friction, radiation or thermal exposure. The affected area appears red and blanches when touched. A burn that involves the epidermis characterized by skin redness. C34441 Burn C118464 Pediatric Adverse Events Terminology Burns first degree Has Synonym LLT 10006797 MedDRA C116958 Fisher Syndrome Fisher Syndrome Miller Fisher Syndrome An autoimmune process characterized by the clinical triad of ophthalmoplegia, ataxia, and areflexia. An autoimmune process characterized by the clinical triad of ophthalmoplegia, ataxia, and areflexia. C2889 Autoimmune Disease C118464 Pediatric Adverse Events Terminology Fisher syndrome Has Synonym LLT 10076684 MedDRA C111987 Skin Fissure Fissuring Skin Fissure A narrow break in the skin. A narrow break in the skin. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Skin fissure Has Synonym LLT 10040848 MedDRA C3045 Fistula Fistula Pathologic Fistula Abnormal epithelial-lined communication between two anatomical structures. Abnormal epithelial-lined communication between two structures. C36287 Congenital or Acquired Anatomic Abnormality C118464 Pediatric Adverse Events Terminology Fistula Has Synonym LLT 10016717 MedDRA C122470 Fistula Discharge Fistula Discharge Fistula Drainage The leakage of a substance from a fistula. The leakage of a substance from a fistula. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Fistula discharge Has Synonym LLT 10067143 MedDRA C111986 Fixed Drug Eruption Fixed Drug Eruption Round areas of red-purple reaction in the skin that result after drug exposure; these recur in the same location when the medication is readministered. Round areas of red-purple reaction in the skin that result after drug exposure; these recur in the same location when the medication is readministered. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Fixed drug eruption Has Synonym LLT 10016740 MedDRA C117196 Flat Affect Flat Affect The absence of emotional expressiveness. The absence of emotional expressiveness. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Flat affect Has Synonym LLT 10016759 MedDRA C37954 Flatulence Flatulence A state of excessive gas in the alimentary canal. Gas passed per rectum. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Flatulence Has Synonym LLT 10016766 MedDRA C117266 Flight of Ideas Flight of Ideas Rapid succession of thoughts pertaining to different subjects that are still connected. Rapid succession of thoughts pertaining to different subjects that are still connected. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Flight of ideas Has Synonym LLT 10016777 MedDRA C50808 Vitreous Floater Floaters Vitreous Floater Spots before the eyes caused by opaque cell fragments in the vitreous humor or lens. Vitreous opacities which present as small moving spots in the visual field. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Floaters Has Synonym LLT 10016778 MedDRA C116708 Floppy Infant Floppy Infant Congenital Floppy Infant|Floppy Infant Syndrome|Infantile Hypotonia A syndrome of generalized poor muscle tone and muscle weakness presenting in a newborn infant. A condition characterized by poor muscle tone affecting the craniofacial musculature, trunk and limbs that is due to central or peripheral nervous system abnormalities, myopathies, metabolic disorders, endocrine disorders, and acute or chronic illness, which is usually evident at birth or is identified during early life. C98996 Neonatal Disorder C118464 Pediatric Adverse Events Terminology Floppy infant Has Synonym LLT 10051004 MedDRA C78302 Flu-Like Symptoms Flu-Like Symptoms Influenza-Like Illness Complaints describing a pattern similar to influenza, which may include one or more of the following symptoms: fever, chills, muscle or body aches, cough, sore throat, rhinitis, or fatigue. Complaints describing a pattern similar to influenza, which may include one or more of the following symptoms: fever, chills, muscle or body aches, cough, sore throat, rhinitis, or fatigue. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Flu-like symptoms Has Synonym LLT 10016797 MedDRA C26775 Flushing Flushing Flushed Reddening of the skin from a transient increase in blood flow. Reddening of the skin from a transient increase in blood flow. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Flushing Has Synonym LLT 10016825 MedDRA C50689 Partial Seizure Focal Seizure Partial Seizure A transitory alteration in movement, sensation or autonomic nerve function due to abnormal electric activity in a localized area of the cerebral cortex, usually without change in awareness or alertness. Symptoms vary with different lesion locations and may include but not limited to the motor (e.g. rhythmic muscle contractions in one area of the body), somatosensory and sensory alterations manifested by abnormal numbness, paresthesias or other hallucinations, including several types of aura; autonomic and psychic symptoms, e.g. with changes in speech, thought, personality, mood, sensation of deja vu or hallucinations. A seizure originating in a circumscribed area of the brain. C2962 Seizure C118464 Pediatric Adverse Events Terminology Focal seizures Has Synonym LLT 10016843 MedDRA C116897 Fontanelle Bulging Fontanelle Bulging Bulging Fontanel|Fontanel Bulging Membranous areas between cranial bones in a newborn that appear elevated or full. Membranous areas between cranial bones in a newborn that appear elevated or full. C118807 Newborn or Infant Finding C118464 Pediatric Adverse Events Terminology Fontanelle bulging Has Synonym LLT 10016945 MedDRA C121588 Foreign Body Ingestion Foreign Body Ingestion The swallowing of an item not intended for consumption. The swallowing of an item not intended for consumption. C3671 Injury C118464 Pediatric Adverse Events Terminology Foreign body in digestive system, unspecified Related To LLT 10017009 MedDRA C3046 Fracture Fracture Fracture of Bone A traumatic injury to the bone in which the continuity of the bone is broken. A traumatic injury to the bone in which the continuity of the bone is broken. C3671 Injury C118464 Pediatric Adverse Events Terminology Fracture Has Synonym LLT 10017076 MedDRA C116365 Functional Hearing Loss Functional Hearing Loss Hearing loss in the absence of auditory system pathology. Hearing loss in the absence of auditory system pathology. C35731 Hearing Loss C118464 Pediatric Adverse Events Terminology Hearing loss Narrower Than LLT 10019246 MedDRA C97077 Funisitis Funisitis An acute inflammation of the umbilical cord. It is characterized by the presence of polymorphonuclear cells migrating from the fetal umbilical cord vessels through the umbilical cord towards the bacteria containing amniotic fluid. A neutrophilic infiltrate arising from fetal vessels of the umbilical cord extending past the umbilical vessel wall into Wharton's Substance and oriented towards the amniotic cavity. C92719 Fetal Disorder C118464 Pediatric Adverse Events Terminology Funisitis Has Synonym LLT 10064502 MedDRA C34630 Gagging Gagging The sudden, coordinated, involuntary contraction of pharyngeal muscles in an attempt to prevent any matter from passing into the posterior pharynx; it is stimulated by touching the posterior palate, tongue, or pharynx, or by psychic stimuli. The sudden, coordinated, involuntary contraction of pharyngeal muscles in an attempt to prevent any matter from passing into the posterior pharynx; it is stimulated by touching the posterior palate, tongue, or pharynx, or by psychic stimuli. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Gagging Has Synonym LLT 10017572 MedDRA C122478 Gait Unsteady Gait Unsteady A shaky or wobbly manner of walking. A shaky or wobbly manner of walking. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Gait unsteady Has Synonym LLT 10017589 MedDRA C113343 Galactorrhea Galactorrhea Nipple Discharge Excessive secretion of breast milk. Milky discharge from the nipple unrelated to lactation. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Galactorrhea Has Synonym LLT 10017592 MedDRA C115967 Gangrenous Umbilical Hernia Gangrenous Umbilical Hernia A protrusion of necrotic tissue through the abdominal wall under the skin near the umbilicus. A protrusion of necrotic tissue through the abdominal wall under the skin near the umbilicus. C34685 Hernia C118464 Pediatric Adverse Events Terminology Umbilical hernia gangrenous Has Synonym LLT 10045460 MedDRA C26780 Gastritis Gastritis Inflammation of the stomach. Inflammation of the stomach. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Gastritis Has Synonym LLT 10017853 MedDRA C34632 Gastroenteritis Gastroenteritis An inflammatory disorder that affects the upper and lower gastrointestinal tract. Most commonly, this is attributed to viruses; however bacteria, parasites or adverse reactions can also be the culprit. Symptoms include acute diarrhea and vomiting. Inflammation of the stomach and small intestine. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Gastroenteritis Has Synonym LLT 10017888 MedDRA C113396 Infantile Gastroesophageal Reflux Gastroesophageal Reflux Infant Reflux|Infant Regurgitation|Spilling|Spitting Up Effortless regurgitation of gastric contents that commonly occurs in infants, usually right after feeding or burping. Effortless regurgitation of food, milk, and saliva that commonly occurs in infants, usually right after feeding or burping. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Gastroesophageal reflux Has Synonym LLT 10017924 MedDRA C26781 Gastroesophageal Reflux Disease Gastroesophageal Reflux Disease GERD A chronic disorder characterized by reflux of the gastric and/or duodenal contents into the distal esophagus. It is usually caused by incompetence of the lower esophageal sphincter. Symptoms include heartburn and acid indigestion. It may cause injury to the esophageal mucosa. Reflux of stomach contents with symptoms and/or complications from the reflux act. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Gastroesophageal reflux disease Has Synonym LLT 10066874 MedDRA C48592 Gastrointestinal Hemorrhage Gastrointestinal Bleed Gastrointestinal Hemorrhage Bleeding originating from any part of the gastrointestinal tract. Hemorrhage originating at any site located within the gastrointestinal tract. C26791 Hemorrhage C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Gastrointestinal bleed Has Synonym LLT 10017935 MedDRA C80512 Gastroparesis Gastroparesis Paralysis of the muscles of the stomach wall resulting in delayed emptying of the gastric contents into the small intestine. Paralysis of the muscles of the stomach wall resulting in delayed emptying of the gastric contents into the small intestine. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Gastroparesis Has Synonym LLT 10018043 MedDRA C122646 Gastrostomy Site Gastrostomy Site A surgically created external opening into the stomach. A surgically created external opening into the stomach. C122638 Ostomy Site C118464 Pediatric Adverse Events Terminology C99138 Germinal Matrix Hemorrhage of the Newborn Germinal Matrix Hemorrhage of Newborn Grade 1 Intraventricular (Nontraumatic) Hemorrhage of Fetus and Newborn|Grade 1 Intraventricular Hemorrhage of the Newborn|Intraventricular (Nontraumatic) Hemorrhage, Grade 1, of Fetus and Newborn|Intraventricular Hemorrhage of Newborn Grade 1|Subependymal Germinal Matrix Hemorrhage of Newborn Bleeding into the thick layer of immature cells under the ependymal lining at the ventrolateral aspect of the lateral cerebral ventricles of a newborn. Bleeding into the thick layer of immature cells under the ependymal lining at the ventrolateral aspect of the lateral cerebral ventricles. C50896 Intraventricular Hemorrhage C98996 Neonatal Disorder C118464 Pediatric Adverse Events Terminology Germinal matrix hemorrhage Has Synonym LLT 10066952 MedDRA C34636 Gingivitis Gingivitis A disorder involving inflammation of the gums; may affect surrounding and supporting structures of the teeth. Inflammation of the gums. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Gingivitis Has Synonym LLT 10018292 MedDRA C26782 Glaucoma Glaucoma Increased pressure in the eyeball due to obstruction of the outflow of aqueous humor. Optic nerve damage secondary to increased intraocular pressure. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Glaucoma Has Synonym LLT 10018304 MedDRA C34642 Globus Hystericus Globus Persistent or intermittent non-painful sensation of a lump or foreign body in the throat occurring between meals in the absence of dysphagia, odynophagia, evidence of gastroesophageal acid reflux, or histopathogically based esophageal motility disorders. Persistent or intermittent non-painful sensation of a lump or foreign body in the throat occurring between meals in the absence of dysphagia, odynophagia, evidence of gastroesophageal acid reflux, or histopathologically based esophageal motility disorders. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Globus feeling in pharynx Has Synonym LLT 10051180 MedDRA C112199 Glossitis Glossitis Inflammation of the tongue. Inflammation of the tongue. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Glossitis Has Synonym LLT 10018386 MedDRA C34646 Glucose Intolerance Glucose Intolerance The inability to regulate blood glucose levels resulting in hyperglycemia. The impairment of glucose metabolism, which results in hyperglycemia. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Glucose intolerance Has Synonym LLT 10052426 MedDRA C113217 Gonadotropin-Dependent Precocious Puberty Gonadotropin-Dependent Precocious Puberty Central Precocious Puberty|Gonadotropin-releasing Hormone-dependent Precocious Puberty|True Precocious Puberty Premature onset of sexual development triggered by the premature secretion of gonadotropins. Precocious puberty due to premature activation of the hypothalamic-pituitary-gonadal axis. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Gonadotropin dependent precocious puberty Has Synonym LLT 10075911 MedDRA C113219 Gonadotropin-Independent Precocious Puberty Gonadotropin-Independent Precocious Puberty Peripheral Precocious Puberty Premature development of secondary sexual characteristics due to the presence of sex steroids independent of pituitary gonadotropin release. Precocious puberty due to increased secretion of gonadal sex steroids independent of pituitary gonadotropin release. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Gonadotropin independent precocious puberty Has Synonym LLT 10075904 MedDRA C3063 Graft Versus Host Disease Graft Versus Host Disease GvHD A reaction, which may be fatal, in an immunocompromised subject (host) who has received an antigenically incompatible tissue transplant (graft) from an immunocompetent donor. The reaction is secondary to the activation of the transplanted cells against those host tissues that express an antigen not expressed by the donor, and is seen most commonly following bone marrow transplantation; acute disease is seen after 5-40 days, and chronic disease occurs weeks to months after transplantation. A reaction, which may be fatal, in an immunocompromised subject (host) who has received an antigenically incompatible tissue transplant (graft) from an immunocompetent donor. The reaction is secondary to the activation of the transplanted cells against those host tissues that express an antigen not expressed by the donor, and is seen most commonly following stem cell transplantation; acute disease is seen after 5-40 days, and chronic disease occurs weeks to months after transplantation. C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Graft versus host disease Has Synonym LLT 10018651 MedDRA C3064 Granuloma Granuloma An inflammatory reaction usually caused by infectious organisms, foreign bodies, or cholesterol deposits. It is characterized by the presence of epithelioid histiocytes and chronic inflammation. A lesion characterized by the presence of epithelioid histiocytes and chronic inflammation. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Granuloma Has Synonym LLT 10018691 MedDRA C3071 Graves Disease Graves Disease Basedow Disease Hyperthyroidism associated with diffuse hyperplasia of the thyroid gland (goiter), resulting from production of antibodies that are directed against the thyrotropin receptor complex of the follicular epithelial cells. As a result, the thyroid gland enlarges and secrets increased amounts of thyroid hormones. An autoimmune condition characterized by excessive immunoglobulin stimulation of the thyroid gland resulting in hyperthyroidism. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Graves' disease Has Synonym LLT 10018706 MedDRA C114702 Gross Hematuria Gross Hematuria Visible Hematuria The visible presence of blood in the urine. The visible presence of blood in the urine. C36286 Urinary System Finding C118464 Pediatric Adverse Events Terminology Frank hematuria Has Synonym LLT 10060539 MedDRA C116601 Gross Motor Delay Gross Motor Delay Abnormally late development of the coordination of the muscles, bones, and/or nerves that produces whole body and large muscle group movements. Failure to meet, or late achievement of motor milestones pertaining to large muscles that control fundamental movement patterns, including locomotion, body manipulation and object control. C116943 Motor Developmental Delay C118464 Pediatric Adverse Events Terminology Gross motor delay Has Synonym LLT 10069118 MedDRA C113100 Growth Failure Growth Failure Linear Growth Failure Less than normal linear growth in an infant or child. Subnormal linear growth rate in an infant, child, or adolescent based on the normative values for the age and sex of the reference population. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Growth failure Has Synonym LLT 10071095 MedDRA C112835 Growth Hormone Deficiency Growth Hormone Deficiency GH Deficiency|Somatotropin Deficiency Insufficient production of growth hormone. Insufficient growth hormone secretion. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Growth hormone deficiency Has Synonym LLT 10056438 MedDRA C112834 Growth Hormone Excess Growth Hormone Excess Overproduction of growth hormone, a protein-based peptide that stimulates growth, cell reproduction, and cell regeneration. Persistently elevated serum concentration of growth hormone. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Growth hormone excess Has Synonym LLT 10018750 MedDRA C116345 Guillain-Barre Syndrome Guillain-Barre Syndrome A rapidly progressive autoimmune disorder of the peripheral nervous system characterized by limb paresthesias, areflexia, and generalized muscle weakness or paralysis that often begins in the legs and spreads to the arms, torso, and face. A progressive autoimmune disorder of the peripheral nervous system characterized by respiratory insufficiency, limb paresthesias, areflexia, and generalized muscle weakness or paralysis that often begins in the legs and spreads to the arms, torso, and face. C2889 Autoimmune Disease C118464 Pediatric Adverse Events Terminology Guillain-Barre syndrome Has Synonym LLT 10018767 MedDRA C118177 Gustatory Hallucination Gustatory Hallucination Perception of a taste in the absence of a corresponding stimulus. Perception of a taste in the absence of a corresponding stimulus. C37961 Hallucination C118464 Pediatric Adverse Events Terminology Hallucination gustatory Has Synonym LLT 10019065 MedDRA C3073 Gynecomastia Gynecomastia Development of breast tissue in males. Presence of breast tissue in males. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Gynecomastia Has Synonym LLT 10018801 MedDRA C118456 Hair Tourniquet Hair Tourniquet Hair-Thread Tourniquet Syndrome A condition in which a hair or thread becomes wrapped around a digit obstructing blood flow. A condition in which a hair or thread becomes wrapped around a digit obstructing blood flow. C3671 Injury C118464 Pediatric Adverse Events Terminology Hair-thread tourniquet syndrome Has Synonym LLT 10063966 MedDRA C37961 Hallucination Hallucination A false sensory perception in the absence of an external stimulus, as distinct from an illusion which is a misperception of an external stimulus. Perception of an object or event without an external source or stimulus; which is perceived as real. C63711 Sensory Disorder C118464 Pediatric Adverse Events Terminology Hallucination Has Synonym LLT 10019063 MedDRA C112829 Harlequin Reaction Harlequin Reaction Transient blanching of the lower half of the body while in the lateral recumbent position, most commonly seen in premature or low birth weight infants. Transient blanching of the lower half of the body while in the lateral recumbent position, most commonly seen in premature or low birth weight infants. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Harlequin skin reaction Has Synonym LLT 10074977 MedDRA C27191 Hashimoto Thyroiditis Hashimoto Thyroiditis Chronic Lymphocytic Thyroiditis|Hashimoto Disease|Hashimoto's Disease|Hashimoto's Thyroiditis|Lymphocytic Thyroiditis An autoimmune disorder caused by the production of autoantibodies against thyroid tissue. There is progressive destruction of the thyroid follicles leading to hypothyroidism. An autoimmune disorder characterized by inflammation and lymphocytic infiltration of the thyroid gland, sometimes associated with reduced thyroid function. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Hashimoto's disease Has Synonym LLT 10019166 MedDRA C113147 Hashitoxicosis Hashitoxicosis Hashimoto Toxicosis Severe, transient hyperthyroidism associated with Hashimoto thyroiditis. Transient hyperthyroidism associated with Hashimoto thyroiditis. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Hashitoxicosis Has Synonym LLT 10067873 MedDRA C34661 Headache Headache Pain in various parts of the head, not confined to the area of distribution of any nerve. Head pain or discomfort. C87124 Central Nervous System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Headache Has Synonym LLT 10019211 MedDRA C35731 Hearing Loss Hearing Loss A partial or complete loss of hearing in one or both ears. It is classified as conductive, sensory, or central. Impaired ability to hear. C63711 Sensory Disorder C118464 Pediatric Adverse Events Terminology Hearing loss Has Synonym LLT 10019246 MedDRA C50577 Heart Failure Heart Failure Cardiac Failure Inability of the heart to pump blood at an adequate rate to meet tissue metabolic requirements. Clinical symptoms of heart failure include: unusual dyspnea on light exertion, recurrent dyspnea occurring in the supine position, fluid retention or rales, jugular venous distension, pulmonary edema on physical exam, or pulmonary edema on chest x-ray presumed to be cardiac dysfunction. Inability of the heart to meet tissue metabolic requirements. C3079 Heart Disorder C118464 Pediatric Adverse Events Terminology Heart failure Has Synonym LLT 10019279 MedDRA C34670 Heartburn Heartburn Abdominal discomfort with retrosternal pain usually associated with gastroesophageal reflux.. Abdominal discomfort with retrosternal pain usually associated with gastroesophageal reflux. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Heartburn Has Synonym LLT 10019326 MedDRA C3085 Hemangioma Hemangioma A benign vascular lesion characterized by the formation of capillary-sized or cavernous vascular channels. A benign, vascular neoplasm characterized by the formation of capillary-sized vascular channels. C3262 Neoplasm C118464 Pediatric Adverse Events Terminology Hemangioma Has Synonym LLT 10019386 MedDRA C98936 Hematochezia Hematochezia Bloody Stool The passage of fresh blood from the anus. The blood is usually seen in the stools. The most common cause is lower gastrointestinal tract hemorrhage. The presence of fresh blood mixed in the fecal matter; usually as a result of lower gastrointestinal tract hemorrhage. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Hematochezia Has Synonym LLT 10060544 MedDRA C50579 Hematoma Hematoma A localized collection of blood, usually clotted, in an organ, space, or tissue, due to a break in the wall of a blood vessel. A localized collection of extra vascular blood. C36287 Congenital or Acquired Anatomic Abnormality C118464 Pediatric Adverse Events Terminology Hematoma Has Synonym LLT 10019428 MedDRA C3090 Hematuria Hematuria Blood in the urine. Blood in the urine. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Hematuria Has Synonym LLT 10019450 MedDRA C118731 Hemianopsia Hemianopsia Lack of sight in half of the normal field of vision. Lack of sight in half of the normal field of vision. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Hemianopsia Has Synonym LLT 10019458 MedDRA C117081 Hemicrania Continua Hemicrania Continua A unilateral headache of moderate intensity with exacerbations of severe pain, not attributed to another disorder, that continuously persists for more than three months, and presents with ipsilateral autonomic symptoms during exacerbations. A unilateral headache of moderate intensity with exacerbations of severe pain, not attributed to another disorder, that continuously persists for more than three months, and presents with ipsilateral autonomic symptoms during exacerbations. C89715 Migraine C118464 Pediatric Adverse Events Terminology Cephalalgia Narrower Than LLT 10008011 MedDRA C122583 Hemiparesis Hemiparesis Weakness or incomplete paralysis of either the left or right side of the body. Weakness or incomplete paralysis of either the left or right side of the body. C4731 Neuropathy C118464 Pediatric Adverse Events Terminology Hemiparesis Has Synonym LLT 10019465 MedDRA C114724 Hemodialysis Catheter Infection Hemodialysis Catheter Infection A local or systemic infection associated with the use of a hemodialysis catheter. A local or systemic infection associated with the use of a hemodialysis catheter. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Catheter infection Narrower Than LLT 10051387 MedDRA C114728 Hemodialysis Catheter-Associated Bacteremia Hemodialysis Catheter-Associated Bacteremia The presence of bacteria in the blood caused by an infected hemodialysis catheter. A bacteremia resulting from an infection of a hemodialysis catheter. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Catheter bacteremia Narrower Than LLT 10062979 MedDRA C122507 Hemoglobin A1c Increased Hemoglobin A1c Increased A laboratory test result demonstrating an increase in the glycosylated hemoglobin in a blood sample. A laboratory test result demonstrating an increase in the glycosylated hemoglobin in a blood sample. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hemoglobin A1C increased Has Synonym LLT 10051578 MedDRA C80085 Hemoglobin Decreased Hemoglobin Decreased A laboratory test result demonstrating decreased levels of hemoglobin in a biological specimen. A laboratory test result demonstrating decreased levels of hemoglobin in a biological specimen. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hemoglobin decreased Has Synonym LLT 10019483 MedDRA C34677 Hemoglobinuria Hemoglobinuria A laboratory test result which indicates free hemoglobin in the urine. The presence of hemoglobin in the urine. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Hemoglobinuria Has Synonym LLT 10019489 MedDRA C37965 Hemolysis Hemolysis Disruption of the integrity of the erythrocyte membrane causing release of hemoglobin. Red blood cell rupture with resulting release of hemoglobin into the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hemolysis Has Synonym LLT 10019491 MedDRA C75545 Hemolytic Uremic Syndrome Hemolytic Uremic Syndrome HUS|Hemolytic-Uremic Syndrome Acute kidney injury associated with microangiopathic hemolytic anemia and thrombocytopenia. Acute kidney injury associated with microangiopathic hemolytic anemia and thrombocytopenia. C26323 Hematologic Disorder C118464 Pediatric Adverse Events Terminology Hemolytic-uremic syndrome Has Synonym LLT 10019516 MedDRA C111644 Hemopericardium Hemopericardium An accumulation of blood within the pericardial sac. An accumulation of blood within the pericardial sac. C101327 Pericardial Anomaly C118464 Pediatric Adverse Events Terminology Hemopericardium Has Synonym LLT 10019517 MedDRA C3094 Hemoptysis Hemoptysis Coughing up blood from the respiratory tract. Coughing up blood from the respiratory tract. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Hemoptysis Has Synonym LLT 10019523 MedDRA C26791 Hemorrhage Hemorrhage Bleeding The flow of blood from a ruptured blood vessel. Loss of blood. C2931 Cardiovascular Disorder C118464 Pediatric Adverse Events Terminology Hemorrhage Has Synonym LLT 10019524 MedDRA C95803 Hemorrhagic Cerebrovascular Accident Hemorrhagic Cerebrovascular Accident Hemorrhagic Stroke An acute episode of focal or global cerebral or spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid hemorrhage. Brain tissue necrosis due to a an intracerebral or subarachnoid bleed. C3390 Cerebrovascular Accident C118464 Pediatric Adverse Events Terminology Hemorrhagic cerebral infarction Has Synonym LLT 10055278 MedDRA C114666 Hemorrhagic Cystitis Hemorrhagic Cystitis Inflammation of the bladder resulting in bloody urine. Inflammation of the bladder resulting in bloody urine. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Hemorrhagic cystitis Has Synonym LLT 10019598 MedDRA C26792 Hemorrhoid Hemorrhoid Dilated veins in the anal canal. Dilated veins in the anal canal. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Hemorrhoids Has Synonym LLT 10019611 MedDRA C50582 Hemothorax Hemothorax A collection of blood in the pleural cavity. The accumulation of blood within the pleural cavity. C45233 Respiratory System Finding C118464 Pediatric Adverse Events Terminology Hemothorax Has Synonym LLT 10019614 MedDRA C34963 Henoch-Schönlein Purpura Henoch-Schönlein Purpura HSP A systemic, usually self-limited immune complex vasculitis, characterized by immunoglobulin A deposition in the small vessels and kidneys. It is manifested with small hemorrhages in the skin, gastrointestinal symptoms, arthritis, and nephropathy. A systemic, usually self-limited immune complex vasculitis, characterized by immunoglobulin A deposition in the small vessels and kidneys. It is manifested with small hemorrhages in the skin, gastrointestinal symptoms, arthritis, and nephropathy. C2931 Cardiovascular Disorder C118464 Pediatric Adverse Events Terminology Henoch-Schonlein purpura Has Synonym LLT 10019617 MedDRA C99111 Heparin Induced Thrombocytopenia Heparin-Induced Thrombocytopenia HIT|Heparin Induced Thrombocytopenia A life-threatening complication of heparin therapy. It results in immune-mediated thrombocytopenia and, in 25-50 percent of the patients, thrombotic complications. A complication of heparin therapy. It results in immune-mediated thrombocytopenia and, in 25-50 percent of the patients, thrombotic complications. C99110 Drug-Induced Thrombocytopenia C3991 Immune Thrombocytopenia C118464 Pediatric Adverse Events Terminology Heparin-induced thrombocytopenia Has Synonym LLT 10072326 MedDRA C35294 Hepatic Mass Hepatic Mass A space-occupying pathologic process that affects the liver parenchyma. A space-occupying pathologic process that affects the liver parenchyma. C3262 Neoplasm C118464 Pediatric Adverse Events Terminology Hepatic mass Has Synonym LLT 10057110 MedDRA C3095 Hepatitis Hepatitis Inflammation of the liver; usually from a viral infection, but sometimes from toxic agents. Inflammation of the liver. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Hepatitis Has Synonym LLT 10019717 MedDRA C3728 Hepatoblastoma Hepatoblastoma A malignant liver neoplasm that occurs almost exclusively in infants, although isolated cases in older children and adults have been reported. Grossly, hepatoblastoma is solid, well circumscribed, and more often solitary than multiple. Microscopically, most of the tumors are composed exclusively of immature hepatocytic elements. About a fourth of hepatoblastomas contain a stromal component that may be undifferentiated or develop into bone or cartilage. The treatment of choice for hepatoblastoma is surgical excision with adjuvant therapy. Liver transplantation is being increasingly used as well. A malignant liver tumor that arises from precursors of hepatocytes. It occurs almost exclusively in infants. The lungs are the most common site of metastasis. C34803 Primary Malignant Liver Neoplasm C118464 Pediatric Adverse Events Terminology Hepatoblastoma Has Synonym LLT 10062001 MedDRA C26946 Hepatocellular Damage Hepatocellular Liver Injury Disruption of hepatocyte function due to liver injury. Perturbation of hepatocyte function due to liver injury. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Hepatocellular injury Has Synonym LLT 10019837 MedDRA C118732 Heteronymous Visual Field Defect Heteronymous Visual Field Defect A bilateral visual field defect on opposite sides of the visual space of each eye (right or left). A bilateral visual field defect on opposite sides of the visual space of each eye (right or left). C118727 Visual Field Defect C118464 Pediatric Adverse Events Terminology Visual field defect Narrower Than LLT 10047555 MedDRA C37966 Hiccough Hiccup Singultus An involuntary contraction of the diaphragm against closed vocal cords, producing the "hic" sound. An involuntary contraction of the diaphragm against closed vocal cords, producing the "hic" sound. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Hiccup Has Synonym LLT 10020038 MedDRA C112190 Hidradenitis Hidradenitis Inflammation of the apocrine sweat glands, characterized by redness, itching, pain or swelling of the sweat glands, usually in the axillae or groin. Inflammation of the apocrine sweat glands, characterized by redness, itching, pain or swelling of the sweat glands, usually in the axillae or groin. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Hidradenitis Has Synonym LLT 10020040 MedDRA C61444 Hirsutism Hirsutism Male-pattern hair growth on a female. Male-pattern hair growth in a female individual. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Hirsutism Has Synonym LLT 10020112 MedDRA C3108 HIV Infection HIV Infection An infection caused by the human immunodeficiency virus. Infection caused by the human immunodeficiency virus. C26726 Infectious Disorder C118464 Pediatric Adverse Events Terminology HIV infection Has Synonym LLT 10020161 MedDRA C9357 Hodgkin Lymphoma Hodgkin Lymphoma Hodgkin's Disease|Hodgkin's Lymphoma A lymphoma, previously known as Hodgkin's disease, characterized by the presence of large tumor cells in an abundant admixture of nonneoplastic cells. There are two distinct subtypes: nodular lymphocyte predominant Hodgkin lymphoma and classical Hodgkin lymphoma. Hodgkin lymphoma involves primarily lymph nodes. A malignant neoplasm of the lymphatic system that is comprised of abnormal lymphocytes and is characterized by the presence of Reed-Sternberg cells. C3208 Lymphoma C118464 Pediatric Adverse Events Terminology Hodgkin's lymphoma Has Synonym LLT 10020328 MedDRA C118205 Homicidal Ideation Homicidal Ideation Thinking about ending or making plans to end another's life. Thinking about ending or making plans to end another's life. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Homicidal ideation Has Synonym LLT 10049666 MedDRA C118733 Homonymous Visual Field Defect Homonymous Visual Field Defect A bilateral visual field defect on the same side of visual space of each eye (right or left). A bilateral visual field defect on the same side of visual space of each eye (right or left). C118727 Visual Field Defect C118464 Pediatric Adverse Events Terminology Visual field defect Narrower Than LLT 10047555 MedDRA C28155 Horner Syndrome Horner Syndrome Interruption of sympathetic innervation to eye and face. Interruption of sympathetic nerve innervation to eye and face. C2934 Central Nervous System Disorder C118464 Pediatric Adverse Events Terminology Horner's syndrome Has Synonym LLT 10020392 MedDRA C114847 Human Leukocyte Antigen Sensitization Human Leukocyte Antigen Sensitization Presence of preformed antibodies to donor human leukocyte antigen (HLA). Presence of preformed antibodies to donor human leukocyte antigen (HLA). C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Human leukocyte antigen test positive Has Synonym LLT 10073015 MedDRA C3111 Hydrocephalus Hydrocephalus A disorder characterized by an abnormal increase of cerebrospinal fluid in the ventricles of the brain. An abnormal accumulation of cerebrospinal fluid within the ventricles of the brain. C96413 Brain Disorder C118464 Pediatric Adverse Events Terminology Hydrocephalus Has Synonym LLT 10020508 MedDRA C26796 Hydronephrosis Hydronephrosis Dilation of the urinary collecting space in the kidney. Dilation of the urinary collecting space in the kidney. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Hydronephrosis Has Synonym LLT 10020524 MedDRA C116338 Hydrothorax Hydrothorax The accumulation of serous fluid within the pleural cavity. The accumulation of serous fluid within the pleural cavity. C45233 Respiratory System Finding C118464 Pediatric Adverse Events Terminology Hydrothorax Has Synonym LLT 10048612 MedDRA C34706 Hyperactivity Hyperactivity Increased motor activity that is not goal directed. Increased motor activity that is not goal directed. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Hyperactivity Has Synonym LLT 10020558 MedDRA C116366 Hyperacusis Hyperacusis A disorder in which an individual has an abnormally low noise tolerance, and increased sensitivity to sounds. Abnormally increased perception of sound. C63711 Sensory Disorder C118464 Pediatric Adverse Events Terminology Hyperacusis Has Synonym LLT 10020559 MedDRA C114848 Hyperacute Allograft Rejection Hyperacute Allograft Rejection An immediate rejection of transplanted tissue caused by the presence of preformed antibodies to donor human leukocyte antigens. An immediate rejection of transplanted tissue caused by the presence of preformed antibodies to donor human leukocyte antigens. C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Hyperacute allograft rejection Has Synonym LLT 10076685 MedDRA C113212 Hyperaldosteronemia Hyperaldosteronemia Abnormally high levels of aldosterone in the blood. Abnormally high levels of aldosterone in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hyperaldosteronemia Has Synonym LLT 10075910 MedDRA C113213 Hyperaldosteronism Hyperaldosteronism Aldosteronism Overproduction of aldosterone by the adrenal glands, which may lead to hypokalemia and/or hypernatremia. The condition that results from prolonged exposure to a supranormal concentration of aldosterone, characterized by hypertension, and may include hypokalemia. C36292 Laboratory Test Result C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Hyperaldosteronism Has Synonym LLT 10020571 MedDRA C34703 Hyperalgesia Hyperalgesia Abnormally increased pain sense. Abnormally increased pain sense. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Hyperalgesia Has Synonym LLT 10020573 MedDRA C98950 Hyperammonemia Hyperammonemia Elevated Ammonia Level A laboratory test result demonstrating an increased concentration of ammonia in the blood. A laboratory test result demonstrating an increased concentration of ammonia in the blood. C27120 Electrolyte Disorder C118464 Pediatric Adverse Events Terminology Hyperammonemia Has Synonym LLT 10020576 MedDRA C113755 Hyperamylasemia Hyperamylasemia Elevated Amylase Abnormally high level of amylase in the blood. Abnormally high level of amylase in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hyperamylasemia Has Synonym LLT 10062777 MedDRA C113215 Androgen Excess Hyperandrogenism Androgen Excess Excessive secretion of androgens from the adrenal glands or gonads. Clinical manifestations may include virilization. Excessive secretion of androgens by the adrenal glands and/or gonads. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Hyperandrogenism Has Synonym LLT 10065597 MedDRA C27088 Hyperbilirubinemia Hyperbilirubinemia Abnormally high level of bilirubin in the blood. Excess bilirubin is associated with jaundice. Abnormally high level of bilirubin in the blood. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Hyperbilirubinemia Has Synonym LLT 10020582 MedDRA C3112 Hypercalcemia Hypercalcemia Abnormally high concentration of calcium in the peripheral blood. Abnormally high level of calcium in the blood. C27120 Electrolyte Disorder C118464 Pediatric Adverse Events Terminology Hypercalcemia Has Synonym LLT 10020587 MedDRA C114707 Hypercalciuria Hypercalcuria Abnormally high level of calcium in the urine. Abnormally high level of calcium in the urine. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hypercalciuria Has Synonym LLT 10020590 MedDRA C122721 Hypercarbia Hypercarbia Excessive concentration of carbon dioxide in the blood. Excessive concentration of carbon dioxide in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hypercarbia Has Synonym LLT 10020593 MedDRA C37967 Hypercholesterolemia Hypercholesterolemia A laboratory test result indicating an increased amount of cholesterol in the blood. Abnormally high level of cholesterol in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hypercholesterolemia Has Synonym LLT 10020604 MedDRA C113208 Hypercortisolemia Hypercortisolemia Abnormally high level of cortisol in the blood. Abnormally high levels of cortisol in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hypercortisolemia Has Synonym LLT 10075914 MedDRA C116376 Hyperesthesia Hyperesthesia Increased sensitivity to tactile stimulation. Increased sensitivity to tactile stimulation. C28246 Dysesthesia C118464 Pediatric Adverse Events Terminology Hyperesthesia Has Synonym LLT 10020622 MedDRA C113344 Hyperestrogenism Hyperestrogenism Estrogen Excess Abnormally high level of estrogen. Abnormally high level of estrogen. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hyperestrogenism Has Synonym LLT 10020624 MedDRA C113740 Hyperfibrinogenemia Hyperfibrinogenemia Fibrinogenemia Abnormally high level of fibrinogen in the blood. Abnormally high level of fibrinogen in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hyperfibrinogenemia Has Synonym LLT 10054407 MedDRA C113102 Hyperglucagonemia Hyperglucagonemia Abnormally high levels of glucagon in the blood, which may manifest as hyperglycemia and/or necrolytic migratory erythema. Abnormally high levels of glucagon in the blood, which may manifest as hyperglycemia and/or necrolytic migratory erythema. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hyperglucagonemia Has Synonym LLT 10054410 MedDRA C26797 Hyperglycemia Hyperglycemia Elevated Blood Glucose Abnormally high level of glucose in the blood. Plasma glucose concentration above the reference range. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hyperglycemia Has Synonym LLT 10020639 MedDRA C113348 Hypergonadotropic Hypogonadism Hypergonadotropic Hypogonadism Primary Gonadal Failure Ovarian or testicular dysfunction associated with high levels of gonadotropins. Ovarian or testicular dysfunction that results in high concentrations of gonadotropins. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Primary gonadal failure Has Synonym LLT 10075905 MedDRA C78345 Hyperhidrosis Hyperhidrosis Excessive perspiration. Excessive sweating . C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Hyperhidrosis Has Synonym LLT 10020642 MedDRA C84770 Hyperhomocysteinemia Hyperhomocysteinemia A serious metabolic condition caused by mutations in the MTHFR gene, medications, or nutritional deficiency. It results in increased levels of homocysteine in the blood. Patients with this condition are at an increased risk for recurrent blood clots formation and cardiovascular accidents. Abnormally high level of homocysteine in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hyperhomocysteinemia Has Synonym LLT 10055180 MedDRA C113104 Hyperinsulinemia Hyperinsulinemia Abnormally high levels of insulin in the blood. Blood insulin concentrations above the reference range for age. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hyperinsulinemia Has Synonym LLT 10020643 MedDRA C37968 Hyperkalemia Hyperkalemia Higher than normal levels of potassium in the circulating blood; associated with kidney failure or sometimes with the use of diuretic drugs. Abnormally high level of potassium in the blood. C27120 Electrolyte Disorder C118464 Pediatric Adverse Events Terminology Hyperkalemia Has Synonym LLT 10020647 MedDRA C116575 Hyperkinesia Hyperkinesia Excessive movement. Excessive movement. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Hyperkinesia Has Synonym LLT 10020651 MedDRA C122513 Hyperlactemia Hyperlactemia Elevated Lactate Level Abnormally high level of lactate in the blood. Abnormally high concentration of lactate in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Lactate blood increased Has Synonym LLT 10023651 MedDRA C78435 Hyperlipasemia Hyperlipasemia Elevated Lipase A laboratory test result which indicates increased levels of lipase in a biologic specimen. Abnormally high level of lipase in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hyperlipasemia Has Synonym LLT 10067840 MedDRA C37969 Hypermagnesemia Hypermagnesemia Higher than normal levels of magnesium in the circulating blood. Abnormally high level of magnesium in the blood. C27120 Electrolyte Disorder C118464 Pediatric Adverse Events Terminology Hypermagnesemia Has Synonym LLT 10020670 MedDRA C37970 Hypernatremia Hypernatremia Higher than normal levels of sodium in the circulating blood. Abnormally high level of sodium in the blood. C27120 Electrolyte Disorder C118464 Pediatric Adverse Events Terminology Hypernatremia Has Synonym LLT 10020680 MedDRA C48259 Hyperparathyroidism Hyperparathyroidism Hyperfunction of the parathyroid glands resulting in the overproduction of parathyroid hormone. It may be primary or secondary; primary hyperparathyroidism is caused by parathyroid adenoma, parathyroid hyperplasia, parathyroid carcinoma, and multiple endocrine neoplasia. It is associated with hypercalcemia and hypophosphatemia. Signs and symptoms include weakness, fatigue, nausea, vomiting, constipation, depression, bone pain, osteoporosis, cystic bone lesions, and kidney stones. Secondary hyperparathyroidism is caused by the chronic stimulation of the parathyroid glands in patients with chronic renal failure, rickets, and malabsorption syndromes. Elevated concentration of parathyroid hormone. Causes include conditions originating within the parathyroid glands (primary), in response to hypocalcemia and hyperphosphatemia (secondary), and renal disease (tertiary). Characteristics may include polyuria, polydipsia, constipation, lethargy, cognitive dysfunction, hypercalciuria, nephrolithiasis, and bone demineralization or reduced bone mineral density. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Hyperparathyroidism Has Synonym LLT 10020705 MedDRA C118180 Hyperphagia Hyperphagia Excessive appetite. Excessive appetite. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Hyperphagia Has Synonym LLT 10020710 MedDRA C113750 Hyperphosphatemia Hyperphosphatemia Abnormally high level of phosphate in the blood. Abnormally high level of phosphate in the blood. C27120 Electrolyte Disorder C118464 Pediatric Adverse Events Terminology Hyperphosphatemia Has Synonym LLT 10020712 MedDRA C79731 Skin Hyperpigmentation Hyperpigmentation Darkening of the skin due to excessive melanin deposition. Causes include skin injuries, pregnancy, eczema, and Addison disease. Abnormal darkening of the skin. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Skin hyperpigmentation Has Synonym LLT 10040865 MedDRA C113345 Hyperprogesteronism Hyperprogesteronism Progesterone Excess Abnormally high level of progesterone. Abnormally high level of progesterone. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hyperprogesteronism Has Synonym LLT 10075897 MedDRA C113168 Hyperprolactinemia Hyperprolactinemia Abnormally high level of prolactin in the blood. Supranormal concentration of prolactin. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hyperprolactinemia Has Synonym LLT 10020739 MedDRA C111817 Hyperpyrexia Hyperpyrexia Extreme elevation of body temperature above normal. Extreme elevation of body temperature above normal. C50589 Hyperthermia C118464 Pediatric Adverse Events Terminology Hyperpyrexia Has Synonym LLT 10020741 MedDRA C3114 Hypersensitivity Hypersensitivity Reaction An immune response that occurs following exposure to an innocuous antigen, but that does not require the presence of preformed antibodies to the antigen. An excessive immune system response to a substance that is not usually considered harmful. C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Hypersensitivity reaction Has Synonym LLT 10020756 MedDRA C118189 Hypersexualism Hypersexualism Excessive sexual behavior. Excessive sexual behavior. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Hypersexuality Has Synonym LLT 10066364 MedDRA C78346 Hypersomnia Hypersomnia A sleep disorder characterized by excessive sleepiness. Excessive or prolonged sleep. C3376 Sleep Disorder C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Hypersomnia Has Synonym LLT 10020765 MedDRA C3117 Hypertension Hypertension Blood pressure that is abnormally high. Abnormally high blood pressure. C2931 Cardiovascular Disorder C35552 Cardiovascular System Finding C118464 Pediatric Adverse Events Terminology Hypertension Has Synonym LLT 10020772 MedDRA C50589 Hyperthermia Hyperthermia A condition characterized by an abnormally high body temperature. In a hyperthermic state, the hypothalamic set-point is normal but body temperature increases and overrides the ability to lose heat, resulting from exogenous heat exposure or endogenous heat production. Elevation of body temperature above normal due to the production or absorption of more heat than the body is able to dissipate. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Hyperthermia Has Synonym LLT 10020843 MedDRA C3123 Hyperthyroidism Hyperthyroidism Overactivity of the thyroid gland resulting in overproduction of thyroid hormone and increased metabolic rate. Causes include diffuse hyperplasia of the thyroid gland (Graves' disease), single nodule in the thyroid gland, and thyroiditis. The symptoms are related to the increased metabolic rate and include weight loss, fatigue, heat intolerance, excessive sweating, diarrhea, tachycardia, insomnia, muscle weakness, and tremor. Increased secretion of thyroid hormone(s) by the thyroid gland. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Hyperthyroidism Has Synonym LLT 10020850 MedDRA C87085 Hypertonia Hypertonia Increased Muscle Tone A condition of increased muscle tone manifested by increased resistance of the muscle to passive stretching. Abnormally high muscle tone. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Hypertonia Has Synonym LLT 10020852 MedDRA C79597 Hypertrichosis Hypertrichosis Excessive hair growth anywhere on the body. Excessive hair growth anywhere on the body. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Hypertrichosis Has Synonym LLT 10020864 MedDRA C37971 Hypertriglyceridemia Hypertriglyceridemia A laboratory test result indicating elevated triglyceride concentration in the blood. Abnormally high level of triglycerides in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hypertriglyceridemia Has Synonym LLT 10020870 MedDRA C26997 Hypertrophic Scar Hypertrophic Scar A permanent mark on the skin caused by deposits of excessive amounts of collagen during wound healing. It is elevated and does not extend beyond the original boundaries of the wound; the elevation may stabilize or regress spontaneously. A permanent mark on the skin caused by deposits of excessive amounts of collagen during wound healing. It is elevated and does not extend beyond the original boundaries of the wound; the elevation may stabilize or regress spontaneously. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Hypertrophic scar Has Synonym LLT 10020879 MedDRA C3961 Hyperuricemia Hyperuricemia Elevated blood concentrations of uric acid. Abnormally high level of uric acid in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hyperuricemia Has Synonym LLT 10020907 MedDRA C50590 Hyperventilation Hyperventilation Abnormally prolonged, rapid, and deep breathing. An increase in ventilation manifested by hypocapnea and respiratory alkalosis. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Hyperventilation Has Synonym LLT 10020910 MedDRA C50591 Hypervolemia Hypervolemia Fluid Overload Too much fluid in the blood. Too much fluid in the blood. C9229 Systemic Disorder C118464 Pediatric Adverse Events Terminology Hypervolemia Has Synonym LLT 10020920 MedDRA C50592 Hyphema Hyphema Hemorrhage within the anterior chamber of the eye; bloodshot. Blood in the anterior eye chamber. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Hyphema Has Synonym LLT 10020924 MedDRA C37972 Hypoalbuminemia Hypoalbuminemia Concentration of serum albumin below normal limits for the age related normal range. Concentration of serum albumin below normal limits for the age related normal range. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hypoalbuminemia Has Synonym LLT 10020943 MedDRA C37973 Hypocalcemia Hypocalcemia Lower than normal levels of calcium in the circulating blood. Abnormally low level of calcium in the blood. C27120 Electrolyte Disorder C118464 Pediatric Adverse Events Terminology Hypocalcemia Has Synonym LLT 10020949 MedDRA C114708 Hypocitraturia Hypocitraturia Abnormally low level of citrate in the urine. Abnormally low level of citrate in the urine. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hypocitraturia Has Synonym LLT 10070871 MedDRA C113211 Hypocortisolemia Hypocortisolemia Hypocortisolism Abnormally low level of cortisol in the blood. Abnormally low level of cortisol in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hypocortisolemia Has Synonym LLT 10075908 MedDRA C50445 Hypoesthesia Hypoesthesia Hypesthesia Impairment of tactile sensitivity manifesting as partial loss of sensitivity to sensory stimuli. Decreased sensitivity to tactile stimulation. C28246 Dysesthesia C118464 Pediatric Adverse Events Terminology Hypoesthesia Has Synonym LLT 10020976 MedDRA C116373 Hypogeusia Hypogeusia Decreased ability to taste. Decreased ability to taste. C28246 Dysesthesia C118464 Pediatric Adverse Events Terminology Hypogeusia Has Synonym LLT 10020989 MedDRA C3126 Hypoglycemia Hypoglycemia Abnormally low level of glucose in the blood. Abnormally low level of glucose in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hypoglycemia Has Synonym LLT 10021005 MedDRA C113347 Hypogonadotropic Hypogonadism Hypogonadotropic Hypogonadism Central Hypogonadism Abnormal ovarian or testicular function due to insufficient hormonal stimulation from the hypothalamic-pituitary axis. Hypogonadism due to an intrinsic deficiency of gonadotropin secretion. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Secondary Hypogonadism Hypogonadotrophic hypogonadism Has Synonym LLT 10021012 MedDRA C34718 Hypohidrosis Hypohidrosis Reduced sweating. Causes include burns, dehydration, radiation, and leprosy. Abnormally diminished sweating. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Hypohidrosis Has Synonym LLT 10021013 MedDRA C37974 Hypokalemia Hypokalemia Lower than normal levels of potassium in the circulating blood. Abnormally low level of potassium in the blood. C27120 Electrolyte Disorder C118464 Pediatric Adverse Events Terminology Hypokalemia Has Synonym LLT 10021018 MedDRA C116576 Hypokinesia Hypokinesia Diminished movement. Diminished movement. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Hypokinesia Has Synonym LLT 10021021 MedDRA C37975 Hypomagnesemia Hypomagnesemia Lower than normal levels of magnesium in the circulating blood. Abnormally low level of magnesium in the blood. C27120 Electrolyte Disorder C118464 Pediatric Adverse Events Terminology Hypomagnesemia Has Synonym LLT 10021028 MedDRA C78349 Hypomania Hypomanic Mood A less severe form of mania characterized by elevated mood, hyperactivity, and grandiosity. In contrast to mania, these symptoms do not cause significant impairment of the individual's productivity at work, or social and family relationships. An emotional state characterized by mild to moderate elevation of mood without relevant effect on functioning. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Hypomania Has Synonym LLT 10021030 MedDRA C37976 Hyponatremia Hyponatremia Lower than normal levels of sodium in the circulating blood. Abnormally low level of sodium in the blood. C27120 Electrolyte Disorder C118464 Pediatric Adverse Events Terminology Hyponatremia Has Synonym LLT 10021038 MedDRA C78350 Hypoparathyroidism Hypoparathyroidism An endocrine disorder characterized by decreased production of parathyroid hormone by the parathyroid glands. It is usually caused by damage of the parathyroid glands during head and neck surgery. Signs and symptoms include muscle cramps, abdominal pain, dry skin, brittle nails, cataracts, tetany, and convulsions. Decreased production or secretion of parathyroid hormone by the parathyroid gland, resulting in hypocalcemia due to decreased release of calcium and phosphate from bone matrix, decreased renal calcium reabsorption, and decreased renal production of 1,25-dihydroxyvitamin D-3, which decreases intestinal absorption of calcium. Hypoparathyroidism is also associated with hyperphosphatemia as a result of hypophosphaturia. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Hypoparathyroidism Has Synonym LLT 10021041 MedDRA C121574 Hypophagia Hypophagia Decreased Oral Intake|Poor Oral Intake Reduced ingestion of food. Reduced ingestion of food. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Hypophagia Has Synonym LLT 10063743 MedDRA C116339 Hypophonia Hypophonia The inability to produce speech sounds at normal volume. The inability to produce speech sounds at normal volume. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Hypophonia Has Synonym LLT 10069366 MedDRA C37977 Hypophosphatemia Hypophosphatemia Lower than normal levels of phosphates in the circulating blood. Abnormally low level of phosphate in the blood. C27120 Electrolyte Disorder C118464 Pediatric Adverse Events Terminology Hypophosphatemia Has Synonym LLT 10021059 MedDRA C78610 Skin Hypopigmentation Hypopigmentation Pigment Dilution Abnormal lightening of skin due to decreased melanin production or deposition. Vitiligo, albinism, and leukoderma are among the disorders that are associated with skin hypopigmentation. A condition characterized by an abnormal loss of color to the skin due to the depletion of melanocytes or melanin. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Skin hypopigmentation Related To LLT 10040868 MedDRA C113346 Hypoprogesteronism Hypoprogesteronism Progesterone Deficiency Abnormally low level of progesterone. Abnormally low level of progesterone. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hypoprogesteronism Has Synonym LLT 10075898 MedDRA C50593 Hypopyon Hypopyon An accumulation of pus in the anterior chamber of the eye. Layering of inflammatory cells in the anterior chamber of the eye. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Hypopyon Has Synonym LLT 10021086 MedDRA C116368 Hyposmia Hyposmia Decreased ability to smell. Decreased ability to smell. C28246 Dysesthesia C118464 Pediatric Adverse Events Terminology Hyposmia Has Synonym LLT 10050515 MedDRA C3128 Hypotension Hypotension Low Blood Pressure Blood pressure that is abnormally low. Abnormally low blood pressure, which is usually symptomatic. C35552 Cardiovascular System Finding C118464 Pediatric Adverse Events Terminology Hypotension Has Synonym LLT 10021097 MedDRA C78351 Hypothermia Hypothermia Abnormally low body temperature. Abnormally low body temperature. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Hypothermia Has Synonym LLT 10021113 MedDRA C26800 Hypothyroidism Hypothyroidism Abnormally low levels of thyroid hormone. Reduced secretion of thyroid hormone(s) by the thyroid gland. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Hypothyroidism Has Synonym LLT 10021114 MedDRA C87070 Hypotonia Hypotonia Poor Muscle Tone A condition of decreased tone of the skeletal muscles and diminished resistance to passive stretching. Abnormally low muscle tone. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Hypotonia Has Synonym LLT 10021118 MedDRA C113670 Hypotonic-Hyporesponsive Episode Hypotonic-Hyporesponsive Episode Acute onset of unresponsiveness or diminished level of consciousness, associated with loss of muscle tone and pallor or cyanosis, that occurs within 48 hours after childhood immunizations. It is primarily associated with pertussis-containing vaccines administered to children under two years of age. Acute onset of unresponsiveness or diminished level of consciousness, associated with loss of muscle tone and pallor or cyanosis that occurs within 48 hours after childhood immunizations. It is primarily associated with pertussis-containing vaccines administered to children under two years of age. C87124 Central Nervous System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Hypotonic-hyporesponsive episode Has Synonym LLT 10021121 MedDRA C50594 Hypoventilation Hypoventilation A state in which there is a reduced amount of air entering the pulmonary alveoli. A decrease in ventilation resulting in hypercapnea. C45233 Respiratory System Finding C118464 Pediatric Adverse Events Terminology Hypoventilation Has Synonym LLT 10021133 MedDRA C50595 Hypovolemia Hypovolemia Abnormally decreased volume of circulating fluid (plasma) in body. Too little fluid in the blood. C9229 Systemic Disorder C118464 Pediatric Adverse Events Terminology Hypovolemia Has Synonym LLT 10021139 MedDRA C93047 Hypoxemia Hypoxemia A finding indicating decreased oxygen levels in the blood. A state of oxygen deficiency in arterial blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Hypoxemia Has Synonym LLT 10021142 MedDRA C3890 Hypoxia Hypoxia A decrease in the amount of oxygen in the body. Symptoms range from mild (impaired judgment, memory loss, impaired motor coordination) to severe (seizures and coma). A condition in which there is low oxygen in the tissues. C45233 Respiratory System Finding C118464 Pediatric Adverse Events Terminology Hypoxia Has Synonym LLT 10021143 MedDRA C122642 Ileostomy Site Ileostomy Site A surgically created external opening into the ileum. A surgically created external opening into the ileum. C122645 Enterostomy Site C118464 Pediatric Adverse Events Terminology C37979 Ileus Ileus Decrease in peristalsis in the absence of a mechanical bowel obstruction. Decrease in peristalsis in the absence of a mechanical bowel obstruction. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Ileus Has Synonym LLT 10021328 MedDRA C3446 Idiopathic Thrombocytopenic Purpura Immune Thrombocytopenic Purpura ITP|Idiopathic Thrombocytopenic Purpura An autoimmune disorder in which the number of circulating platelets is reduced due to their antibody-mediated destruction. ITP is a diagnosis of exclusion and is heterogeneous in origin. Disorder characterized by abnormally low level of circulating platelets, usually with normal hemoglobin/red blood cell and white blood cell levels, and thought to be secondary to autoimmune destruction. C3991 Immune Thrombocytopenia C3408 Thrombocytopenia C118464 Pediatric Adverse Events Terminology Idiopathic thrombocytopenic purpura Has Synonym LLT 10021245 MedDRA C122435 Impaired Balance Impaired Balance Loss of Balance A deficit in equilibrium, which may manifest as unsteady ambulation or inability to maintain an upright position. A deficit in equilibrium, which may manifest as unsteady ambulation or inability to maintain an upright position. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Balance difficulty Has Synonym LLT 10004070 MedDRA C117271 Impaired Judgment Impaired Judgement Reduced ability to plan, poor decision making. Reduced ability to plan, poor decision making. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Judgement impaired Has Synonym LLT 10023236 MedDRA C99088 Impetigo Impetigo A contagious bacterial cutaneous infection that affects children and is usually caused by Staphylococcus aureus. It usually presents in the face with honey colored scabs. A bacterial skin infection characterized by red sores or blisters that progress to a honey colored crust. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Impetigo Has Synonym LLT 10021531 MedDRA C93213 Impulsive Behavior Impulsivity Initiation of actions without forethought as to the cost, results or consequences. Behavior characterized by reduced control, planning, or consideration of the consequences. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Impulsive behavior Has Synonym LLT 10060909 MedDRA C122786 Incarcerated Inguinal Hernia Incarcerated Inguinal Hernia The trapping of bowel or omentum inside the inguinal canal that cannot be reduced, resulting in inflammation, pain, nausea, and possible bowel obstruction. The trapping of bowel or omentum inside the inguinal canal that cannot be reduced, resulting in inflammation, pain, nausea, and possible bowel obstruction. C34690 Inguinal Hernia C118464 Pediatric Adverse Events Terminology Incarcerated inguinal hernia Has Synonym LLT 10021613 MedDRA C118734 Incongruent Visual Field Defect Incongruent Visual Field Defect Non-identically shaped visual field defect in the same location in both eyes. Non-identically shaped visual field defect in the same location in both eyes. C118727 Visual Field Defect C118464 Pediatric Adverse Events Terminology Visual field defect Narrower Than LLT 10047555 MedDRA C78249 Increased Creatinine Increased Creatinine Elevated Creatinine A laboratory test result demonstrating an increased concentration of creatinine in a biological specimen. A laboratory test result demonstrating an increased concentration of creatinine in a biological specimen. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Creatinine increased Has Synonym LLT 10011368 MedDRA C54355 Increased Drug Level Increased Drug Level A laboratory test result demonstrating an increased concentration of a specific drug. A laboratory test result demonstrating an increased concentration of a specific drug. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Drug level increased Has Synonym LLT 10013722 MedDRA C117171 Increased Energy Increased Energy Feeling of excessive energy, which may be associated with increased activity. Feeling of excessive energy that may be associated with increased activity. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Energy increased Has Synonym LLT 10048779 MedDRA C78433 Increased Libido Increased Libido Increased sexual desire. An increase in overall desire for sexual activity. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Increased libido Has Synonym LLT 10021669 MedDRA C121630 Increased Respiratory Secretion Increased Respiratory Secretion Increased Respiratory Secretions An increase in respiratory secretions. An increase in respiratory secretions. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Increased bronchial secretion Has Synonym LLT 10062530 MedDRA C34692 Indirect Inguinal Hernia Indirect Inguinal Hernia A protrusion of the abdominal cavity contents into the inguinal canal through the deep and superficial inguinal rings. The protrusion of abdominal cavity contents into the inguinal canal, lateral to the inferior epigastric vessels. C34690 Inguinal Hernia C118464 Pediatric Adverse Events Terminology Indirect inguinal hernia Has Synonym LLT 10021715 MedDRA C25534 Induration Induration The quality of being hard, the process of hardening, or an abnormally hard spot or place, particularly of the skin. The quality of being hard, the process of hardening, or an abnormally hard spot or place, particularly of the skin. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Induration Has Synonym LLT 10060708 MedDRA C122587 Indwelling Urinary Catheter Indwelling Urinary Catheter A hollow tube that is inserted and left in the bladder to promote the drainage of urine. A hollow tube that is inserted and left in the bladder to promote the drainage of urine. C62103 Device C118464 Pediatric Adverse Events Terminology C117267 Infant Irritability Infant Irritability Irritability, Infant Crying easily, difficult to console. Crying easily, difficult to console. C118807 Newborn or Infant Finding C118464 Pediatric Adverse Events Terminology Irritability Narrower Than LLT 10022998 MedDRA C118423 Infantile Cortical Hyperostosis Infantile Cortical Hyperostosis Caffey Disease A self-limited inflammatory disorder of unknown etiology found in infants that causes swelling of the soft tissue, changes to bone, and irritability. An autosomal dominant condition caused by mutation(s) in the COL1A1 gene encoding the collagen alpha-1(I) chain. This disease is an acute inflammatory condition of infancy that causes soft tissue swelling (mostly of chin/cheeks), bone thickening/widening (particularly of the mandible/clavicles/long bones), pain, and irritability. This disease generally resolves by the 3rd year of life, although some bony deformity may persist. C89328 Pediatric Disorder C118464 Pediatric Adverse Events Terminology Infantile cortical hyperostosis Has Synonym LLT 10073206 MedDRA C116529 Infantile Spasm Infantile Spasms Seizures in the first years of life characterized by flexion and extension jerks of the neck, trunk, and extremities. Seizures in the first years of life characterized by flexion and extension jerks of the neck, trunk, and extremities. C2962 Seizure C118464 Pediatric Adverse Events Terminology Infantile spasms Has Synonym LLT 10021750 MedDRA C26726 Infectious Disorder Infectious Disorder Clinical Infection|ID|Infectious Disease A disorder resulting from the presence and activity of a microbial, viral, fungal, or parasitic agent. It can be transmitted by direct or indirect contact. A disorder resulting from the presence and activity of a microbial, viral, fungal, or parasitic agent. It can be transmitted by direct or indirect contact. C2991 Disease or Disorder C118464 Pediatric Adverse Events Terminology Infection Has Synonym LLT 10021789 MedDRA C118749 Infectious Keratitis Infectious Keratitis Inflammation of the cornea secondary to an infectious process. Inflammation of the cornea secondary to an infectious process. C26805 Keratitis C118464 Pediatric Adverse Events Terminology Infective keratitis Has Synonym LLT 10076672 MedDRA C78599 Infectious Rhinitis Infectious Rhinitis Non-Allergic Rhinitis An inflammatory process affecting the nasal mucosa, usually caused by viruses (e.g., rhinovirus, adenovirus, parainfluenza virus, and coronavirus). It is characterized by chills, headaches, mucopurulent nasal discharge, coughing, and facial pain. Inflammation of the mucous membrane lining the nose due to infection. C26726 Infectious Disorder C118464 Pediatric Adverse Events Terminology Infective rhinitis Has Synonym LLT 10021921 MedDRA C35298 Inferior Vena Cava Occlusion Inferior Vena Cava Occlusion Blockage of the lumen of the inferior vena cava. Blockage of the lumen of the inferior vena cava. C99137 Great Vessels Abnormality C118464 Pediatric Adverse Events Terminology Inferior vena caval occlusion Has Synonym LLT 10058987 MedDRA C111645 Inferior Vena Cava Stenosis Inferior Vena Cava Stenosis Abnormal narrowing of the lumen of the inferior vena cava. Abnormal narrowing of the lumen of the inferior vena cava. C99137 Great Vessels Abnormality C118464 Pediatric Adverse Events Terminology Inferior vena cava stenosis Has Synonym LLT 10074639 MedDRA C3138 Inflammatory Bowel Disease Inflammatory Bowel Disease A spectrum of small and large bowel inflammatory diseases of unknown etiology. It includes Crohn's disease, ulcerative colitis, and colitis of indeterminate type. Chronic inflammatory process affecting the gastrointestinal tract; primarily ulcerative colitis and Crohn's disease. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Inflammatory bowel disease Has Synonym LLT 10021972 MedDRA C53482 Influenza Influenza Flu An acute viral infection of the respiratory tract, occurring in isolated cases, in epidemics, or in pandemics; it is caused by serologically different strains of viruses (influenzaviruses) designated A, B, and C, has a 3-day incubation period, and usually lasts for 3 to 10 days. It is marked by inflammation of the nasal mucosa, pharynx, and conjunctiva; headache; myalgia; often fever, chills, and prostration; and occasionally involvement of the myocardium or central nervous system. An acute viral infection of the respiratory tract, occurring in isolated cases, in epidemics, or in pandemics; it is caused by serologically different strains of viruses (influenzaviruses) designated A, B, and C, has a 3-day incubation period, and usually lasts for 3 to 10 days. It is marked by inflammation of the nasal mucosa, pharynx, and conjunctiva; headache; myalgia; often fever, chills, and prostration; and occasionally involvement of the myocardium or central nervous system. C3439 Viral Infection C118464 Pediatric Adverse Events Terminology Influenza Has Synonym LLT 10022000 MedDRA C34690 Inguinal Hernia Inguinal Hernia The protrusion of a sac-like structure containing fibroadipose tissue through an abnormal opening in the inguinal region. The protrusion of the contents of the abdominal cavity into the inguinal canal. C34685 Hernia C118464 Pediatric Adverse Events Terminology Inguinal hernia Has Synonym LLT 10022016 MedDRA C118713 Inherited Color Blindness Inherited Color Blindness Genetic based difficulty in distinguishing colors. Genetic based difficulty in distinguishing colors. C3891 Color Blindness C118464 Pediatric Adverse Events Terminology Color blindness Narrower Than LLT 10010016 MedDRA C117167 Inner Restlessness Inner Restlessness A feeling of unrest and/or an inability to feel calm or relaxed. A feeling of unrest and/or an inability to feel calm or relaxed. C87124 Central Nervous System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Restlessness Has Synonym LLT 10038743 MedDRA C78366 INR Increased INR Increased Elevated Prothrombin Time International Normalized Ratio|Supratherapeutic International Normalized Ratio A laboratory test result demonstrating an increased ratio of the patient's prothrombin time to a control sample. A laboratory test result demonstrating an increased ratio of the patient's prothrombin time to a control sample. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology INR increased Has Synonym LLT 10022402 MedDRA C28286 Insomnia Insomnia A sleep disorder characterized by difficulty in falling asleep and/or remaining asleep. Difficulty in falling asleep and/or remaining asleep. C3376 Sleep Disorder C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Insomnia Has Synonym LLT 10022437 MedDRA C113101 Insulin Resistance Insulin Resistance Decreased sensitivity to circulating insulin which may result in acanthosis nigicrans, elevated insulin level or hyperglycemia. Decreased insulin signaling such that the glycemic response to a given amount of insulin is reduced. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Insulin resistance Has Synonym LLT 10022489 MedDRA C113169 Insulin Resistance Syndrome Insulin Resistance Syndrome A cluster of closely related metabolic abnormalities associated with insulin resistance that confer an increased risk of the development of type 2 diabetes and cardiovascular disease. These abnormalities may include obesity, high blood pressure, abnormal cholesterol levels, proteinuria, and/or polycystic ovary syndrome. A cluster of closely related metabolic abnormalities associated with insulin resistance that confer an increased risk of the development of type 2 diabetes and cardiovascular disease. These abnormalities may include obesity, high blood pressure, abnormal cholesterol levels, proteinuria, and/or polycystic ovary syndrome. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Insulin resistance syndrome Has Synonym LLT 10022490 MedDRA C95598 Pancreatic Insulinoma Insulinoma An insulin-producing neuroendocrine tumor arising from the beta cells of the pancreas. Patients exhibit symptoms related to hypoglycemia due to inappropriate secretion of insulin. A usually benign tumor of insulin secreting pancreatic beta cells, associated with hypoglycemia. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Insulinoma Has Synonym LLT 10022498 MedDRA C101034 Intentional Trauma Intentional Trauma Non-accidental Trauma|Nonaccidental Trauma An injury that is not the result of an accident or natural causes. An injury that is not the result of an accident or natural causes. C3671 Injury C118464 Pediatric Adverse Events Terminology Intentional injury Has Synonym LLT 10022521 MedDRA C87087 Intercostal Retractions Intercostal Retractions Intercostal Recession The marked inward movement of the muscles between the ribs during inhalation, indicating that there is reduced pressure in the thoracic cavity, and which can be a sign of breathing difficulties. The marked inward movement of the muscles between the ribs during inhalation, indicating that there is reduced pressure in the thoracic cavity, and which can be a sign of breathing difficulties. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Intercostal retraction Has Synonym LLT 10022533 MedDRA C35110 Intermediate Uveitis Intermediate Uveitis Pars Planitis Inflammation of the pars plana. Inflammation of the pars plana. C26909 Uveitis C118464 Pediatric Adverse Events Terminology Intermediate uveitis Has Synonym LLT 10022557 MedDRA C92816 Intermittent Deceleration Intermittent Fetal Heart Rate Deceleration Intermittent Deceleration Fetal heart rate decelerations that occur with less than 50 percent of uterine contractions within a 20 minute timeframe. Fetal heart rate decelerations that occur with less than 50 percent of uterine contractions within a 20 minute timeframe. C92789 Fetal Heart Deceleration C118464 Pediatric Adverse Events Terminology Intermittent fetal heart rate deceleration Has Synonym LLT 10074646 MedDRA C34596 Internal Strabismus Internal Strabismus Esotropia A form of strabismus in which one or both eyes are deviated medially. A form of strabismus in which one or both eyes are deviated medially. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Esotropia Has Synonym LLT 10015475 MedDRA C118742 Intraocular Foreign Body Intraocular Foreign Body External material inside the eyeball. Retained foreign body inside the eye, as a result of a penetrating open globe injury. C118748 Open Globe Injury C118464 Pediatric Adverse Events Terminology Foreign body, intraocular, unspecified Has Synonym LLT 10017052 MedDRA C50617 Intraocular Infection Intraocular Infection Infection within the eye. An infectious process within the eye. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Eye infection intraocular Has Synonym LLT 10054762 MedDRA C118865 Intraocular Lens Dislocation Intraocular Lens Dislocation Displacement of the intraocular lens from the visual axis. Displacement of the intraocular lens from the visual axis. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Intraocular lens dislocation Has Synonym LLT 10052125 MedDRA C50618 Intraocular Pressure Rise Intraocular Pressure Rise Increased Ocular Pressure Increased pressure of the intraocular fluid in the eye. Increased pressure of the intraocular fluid in the eye. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Intraocular pressure increased Has Synonym LLT 10022806 MedDRA C113382 Intrapartum Stillbirth Intrapartum Stillbirth Fetal death greater than or equal to 20 weeks of gestation during labor with Apgar scores of 0 at 1 minute, 5 minutes and beyond. Fetal death greater than or equal to 20 weeks of gestation during labor with Apgar scores of 0 at 1 minute, 5 minutes and beyond. C90491 Pregnancy Outcome C118464 Pediatric Adverse Events Terminology Stillbirth Narrower Than LLT 10042062 MedDRA C99140 Intraventricular Hemorrhage of the Newborn with Ventricular Dilatation Intraventricular Hemorrhage of the Newborn with Ventricular Dilatation Grade 3 Intraventricular (Nontraumatic) Hemorrhage of Fetus and Newborn|Grade 3 Intraventricular Hemorrhage of the Newborn|Intraventricular (Nontraumatic) Hemorrhage, Grade 3, of Fetus and Newborn|Intraventricular Hemorrhage of Newborn Grade 3 Bleeding into the lateral cerebral ventricles of a newborn infant with ventricular dilatation directly attributable to the acute bleeding. Bleeding into the lateral cerebral ventricles of a newborn infant with ventricular dilatation directly attributable to the acute bleeding. C50896 Intraventricular Hemorrhage C98996 Neonatal Disorder C118464 Pediatric Adverse Events Terminology Intraventricular hemorrhage of fetus or newborn Narrower Than LLT 10022845 MedDRA C99139 Intraventricular Hemorrhage of the Newborn without Ventricular Dilatation Intraventricular Hemorrhage of the Newborn without Ventricular Dilatation Grade 2 Intraventricular (Nontraumatic) Hemorrhage of Fetus and Newborn|Grade 2 Intraventricular Hemorrhage of the Newborn|Intraventricular (Nontraumatic) Hemorrhage, Grade 2, of Fetus and Newborn|Intraventricular Hemorrhage of Newborn Grade 2 Bleeding into the lateral cerebral ventricles of a newborn infant without acute ventricular dilatation. Bleeding into the lateral cerebral ventricles of a newborn infant without acute ventricular dilatation. C50896 Intraventricular Hemorrhage C98996 Neonatal Disorder C118464 Pediatric Adverse Events Terminology Intraventricular hemorrhage of fetus or newborn Narrower Than LLT 10022845 MedDRA C117202 Intraventricular Hemorrhage with Parenchymal Hemorrhage of the Newborn Intraventricular Hemorrhage with Parenchymal Hemorrhage of Newborn Grade 4 Intraventricular Hemorrhage of the Newborn|Intraventricular Hemorrhage of Newborn Grade 4|Intraventricular Hemorrhage with Parenchymal Hemorrhage of the Newborn Bleeding into the lateral cerebral ventricles and the adjacent brain tissue of a newborn infant. Bleeding into the lateral cerebral ventricles and the adjacent brain tissue of a newborn infant. C50896 Intraventricular Hemorrhage C118464 Pediatric Adverse Events Terminology Intraventricular hemorrhage of fetus or newborn Narrower Than LLT 10022845 MedDRA C121661 Intrusive Thought Intrusive Thought An unwelcome and persistent idea, image or thought that is upsetting to an individual. An unwelcome and persistent idea, image, or thought that is upsetting to an individual. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Intrusive thoughts Has Synonym LLT 10077275 MedDRA C113484 Intussusception Intussusception Telescoping or invagination of a part of the intestine into an adjacent segment. Telescoping or invagination of a part of the intestine into an adjacent segment. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Intussusception Has Synonym LLT 10022863 MedDRA C118725 Iridodialysis Iridodialysis A separation of the iris from the ciliary body. A separation of the iris from the ciliary body. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Iridodialysis Has Synonym LLT 10022942 MedDRA C78393 Iron Overload Iron Overload Accumulation of iron in the tissues. It may be a manifestation of an inherited disorder (e.g., hemochromatosis) or acquired (in patients with repeated blood transfusions). Symptoms include hepatomegaly, arthritis, diabetes mellitus, and bronzed skin. If untreated it has a progressive course and may lead to death. Abnormally high level of iron in the tissues. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Iron overload Has Synonym LLT 10065973 MedDRA C50623 Irritability Irritability Excited response to stimuli. Easily angered, annoyed, or impatient. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Irritability Has Synonym LLT 10022998 MedDRA C82343 Irritable Bowel Syndrome Irritable Bowel Syndrome Gastrointestinal symptoms characterized by chronic abdominal pain and altered bowel habits in the absence of any organic cause. Gastrointestinal symptoms characterized by chronic abdominal pain and altered bowel habits in the absence of any organic cause. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Irritable bowel syndrome Has Synonym LLT 10023003 MedDRA C3143 Jaundice Jaundice Yellow pigmentation of the skin, mucous membranes, and the eyes due to hyperbilirubinemia. Causes include liver disease, biliary tract obstruction, and hemolysis. Yellowish pigmentation of the skin, mucous membranes, and the eyes. C3368 Gastrointestinal System Signs and Symptoms C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Jaundice Has Synonym LLT 10023126 MedDRA C122647 Jejunostomy Site Jejunostomy Site A surgically created external opening into the jejunum. A surgically created external opening into the jejunum. C122645 Enterostomy Site C118464 Pediatric Adverse Events Terminology C49052 Joint Effusion Joint Effusion Abnormally increased amount of fluid in a joint cavity, usually as a result of joint inflammation. Excessive fluid within the synovial compartment of a joint. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Joint effusion Has Synonym LLT 10023215 MedDRA C79603 Joint Stiffness Joint Stiffness A sensation of discomfort and tightness while moving a joint. Typically there is decreased joint range of motion. Causes include arthritis, joint overuse, joint injury, and the aging process. A feeling of tension or tightness in one or more joints. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Joint stiffness Has Synonym LLT 10023230 MedDRA C111646 Junctional Ectopic Tachycardia Junctional Ectopic Tachycardia A tachycardia originating in or adjacent to the AV junction. A tachycardia originating in or adjacent to the AV junction. C110938 Tachyarrhythmia C118464 Pediatric Adverse Events Terminology Junctional ectopic tachycardia Has Synonym LLT 10074640 MedDRA C27576 Childhood Dermatomyositis Juvenile Dermatomyositis Childhood Dermatomyositis|JDM An inflammatory myopathy of childhood resulting in muscle weakness, and associated with a characteristic skin rash. An inflammatory myopathy of childhood resulting in symmetric proximal muscle weakness, and associated with characteristic cutaneous findings, such as heliotrope rash or Gottron's papules. C2889 Autoimmune Disease C118464 Pediatric Adverse Events Terminology Childhood dermatomyositis Has Synonym LLT 10008521 MedDRA C114357 Juvenile Idiopathic Arthritis Juvenile Idiopathic Arthritis JIA A group of chronic, inflammatory childhood disorders of unknown etiology that primarily involve joints. An umbrella term for arthritis of unknown etiology that begins before the sixteenth birthday, and persists for at least six weeks; other known conditions are excluded. Categories include: systemic, oligoarticular, polyarticular rheumatoid factor positive, polyarticular rheumatoid factor negative, psoriatic, enthesitis-related, or undifferentiated. C2889 Autoimmune Disease C118464 Pediatric Adverse Events Terminology Juvenile idiopathic arthritis Has Synonym LLT 10059176 MedDRA C114358 Juvenile Polymyositis Juvenile Polymyositis An idiopathic inflammatory myopathy of childhood resulting in muscle weakness. An idiopathic inflammatory myopathy of childhood resulting in muscle weakness. C2889 Autoimmune Disease C118464 Pediatric Adverse Events Terminology Juvenile polymyositis Has Synonym LLT 10076673 MedDRA C114361 Juvenile Psoriatic Arthritis Juvenile Psoriatic Arthritis Childhood arthritis typically associated with psoriasis. Childhood arthritis typically associated with psoriasis. C2889 Autoimmune Disease C118464 Pediatric Adverse Events Terminology Juvenile psoriatic arthritis Has Synonym LLT 10076674 MedDRA C27179 Juvenile Rheumatoid Arthritis Juvenile Rheumatoid Arthritis (AQ) An older, deprecated term that encompassed three major types of autoimmune or autoinflammatory arthritis in children: systemic-onset, pauciarticular, or polyarticular arthritis. The juvenile rheumatoid arthritis classification system has been replaced by the International League of Associations for Rheumatology (ILAR) juvenile idiopathic arthritis classification system. An older, deprecated term that encompassed three major types of autoimmune or autoinflammatory arthritis in children: systemic-onset, pauciarticular, or polyarticular arthritis. The juvenile rheumatoid arthritis classification system has been replaced by the International League of Associations for Rheumatology (ILAR) juvenile idiopathic arthritis classification system. C2889 Autoimmune Disease C118464 Pediatric Adverse Events Terminology JRA Juvenile rheumatoid arthritis Has Synonym LLT 10023267 MedDRA C114347 Juvenile Spondyloarthritis Juvenile Spondyloarthritis JSpA|Juvenile Spondyloarthropathy A group of chronic, inflammatory childhood diseases characterized by arthritis and enthesitis. This disorder can affect the axial skeleton in late childhood or young adulthood. Onset of spondyloarthritis before 18 years of age, and less commonly associated with axial disease. Encompasses the juvenile idiopathic arthritis categories of enthesitis-related arthritis and psoriatic arthritis, and includes many cases of undifferentiated arthritis. C2889 Autoimmune Disease C118464 Pediatric Adverse Events Terminology Juvenile spondyloarthritis Has Synonym LLT 10076675 MedDRA C34825 Kawasaki Disease Kawasaki Disease Infantile Polyarteritis Nodosa|Mucocutaneous Lymph Node Syndrome A vasculitis characterized by inflammation of the arteries, particularly the coronary arteries. The vasculitis may lead to aneurysm formation and possibly, heart attacks. It affects young children who usually present with persistent high fever, redness of the mucous membranes of the mouth, redness of the palms and soles, skin rashes, lymphadenitis, and joint pain and swelling. Medium-sized vessel vasculitis seen primarily in young children with predilection for the coronary arteries. Diagnosis is based on clinical findings of persistent high fever, changes in lips and oral mucous membranes, erythema and edema of hands/feet and later desquamation, bilateral bulbar conjunctivitis, unilateral cervical adenopathy, polymorphous rash. C26912 Vasculitis C118464 Pediatric Adverse Events Terminology Kawasaki's disease Has Synonym LLT 10023320 MedDRA C3145 Keloid Keloid An irregularly shaped, elevated mark on the skin caused by deposits of excessive amounts of collagen during wound healing. It extends beyond the original boundaries of the wound and may enlarge progressively. An irregularly shaped, elevated mark on the skin caused by deposits of excessive amounts of collagen during wound healing. It extends beyond the original boundaries of the wound and may enlarge progressively. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Keloid Has Synonym LLT 10023329 MedDRA C26805 Keratitis Keratitis Inflammation of the cornea. Inflammation of the cornea. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Keratitis Has Synonym LLT 10023332 MedDRA C84799 Kernicterus Kernicterus Bilirubin Encephalopathy A rare neurologic disorder occurring in infants with jaundice. It results from brain damage by existing high levels of unconjugated-indirect bilirubin. A condition characterized by sensorineural hearing impairment, choreoathetoid movements, paralysis of upward gaze and hypoplasia of dental enamel due bilirubin deposition in the grey matter of the central nervous system as a consequence of increased levels of unconjugated bilirubin in the serum. C26920 Encephalopathy C118464 Pediatric Adverse Events Terminology Kernicterus Has Synonym LLT 10023376 MedDRA C122512 Ketonuria Ketonuria The presence of ketone bodies in the urine. The presence of ketone bodies in the urine. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Ketonuria Has Synonym LLT 10023388 MedDRA C114844 Renal Allograft Thrombosis Kidney Allograft Thrombosis Thrombus formation within the arterial or venous system of a donor kidney post transplantation. Thrombus formation within the arterial or venous system of a donor kidney post transplantation. C26891 Thrombosis C118464 Pediatric Adverse Events Terminology Graft thrombosis Narrower Than LLT 10051269 MedDRA C114592 Renal Impairment Kidney Impairment Renal Impairment Diminished kidney function. Diminished kidney function. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Renal impairment Has Synonym LLT 10062237 MedDRA C114667 Nephrolithiasis Kidney Stone Nephrolithiasis|Renal Calculi The presence of a calculus in the pelvis of the kidney; this is most often composed of mineral salts and proteins. A crystalline mass in the pelvis of the kidney that is composed of mineral salts and proteins. C36286 Urinary System Finding C118464 Pediatric Adverse Events Terminology Kidney stone Has Synonym LLT 10023436 MedDRA C116724 Klumpke Palsy Klumpke's Palsy Dejerine-Klumpke Palsy Weakness or paralysis of muscles in the forearm or hand due to damage of the lower brachial plexus. A condition characterized by reduced or absent movement of the ipsilateral hand as a consequence of an injury to cervical root 8 and thoracic root 1, also known as the lower brachial plexus. C103231 Brachial Plexus Injury C118464 Pediatric Adverse Events Terminology Klumpke's palsy Has Synonym LLT 10023466 MedDRA C90501 Labored Breathing Labored Breathing Breathing that requires observed effort or an increased amount of energy. Breathing that requires observed effort or an increased amount of energy. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Labored breathing Has Synonym LLT 10023552 MedDRA C50446 Laceration Laceration A cut or tear in any tissue. A cut or tear in any tissue. C3671 Injury C118464 Pediatric Adverse Events Terminology Laceration Has Synonym LLT 10023572 MedDRA C118857 Lamellar Laceration of the Globe Lamellar Laceration of the Globe Traumatic injury to the globe, resulting in a partial thickness wound of the eyewall (cornea and/or sclera). (adapted from the Birmingham Eye Trauma Terminology System (BETTS)) Traumatic injury to the globe, resulting in a partial thickness wound of the eyewall (cornea and/or sclera). (adapted from the International Society of Ocular Trauma-Birmingham Eye Trauma Terminology System (BETTS)) C118747 Closed Globe Injury C118464 Pediatric Adverse Events Terminology Lamellar laceration of the globe Has Synonym LLT 10076686 MedDRA C87092 Large for Gestational Age Large for Gestational Age Large for Dates Baby A fetus or infant who is larger than expected for the age or gender, or who has a birth weight greater than the 90th percentile. An estimated fetal or neonatal weight exceeding 90% of expected weight for gestational age. C92711 Fetal Finding C118464 Pediatric Adverse Events Terminology Large for gestational age Has Synonym LLT 10023790 MedDRA C26811 Laryngitis Laryngitis An acute or chronic, bacterial or viral inflammatory process affecting the larynx. Signs and symptoms include sore throat, cough, swallowing difficulties, and hoarseness. Inflammation of the larynx. C118420 Otolaryngologic Disorder C118464 Pediatric Adverse Events Terminology Laryngitis Has Synonym LLT 10023874 MedDRA C98971 Laryngomalacia Laryngomalacia Increased collapsibility of the larynx. An abnormality characterized by softening of the laryngeal cartilage typically presenting with stridor. C97173 Congenital Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Laryngomalacia Has Synonym LLT 10060786 MedDRA C79609 Laryngospasm Laryngospasm Paroxysmal spasmodic muscular contraction of the vocal cords. It is brief, usually lasting for less than one minute, interrupting the speech and breathing and may produce a high-pitched breathing sound. It may occur under anesthesia or may be associated with gastroesophageal reflex disease. The involuntary adduction of the vocal cords resulting in airway obstruction on inspiration. C45233 Respiratory System Finding C118464 Pediatric Adverse Events Terminology Laryngospasm Has Synonym LLT 10023891 MedDRA C93083 Lassitude Lassitude Physical or mental fatigue. Physical or mental fatigue. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Lassitude Has Synonym LLT 10023929 MedDRA C112863 Late Fetal Death Late Fetal Death Death of a fetus at 16 weeks, 0 days to 19 weeks, 6 days of gestation. Death of a fetus at 16 weeks, 0 days to 19 weeks, 6 days of gestation. C50620 Fetal Death C118464 Pediatric Adverse Events Terminology Late fetal death Has Synonym LLT 10076687 MedDRA C92822 Late Deceleration Late Fetal Heart Rate Deceleration Late Deceleration|Late Fetal Heart Deceleration A gradual decrease in the fetal heart rate and return to baseline that is associated with a uterine contraction. The nadir of the deceleration occurs after the peak of the uterine contraction, and the time from onset to nadir of the deceleration is greater than or equal to 30 seconds. A gradual decrease in the fetal heart rate and return to baseline that is associated with a uterine contraction. The nadir of the deceleration occurs after the peak of the uterine contraction, and the time from onset to nadir of the deceleration is greater than or equal to 30 seconds. C92789 Fetal Heart Deceleration C118464 Pediatric Adverse Events Terminology Late deceleration Has Synonym LLT 10058343 MedDRA C116773 Late Neonatal Death Late Neonatal Mortality Death of live newborn between 7and 27 days after birth. Death of live-born infants occurring at 7 to 27 days of age. C80082 Neonatal Death C118464 Pediatric Adverse Events Terminology Late neonatal death Has Synonym LLT 10076741 MedDRA C114938 Late Preterm Infant Late Preterm Infant Near Term Infant A newborn infant greater than or equal to 34 weeks, 0 days and less than 37 weeks, 0 days gestational age. A newborn infant greater than or equal to 34 weeks, 0 days and less than 37 weeks, 0 days gestational age. C16731 Newborn C118464 Pediatric Adverse Events Terminology Late preterm infant Has Synonym LLT 10076688 MedDRA C50629 Left Ventricular Dysfunction Left Ventricular Dysfunction Impairment of the left ventricle to either fill or eject adequately. Impairment of the left ventricle to either fill or eject adequately. C111655 Ventricular Dysfunction C118464 Pediatric Adverse Events Terminology Left ventricular dysfunction Has Synonym LLT 10049694 MedDRA C84816 Lennox-Gastaut Syndrome Lennox-Gastaut Syndrome A syndrome characterized by frequent episodes of epilepsy during childhood. The epileptic episodes may be tonic, atonic, myoclonic, or absence seizures. It may be accompanied by mental retardation and behavioral problems. A severe form of childhood epilepsy that is characterized by frequent seizures of multiple types, a distinct electroencephalogram pattern consisting of slow spike-waves between seizures, behavioral disturbances, and cognitive dysfunction. C3020 Epilepsy C118464 Pediatric Adverse Events Terminology Lennox-Gastaut syndrome Has Synonym LLT 10048816 MedDRA C78416 Lethargy Lethargy Listless Decreased consciousness characterized by mental and physical inertness. A profound lack of mental and physical energy. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Lethargy Has Synonym LLT 10024264 MedDRA C3161 Leukemia Leukemia Leukemia, Disease A malignant (clonal) hematologic disorder, involving hematopoietic stem cells and characterized by the presence of primitive or atypical myeloid or lymphoid cells in the bone marrow and the blood. Leukemias are classified as acute or chronic based on the degree of cellular differentiation and the predominant cell type present. Leukemia is usually associated with anemia, fever, hemorrhagic episodes, and splenomegaly. Common leukemias include acute myeloid leukemia, chronic myelogenous leukemia, acute lymphoblastic or precursor lymphoblastic leukemia, and chronic lymphocytic leukemia. Treatment is vital to patient survival; untreated, the natural course of acute leukemias is normally measured in weeks or months, while that of chronic leukemias is more often measured in months or years. A cancer of the blood or bone marrow that is characterized by increased production of abnormal blood cells. C9305 Cancer C118464 Pediatric Adverse Events Terminology Leukemia Has Synonym LLT 10024329 MedDRA C35524 Leukocytosis Leukocytosis A laboratory test result indicating an increased number of white blood cells in the peripheral blood. Abnormally high level of white blood cells in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Leukocytosis Has Synonym LLT 10024378 MedDRA C112821 Leukoderma Leukoderma Localized loss of skin pigmentation, often in patches. Localized loss of skin pigmentation, often in patches. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Leukoderma Has Synonym LLT 10024380 MedDRA C112815 Leukonychia Leukonychia Any white discoloration of the nails or nail plates. Any white discoloration of the nails or nail plates. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Leukonychia Has Synonym LLT 10050658 MedDRA C26816 Leukopenia Leukopenia Leukocytopenia A laboratory test result indicating a decreased number of white blood cells in the peripheral blood. Abnormally low level of white blood cells in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Leukopenia Has Synonym LLT 10024384 MedDRA C3186 Leukoplakia Leukoplakia A white patch or plaque on a mucous membrane that cannot be characterized clinically or pathologically as any other disease. The diagnosis of leukoplakia is one of exclusion; other conditions such as candidiasis, lichen planus, leukoedema, etc., must be ruled out before a diagnosis of leukoplakia can be made. Leukoplakia may be a premalignant condition. Thick, white or gray patches on the oral mucosa. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Leukoplakia Has Synonym LLT 10062037 MedDRA C111974 Lichenification Lichenification Thickening and hardening of the skin associated with chronic inflammation or irritation. Thickening and hardening of the skin associated with chronic inflammation or irritation. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Lichenification Has Synonym LLT 10024438 MedDRA C34780 Lichenoid Drug Eruption Lichenoid Drug Eruption Drug-induced Lichen Planus A red or violaceous flat-topped, papular eruption that is induced by exposure to a variety of medications or environmental agents. A red or purple flat-topped, papular eruption that is induced by exposure to a variety of medications or environmental agents. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Drug eruption lichen planus-like Has Synonym LLT 10013690 MedDRA C118866 Lid Retraction Lid Retraction Abnormal superior displacement of resting upper lid margin or abnormal inferior displacement of resting lower lid margin. Abnormal superior displacement of resting upper lid margin or abnormal inferior displacement of resting lower lid margin. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Eyelid retraction Has Synonym LLT 10015997 MedDRA C103921 Lissencephaly Lissencephaly A rare genetic brain malformation characterized by smooth folds and grooves in the brain. There are approximately 20 different types of lissencephaly that are identified by various symptoms. A brain malformation characterized by smooth folds and grooves in the brain. C97172 Congenital Nervous System Disorder C118464 Pediatric Adverse Events Terminology Lissencephaly Has Synonym PT 10048911 MedDRA C72069 Localized Scleroderma Localized Scleroderma Morphea A chronic disorder, possibly autoimmune, marked by excessive production of collagen which results in hardening and thickening of body tissues. Localized scleroderma typically affects the skin, with formation of patches or lines of thick and unyielding tissue; there can be muscle and underlying tissue involvement as well as occasional joint complications. The affected areas of skin can be restrictive and disfiguring. The shape, depth and location of the affected area is used to classify one of the four types of local scleroderma. An individual can have a combination of localized scleroderma types. An autoimmune disorder marked by excessive production of collagen resulting in hardening and thickening of skin, with formation of patches or lines of thick and unyielding tissue. There can also be musculoskeletal and underlying tissue involvement. The affected areas of skin can be restrictive and disfiguring. C26746 Scleroderma C118464 Pediatric Adverse Events Terminology Morphea Related To LLT 10027979 MedDRA C34786 Long QT Syndrome Long QT Syndrome A ventricular arrhythmia characterized by a long QT interval, and accompanied by syncopal episodes sometimes leading to sudden death due to paroxysmal ventricular arrhythmia. This arrhythmia is associated with a prolongation of repolarization following depolarization of the cardiac ventricles. The prolongation of the Q-T interval combined with torsades de pointes manifests as several different forms; some may be acquired or congenital; some may lead to serious arrhythmia and sudden cardiac death. A syndrome characterized by a propensity to develop life-threatening arrhythmias usually in the context of a prolonged corrected QT interval. C95834 Congenital Heart Disease C118464 Pediatric Adverse Events Terminology Long QT syndrome Has Synonym LLT 10024803 MedDRA C50635 Loss of Consciousness Loss of Consciousness An inability to purposefully respond to stimuli. An inability to purposefully respond to stimuli. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Loss of consciousness Has Synonym LLT 10024855 MedDRA C50640 Low Blood Oxygen Saturation Low Blood Oxygen Saturation Desaturation A low level of the degree to which oxygen is bound to hemoglobin given as a percentage calculated by dividing the maximum oxygen capacity into the actual oxygen content and multiplying by 100. Oxygen saturation usually is measured using pulse oximetry. A decrease in the concentration of oxyhemoglobin as contrasted to the concentration deoxyhemoglobin in the blood. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Oxygen saturation low Has Synonym LLT 10033321 MedDRA C122574 Lupus Flare Lupus Flare An exacerbation of the chronic disease lupus. An exacerbation of the chronic disease lupus. C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology SLE flare Has Synonym LLT 10065992 MedDRA C26821 Lymphadenitis Lymphadenitis Adenitis Acute or chronic inflammation of one or more lymph nodes. It is usually caused by an infectious process. Inflammation of one or more lymph nodes. C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Lymphadenitis Has Synonym LLT 10025188 MedDRA C50764 Lymphadenopathy Lymphadenopathy Adenopathy An enlarged lymph node. Causes include viral and bacterial infections and cancers that affect the lymph nodes. Abnormal enlargement of the lymph nodes. C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Lymphadenopathy Has Synonym LLT 10025197 MedDRA C26823 Lymphopenia Lymphocytopenia An abnormally small number of lymphocytes in the circulating blood. Abnormally low level of circulating lymphocytes in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Lymphocytopenia Has Synonym LLT 10025278 MedDRA C34791 Lymphocytosis Lymphocytosis A laboratory test result indicating an abnormal increase in the number of lymphocytes in the peripheral blood, effusions, or bone marrow. Abnormally high level of lymphocytes in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Lymphocytosis Has Synonym LLT 10025280 MedDRA C3208 Lymphoma Lymphoma A malignant (clonal) proliferation of B- lymphocytes or T- lymphocytes which involves the lymph nodes, bone marrow and/or extranodal sites. This category includes Non-Hodgkin lymphomas and Hodgkin lymphomas. A malignant neoplasm of the lymphatic system that is comprised of abnormal lymphocytes. C9305 Cancer C118464 Pediatric Adverse Events Terminology Lymphoma Has Synonym LLT 10025310 MedDRA C35268 Macrocephaly Macrocephaly An abnormal increase in head circumference, which can have a variety of causes, including hydrocephalus, enlarged brain, and cranial hyperostosis. An abnormal increase in head circumference, which can have a variety of causes, including hydrocephalus, enlarged brain, and cranial hyperostosis. C2934 Central Nervous System Disorder C118464 Pediatric Adverse Events Terminology Macrocephaly Has Synonym LLT 10050183 MedDRA C114471 Macrophage Activation Syndrome Macrophage Activation Syndrome MAS|Reactive Hemophagocytic Lymphohistiocytosis A complication of rheumatic disease that is caused by excessive activation and uncontrolled proliferation of T lymphocytes and well-differentiated macrophages. It is characterized by fever, pancytopenia, liver insufficiency, coagulopathy and neurologic symptoms. A potentially fatal complication of rheumatic disease characterized by fever, pancytopenia, hemophagocytosis, hyperferritinemia, liver insufficiency, coagulopathy and neurologic symptoms. C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Macrophage activation syndrome Has Synonym LLT 10053867 MedDRA C118305 Macropsia Macropsia An alteration in visual perception that causes objects to appear larger than their actual size. An alteration in visual perception that causes objects to appear larger than their actual size. C26835 Nervous System Disorder C118464 Pediatric Adverse Events Terminology Macropsia Has Synonym LLT 10025393 MedDRA C35468 Macular Edema Macular Edema Accumulation of intraretinal fluid and protein in the macula, which may result in swelling and decreased central vision. Accumulation of intraretinal fluid and protein in the macula, which may result in swelling and decreased central vision. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Macular edema Has Synonym LLT 10054467 MedDRA C43278 Macular Lesion Macule A flat lesion characterized by change in the skin color. A localized area of skin that is discolored and not elevated. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Macule Has Synonym LLT 10025421 MedDRA C113483 Malabsorption Malabsorption Inadequate absorption of nutrients in the small intestine. Inadequate absorption of nutrients in the small intestine. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Malabsorption Has Synonym LLT 10025476 MedDRA C3832 Malaise Malaise A feeling of general discomfort or uneasiness, an out-of-sorts feeling. A nonspecific feeling of bodily discomfort, fatigue and/or unease. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Malaise Has Synonym LLT 10025482 MedDRA C34797 Malaria Malaria A protozoan infection caused by the genus Plasmodium. There are four species of Plasmodium that can infect humans: Plasmodium falciparum, vivax, ovale, and malariae. It is transmitted to humans by infected mosquitoes. Signs and symptoms include paroxysmal high fever, sweating, chills, and anemia. Plasmodium parasite infection, characterized by fever, flu-like symptoms, anemia, and jaundice, that may be transmitted through infected mosquito bites, blood transfusion, organ transplant, contaminated needles or syringes, or before or during birth. C34953 Protozoal Infection C118464 Pediatric Adverse Events Terminology Malaria Has Synonym LLT 10025487 MedDRA C3568 Malignant Brain Neoplasm Malignant Brain Tumor A primary or metastatic malignant neoplasm affecting the brain. An abnormal solid mass arising within the brain with histologic features suggesting the potential to metastasize. C9305 Cancer C118464 Pediatric Adverse Events Terminology Malignant neoplasm of brain Has Synonym LLT 10025783 MedDRA C84869 Malignant Hyperthermia Syndrome Malignant Hyperthermia Malignant Hyperpyrexia A rare disorder characterized by rapid rise of the body temperature, accompanied by rhabdomyolysis and, if untreated, by collapse and death. It occurs in susceptible individuals who receive certain drugs for general anesthesia, gas anesthetics, or succinylcholine. It may be inherited in an autosomal dominant pattern. A rare drug reaction characterized by a rapid rise of the body temperature and rhabdomyolysis. C9229 Systemic Disorder C118464 Pediatric Adverse Events Terminology Malignant hyperthermia Has Synonym LLT 10025607 MedDRA C118393 Malunion of Bone Malunion Malunion of Bone Faulty healing of bone, resulting in improper anatomical alignment. Faulty healing of bone, resulting in improper anatomical alignment. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Fracture malunion Has Synonym LLT 10017085 MedDRA C117248 Manic Mood Manic Mood An emotional state characterized by marked to extreme elevation of mood with noticeable effect of functioning. An emotional state characterized by marked to extreme elevation of mood with noticeable effect on functioning. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Manic Has Synonym LLT 10026752 MedDRA C111765 Marked Baseline Fetal Heart Rate Variability Marked Baseline Fetal Heart Rate Variability Exaggerated Baseline Variability|Hypervariability|Marked Baseline Variability A baseline fetal heart rate with an amplitude range that is greater than 25 beats per minute. A baseline fetal heart rate with an amplitude range that is greater than 25 beats per minute. C92790 Fetal Heart Rate Variability C118464 Pediatric Adverse Events Terminology Marked baseline fetal heart rate variability Has Synonym LLT 10074648 MedDRA C34808 Mass Mass A benign or malignant pathologic structure in any part of the body, resulting from a neoplastic accumulation of cells, inflammatory cells, or cystic changes. A benign or malignant pathologic structure in any part of the body, resulting from a neoplastic accumulation of cells, inflammation, or cystic changes. C3262 Neoplasm C118464 Pediatric Adverse Events Terminology Mass Has Synonym LLT 10026865 MedDRA C102977 Meconium Peritonitis Meconium Peritonitis Inflammation of the peritoneum caused by an intrauterine intestinal perforation leading to presence of meconium within the fetal peritoneal cavity. This is frequently seen as intra-abdominal calcifications on imaging. Inflammation of the peritoneum caused by an intrauterine intestinal perforation leading to presence of meconium within the fetal peritoneal cavity. This is frequently seen as intra-abdominal calcifications on imaging. C26726 Infectious Disorder C118464 Pediatric Adverse Events Terminology Meconium peritonitis Has Synonym LLT 10058113 MedDRA C35295 Mediastinal Mass Mediastinal Mass A mass present in the mediastinal space. A mass present in the mediastinal space. C3262 Neoplasm C118464 Pediatric Adverse Events Terminology Mediastinal mass Has Synonym LLT 10027076 MedDRA C122712 Medical Device Dislodged Medical Device Dislodged A medical device that was placed properly, but which has moved from the intended location. A medical device that was placed properly, but which has moved from the intended location. C78254 Device Complication C118464 Pediatric Adverse Events Terminology Device dislodgement Has Synonym LLT 10072054 MedDRA C122710 Medical Device Failure Medical Device Failure A medical device that is no longer functioning. A medical device that is no longer functioning. C78254 Device Complication C118464 Pediatric Adverse Events Terminology Device failure Narrower Than LLT 10056871 MedDRA C122711 Medical Device Malfunction Medical Device Malfunction A medical device that is functioning incorrectly. A medical device that is functioning incorrectly. C78254 Device Complication C118464 Pediatric Adverse Events Terminology Device malfunction Has Synonym LLT 10063829 MedDRA C122713 Medical Device Misplaced Medical Device Misplaced A medical device that was placed in an unintended location. A medical device that was placed in an unintended location. C78254 Device Complication C118464 Pediatric Adverse Events Terminology Device dislocation Has Synonym LLT 10064684 MedDRA C3222 Medulloblastoma Medulloblastoma A malignant, invasive embryonal neoplasm arising from the cerebellum. It occurs predominantly in children and has the tendency to metastasize via the cerebrospinal fluid pathways. Signs and symptoms include truncal ataxia, disturbed gait, lethargy, headache, and vomiting. There are four histologic variants: classic medulloblastoma, large cell/anaplastic medulloblastoma, desmoplastic/nodular medulloblastoma, and medulloblastoma with extensive nodularity. A rapidly progressive cancer of the brain that originates in the cerebellum. C3268 Nervous System Neoplasm C118464 Pediatric Adverse Events Terminology Medulloblastoma Has Synonym LLT 10027107 MedDRA C34382 Megaloblastic Anemia Megaloblastic Anemia Anemia characterized by the presence of unusually large erythroblasts in the bone marrow called megaloblasts. It is usually caused by vitamin B12 or folic acid deficiency. Other causes include toxins and drugs. A disorder characterized by low red blood cells and/or hemoglobin and abnormally large, immature circulating red blood cells. C34381 Macrocytic Anemia C2869 Anemia C118464 Pediatric Adverse Events Terminology Megaloblastic anemia Has Synonym LLT 10027129 MedDRA C3224 Melanoma Melanoma A malignant, usually aggressive tumor composed of atypical, neoplastic melanocytes. Most often, melanomas arise in the skin (cutaneous melanomas) and include the following histologic subtypes: superficial spreading melanoma, nodular melanoma, acral lentiginous melanoma, and lentigo maligna melanoma. Cutaneous melanomas may arise from acquired or congenital melanocytic or dysplastic nevi. Melanomas may also arise in other anatomic sites including the gastrointestinal system, eye, urinary tract, and reproductive system. Melanomas frequently metastasize to lymph nodes, liver, lungs, and brain. A malignant neoplasm comprised of melanocytes typically arising in the skin. C9305 Cancer C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Melanoma Has Synonym LLT 10053571 MedDRA C112824 Melasma Melasma Symmetrical patches of tan or brown discoloration on the skin of the face that darken with sun exposure. Symmetrical patches of tan or brown discoloration on the skin of the face that darken with sun exposure. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Melasma Has Synonym LLT 10027161 MedDRA C86571 Melena Melena Abnormally dark tarry feces containing blood, usually from gastrointestinal bleeding. Abnormally dark tarry feces containing blood, usually due to gastrointestinal bleeding. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Melena Has Synonym LLT 10027162 MedDRA C113398 Melena Neonatorum Melena Neonatorum Melena Neonatal|Neonatal Melena Abnormally dark tarry feces containing blood, usually due to gastrointestinal bleeding or swallowed maternal blood in neonates. Abnormally dark tarry feces containing blood, usually due to gastrointestinal bleeding or swallowed maternal blood in neonates. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Melaena neonatal Has Synonym LLT 10049777 MedDRA C3230 Meningioma Meningioma A generally slow growing tumor attached to the dura mater. It is composed of neoplastic meningothelial (arachnoidal) cells. It typically occurs in adults, often women and it has a wide range of histopathological appearances. Of the various subtypes, meningothelial, fibrous and transitional meningiomas are the most common. Most meningiomas are WHO grade I tumors, and some are WHO grade II or III tumors. Most subtypes share a common clinical behavior, although some subtypes are more likely to recur and follow a more aggressive clinical course. (Adapted from WHO) A usually benign tumor that develops in the meninges. C3268 Nervous System Neoplasm C118464 Pediatric Adverse Events Terminology Meningioma Has Synonym LLT 10027191 MedDRA C79694 Meningismus Meningismus The symptoms of neck stiffness, headache, and photophobia resulting from meningeal irritation. Causes include subarachnoid hemorrhage and acute febrile diseases. The symptoms of neck stiffness, headache, and photophobia resulting from meningeal irritation. C87124 Central Nervous System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Meningismus Has Synonym LLT 10027198 MedDRA C26828 Meningitis Meningitis A disorder characterized by acute inflammation of the meninges of the brain and/or spinal cord. Inflammation of the membranes surrounding the brain and spinal cord. C27582 Central Nervous System Infectious Disease C118464 Pediatric Adverse Events Terminology Meningitis Has Synonym LLT 10027199 MedDRA C34813 Meningoencephalitis Meningoencephalitis Inflammation of the meninges and brain, generally secondary to an infectious cause. Pathogens may be bacterial, viral, fungal, or protozoan. Inflammation of the meninges and brain. C27582 Central Nervous System Infectious Disease C118464 Pediatric Adverse Events Terminology Meningoencephalitis Has Synonym LLT 10027282 MedDRA C26829 Menorrhagia Menorrhagia Heavy bleeding during regular menstruation. Abnormally heavy bleeding during menstruation. C27020 Female Reproductive System Disorder C118464 Pediatric Adverse Events Terminology Menorrhagia Has Synonym LLT 10027313 MedDRA C34815 Menstrual Disorder Menstrual Problem A category of conditions related to menses. Category of disorders related to menstruation. C27020 Female Reproductive System Disorder C118464 Pediatric Adverse Events Terminology Menstrual disorder Has Synonym LLT 10027327 MedDRA C84392 Mental Retardation Mental Retardation A developmental disorder characterized by less than average intelligence and significant limitations in adaptive behavior with onset before the age of 18. A condition of arrested or incomplete development of the mind, which is especially characterized by impairment of skills manifested during the developmental period, which contribute to the overall level of intelligence, i.e. cognitive, language, motor, and social abilities. C92190 Pediatric Psychiatric Disorder C118464 Pediatric Adverse Events Terminology Mental retardation Has Synonym LLT 10027378 MedDRA C28228 Metabolic Acidosis Metabolic Acidosis Increased acidity in the blood secondary to acid base imbalance. Causes include diabetes, kidney failure and shock. Abnormally decreased pH levels in the blood due to excessive accumulation of acid or insufficient generation of base. C27120 Electrolyte Disorder C118464 Pediatric Adverse Events Terminology Metabolic acidosis Has Synonym LLT 10027417 MedDRA C114478 Metabolic Alkalosis Metabolic Alkalosis Abnormally increased pH levels in the blood due to excessive loss of acid and/or accumulation of base. Abnormally increased pH levels in the blood due to excessive loss of acid and/or accumulation of base. C27120 Electrolyte Disorder C118464 Pediatric Adverse Events Terminology Metabolic alkalosis Has Synonym LLT 10027423 MedDRA C115248 Methicillin-Resistant Staphylococcus Aureus Infection Methicillin-Resistant Staphylococcus aureus Infection A bacterial infection that is caused by Staphylococcus aureus and is resistant to methicillin treatment. A bacterial infection that is caused by Staphylococcus aureus and is resistant to methicillin treatment. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Methicillin-resistant Staphylococcus aureus infection Has Synonym LLT 10027508 MedDRA C122523 Methicillin-Resistant Staphylococcus Aureus Pneumonia Methicillin-Resistant Staphylococcus aureus Pneumonia Pneumonia that is caused by Staphylococcus aureus and is resistant to methicillin treatment. Pneumonia that is caused by Staphylococcus aureus and is resistant to methicillin treatment. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Methicillin-resistant Staphylococcus aureus pneumonia Has Synonym LLT 10058931 MedDRA C118304 Micropsia Micropsia An alteration in visual perception that causes objects to appear smaller than their actual size. An alteration in visual perception that causes objects to appear smaller than their actual size. C26835 Nervous System Disorder C118464 Pediatric Adverse Events Terminology Micropsia Has Synonym LLT 10027551 MedDRA C89715 Migraine Migraine Migraine Headache A common, severe type of vascular headache often associated with increased sympathetic activity, resulting in nausea, vomiting, and light sensitivity. A headache disorder characterized by recurrent episodes of moderate to severe pulsating pain, and may be associated with nausea, vomiting, photophobia , phonophobia, and worsening with exertion. C34661 Headache C118464 Pediatric Adverse Events Terminology Migraine Has Synonym LLT 10027599 MedDRA C117005 Migraine With Aura Migraine With Aura A migraine disorder characterized by episodes that are preceded by focal neurological symptoms. A migraine disorder characterized by episodes that are preceded by focal neurological symptoms. C89715 Migraine C118464 Pediatric Adverse Events Terminology Migraine with aura Has Synonym LLT 10027607 MedDRA C117004 Migraine Without Aura Migraine Without Aura Common Migraine A migraine disorder characterized by episodes that occur in the absence of preceding focal neurological symptoms. A migraine disorder characterized by episodes that occur in the absence of preceding focal neurological symptoms. C89715 Migraine C118464 Pediatric Adverse Events Terminology Migraine without aura Has Synonym LLT 10052787 MedDRA C117069 Migraine-Triggered Seizure Migraine-triggered Seizure A seizure triggered by a migraine. A seizure triggered by a migraine. C2962 Seizure C118464 Pediatric Adverse Events Terminology Migraine-triggered seizure Has Synonym LLT 10076676 MedDRA C117024 Migrainous Infarction Migrainous Infarction Migraine associated with an ischemic brain lesion. Migraine associated with an ischemic brain lesion. C89715 Migraine C118464 Pediatric Adverse Events Terminology Migrainous infarction Has Synonym LLT 10056237 MedDRA C3238 Milium Cyst Milia Small (one to two mm), firm, white cysts on the skin. Small (one to two mm), firm, white cysts. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Milia Has Synonym LLT 10027626 MedDRA C34820 Miliaria Miliaria Heat Rash|Prickly Heat A small (one mm or less) vesicular, papular or pustular monomorphous rash, which is associated with heat, fever or occlusion of sweat glands. A small (one mm or less), vesicular, papular or pustular monomorphous rash, which is associated with heat, fever or occlusion of sweat glands. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Miliaria Has Synonym LLT 10027627 MedDRA C111767 Minimal Baseline Fetal Heart Rate Variability Minimal Baseline Fetal Heart Rate Variability Minimal Baseline Variability A baseline fetal heart rate with a detectable amplitude range that is greater than undetectable but less than or equal to five beats per minute. A baseline fetal heart rate with a detectable amplitude range that is greater than undetectable but less than or equal to five beats per minute. C92790 Fetal Heart Rate Variability C118464 Pediatric Adverse Events Terminology Minimal baseline fetal heart rate variability Has Synonym LLT 10074650 MedDRA C118675 Mitochondrial Enzyme Deficiency Mitochondrial Enzyme Deficiency A constellation of disorders whose common thread is the insufficient quantity of one or more mitochondrial enzymes. A constellation of disorders whose common thread is the insufficient quantity of one or more mitochondrial enzymes. C3492 Enzyme Deficiency C118464 Pediatric Adverse Events Terminology Mitochondrial enzyme deficiency Has Synonym LLT 10067729 MedDRA C26974 Mixed Hearing Loss Mixed Hearing Loss Hearing loss characterized by a combination of conductive and sensorineural hearing loss. It is caused by problems in both the inner ear and middle or outer ear. A combination of conductive and sensorineural hearing loss. C35731 Hearing Loss C118464 Pediatric Adverse Events Terminology Mixed conductive and sensorineural hearing loss Has Synonym LLT 10027753 MedDRA C118719 Monocular Diplopia Monocular Diplopia Perception of more than one image when viewing with one eye. Perception of more than one image when viewing with one eye. C37941 Diplopia C118464 Pediatric Adverse Events Terminology Monocular diplopia Has Synonym LLT 10076689 MedDRA C113714 Monocytopenia Monocytopenia Abnormally low level of monocytes in the blood. Abnormally low level of monocytes in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Monocytopenia Has Synonym LLT 10027905 MedDRA C35147 Monocytosis Monocytosis Abnormally high level of monocytes in the blood. Abnormally high level of monocytes in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Monocytosis Has Synonym LLT 10027906 MedDRA C117252 Mood Lability Mood Lability Emotional Lability|Mood Swing A condition of frequent mood changes associated with excessive emotional reactions. A condition of frequent mood changes associated with excessive emotional reactions. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Emotional lability Has Synonym LLT 10014555 MedDRA C116600 Motor Deficit Motor Deficits Loss of movement function. Movement impairment. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Motor dysfunction Has Synonym LLT 10061296 MedDRA C116943 Motor Developmental Delay Motor Developmental Delay Failure to meet, or late achievement of motor development milestones. Failure to meet, or late achievement of motor development milestones. C116942 Developmental Delay C89330 Developmental Disorder C118464 Pediatric Adverse Events Terminology Motor developmental delay Has Synonym LLT 10070302 MedDRA C117168 Motor Restlessness Motor Restlessness An inability to be still and/or the need to move. An inability to be still and/or the need to move. C5039 Motor Manifestations C118464 Pediatric Adverse Events Terminology Motor restlessness Has Synonym LLT 10028006 MedDRA C116925 Motor Stereotypy Motor Stereotypies Persistent volitional repetition of non-purposeful movement. Persistent volitional, repetition of non-purposeful movement. C116757 Movement Disorders C118464 Pediatric Adverse Events Terminology Stereotypic movement disorder Has Synonym LLT 10042005 MedDRA C116759 Motor Tic Motor Tic A tic affecting muscle movement. A tic affecting muscle movement. C116758 Tic C118464 Pediatric Adverse Events Terminology Motor tic Has Synonym LLT 10066770 MedDRA C87095 Mottling Mottling Skin Mottling Irregularly shaped, patchy discolorations in the skin. Irregularly shaped and discolored patches on the skin. C36281 Integumentary System Finding C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Mottled skin Has Synonym LLT 10028010 MedDRA C116757 Movement Disorder Movement Disorders Neurological conditions resulting in abnormal voluntary or involuntary movement, which may impact the speed, fluency, quality and ease of movement. Neurological conditions resulting in abnormal voluntary or involuntary movement, which may impact the speed, fluency, quality and ease of movement. C2934 Central Nervous System Disorder C118464 Pediatric Adverse Events Terminology Movement disorder Has Synonym LLT 10028035 MedDRA C118316 Mucosal Ulcer Mucosal Ulcer A circumscribed loss of integrity of the mucous membrane. A circumscribed loss of integrity of the mucous membrane. C3426 Ulcer C118464 Pediatric Adverse Events Terminology Mucosal ulceration Has Synonym LLT 10028124 MedDRA C115965 Mucositis Mucositis Inflammation of the mucous membranes. Inflammation of the mucous membranes. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Mucositis Has Synonym LLT 10028127 MedDRA C75568 Multiple Organ Failure Multi-Organ Failure Complete impairment of two or more organs or organ systems. Complete impairment of two or more organs or organ systems. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Multi-organ failure Has Synonym LLT 10028154 MedDRA C3243 Multiple Sclerosis Multiple Sclerosis A progressive autoimmune disorder affecting the central nervous system resulting in demyelination. Patients develop physical and cognitive impairments that correspond with the affected nerve fibers. An autoimmune demyelinating disease characterized by a relapsing-remitting or progressive pattern of central nervous system impairment. C2889 Autoimmune Disease C2934 Central Nervous System Disorder C118464 Pediatric Adverse Events Terminology Multiple sclerosis Has Synonym LLT 10028245 MedDRA C30085 Muscle Contraction Muscle Contraction The process where thick (myosin) and thin (actin) filaments slide against each other to produce a shortening or tensing of the muscle cell or fiber. The process where thick (myosin) and thin (actin) filaments slide against each other to produce a shortening or tensing of the muscle cell or fiber. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology C34827 Muscle Cramp Muscle Cramping Spasm A sustained, sudden and involuntary contraction of a muscle or group of muscles. Sudden and involuntary contraction of a muscle or group of muscles. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Cramp muscle Has Synonym LLT 10011291 MedDRA C50659 Muscular Rigidity Muscle Rigidity Muscles Rigid An involuntary, persistent state of firm, tense muscles with marked resistance to passive movement. An involuntary, persistent state of firm, tense muscles with marked resistance to passive movement. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Muscle rigidity Has Synonym LLT 10028330 MedDRA C118433 Muscle Stiffness Muscle Stiffness A feeling of tension or tightness in one or more muscles. A feeling of tension or tightness in one or more muscles. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Muscle stiffness Has Synonym LLT 10028339 MedDRA C50658 Muscle Weakness Muscle Weakness A reduction in the strength of one or more muscles. Diminished strength in a muscle. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Muscle weakness Has Synonym LLT 10028350 MedDRA C78238 Chest Wall Pain Musculoskeletal Chest Pain Painful sensation in the chest wall region. Pain that originates in the bones, muscles, tendons, or ligaments in the chest. C3303 Pain C118464 Pediatric Adverse Events Terminology Musculoskeletal chest pain Has Synonym LLT 10050819 MedDRA C27009 Myalgia Myalgia Muscle Pain Painful sensation originating from a muscle or group of muscles. Pain localized to muscle tissue. C3303 Pain C118464 Pediatric Adverse Events Terminology Myalgia Has Synonym LLT 10028411 MedDRA C122526 Mycoplasmal Pneumonia Mycoplasmal Pneumonia Pneumonia caused by Mycoplasma pneumoniae. Signs and symptoms include productive cough, fever, chills, shortness of breath, and chest pain. Pneumonia caused by Mycoplasma pneumoniae. Signs and symptoms include productive cough, fever, chills, shortness of breath, and chest pain. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Mycoplasmal pneumonia Has Synonym LLT 10028478 MedDRA C26832 Myelitis Myelitis An inflammatory process affecting the spinal cord. Causes include viral infections, autoimmune disorders, vascular disorders, and toxic agents. Symptoms include weakness, paresthesia, sensory loss, pain, and incontinence. Inflammation of the spinal cord. C2934 Central Nervous System Disorder C118464 Pediatric Adverse Events Terminology Myelitis Has Synonym LLT 10028524 MedDRA C3247 Myelodysplastic Syndrome Myelodysplastic Syndrome A clonal hematopoietic disorder characterized by dysplasia and ineffective hematopoiesis in one or more of the hematopoietic cell lines. The dysplasia may be accompanied by an increase in myeloblasts, but the number is less than 20%, which, according to the WHO guidelines, is the requisite threshold for the diagnosis of acute myeloid leukemia. It may occur de novo or as a result of exposure to alkylating agents and/or radiotherapy. (WHO, 2001) A pre-malignant disorder characterized by blood cytopenias and abnormalities in bone marrow morphology. C3262 Neoplasm C118464 Pediatric Adverse Events Terminology Myelodysplastic syndrome Has Synonym LLT 10028533 MedDRA C27996 Myocardial Infarction Myocardial Infarction Gross necrosis of the myocardium, as a result of interruption of the blood supply to the area, as in coronary thrombosis. Necrosis of the myocardium, as a result of interruption of the blood supply to the area. C25738 Infarct C3079 Heart Disorder C118464 Pediatric Adverse Events Terminology Myocardial infarction Has Synonym LLT 10028596 MedDRA C34831 Myocarditis Myocarditis Inflammation of the muscle tissue of the heart. Inflammation of the myocardium. C3079 Heart Disorder C118464 Pediatric Adverse Events Terminology Myocarditis Has Synonym LLT 10028606 MedDRA C34832 Myoclonic Jerk Myoclonic Jerk A sudden, involuntary contraction of a muscle or group of muscles; these movements may develop as a symptom of a number of neurological diseases, including epilepsy, Parkinson's disease, Alzheimer's disease, or Creutzfeldt-Jacob disease. A sudden, involuntary contraction of a muscle or group of muscles; these movements may develop as a symptom of a number of neurological diseases, including epilepsy, Parkinson's disease, Alzheimer's disease, or Creutzfeldt-Jacob disease. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Myoclonic jerks Has Synonym LLT 10028621 MedDRA C116924 Myoclonus Myoclonus A rapid, involuntary jerk of a muscle or group of muscles. A rapid, involuntary jerk of a muscle or group of muscles. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Myoclonus Has Synonym LLT 10028622 MedDRA C114705 Myoglobinuria Myoglobinuria The presence of myoglobin in the urine. The presence of myoglobin in the urine. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Myoglobinuria Has Synonym LLT 10028629 MedDRA C27578 Myositis Myositis An inflammatory process affecting the skeletal muscles. Causes include infections, injuries, and autoimmune disorders. Inflammation affecting the skeletal muscles. C107377 Musculoskeletal System Disorder C118464 Pediatric Adverse Events Terminology Myositis Has Synonym LLT 10028653 MedDRA C78500 Nasal Congestion Nasal Congestion The blockage of the nasal passage due to mucosal edema. It is usually the result of a viral infection or an allergic reaction. The blockage of the nasal passage due to mucosal edema or secretions. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Nasal congestion Has Synonym LLT 10028735 MedDRA C34837 Nasopharyngitis Nasopharyngitis An inflammatory process that affects the nasopharynx. Inflammation of the nasopharynx. C118420 Otolaryngologic Disorder C118464 Pediatric Adverse Events Terminology Nasopharyngitis Has Synonym LLT 10028810 MedDRA C3258 Nausea Nausea Upper abdominal discomfort associated with an urge to vomit. Upper abdominal discomfort associated with an urge to vomit. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Nausea Has Synonym LLT 10028813 MedDRA C84915 Necrotizing Enterocolitis Necrotizing Enterocolitis NEC|Necrotizing Enterocolitis in Fetus or Newborn A fulminating disease of neonates in which there is extensive mucosal ulceration, pseudomembrane formation, submucosal hemorrhage, and necrosis usually of the right colon, cecum, terminal ileum, and appendix, possibly due to perinatal intestinal ischemia and bacterial invasion. Progression can lead to necrosis, perforation and/or scarring of the intestinal tract. A disease of neonates in which there is extensive mucosal ulceration, pseudomembrane formation, submucosal hemorrhage, and necrosis. C98996 Neonatal Disorder C118464 Pediatric Adverse Events Terminology Necrotizing enterocolitis Has Synonym LLT 10055646 MedDRA C80082 Neonatal Death Neonatal Death Death of a live newborn during the first 28 days of life. Death of a live-born infant during the first 28 days after birth. C90491 Pregnancy Outcome C28554 Death C118464 Pediatric Adverse Events Terminology Death neonatal Has Synonym LLT 10011912 MedDRA C115988 Neonatal Herpes Simplex Infection Neonatal Herpes Simplex Infection Infection in the first month of life caused by the Herpes simplex virus. Infection in the first month of life caused by the Herpes simplex virus. C99231 Neonatal Infectious Disorder C118464 Pediatric Adverse Events Terminology Congenital herpes simplex infection Has Synonym LLT 10019949 MedDRA C84919 Nephrogenic Diabetes Insipidus Nephrogenic Diabetes Insipidus Diabetes insipidus caused by insensitivity of the kidneys to antidiuretic hormone. Diabetes insipidus caused by insensitivity of the kidneys to antidiuretic hormone (vasopressin), which is caused by mutation(s) in the AVPR2 gene, encoding the vasopressin V2 receptor (antidiuretic hormone receptor), or by mutation(s) in the AQP2 gene, encoding aquaporin-2. Inheritance may by X-linked (AVPR2) or autosomal dominant or recessive (AQP2). C43263 Diabetes Insipidus C118464 Pediatric Adverse Events Terminology Nephrogenic diabetes insipidus Has Synonym LLT 10029147 MedDRA C115158 Nephrogenic Systemic Fibrosis Nephrogenic Systemic Fibrosis Fibrosis of the skin, joints and other organs usually associated with gadolinium exposure in the setting of kidney failure. Fibrosis of the skin, joints and other organs usually associated with gadolinium exposure in the setting of kidney failure. C9229 Systemic Disorder C118464 Pediatric Adverse Events Terminology Nephrogenic systemic fibrosis Has Synonym LLT 10067467 MedDRA C122648 Nephrostomy Site Nephrostomy Site A surgically created external opening into the renal pelvis. A surgically created external opening into the renal pelvis. C122638 Ostomy Site C118464 Pediatric Adverse Events Terminology C79695 Neuralgia Neuralgia Intense painful sensation along a nerve or group of nerves. It is caused by irritation or trauma to a nerve or inflammation of a nerve. Intense painful sensation along a nerve or group of nerves. C3303 Pain C118464 Pediatric Adverse Events Terminology Neuralgia Has Synonym LLT 10029223 MedDRA C116381 Neuritis Neuritis Inflammation of a nerve. Inflammation of the nerve. C27580 Peripheral Nervous System Disorder C118464 Pediatric Adverse Events Terminology Neuritis Has Synonym LLT 10029240 MedDRA C3270 Neuroblastoma Neuroblastoma A neuroblastic tumor characterized by the presence of neuroblastic cells, the absence of ganglion cells, and the absence of a prominent Schwannian stroma formation. A malignant neoplasm comprised of neuroblasts that commonly arises in or near the adrenal glands. C3268 Nervous System Neoplasm C118464 Pediatric Adverse Events Terminology Neuroblastoma Has Synonym LLT 10029260 MedDRA C111963 Neurodermatitis Neurodermatitis Lichen Simplex Chronicus Skin findings arising from repeated rubbing, picking or scratching of a real or imagined irritation of the skin. Skin findings arising from repeated rubbing, picking or scratching of a real or imagined irritation of the skin. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Neurodermatitis Has Synonym LLT 10029263 MedDRA C89338 Neurodevelopmental Disorder Neurodevelopmental Disorder A childhood disorder that has a neurological basis and manifests as a developmental disability. Conditions characterized by impaired central nervous system function occurring in childhood. C26835 Nervous System Disorder C89330 Developmental Disorder C118464 Pediatric Adverse Events Terminology Neurodevelopmental disorder Has Synonym LLT 10064062 MedDRA C98990 Neuronal Migration Disorder Neuronal Migration Abnormalities Migration Defects|Neuronal Migration Disorder A diverse group of congenital brain developmental disorders characterized by defects in neuronal migration in the brain during early fetal development. The neuronal migration defects result in brain abnormalities that are usually manifested with mental retardation and epilepsy. A developmental brain abnormality characterized by abnormal migration of neurons during cortical development. C96412 Brain Development Abnormality C97172 Congenital Nervous System Disorder C118464 Pediatric Adverse Events Terminology Neuronal migration disorder Has Synonym LLT 10076677 MedDRA C80520 Neutropenia Neutropenia Granulocytopenia A decrease in the number of neutrophils in the peripheral blood. Abnormally low level of neutrophils in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Neutropenia Has Synonym LLT 10029354 MedDRA C35164 Neutrophilia Neutrophilia Granulocytosis Abnormally high level of neutrophils in the blood. Abnormally high level of neutrophils in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Neutrophilia Has Synonym LLT 10029379 MedDRA C112211 Neutrophilic Eccrine Hidradenitis Neutrophilic Eccrine Hidradenitis Painful red or pink edematous nodules most commonly found on the palmar and/or plantar regions. Painful red or pink edematous nodules most commonly found on the palmar and/or plantar regions. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Neutrophilic eccrine hidradenitis Has Synonym LLT 10056957 MedDRA C117082 New Daily Persistent Headache New Daily Persistent Headache A bilateral, unremitting headache of mild to moderate intensity that occurs daily and may be associated with photophobia, phonophobia, or mild nausea. A bilateral, unremitting headache of mild to moderate intensity that occurs daily and may be associated with photophobia, phonophobia, or mild nausea. C34661 Headache C118464 Pediatric Adverse Events Terminology New daily persistent headache Has Synonym LLT 10076678 MedDRA C114852 New Onset Diabetes After Transplant New Onset Diabetes After Transplant Development of diabetes after transplant, usually associated with calcineurin inhibitor use. Development of diabetes after transplant, usually associated with calcineurin inhibitor use. C2985 Diabetes Mellitus C118464 Pediatric Adverse Events Terminology Post transplant diabetes mellitus Has Synonym LLT 10063634 MedDRA C34850 Night Blindness Night Blindness Nyctalopia An inability to see clearly in dim light; due to a deficiency of vitamin A or to a retinal disorder. Poor visual function in dim light. C97109 Blindness C118464 Pediatric Adverse Events Terminology Night blindness Has Synonym LLT 10029404 MedDRA C3279 Night Sweats Night Sweats Perspiration experienced nocturnally that is unrelated to environmental temperature. Nocturnal perspiration that is unrelated to environmental temperature. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Night sweats Has Synonym LLT 10029410 MedDRA C117287 Night Terrors Night Terrors Sleep Terrors Episodes of abrupt awakening associated with screaming, agitation and hyperarousal. Episodes of abrupt awakening associated with screaming, agitation and hyperarousal. C3376 Sleep Disorder C118464 Pediatric Adverse Events Terminology Night terrors Has Synonym LLT 10029411 MedDRA C117263 Nightmare Nightmare A disturbing dream that occurs during rapid eye movement sleep and results in feelings of strong terror, fear, distress, or anxiety. A disturbing dream that results in feelings of fear, distress, or anxiety. C3376 Sleep Disorder C118464 Pediatric Adverse Events Terminology Nightmare Has Synonym LLT 10029412 MedDRA C82673 Nocturia Nocturia Frequent episodes of urination during the night. The frequent need to urinate at night. C36286 Urinary System Finding C118464 Pediatric Adverse Events Terminology Nocturia Has Synonym LLT 10029446 MedDRA C34664 Noise Induced Hearing Loss Noise-Induced Hearing Loss A condition in which a person loses the ability to hear due to exposure to high intensity sound. Hearing loss resulting from either chronic exposure to loud noises, or exposure to extremely loud bursts of noise. C35731 Hearing Loss C118464 Pediatric Adverse Events Terminology Noise-induced hearing loss Has Synonym LLT 10029500 MedDRA C116347 Non-Communicating Hydrocephalus Non-Communicating Hydrocephalus Obstructive Hydrocephalus An abnormal accumulation of cerebrospinal fluid within the ventricles of the brain that occurs as a consequence of an obstruction at any location within the ventricular system that prevents cerebrospinal fluid flowing into the subarachnoid space. An abnormal accumulation of cerebrospinal fluid within the ventricles of the brain that occurs as a consequence of an obstruction at any location within the ventricular system that prevents cerebrospinal fluid flowing into the subarachnoid space. C3111 Hydrocephalus C118464 Pediatric Adverse Events Terminology Non-communicating hydrocephalus Has Synonym LLT 10076690 MedDRA C3211 Non-Hodgkin Lymphoma Non-Hodgkin Lymphoma Non-Hodgkin's Lymphoma Distinct from Hodgkin lymphoma both morphologically and biologically, non-Hodgkin lymphoma (NHL) is characterized by the absence of Reed-Sternberg cells, can occur at any age, and usually presents as a localized or generalized lymphadenopathy associated with fever and weight loss. The clinical course varies according to the morphologic type. NHL is clinically classified as indolent, aggressive, or having a variable clinical course. NHL can be of B-or T-/NK-cell lineage. A malignant neoplasm of the lymphatic system that is comprised of abnormal lymphocytes in the absence of Reed-Sternberg cells. C3208 Lymphoma C118464 Pediatric Adverse Events Terminology Non-Hodgkin's lymphoma Has Synonym LLT 10029547 MedDRA C50563 Fetal Distress Nonreassuring Fetal Status Fetal Distress|Fetal Intolerance of Labor Signs or symptoms which may be indicative of distress to a fetus, which may include repetitive variable decelerations, fetal tachycardia or bradycardia, late decelerations, or low biophysical profile. Signs or symptoms which may be indicative of distress to a fetus, which may include repetitive variable decelerations, fetal tachycardia or bradycardia, late decelerations, or low biophysical profile. C81236 Birth Complication C92711 Fetal Finding C118464 Pediatric Adverse Events Terminology Foetal distress syndrome Related To LLT 10016855 MedDRA C118392 Nonunion of Bone Nonunion Nonunion of Bone The permanent failure of bone to heal, commonly due to a fracture or an osteotomy. The permanent failure of bone to heal, commonly due to a fracture or an osteotomy. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Nonunion of fracture Has Synonym LLT 10029746 MedDRA C115164 Nosocomial Infection Nosocomial Infection HAI|Healthcare-Associated Infection|Hospital-Acquired Infection|Hospital-Onset Infection An infection acquired in a hospital or other healthcare setting. An infection acquired in a hospital or other healthcare setting. C26726 Infectious Disorder C118464 Pediatric Adverse Events Terminology Nosocomial infection Has Synonym LLT 10029803 MedDRA C34857 Numbness Numbness A loss of the sensation of feeling in an area of the body. A loss of the sensation of feeling in an area of the body. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Numbness Has Synonym LLT 10029829 MedDRA C3282 Nystagmus Nystagmus Involuntary movements of the eyeballs. The presence or absence of nystagmus is often used in the diagnosis of a variety of neurological and visual disorders. Repetitive and involuntary movement of the eyes. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Nystagmus Has Synonym LLT 10029864 MedDRA C117285 Obsessive Thinking Obsessive Thinking A series of thoughts that are difficult to suppress and may be a consequence or cause of anxiety. A series of thoughts that are difficult to suppress and may be a consequence or cause of anxiety. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Obsessive thoughts Has Synonym LLT 10029897 MedDRA C116337 Obstructive Sleep Apnea Obstructive Sleep Apnea Obstructive Apnea Cessation of air flow during sleep due to upper airway obstruction. Cessation of air flow during sleep due to upper airway obstruction. C26884 Sleep Apnea C118464 Pediatric Adverse Events Terminology Obstructive sleep apnea syndrome Has Synonym LLT 10055577 MedDRA C118858 Ocular Contusion Ocular Contusion A closed globe injury without violation of the eyewall (cornea and/or sclera), resulting in injury to one or more intraocular structures. (adapted from the Birmingham Eye Trauma Terminology System (BETTS)) A closed globe injury without violation of the eyewall (cornea and/or sclera), resulting in injury to one or more intraocular structures. (adapted from the International Society of Ocular Trauma-Birmingham Eye Trauma Terminology System (BETTS)) C118747 Closed Globe Injury C118464 Pediatric Adverse Events Terminology Eye contusion Has Synonym LLT 10073354 MedDRA C118739 Ocular Foreign Body Ocular Foreign Body External material that enters the eye. External material that enters the eye. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Foreign body in eye Has Synonym LLT 10017012 MedDRA C3285 Ocular Hypertension Ocular Hypertension Pressure Behind Eyeballs Abnormally high intraocular pressure. Abnormally high intraocular pressure. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Ocular hypertension Has Synonym LLT 10030043 MedDRA C118863 Oculocardiac Reflex Oculocardiac Reflex Slowing or cessation of the heart rate secondary to traction on the extraocular muscle. Slowing or cessation of heart rate secondary to traction on the extraocular muscle. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Oculocardiac reflex Has Synonym LLT 10076703 MedDRA C116333 Oculo-Respiratory Syndrome Oculo-respiratory-syndrome A transient condition that can occur following influenza vaccination that is characterized by bilateral conjunctivitis, facial edema, and upper respiratory symptoms. A transient condition that can occur following influenza vaccination that is characterized by bilateral conjunctivitis, facial edema, and upper respiratory symptoms. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Oculo-respiratory syndrome Has Synonym LLT 10063074 MedDRA C118175 Olfactory Hallucination Olfactory Hallucination Perception of a smell in the absence of a corresponding stimulus. Perception of a smell in the absence of a corresponding stimulus. C37961 Hallucination C118464 Pediatric Adverse Events Terminology Olfactory hallucination Has Synonym LLT 10030280 MedDRA C92839 Oligohydramnios Oligohydramnios A lower than normal quantity of amniotic fluid in the amniotic sac as compared to normal values. Typically associated with an amniotic fluid index (AFI) of less than 5 cm or a single maximum vertical pocket (MVP) of less than 2 cm. A lower than normal quantity of amniotic fluid in the amniotic sac. Typically associated with an amniotic fluid index (AFI) of less than 5 cm or a single maximum vertical pocket (MVP) of less than 2 cm. C34941 Pregnancy Complication C92719 Fetal Disorder C118464 Pediatric Adverse Events Terminology Oligohydramnios Has Synonym LLT 10030289 MedDRA C113341 Oligomenorrhea Oligomenorrhea Infrequent menstrual periods. Infrequent menstrual periods. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Oligomenorrhea Has Synonym LLT 10030294 MedDRA C34860 Oligospermia Oligospermia Low Sperm Count Decreased number of spermatozoa in the semen. Decreased number of spermatozoa in the semen. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Oligospermia Has Synonym LLT 10030300 MedDRA C114698 Oliguria Oliguria Decreased Urine Output Abnormally low urine output. Abnormally low urine output. C36286 Urinary System Finding C118464 Pediatric Adverse Events Terminology Oliguria Has Synonym LLT 10030302 MedDRA C116008 Omphalitis Omphalitis Inflammation of the umbilical cord stump in newborns. Inflammation of the umbilical cord stump in newborns. C98996 Neonatal Disorder C118464 Pediatric Adverse Events Terminology Omphalitis Has Synonym LLT 10030306 MedDRA C112213 Onychodystrophy Onychodystrophy Deformity or discoloration of a fingernail or toenail. Deformity or discoloration of a fingernail or toenail. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Onychodystrophy Has Synonym LLT 10073339 MedDRA C112212 Onycholysis Onycholysis A nail condition characterized by spontaneous separation of a fingernail or toenail from its nail bed. A nail disorder characterized by spontaneous separation of a fingernail or toenail from its nail bed. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Onycholysis Has Synonym LLT 10030337 MedDRA C112214 Onychomycosis Onychomycosis Tinea Unguium Fungal infection of a fingernail or toenail. Fungal infection of a fingernail or toenail. C3371 Skin Disorder C26726 Infectious Disorder C118464 Pediatric Adverse Events Terminology Onychomycosis Has Synonym LLT 10030338 MedDRA C34641 Open Angle Glaucoma Open Angle Glaucoma Chronic outflow obstruction of the eye's drainage canals that can lead to increased internal eye pressure and optic nerve damage. Optic nerve damage secondary to chronic outflow obstruction. C26782 Glaucoma C118464 Pediatric Adverse Events Terminology Open angle glaucoma Has Synonym LLT 10030348 MedDRA C34624 Open Fracture Open Fracture A traumatic break to the bone in which the continuity of the bone has broken through the skin. A traumatic break to the bone in which the continuity of the bone has broken through the skin . C3046 Fracture C118464 Pediatric Adverse Events Terminology Open fracture Has Synonym LLT 10030527 MedDRA C118748 Open Globe Injury Open Globe Injury A full thickness wound of the eyewall (sclera and cornea). (Birmingham Eye Trauma Terminology System (BETTS)) A full thickness wound of the eyewall (sclera and cornea). (courtesy of the International Society of Ocular Trauma-Birmingham Eye Trauma Terminology System (BETTS)) C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Open globe injury Has Synonym LLT 10076717 MedDRA C117261 Oppositional Behavior Oppositionality Oppositional Behavior Negative, defiant, or hostile behavior directed towards authority. Negative, defiant, or hostile behavior directed towards authority. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Oppositional Has Synonym LLT 10030903 MedDRA C118720 Opsoclonus Opsoclonus A rapid, multivectorial, conjugate, involuntary eye movement, without an intersaccadic interval. A rapid, multivectoral, conjugate, involuntary eye movement, without an intersaccadic interval. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Myoclonus Narrower Than LLT 10028622 MedDRA C118872 Optic Disc Edema Optic Disc Edema Swelling of the optic disc in the absence of increased intracranial pressure. Swelling of the optic disc in the absence of increased intracranial pressure. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Papilledema Has Synonym LLT 10033703 MedDRA C84950 Optic Neuritis Optic Neuritis A disorder characterized by inflammation of the optic nerve. Causes include autoimmune disorders, infections, toxins, drugs, and multiple sclerosis. It may manifest with acute loss of vision and pain. Inflammation of the optic nerve. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Optic neuritis Has Synonym LLT 10030942 MedDRA C118711 Optic Neuropathy Optic Neuropathy Disorder of the optic nerve. Damage to the optic nerve. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Optic neuropathy Has Synonym LLT 10061323 MedDRA C28137 Oral Candidiasis Oral Candidiasis Thrush Infection of the mucosal lining of the mouth with the fungus Candida albicans. Infection of the mucosal lining of the mouth with the fungus Candida albicans. C26726 Infectious Disorder C118464 Pediatric Adverse Events Terminology Oral candidiasis Has Synonym LLT 10030963 MedDRA C99000 Orbital Cellulitis Orbital Cellulitis Inflammation of the eye tissues posterior to the orbital septum, and generally secondary to an infection spread from adjacent sinuses. Signs and symptoms of the affected eye include sudden loss of vision, erythema, edema, decreased eye movement, and pain. Treatment is conducted via intravenous antibiotics, observation, and surgical intervention when necessary. An infection of the orbital tissue, posterior to the orbital septum. C26715 Cellulitis C118464 Pediatric Adverse Events Terminology Orbital cellulitis Has Synonym LLT 10031036 MedDRA C118708 Orbital Contusion Orbital Contusion Bruising of the skin and soft tissue surrounding the eye. Bruising of the skin and/or soft tissue surrounding the eye. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Periorbital contusion Has Synonym LLT 10062515 MedDRA C118744 Orbital Fracture Orbital Fracture A break in the orbital bone. A break in an orbital bone. C26767 Eye Disorder C3046 Fracture C118464 Pediatric Adverse Events Terminology Orbital fracture Has Synonym LLT 10063638 MedDRA C118752 Orbital Muscle Entrapment Orbital Muscle Entrapment The binding of one or more ocular muscles by orbital bone pieces, resulting in decreased eye mobility. The tethering of one or more ocular muscles by adjacent orbital bone pieces, resulting in reduced extraocular movement. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Eye muscle entrapment Has Synonym LLT 10065088 MedDRA C97145 Orchitis Orchitis Inflammation of one or both testes due to viral or bacterial infections. Signs and symptoms include enlargement or tenderness of the affected testis, inguinal lymphadenopathy, blood in the semen, and pain during urination, intercourse, or ejaculation. Inflammation of one or both testicles. C27019 Male Reproductive System Disorder C118464 Pediatric Adverse Events Terminology Orchitis Has Synonym LLT 10031064 MedDRA C113588 Oropharyngeal Dysphagia Oropharyngeal Dysphagia Difficulty in swallowing due to an abnormality in the mouth or throat. Difficulty in swallowing due to an abnormality in the mouth or throat. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Oropharyngeal dysphagia Has Synonym LLT 10075766 MedDRA C84970 Orthostatic Hypotension Orthostatic Hypotension Sudden fall of the blood pressure of at least 20/10 mm Hg when a person stands up. A sudden fall in blood pressure upon rising to a standing position. C3128 Hypotension C118464 Pediatric Adverse Events Terminology Orthostatic hypotension Has Synonym LLT 10031127 MedDRA C84978 Osteochondrodysplasia Osteochondrodysplasia Congenital Skeletal Dysplasia|Skeletal Dysplasia A term referring to disorders characterized by abnormalities in the development of bones and cartilage. Abnormalities in development and growth of bone and cartilage. C89337 Congenital Musculoskeletal Defect C118464 Pediatric Adverse Events Terminology Skeletal dysplasia Has Synonym LLT 10072610 MedDRA C27577 Osteomyelitis Osteomyelitis An acute or chronic inflammation of the bone and its structures due to infection with pyogenic bacteria. Inflammation of the bone, usually due to infection. C107377 Musculoskeletal System Disorder C118464 Pediatric Adverse Events Terminology Osteomyelitis Has Synonym LLT 10031252 MedDRA C34880 Bone Necrosis Osteonecrosis Death of bone tissue due to traumatic or nontraumatic causes. Death of bone tissue. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Osteonecrosis Has Synonym LLT 10031264 MedDRA C9145 Osteosarcoma Osteosarcoma A usually aggressive malignant bone-forming mesenchymal neoplasm, predominantly affecting adolescents and young adults. It usually involves bones and less frequently extraosseous sites. It often involves the long bones (particularly distal femur, proximal tibia, and proximal humerus). Pain with or without a palpable mass is the most frequent clinical symptom. It may spread to other anatomic sites, particularly the lungs. A malignant neoplasm of connective tissue origin that produces bone or osteoid. C9118 Sarcoma C118464 Pediatric Adverse Events Terminology Osteosarcoma Has Synonym LLT 10031291 MedDRA C122409 Ostomy Site Pain Ostomy Site Pain Pain at the site of an ostomy. Pain at the site of an ostomy. C3303 Pain C118464 Pediatric Adverse Events Terminology Stoma site pain Has Synonym LLT 10057843 MedDRA C79601 Otitis Externa Otitis Externa External Otitis Inflammation of the anatomical structures of the outer ear and ear canal, which is most often caused by an infectious process. Symptoms include erythema, edema, and pain. Inflammation of the outer ear and/or ear canal. C118420 Otolaryngologic Disorder C118464 Pediatric Adverse Events Terminology Otitis externa Has Synonym LLT 10033072 MedDRA C34885 Otitis Media Otitis Media Medial Otitis Inflammation of the anatomical structures of the middle ear, which is most often caused by an infectious process. Symptoms include erythema and edema of the tympanic membrane, pain, and possibly fever. Inflammation of the middle ear. C118420 Otolaryngologic Disorder C118464 Pediatric Adverse Events Terminology Otitis media Has Synonym LLT 10033078 MedDRA C35199 Otorrhea Otorrhea Ear Drainage Discharge or drainage of fluid from the ear. Discharge or drainage of fluid from the ear. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Otorrhea Has Synonym LLT 10033099 MedDRA C3873 Ovarian Germ Cell Tumor Ovarian Germ Cell Tumor A neoplasm that arises from the ovary and originates from germ cells. Representative examples include teratoma, embryonal carcinoma, yolk sac tumor, and dysgerminoma. A neoplasm arising from gonadal tissue within the ovary. C114801 Childhood Gonadal Germ Cell Tumor C118464 Pediatric Adverse Events Terminology Ovarian germ cell tumor Has Synonym LLT 10075820 MedDRA C50850 Oversedated Oversedation A level of sedation that is greater than the intended level. The level of sedation that is greater than the intended level. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Oversedation Has Synonym LLT 10033305 MedDRA C114802 Page Kidney Page Kidney Hypertension resulting from activation of the renin-angiotensin system in response to prolonged compression of the renal parenchyma and blood vessels. Hypertension resulting from activation of the renin-angiotensin system in response to prolonged compression of the renal parenchyma and blood vessels. C9229 Systemic Disorder C118464 Pediatric Adverse Events Terminology Page kidney Has Synonym LLT 10076704 MedDRA C3303 Pain Pain The sensation of discomfort, distress, or agony, resulting from the stimulation of specialized nerve endings. An unpleasant sensation associated with real or perceived physical or mental trauma. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Pain Has Synonym LLT 10033371 MedDRA C50685 Pallor Pallor An unusual or extreme paleness, state of decreased skin or mucosal coloration. A condition characterized by an abnormal loss of color to the skin or mucous membranes due to reduced delivery of saturated hemoglobin. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Pallor Has Synonym LLT 10033546 MedDRA C34748 Palmoplantar Keratoderma Palmoplantar Keratoderma A group of autosomal dominant, autosomal recessive, X-linked inherited or acquired disorders characterized by the thickening of the palms and soles due to hyperkeratosis. A group of skin disorders characterized by thickening of the palms and soles due to hyperkeratosis. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Palmoplantar keratoderma Has Synonym LLT 10033554 MedDRA C35499 Vascular Purpura Palpable Purpura Vascular Purpura A raised vasculitic hemorrhage into the skin and/or mucous membranes. A raised vasculitic hemorrhage into the skin and/or mucous membranes. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Palpable purpura Has Synonym LLT 10056872 MedDRA C37999 Palpitation Palpitation An unpleasant sensation of irregular and/or forceful beating of the heart. The sensation of an irregular and/or forceful heart beat. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Palpitation Has Synonym LLT 10033556 MedDRA C116721 Palsy Palsy Muscle weakness or paralysis of neurologic origin. Muscle weakness or paralysis of neurologic origin. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Palsy Has Synonym LLT 10033558 MedDRA C3306 Pancreatitis Pancreatitis Inflammation of the pancreas. Inflammation of the pancreas. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Pancreatitis Has Synonym LLT 10033645 MedDRA C34889 Pancytopenia Pancytopenia A finding of low numbers of red and white blood cells and platelets in the peripheral blood. Abnormally low level of red blood cells, white blood cells, and platelets in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Pancytopenia Has Synonym LLT 10033661 MedDRA C110940 Panhypopituitarism Panhypopituitarism Complete Hypopituitarism Insufficient production of all the anterior pituitary hormones. A deficiency of all anterior pituitary hormones, without necessary involvement of the hormones of the posterior pituitary gland (oxytocin and vasopressin). C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Panhypopituitarism Has Synonym LLT 10033662 MedDRA C112112 Panniculitis Panniculitis Inflammation of the subcutaneous adipose tissue. Inflammation of the subcutaneous adipose tissue. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Panniculitis Has Synonym LLT 10033675 MedDRA C84989 Panuveitis Panuveitis A disorder characterized by inflammation of the entire uvea which includes the iris, ciliary body, and choroid. Causes include systemic infections, sarcoidosis, and cancers. Inflammation of all layers of the uvea. C26909 Uveitis C118464 Pediatric Adverse Events Terminology Panuveitis Has Synonym LLT 10033687 MedDRA C3307 Papilledema Papilledema Swelling around the optic disc, usually due to increased intracranial pressure or pressure on the optic nerve by a tumor. Swelling of the optic disc secondary to increased intracranial pressure. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Papilledema Has Synonym LLT 10033703 MedDRA C39690 Papular Lesion Papule A small (less than 5-10 mm) elevation of skin that is non-suppurative. A small (less than 5-10 mm), elevation of skin that is non-suppurative. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Papule Has Synonym LLT 10033733 MedDRA C94546 Paranoia Paranoia An irrational fear of harm by others, or distrust of others. An irrational fear of harm by or distrust of others. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Paranoia Has Synonym LLT 10033864 MedDRA C94836 Parasomnia Parasomnia A group of sleep disorders causing disruption of sleep. Representative examples include nightmare disorders, sleep terror disorders, sleepwalking, and restless leg syndrome. Abnormal behavior or movements during sleep. C3376 Sleep Disorder C118464 Pediatric Adverse Events Terminology Parasomnia Has Synonym LLT 10061910 MedDRA C98619 Parenteral Nutrition - Associated Cholestasis Parenteral Nutrition - Associated Cholestasis TPN Acquired Cholestasis|TPN Associated Cholestasis Cholestasis that results from prolonged total parenteral nutrition. It is caused by diminished bile flow from the liver into the duodenum. It may result in cirrhosis and liver failure. Preterm infants are most susceptible to liver damage. Diminished bile flow from the liver into the duodenum as a result of prolonged parenteral nutrition or total parenteral nutrition. C83006 Cholestasis C118464 Pediatric Adverse Events Terminology Parenteral nutrition associated cholestasis Has Synonym LLT 10074152 MedDRA C28177 Paresthesia Paresthesia Abnormal cutaneous sensations of tingling, numbness, pressure, cold, and warmth that an individual experiences without the presence of a stimulus. It results from functional disturbances of sensory neurons. Causes include peripheral vascular disease, peripheral neuropathy, and nerve damage. Abnormal cutaneous sensations of tingling, numbness, pressure, cold, and/or warmth. C28246 Dysesthesia C118464 Pediatric Adverse Events Terminology Paresthesia Has Synonym LLT 10033987 MedDRA C116922 Parkinsonism Parkinsonism Parkinsonian Symptoms One or more of the following symptoms including bradykinesia associated with rigidity, resting tremor, gait disturbance, which may be due to multiple etiologies. One or more of the following symptoms including bradykinesia associated with rigidity, resting tremor, gait disturbance, which may be due to multiple etiologies. C87124 Central Nervous System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Parkinsonism Has Synonym LLT 10034010 MedDRA C112215 Paronychial Inflammation Paronychial Inflammation Swelling and redness of the nail folds. Swelling and redness of the nail folds. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Nail fold inflammation Has Synonym LLT 10074978 MedDRA C86949 Parosmia Parosmia An olfactory disturbance where the sense of smell inaccurately conveys disagreeable sensations. Distorted perception of smells. C28246 Dysesthesia C118464 Pediatric Adverse Events Terminology Parosmia Has Synonym LLT 10034018 MedDRA C114281 Parotitis Parotitis Inflammation of the parotid glands. Inflammation of the parotid glands. C118420 Otolaryngologic Disorder C118464 Pediatric Adverse Events Terminology Parotitis Has Synonym LLT 10034038 MedDRA C36192 Arteriovenous Fistula Pathologic AV Fistula Pathologic Arteriovenous Fistula An unintended connection between an artery and vein. An unintended connection between an artery and vein. C3045 Fistula C35117 Vascular Disorder C118464 Pediatric Adverse Events Terminology Arteriovenous fistula Has Synonym LLT 10003226 MedDRA C113099 Pediatric Failure to Thrive Pediatric Failure to Thrive Failure to Thrive Less than normal weight gain in an infant or child, which may include poor linear and head growth. Suboptimal weight gain in an infant or child, which, if severe and/or prolonged, may lead to impaired linear and head growth. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Failure to thrive Narrower Than LLT 10016165 MedDRA C40122 Pelvic Pain Pelvic Pain Painful sensation in the pelvis. Pain in the pelvic region. C3303 Pain C118464 Pediatric Adverse Events Terminology Pelvic pain Has Synonym LLT 10034263 MedDRA C118869 Penetrating Open Globe Injury Penetrating Open Globe Injury Full thickness wound of the eyewall (cornea and/or sclera) caused by the entry of a sharp object into the eye. (adapted from the Birmingham Eye Trauma Terminology System (BETTS)) Full thickness wound of the eyewall (cornea and/or sclera) caused by the entry of a sharp object into the eye. (adapted from the Birmingham Eye Trauma Terminology System (BETTS)) C118748 Open Globe Injury C118464 Pediatric Adverse Events Terminology Penetrating open globe injury Has Synonym LLT 10076718 MedDRA C3318 Peptic Ulcer Peptic Ulcer A mucosal erosion that occurs in the esophagus, stomach or duodenum. Symptoms can include abdominal pain, nausea and vomiting, and bleeding. A mucosal injury that occurs in the stomach or duodenum. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Peptic ulcer Has Synonym LLT 10034341 MedDRA C118870 Perforating Open Globe Injury Perforating Open Globe Injury Open globe injury with both entrance and exit wounds in the eyewall (cornea and/or sclera) caused by the same object. Open globe injury with both entrance and exit wounds in the eyewall (cornea and/or sclera) caused by the same object. (adapted from the International Society of Ocular Trauma-Birmingham Eye Trauma Terminology System (BETTS)) C118748 Open Globe Injury C118464 Pediatric Adverse Events Terminology Perforating open globe injury Has Synonym LLT 10076719 MedDRA C4080 Perforation Perforation A hole or opening made through a membrane or other tissue or material. A hole or opening made through a membrane or other tissue. C3671 Injury C118464 Pediatric Adverse Events Terminology Perforation Has Synonym LLT 10076705 MedDRA C3319 Pericardial Effusion Pericardial Effusion Fluid collection within the pericardial sac, usually due to inflammation. Fluid collection within the pericardial sac. C101327 Pericardial Anomaly C118464 Pediatric Adverse Events Terminology Pericardial effusion Has Synonym LLT 10034474 MedDRA C34915 Pericarditis Pericarditis An inflammatory process affecting the pericardium. Inflammation of the pericardium, frequently manifested as chest pain, friction rub, pericardial effusion, or ST segment elevation on EKG. C101327 Pericardial Anomaly C118464 Pediatric Adverse Events Terminology Pericarditis Has Synonym LLT 10034484 MedDRA C116313 Perinatal Depression Perinatal Depression Birth Depression A condition characterized by cardiorespiratory and neurological depression following birth. A condition characterized by cardiorespiratory and neurological depression following birth. C26871 Respiratory System Disorder C35095 Perinatal Disorder C118464 Pediatric Adverse Events Terminology Birth Asphyxia|Fetal Asphyxia|Intrapartum Asphyxia|Perinatal Asphyxia Perinatal disorder Narrower Than LLT 10034507 MedDRA C118676 Perinatal Mortality Perinatal Mortality Fetal or infant death during the period of time that includes the antepartum, intrapartum, and neonatal stages. Fetal or infant death during the period of time that includes the antepartum, Intrapartum, and neonatal stages. C90491 Pregnancy Outcome C118464 Pediatric Adverse Events Terminology Perinatal death Has Synonym LLT 10076720 MedDRA C115786 Perinephric Hematoma Perinephric Hematoma A collection of blood around the kidney. A collection of blood around the kidney. C50579 Hematoma C118464 Pediatric Adverse Events Terminology Retroperitoneal hematoma Related To LLT 10058361 MedDRA C78262 Edema Limbs Peripheral Edema Swelling due to an excessive accumulation of fluid in the upper or lower extremities. Accumulation of an excessive amount of fluid in cells or intercellular tissues of the limbs. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Peripheral edema Has Synonym LLT 10034570 MedDRA C118736 Peripheral Visual Field Defect Peripheral Visual Field Defect Reduced or abnormal sight in the peripheral visual field. Reduced or abnormal sight in the peripheral visual field. C118727 Visual Field Defect C118464 Pediatric Adverse Events Terminology Peripheral vision defective Has Synonym LLT 10034642 MedDRA C114725 Peritoneal Dialysis Catheter Infection Peritoneal Dialysis Catheter Infection A local or systemic infection associated with the use of a peritoneal dialysis catheter. A local or systemic infection associated with the use of a peritoneal dialysis catheter. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Catheter infection Narrower Than LLT 10051387 MedDRA C114751 Peritoneal Dialysis Catheter-Associated Peritonitis Peritoneal Dialysis Catheter-Associated Peritonitis Infection of the peritoneum related to a peritoneal dialysis catheter. Infection of the peritoneum related to a peritoneal dialysis catheter. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Peritonitis Narrower Than LLT 10034674 MedDRA C26849 Peritonitis Peritonitis Inflammation of the peritoneum due to infection by bacteria or fungi. Causes include liver disease, perforation of the gastrointestinal tract or biliary tract, and peritoneal dialysis. Patients usually present with abdominal pain and tenderness, fever, chills, and nausea and vomiting. It is an emergency medical condition that requires prompt medical attention and treatment. Inflammation of the peritoneum. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Peritonitis Has Synonym LLT 10034674 MedDRA C117272 Periventricular Hemorrhage of the Newborn Periventricular Hemorrhage of Newborn Periventricular Hemorrhage of the Newborn Bleeding into the brain tissue adjacent to the lateral cerebral ventricles of newborn infant. Bleeding into the brain tissue adjacent to the lateral cerebral ventricles of a newborn infant. C50438 Intracranial Hemorrhage C118464 Pediatric Adverse Events Terminology Periventricular hemorrhage neonatal Has Synonym LLT 10076730 MedDRA C99013 Periventricular Leukomalacia Periventricular Leukomalacia PVL Necrosis and softening of the white matter around the ventricles in the brain. It is usually seen in preterm infants and caused by lack of blood flow and oxygenation in the periventricular brain parenchyma. A form of cerebral white matter injury usually seen in preterm infants that is characterized by necrotic degeneration or gliosis of white matter adjacent to the cerebral ventricles, that may evolve into focal cysts. C98920 Encephalomalacia C118464 Pediatric Adverse Events Terminology Periventricular leukomalacia Has Synonym LLT 10052594 MedDRA C3323 Petechia Petechiae Purple or red hemorrhagic pinpoint spots in the skin or mucous membranes. Purple or red hemorrhagic pinpoint spots in the skin or mucous membranes. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Petechiae Has Synonym LLT 10034754 MedDRA C116375 Phantogeusia Phantom Taste Perception A lingering, usually unpleasant, taste without the associated stimulus. A lingering, usually unpleasant, taste without the associated stimulus. C28246 Dysesthesia C118464 Pediatric Adverse Events Terminology Phantom taste perception Has Synonym LLT 10076721 MedDRA C116372 Phantosmia Phantosmia Detection of odors that are not present. Detection of odors that are not present. C28246 Dysesthesia C118464 Pediatric Adverse Events Terminology Phantosmia Has Synonym LLT 10067906 MedDRA C26851 Pharyngitis Pharyngitis Sore Throat Inflammation of the throat most often caused by viral and bacterial infections. Other causes include allergens, chemical substances, and trauma. Inflammation of the throat. C118420 Otolaryngologic Disorder C118464 Pediatric Adverse Events Terminology Pharyngitis Has Synonym LLT 10034835 MedDRA C38003 Phlebitis Phlebitis Inflammation of a vein. Inflammation of a vein. C35117 Vascular Disorder C118464 Pediatric Adverse Events Terminology Phlebitis Has Synonym LLT 10034879 MedDRA C116760 Phonic Tic Phonic Tic Vocal Tic A vocal tic. A vocal tic. C116758 Tic C118464 Pediatric Adverse Events Terminology Vocal tic Has Synonym LLT 10066771 MedDRA C122579 Phonophobia Phonophobia A fear of sounds, which can include fear of voices, including one's own voice, in addition to other sounds. A fear of sounds, which can include fear of voices, including one's own voice, in addition to other sounds. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Phonophobia Has Synonym LLT 10054956 MedDRA C118750 Photokeratitis Photokeratitis Ultraviolet Keratitis Injury to the cornea secondary to ultraviolet light. Injury to the cornea secondary to ultraviolet light. C26805 Keratitis C118464 Pediatric Adverse Events Terminology Photokeratitis Has Synonym LLT 10034944 MedDRA C28210 Photophobia Photophobia Ocular Photosensitivity Increased sensitivity of the eyes to light, which can result in the avoidance of light exposure. Increased reactivity of the eye to light exposure. C99208 Eye Finding C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Photophobia Has Synonym LLT 10034960 MedDRA C99016 Phrenic Nerve Injury Phrenic Nerve Injury Damage to the phrenic nerve. Damage to the phrenic nerve, resulting in paralysis of the ipsilateral hemidiaphragm. C3671 Injury C118464 Pediatric Adverse Events Terminology Phrenic nerve paralysis Has Synonym LLT 10064964 MedDRA C21129 Physical Dependence Physical Dependence The neuroadaptation of the body to the presence of an opioid, and is characterized by the onset of acute symptoms and signs of withdrawal if the opioid is stopped or an opioid antagonist is administered. A physiological state characterized by tolerance to a pharmacological substance and symptoms of withdrawal if use is abruptly ended. C26835 Nervous System Disorder C118464 Pediatric Adverse Events Terminology Dependence physiological Has Synonym LLT 10012351 MedDRA C92566 Pica Eating Disorder Pica An eating disorder characterized by the persistent eating of nonnutritive substances such as clay or soil; this behavior must be inappropriate to the level of the individual's development. Desire for and/or consumption of non-food products. C89332 Eating Disorder C118464 Pediatric Adverse Events Terminology Pica Has Synonym LLT 10035001 MedDRA C78492 Nail Discoloration Pigmentary Change of Nails Chromonychia A change in the color of the nail. Abnormal changes in nail color. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Nail pigmentation Has Synonym LLT 10058455 MedDRA C124224 Pigmentary Change in Skin Pigmentary Change of Skin Abnormal skin pigmentation. Changes in skin pigmentation. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Abnormal pigmentation Has Synonym LLT 10000165 MedDRA C39624 Skin Plaque Plaque A large (greater than 5-10 mm) raised skin lesion with a wide, flat surface. A large (greater than 5-10 mm) raised skin lesion with a wide, flat surface. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Skin plaque Broader Than LLT 10067723 MedDRA C113756 Pleocytosis Pleocytosis Abnormally high cell count in a body fluid. Abnormally high cell count in a body fluid. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Pleocytosis Has Synonym LLT 10035551 MedDRA C3331 Pleural Effusion Pleural Effusion Increased amounts of fluid within the pleural cavity. Symptoms include shortness of breath, cough, and chest pain. It is usually caused by lung infections, congestive heart failure, pleural and lung tumors, connective tissue disorders, and trauma. An accumulation of fluid in the pleural cavity. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Pleural effusion Has Synonym LLT 10035598 MedDRA C26860 Pleuritis Pleuritis Pleurisy Inflammation of the pleura. It is usually caused by infections. Chest pain while breathing or coughing is the presenting symptom. Inflammation of the pleura. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Pleuritis Has Synonym LLT 10035624 MedDRA C122785 Pneumatosis Pneumatosis The presence of gas in an anatomical location where it is not normally found. The presence of gas in an anatomical location where it is not normally found. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Pneumatosis Has Synonym LLT 10051986 MedDRA C122580 Pneumatosis Intestinalis Pneumatosis Intestinalis The presence of gas within the wall of the large or small intestine. The presence of gas within the wall of the large or small intestine. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Pneumatosis intestinalis Has Synonym LLT 10057030 MedDRA C3333 Pneumonia Pneumonia An acute, acute and chronic, or chronic inflammation focally or diffusely affecting the lung parenchyma, due to infections (viruses, fungi, mycoplasma, or bacteria), treatment (e.g. radiation), or exposure (inhalation) to chemicals. Symptoms include cough, shortness of breath, fevers, chills, chest pain, headache, sweating, and weakness. A condition resulting from infection in one or both lungs. C3198 Lung Disorder C118464 Pediatric Adverse Events Terminology Pneumonia Has Synonym LLT 10035664 MedDRA C113159 Pneumonitis Pneumonitis An inflammatory process affecting the lung parenchyma. It is a milder form of lung inflammation compared to pneumonia. Inflammation of the lung parenchyma. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Pneumonitis Has Synonym LLT 10035742 MedDRA C99012 Pneumoperitoneum Pneumoperitoneum Free air within the peritoneal cavity. Free air within the peritoneal cavity. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Pneumoperitoneum Has Synonym LLT 10048299 MedDRA C38006 Pneumothorax Pneumothorax Abnormal presence of air in the pleural cavity. A collection of air or other gas between the visceral and parietal pleura. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Pneumothorax Has Synonym LLT 10035759 MedDRA C53975 Poikiloderma Poikiloderma A localized skin condition commonly associated with sun exposure that is characterized by variegated discoloration, telangiectasia and atrophy. A localized skin condition commonly associated with sun exposure that is characterized by variegated discoloration, telangiectasia and atrophy. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Poikiloderma Has Synonym LLT 10057041 MedDRA C26863 Polycythemia Polycythemia Abnormally high mass or concentration of red blood cells in the blood, either due to an increase in erythropoiesis or a decrease in plasma volume. Abnormally high mass or concentration of red blood cells in the blood, either due to an increase in erythropoiesis or a decrease in plasma volume. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Polycythemia Has Synonym LLT 10036058 MedDRA C50700 Polydipsia Polydipsia Chronic excessive intake of water; it may be from an organic cause, such as the dehydration of diabetes mellitus, diabetes insipidus, or a reaction to medication, or from a psychological cause. When untreated it can lead to water intoxication. Excessive thirst. C36286 Urinary System Finding C118464 Pediatric Adverse Events Terminology Polydipsia Has Synonym LLT 10036067 MedDRA C92848 Polyhydramnios Polyhydramnios An excess quantity of amniotic fluid in the amniotic sac as compared to normal values. Typically associated with an amniotic fluid index (AFI) of greater than or equal to 25 cm or a single maximum vertical pocket (MVP) of greater than 8 cm. An excess quantity of amniotic fluid in the amniotic sac as compared to normal values. Typically associated with an amniotic fluid index (AFI) of greater than or equal to 25 cm or a single maximum vertical pocket (MVP) of greater than 8 cm. C34941 Pregnancy Complication C92719 Fetal Disorder C118464 Pediatric Adverse Events Terminology Polyhydramnios Has Synonym LLT 10036079 MedDRA C116936 Polymicrogyria Polymicrogyria A developmental brain abnormality characterized by an excessive amount of small convolutions on the surface of the brain and cognitive dysfunction. A developmental brain abnormality characterized by an excessive amount of small convolutions on the surface of the brain and cognitive dysfunction. C2934 Central Nervous System Disorder C118464 Pediatric Adverse Events Terminology Polymicrogyria Has Synonym LLT 10073489 MedDRA C111648 Polymorphic Ventricular Tachycardia Polymorphic Ventricular Tachycardia A ventricular tachycardia that is irregular in rate and rhythm. A ventricular tachycardia that is irregular in rate and rhythm. C26924 Ventricular Arrhythmia C118464 Pediatric Adverse Events Terminology Polymorphic ventricular tachycardia Has Synonym LLT 10036095 MedDRA C118303 Polyuria Polyuria Excessive or frequent urination. Excessive or frequent urination. C36286 Urinary System Finding C118464 Pediatric Adverse Events Terminology Polyuria Has Synonym LLT 10036142 MedDRA C87111 Poor Feeding Poor Feeding Occurs either when an infant shows no interest in feeding or when there is an inability to take in adequate nutrition. Poor feeding is a nonspecific symptom of many disorders, including neurological, genetic, structural, metabolic, and infectious diseases. A non-specific symptom characterized by inadequate oral nutritional intake that may be associated with several different disorders. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Poor feeding infant Broader Than LLT 10075316 MedDRA C111659 Poor Weight Gain Poor Weight Gain Failure to Gain Weight|Inadequate Weight Gain|Low Weight Gain Slower than normal rate of weight increase. Slower than normal rate of weight increase. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Poor weight gain Has Synonym LLT 10036164 MedDRA C122425 Port Site Infection Port Site Infection An infection at an anatomic location used for vascular access. An infection at an anatomic location used for vascular access. C26726 Infectious Disorder C118464 Pediatric Adverse Events Terminology Infusion site infection Narrower Than LLT 10054997 MedDRA C3119 Portal Hypertension Portal Hypertension Increased blood pressure in the portal venous system. It is most commonly caused by cirrhosis. Other causes include portal vein thrombosis, Budd-Chiari syndrome, and right heart failure. Complications include ascites, esophageal varices, encephalopathy, and splenomegaly. Increased blood pressure in the portal venous system which manifests as ascites, splenomegaly and/or varices. C3368 Gastrointestinal System Signs and Symptoms C3117 Hypertension C118464 Pediatric Adverse Events Terminology Portal hypertension Has Synonym LLT 10036200 MedDRA C122437 Positive Blood Culture Positive Blood Culture A laboratory test result demonstrating the presence of a specific organism in a blood sample after culture. A laboratory test result demonstrating the presence of a specific organism in a blood sample after culture. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Blood culture positive Has Synonym LLT 10005488 MedDRA C122575 Positive Herpes Simplex Virus Culture Positive Herpes Simplex Virus Culture Laboratory test results demonstrating the presence of the Herpes Simplex virus in a specimen. Laboratory test results demonstrating the presence of the Herpes Simplex virus in a specimen. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Herpes simplex virus test positive Has Synonym LLT 10070233 MedDRA C122582 Positive Pseudomonas Culture Positive Pseudomonas Culture A laboratory test result demonstrating the presence of bacteria from the genus Pseudomonas in a sample after culture. A laboratory test result demonstrating the presence of bacteria from the genus Pseudomonas in a sample after culture. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Pseudomonas test positive Has Synonym LLT 10070135 MedDRA C116378 Posterior Fossa Syndrome Posterior Fossa Syndrome A postoperative syndrome, usually presenting after midline posterior fossa tumor resection, that involves a variety of signs and symptoms including aphasia, mutism or speech disturbances, dysphagia, mobility problems, cranial nerve palsies and emotional instability. A postoperative syndrome, usually presenting after midline posterior fossa tumor resection, that involves a variety of signs and symptoms including aphasia, mutism or speech disturbances, dysphagia, mobility problems, cranial nerve palsies and emotional instability. C2959 Complication C118464 Pediatric Adverse Events Terminology Posterior fossa syndrome Has Synonym LLT 10069579 MedDRA C78598 Reversible Posterior Leukoencephalopathy Syndrome Posterior Reversible Encephalopathy Syndrome PRES|Reversible Occipital Parietal Encephalopathy|Reversible Posterior Cerebral Edema Syndrome|Reversible Posterior Leukoencephalopathy Syndrome An acute or subacute reversible condition characterized by headaches, mental status changes, visual disturbances, and seizures associated with imaging findings of posterior leukoencephalopathy. It has been observed in association with hypertensive encephalopathy, eclampsia, and immunosuppressive and cytotoxic drug treatment. A neurotoxic state associated with posterior cerebral edema and variable neurological symptoms, typically including seizures, visual disturbance, mental status changes and/or headache. C26920 Encephalopathy C118464 Pediatric Adverse Events Terminology Posterior reversible encephalopathy syndrome Has Synonym LLT 10071066 MedDRA C35111 Posterior Uveitis Posterior Uveitis An inflammatory process that affects the choroid. Inflammation of the posterior uveal tract. C26909 Uveitis C118464 Pediatric Adverse Events Terminology Posterior uveitis Has Synonym LLT 10036370 MedDRA C118721 Posterior Vitreous Detatchment Posterior Vitreous Detatchment The separation of the vitreous from the retina. The separation of the vitreous from the retina. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Posterior vitreous detachment Has Synonym LLT 10058006 MedDRA C116383 Post-Hemorrhagic Hydrocephalus Post-Hemorrhagic Hydrocephalus An abnormal accumulation of cerebrospinal fluid within the ventricles of the brain that occurs as a later sequela of an intraventricular or subarachnoid hemorrhage. An abnormal accumulation of cerebrospinal fluid within the ventricles of the brain that occurs as a later sequela of an intraventricular or subarachnoid hemorrhage. C3111 Hydrocephalus C118464 Pediatric Adverse Events Terminology Hydrocephalus Narrower Than LLT 10020508 MedDRA C117084 Post-Herpetic Neuralgia Post-herpetic Neuralgia Pain that occurs after the disappearance of herpes zoster infection lesions. Head or facial pain associated with a cutaneous eruption in the distribution of a nerve that persists or recurs after the onset of herpes zoster infection. C26835 Nervous System Disorder C118464 Pediatric Adverse Events Terminology Post herpetic neuralgia Has Synonym LLT 10036376 MedDRA C116384 Post-Inflammatory Hydrocephalus Post-Inflammatory Hydrocephalus An abnormal accumulation of cerebrospinal fluid within the ventricles of the brain that occurs as a consequence of a central nervous system inflammation. An abnormal accumulation of cerebrospinal fluid within the ventricles of the brain that occurs as a consequence of central nervous system infection and/or inflammation. C3111 Hydrocephalus C118464 Pediatric Adverse Events Terminology Post inflammatory hydrocephalus Has Synonym LLT 10077525 MedDRA C78566 Post-Nasal Drip Postnasal Drip Excessive mucous secretion in the back of the nasal cavity or throat, causing sore throat and/or coughing. It is usually due to allergic rhinitis or a cold. Excessive mucous secretion from the nose draining into the oropharynx. C45233 Respiratory System Finding C118464 Pediatric Adverse Events Terminology Postnasal drip Has Synonym LLT 10036402 MedDRA C114870 Post-Natal Death at 16-20 Weeks Gestation Post-Natal Death at 16-20 Weeks Gestation A fetus of 16-20 weeks gestational age that shows signs of life at birth but dies after delivery. A fetus of 16-20 weeks gestational age that shows signs of life at birth but dies after delivery. C80082 Neonatal Death C118464 Pediatric Adverse Events Terminology Post-natal death at 16-20 weeks gestation Has Synonym LLT 10076722 MedDRA C34938 Postoperative Hemorrhage Postoperative Hemorrhage Bleeding occurring after completion of a surgical procedure, which may occur immediately or may be delayed, and which may or may not be wound related. Bleeding occurring after completion of a surgical procedure, which may occur immediately or may be delayed, and which may or may not be wound related. C2959 Complication C118464 Pediatric Adverse Events Terminology Postoperative hemorrhage Has Synonym LLT 10055322 MedDRA C122581 Postoperative Infection Postoperative Infection Any infection documented following a surgical procedure that was not evident or suspected prior to the procedure. An infection documented following a surgical procedure that was not present or incubating prior to the procedure. C26726 Infectious Disorder C118464 Pediatric Adverse Events Terminology Postoperative infection Has Synonym LLT 10059428 MedDRA C50704 Postoperative Wound Infection Postoperative Wound Infection Infection of a surgical skin incision. Infection of a surgical skin incision. C128320 Infection C2959 Complication C118464 Pediatric Adverse Events Terminology Postoperative wound infection Has Synonym LLT 10036410 MedDRA C111649 Post-Pericardiotomy Syndrome Post-Pericardiotomy Syndrome An inflammatory disorder of the pericardium and pleura seen as a post-operative complication of cardiovascular surgery. An inflammatory disorder of the pericardium and pleura seen as a post-operative complication of cardiovascular surgery. C101327 Pericardial Anomaly C118464 Pediatric Adverse Events Terminology Postpericardiotomy syndrome Has Synonym LLT 10059483 MedDRA C35651 Post-Procedural Pain Post-Procedural Pain Pain experienced after a medical intervention through the time expected for associated acute effects to abate. Pain experienced after a medical intervention through the time expected for associated acute effects to abate. C3303 Pain C118464 Pediatric Adverse Events Terminology Post procedural pain Has Synonym LLT 10049749 MedDRA C114947 Postterm Infant Postterm Infant Post Dates|Postmature A newborn infant greater than or equal to 42 weeks, 0 days gestational age. A newborn infant greater than or equal to 42 weeks, 0 days gestational age. C16731 Newborn C118464 Pediatric Adverse Events Terminology Postmature baby Has Synonym LLT 10036392 MedDRA C4727 Post-Transplant Lymphoproliferative Disorder Post-transplant Lymphoproliferative Disorder Post-transplant lymphoproliferative disorder (PTLD) is a polyclonal (benign) or clonal (malignant) proliferation of lymphoid cells that develops as a consequence of immunosuppression in a recipient of a solid organ or bone marrow allograft. PTLDs comprise a spectrum ranging from early, Epstein-Barr virus (EBV)-driven polyclonal lymphoid proliferations to EBV-positive or EBV- negative lymphomas of predominantly B-cell or less often T-cell type. (WHO, 2001) Abnormal proliferation of B lymphocytes as a complication of immunosuppression occurring after solid organ or allogenic stem cell transplantation. C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Post transplant lymphoproliferative disorder Has Synonym LLT 10051358 MedDRA C79704 Precocious Puberty Precocious Puberty Unusually early sexual maturity. Onset and progression of breast development before the age of 8 years in girls and testicular enlargement before the age of 9 years in boys. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Precocious puberty Has Synonym LLT 10058084 MedDRA C113337 Premature Adrenarche Premature Adrenarche Premature onset of adrenal androgen-mediated secondary sexual characteristics. Premature onset of adrenal androgen secretion resulting in early development of androgen mediated secondary sexual characteristics. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Premature adrenarche Has Synonym LLT 10036589 MedDRA C99024 Premature Closure of Ductus Arteriosus Premature Closure of Ductus Arteriosus Ductus Arteriosus Premature Closure|Premature Closure of the Ductus Arteriosus Closure of the ductus arteriosus prior to birth. Closure of the ductus arteriosus prior to birth. C99137 Great Vessels Abnormality C35729 Congenital Cardiovascular Abnormality C118464 Pediatric Adverse Events Terminology Ductus arteriosus premature closure Has Synonym LLT 10049996 MedDRA C78268 Premature Epiphyseal Fusion Premature Epiphyseal Fusion Abnormally early fusion of the bone growth plate. Abnormally early fusion of the bone growth plate. C89330 Developmental Disorder C118464 Pediatric Adverse Events Terminology Epiphyses premature fusion Has Synonym LLT 10015078 MedDRA C113338 Premature Menarche Premature Menarche Occurrence of the first menstrual period in a female before the usual or expected age. Occurrence of the first menstrual period in a female before the usual or expected age. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Premature menarche Has Synonym LLT 10077320 MedDRA C113342 Premature Thelarche Premature Thelarche Isolated breast development prior to the normal age of pubertal onset in females. Onset of breast development before the lower limit of the normal age of onset of breast development in girls without other signs of puberty. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Premature thelarche Has Synonym LLT 10036612 MedDRA C116367 Presbycusis Presbycusis Bilateral hearing loss caused by progressive degeneration of cochlear structures and central auditory pathways, typically associated with the aging process. Bilateral hearing loss caused by progressive degeneration of cochlear structures and central auditory pathways, typically associated with the aging process. C35731 Hearing Loss C118464 Pediatric Adverse Events Terminology Presbycusis Has Synonym LLT 10036627 MedDRA C115992 Periorbital Cellulitis Preseptal Cellulitis Periorbital Cellulitis An acute infection of the anterior portion of the eyelid and surrounding tissues. An infection of the eyelid and surrounding tissues, anterior to the orbital septum. C26715 Cellulitis C118464 Pediatric Adverse Events Terminology Preseptal cellulitis Has Synonym LLT 10072291 MedDRA C118173 Pressured Speech Pressured Speech Abnormal increased rate and amount of speech, delivered with urgency. Abnormally increased rate and amount of speech, delivered with urgency. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Pressure of speech Has Synonym LLT 10036649 MedDRA C80100 Presyncope Presyncope An episode of lightheadedness and dizziness which may precede an episode of syncope. An episode of lightheadedness and dizziness which may precede an episode of syncope. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Presyncope Has Synonym LLT 10036653 MedDRA C49642 Preterm Infant Preterm Infant A newborn infant less than 37 weeks, 0 days gestational age. A newborn infant less than 37 weeks, 0 days gestational age. C16731 Newborn C118464 Pediatric Adverse Events Terminology Premature baby Has Synonym LLT 10036590 MedDRA C85022 Priapism Priapism Persistent and usually painful erection that lasts for at least four hours in the absence of physical or psychological stimulation, which can be caused by hematologic disorders, including sickle cell disease and leukemia, spinal cord injuries, and medications. Persistent and usually painful erection that lasts for at least four hours, in the absence of physical or psychological stimulation, which can be caused by hematologic disorders, including sickle cell disease and leukemia, spinal cord injuries, and medications. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Priapism Has Synonym LLT 10036661 MedDRA C113172 Primary Adrenal Insufficiency Primary Adrenal Insufficiency A hormonal disorder that occurs when the adrenal glands fail to release adequate amounts of glucocorticoids (cortisol), mineralocorticoids (aldosterone, 11-deoxycorticosterone), and androgens (dehydroepiandrosterone) to meet physiologic needs, despite release of ACTH from the pituitary. Adrenal insufficiency due to a condition originating within the adrenal glands. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Primary adrenal insufficiency Has Synonym LLT 10052381 MedDRA C113339 Primary Amenorrhea Primary Amenorrhea Delayed Menarche Abnormally late or absent menarche in a female with normal secondary sexual characteristics. Abnormally late or absent menarche in a female with normal secondary sexual characteristics. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Primary amenorrhoea Has Synonym LLT 10036672 MedDRA C117078 Primary Cough Headache Primary Cough Headache Valsalva-maneuver Headache Headache triggered by coughing or straining in the absence of an intracranial disorder. Headache triggered by coughing or straining in the absence of an intracranial disorder. C34661 Headache C118464 Pediatric Adverse Events Terminology Primary cough headache Has Synonym LLT 10076707 MedDRA C117079 Primary Exertional Headache Primary Exertional Headache Headache triggered by exercise. Headache triggered by exercise. C34661 Headache C118464 Pediatric Adverse Events Terminology Exertional headache Has Synonym LLT 10068614 MedDRA C48280 Primary Hyperparathyroidism Primary Hyperparathyroidism Hyperfunction of the parathyroid glands resulting in the overproduction of parathyroid hormone. It is caused by parathyroid adenoma, parathyroid hyperplasia, parathyroid carcinoma, and multiple endocrine neoplasia. It is associated with hypercalcemia and hypophosphatemia. Signs and symptoms include weakness, fatigue, nausea, vomiting, constipation, depression, bone pain, osteoporosis, cystic bone lesions, and kidney stones. Hyperparathyroidism due to a condition originating within the parathyroid glands, resulting in hypercalcemia due to increased release of calcium and phosphate from bone matrix, increased renal calcium reabsorption, and increased renal production of 1,25-dihydroxyvitamin D, which increases intestinal absorption of calcium. Primary hyperparathyroidism is also associated with hypophosphatemia as a result of phosphaturia. Clinical features include weakness, fatigue, nausea, vomiting, constipation, depression, and, if chronic, bone pain, osteoporosis, cystic bone lesions, and kidney stones. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Primary hyperparathyroidism Has Synonym LLT 10036693 MedDRA C116343 Idiopathic Hypersomnia Primary Hypersomnia A disorder of central nervous system etiology characterized by excessive sleepiness during the daytime. Excessive daytime sleepiness with a central nervous system origin. C3376 Sleep Disorder C118464 Pediatric Adverse Events Terminology Primary hypersomnia Has Synonym LLT 10036694 MedDRA C113145 Primary Hyperthyroidism Primary Hyperthyroidism Overproduction of thyroid hormone due to a disorder originating within the thyroid gland. Overproduction of thyroid hormone due to a disorder originating within the thyroid gland. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Primary hyperthyroidism Has Synonym LLT 10075899 MedDRA C113214 Primary Hypoparathyroidism Primary Hypoparathyroidism Abnormally low levels of parathyroid hormone due to a disorder originating within the parathyroid glands. Hypoparathyroidism due to a condition originating within the parathyroid glands. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Primary hypoparathyroidism Has Synonym LLT 10075900 MedDRA C113143 Primary Hypothyroidism Primary Hypothyroidism Abnormally low levels of thyroid hormones due to a disorder originating within the thyroid gland. Hypothyroidism due to dysfunction of the thyroid gland. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Primary hypothyroidism Has Synonym LLT 10036697 MedDRA C113352 Primary Ovarian Failure Primary Ovarian Failure Hypergonadotropic Hypogonadism (Female) Absent or premature cessation of ovarian function due to a pathologic process originating within the ovaries. Absent or premature cessation of ovarian function due to an issue originating within the ovaries. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Primary ovarian failure Has Synonym LLT 10036721 MedDRA C113615 Proctalgia Fugax Proctalgia Fugax Recurrent episodes of pain localized to the anus or lower rectum which lasts seconds to minutes. There is no pain between episodes. Recurrent episodes of pain localized to the anus or lower rectum which lasts seconds to minutes. There is no pain between episodes. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Proctalgia fugax Has Synonym LLT 10036773 MedDRA C38011 Proctitis Proctitis An inflammatory process affecting the anus. It is usually caused by sexually transmitted infectious agents and/or inflammatory bowel disease. Inflammation of the rectum. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Proctitis Has Synonym LLT 10036774 MedDRA C78569 Productive Cough Productive Cough A cough accompanied by expectorated secretions. A cough accompanied by expectorated secretions. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Productive cough Has Synonym LLT 10036790 MedDRA C26815 Progressive Multifocal Leukoencephalopathy Progressive Multifocal Leukoencephalopathy A progressive demyelination within the central nervous system associated with reactivation of a latent JC virus infection. A demyelinating central nervous system disease caused by reactivation of the polyomavirus JC, which results in a lytic infection of oligodendrocytes. C26920 Encephalopathy C118464 Pediatric Adverse Events Terminology Progressive multifocal leukoencephalopathy Has Synonym LLT 10036807 MedDRA C113480 Projectile Vomiting Projectile Vomiting Forceful expulsion of the contents of the stomach through the mouth. Expulsion of the contents of the stomach through the mouth with great force. C3442 Vomiting C118464 Pediatric Adverse Events Terminology Vomiting projectile Has Synonym LLT 10047708 MedDRA C36173 Prolapse Prolapse A condition in which an organ or body tissue drops or bulges out of place. Protrusion of an organ or body tissue out of it's normal anatomical position. C36287 Congenital or Acquired Anatomic Abnormality C118464 Pediatric Adverse Events Terminology Prolapse Has Synonym LLT 10076708 MedDRA C92863 Prolonged Acceleration Prolonged Fetal Heart Rate Acceleration Prolonged Acceleration A fetal heart rate acceleration that lasts 2 to less than 10 minutes. A fetal heart rate acceleration that lasts 2 to less than 10 minutes. C92788 Fetal Heart Rate Acceleration C118464 Pediatric Adverse Events Terminology Prolonged fetal heart rate acceleration Has Synonym LLT 10074654 MedDRA C92864 Prolonged Deceleration Prolonged Fetal Heart Rate Deceleration Finding of Prolonged Deceleration|Prolonged Deceleration A decrease in the fetal heart rate below baseline lasting 2 to less than 10 minutes with a decrease from baseline that is greater than or equal to 15 beats per minute. A decrease in the fetal heart rate below baseline lasting 2 to less than 10 minutes with a decrease from baseline that is greater than or equal to 15 beats per minute. C92789 Fetal Heart Deceleration C118464 Pediatric Adverse Events Terminology Prolonged fetal heart rate deceleration Has Synonym LLT 10074656 MedDRA C118178 Proprioceptive Hallucination Proprioceptive Hallucination Perception of the orientation of the body in space, manifesting as a sensation of floating, flying, in the absence of a corresponding stimulus. Perception of the orientation of the body in space, manifesting as a sensation of floating, flying, without a corresponding stimulus. C37961 Hallucination C118464 Pediatric Adverse Events Terminology Proprioceptive hallucination Has Synonym LLT 10076723 MedDRA C111650 Prosthetic Valve Dysfunction Prosthetic Valve Dysfunction Malfunction of a surgically-placed cardiac valve related to the valve itself or the area around the valve. Malfunction of a surgically-placed cardiac valve related to the valve itself or the area around the valve. C45525 Valvular Heart Disorder C118464 Pediatric Adverse Events Terminology Prosthetic cardiac valve malfunction Broader Than LLT 10073511 MedDRA C38012 Proteinuria Proteinuria The presence of abnormal amounts of protein in the urine. The presence of abnormal amounts of protein in the urine. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Proteinuria Has Synonym LLT 10037032 MedDRA C114477 Proximal Tubulopathy Proximal Tubulopathy Proximal Renal Tubule Defect A proximal renal tubular disorder resulting in diminished reabsorption of phosphate, glucose, amino acids, urate, and low molecular weight proteins. A proximal renal tubular disorder resulting in diminished reabsorption of phosphate, glucose, amino acids, urate, and low molecular weight proteins. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Proximal renal tubular dysfunction Has Synonym LLT 10037081 MedDRA C3344 Pruritus Pruritus Itch An intense itching sensation. An itching sensation. C36281 Integumentary System Finding C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Pruritus Has Synonym LLT 10037087 MedDRA C112124 Pseudoporphyria Pseudoporphyria A drug-induced photodermatosis characterized by skin fragility, erythema, and the appearance of tense bullae, erosions and scarring in the absence of abnormalities in porphyrin metabolism. A drug-induced photodermatosis characterized by skin fragility, erythema, and the appearance of tense bullae, erosions and scarring in the absence of abnormalities in porphyrin metabolism. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Pseudoporphyria Has Synonym LLT 10037145 MedDRA C118726 Pseudostrabismus Pseudostrabismus The false appearance of misalignment of the eyes. The false appearance of misalignment of the eyes. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Pseudostrabismus Has Synonym LLT 10072123 MedDRA C27724 Psoriasiform Dermatitis Psoriasiform Dermatitis A chronic, sporadic, acquired pruritic non-infectious skin condition characterized by one or more well defined inflamed (pink or red) patches or plaques of varying size. Any one of a number of inflammatory skin conditions that resemble psoriasis because of their papular and scaly appearance. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Dermatitis psoriasiform Has Synonym LLT 10058675 MedDRA C3346 Psoriasis Psoriasis An autoimmune condition characterized by red, well-delineated plaques with silvery scales that are usually on the extensor surfaces and scalp. They can occasionally present with these manifestations: pustules; erythema and scaling in intertriginous areas, and erythroderma, that are often distributed on extensor surfaces and scalp. An autoimmune condition characterized by red, well-delineated plaques with silvery scales that are usually on the extensor surfaces and scalp. They can occasionally present with these manifestations: pustules; erythema and scaling in intertriginous areas, and erythroderma, that are often distributed on extensor surfaces and scalp. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Psoriasis Has Synonym LLT 10037153 MedDRA C116548 Psychogenic Seizure Psychogenic Seizure Psychogenic Non-Epileptic Seizure Movements, behaviors and sensations similar to a seizure, but due to psychological distress instead of a neurological disorder. Paroxysmal movements, behaviors and sensations similar to a seizure, but due to psychological distress instead of a neurological disorder. C2962 Seizure C118464 Pediatric Adverse Events Terminology Psychogenic seizure Has Synonym LLT 10058895 MedDRA C116725 Psychogenic Tremor Psychogenic Tremor Paroxysmal movements, behaviors and sensations similar to a tremor but due to psychological distress instead of a neurological disorder. Paroxysmal movements, behaviors and sensations similar to a tremor but due to psychological distress instead of a neurological disorder. C38038 Tremor C118464 Pediatric Adverse Events Terminology Psychogenic tremor Has Synonym LLT 10072377 MedDRA C21131 Psychological Dependence Psychological Dependence A behavioral pattern characterized by a craving for the mood-altering effects of a drug and an overwhelming preoccupation with obtaining and using the drug. A strong desire or sense of compulsion to use a pharmacological substance. C2893 Psychiatric Disorder C118464 Pediatric Adverse Events Terminology Dependence psychological Has Synonym LLT 10012352 MedDRA C117164 Psychomotor Agitation Psychomotor Agitation Severe Motor Restlessness Physical restlessness, often associated with increased motor activity. Physical restlessness, often associated with increased motor activity. C5039 Motor Manifestations C118464 Pediatric Adverse Events Terminology Psychomotor agitation Has Synonym LLT 10056436 MedDRA C117194 Psychomotor Retardation Psychomotor Retardation Abnormally slow physical movement. Abnormally slow thought processes and physical movement. C5039 Motor Manifestations C118464 Pediatric Adverse Events Terminology Psychomotor retardation Has Synonym LLT 10037213 MedDRA C78576 Psychosis Psychosis A mental disorder characterized by personality change, impaired functioning, and loss of touch with reality. A mental state characterized by impaired reality which may include perceptual disturbances, abnormal beliefs and disorganized thinking. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Psychosis Has Synonym LLT 10037234 MedDRA C27298 Ptosis Ptosis The drooping of the upper eyelid. The drooping of the upper eyelid. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Ptosis Has Synonym LLT 10037272 MedDRA C113336 Pubertal Failure Pubertal Failure Abnormally absent or incomplete sexual development. Onset of pubertal development followed by failure to complete sexual maturation. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Pubertal failure Has Synonym LLT 10075896 MedDRA C116334 Pulmonary Alveolar Hemorrhage Pulmonary Alveolar Hemorrhage Bleeding in the alveoli. Bleeding in the alveoli. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Pulmonary alveolar hemorrhage Has Synonym LLT 10037314 MedDRA C26868 Pulmonary Edema Pulmonary Edema Accumulation of fluid in the lung tissues causing disturbance of the gas exchange that may lead to respiratory failure. It is caused by direct injury to the lung parenchyma or congestive heart failure. The symptoms may appear suddenly or gradually. Suddenly appearing symptoms include difficulty breathing, feeling of suffocation, and coughing associated with frothy sputum. Gradually appearing symptoms include difficulty breathing while lying in bed, shortness of breath during activity, and weight gain (in patients with congestive heart failure). The accumulation of fluid in the lung parenchyma. C45233 Respiratory System Finding C118464 Pediatric Adverse Events Terminology Pulmonary edema Has Synonym LLT 10037375 MedDRA C50713 Pulmonary Embolism Pulmonary Embolism The obstruction of the pulmonary artery or one of its branches by an embolus, sometimes associated with infarction of the lung. The obstruction of blood flow by an embolus within the pulmonary circulation. C26759 Embolism C118464 Pediatric Adverse Events Terminology Pulmonary embolism Has Synonym LLT 10037377 MedDRA C26869 Pulmonary Fibrosis Pulmonary Fibrosis Pulmonary Interstitial Fibrosis Chronic progressive interstitial lung disorder characterized by the replacement of the lung tissue by connective tissue, leading to progressive dyspnea, respiratory failure, or right heart failure. Causes include chronic inflammatory processes, exposure to environmental irritants, radiation therapy, autoimmune disorders, certain drugs, or it may be idiopathic (no identifiable cause). A interstitial lung disease characterized by the replacement of lung tissue with connective tissue. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Pulmonary fibrosis Has Synonym LLT 10037383 MedDRA C121577 Pulmonary Function Test Decreased Pulmonary Function Test Decreased A decrease in any of the parameters used to measure the mechanical function of the lungs and upper airway. A decrease in any of the parameters used to measure the mechanical function of the lungs and upper airway. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Pulmonary function test decreased Has Synonym LLT 10061922 MedDRA C3120 Pulmonary Hypertension Pulmonary Hypertension Increased pressure within the pulmonary circulation due to lung or heart disorder. Elevated pulmonary vascular pressure. C3117 Hypertension C118464 Pediatric Adverse Events Terminology Pulmonary hypertension Has Synonym LLT 10037400 MedDRA C34571 Pulmonary Interstitial Emphysema Pulmonary Interstitial Emphysema Interstitial Emphysema of Lung|PIE Pathologic accumulation of air in the interstitium of the lungs, which is caused by the rupture of alveoli and terminal bronchioles, and is most often seen in premature infants that need mechanical ventilation for respiratory distress syndrome. Pathologic accumulation of air in the interstitium of the lungs, which is caused by the rupture of alveoli and terminal bronchioles, and is most often seen in premature infants that need mechanical ventilation for respiratory distress syndrome. C3198 Lung Disorder C118464 Pediatric Adverse Events Terminology Interstitial emphysema Has Synonym LLT 10022606 MedDRA C122408 Multiple Pulmonary Nodules Pulmonary Nodules Multiple, small, round or oval, benign or malignant growths in the lung(s), which can be due to infectious, inflammatory, or neoplastic processes. Multiple, small, round or oval, benign or malignant growths in the lung(s), which can be due to infectious, inflammatory, or neoplastic processes. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Lung nodule Narrower Than PT 10049498 MedDRA C111651 Pulmonary Vein Obstruction Pulmonary Vein Obstruction Blockage of the lumen of the pulmonary vein. Blockage of the lumen of the pulmonary vein. C99137 Great Vessels Abnormality C118464 Pediatric Adverse Events Terminology Pulmonary vein obstruction Has Synonym LLT 10074658 MedDRA C78787 Purpura Purpura A small blood vessel hemorrhage into the skin and/or mucous membranes. Newer lesions appear reddish in color. Older lesions are usually a darker purple color and eventually become a brownish-yellow color. Small blood vessel hemorrhage into the skin and/or mucous membranes presenting as red or purplish patches. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Purpura Has Synonym LLT 10037549 MedDRA C50717 Purulent Discharge Purulent Discharge Pus-containing fluid that is draining from an orifice or wound. Pus-containing fluid that is draining from an orifice or wound. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Purulent discharge Has Synonym LLT 10037569 MedDRA C111967 Pustular Eruption Pustular Eruption A diffuse or generalized outbreak of numerous pustules. A diffuse or generalized outbreak of numerous pustules. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Pustular rash Has Synonym LLT 10037576 MedDRA C78582 Pustular Lesion Pustule Pustular Lesion A circumscribed and elevated skin lesion filled with purulent material. A small circumscribed and elevated skin lesion filled with purulent material. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Pustule Has Synonym LLT 10037578 MedDRA C34965 Pyelonephritis Pyelonephritis An inflammatory process affecting the kidney. The cause is most often bacterial, but may also be fungal in nature. Signs and symptoms may include fever, chills, flank pain, painful and frequent urination, cloudy or bloody urine, and confusion. An infection of the kidney. C2890 Bacterial Infection C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Pyelonephritis Has Synonym LLT 10037596 MedDRA C34966 Pyloric Stenosis Pyloric Stenosis Narrowing of the pyloric lumen caused either by hypertrophy of the surrounding muscles or tissue scarring due to a chronic peptic ulcer. Narrowing of the pyloric lumen caused either by hypertrophy of the surrounding muscles or tissue scarring. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Pyloric stenosis Has Synonym LLT 10037621 MedDRA C3480 Lobular Hemangioma Pyogenic Granuloma Lobular Capillary Hemangioma A friable, benign vascular neoplasm with lobular capillary architecture that presents as a raised red skin growth. A friable, benign vascular neoplasm with lobular capillary architecture that presents as a raised red skin growth. C3085 Hemangioma C118464 Pediatric Adverse Events Terminology Pyogenic granuloma Has Synonym LLT 10037649 MedDRA C43245 Pyramidal Tract Dysfunction Pyramidal Tract Syndrome Dysfunction of the corticospinal (pyramidal) tracts of the spinal cord. Symptoms include increased muscle tone in the lower extremities, hyperreflexia, positive Babinski, and decreased fine motor coordination. Dysfunction of the corticospinal tracts of the spinal cord. C2934 Central Nervous System Disorder C118464 Pediatric Adverse Events Terminology Pyramidal tract syndrome Has Synonym LLT 10063636 MedDRA C50720 Pyrogenic Reaction Pyrogenic Reaction Fever reaction due to the presence of bacterial endotoxins. Fever reaction due to the presence of bacterial endotoxins. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Pyrogenic reaction Has Synonym LLT 10076724 MedDRA C71034 Prolonged QT Interval by ECG Finding QT Prolongation An electrocardiographic finding in which the QT interval not corrected for heart rate is prolonged. Thresholds for different age, gender, and patient populations exist. (CDISC) An electrocardiographic finding in which the QT interval corrected for heart rate is prolonged. C35552 Cardiovascular System Finding C118464 Pediatric Adverse Events Terminology QT prolonged Has Synonym LLT 10037705 MedDRA C50721 Quadriplegia Quadriplegia Bilateral Diplegia Paralysis of all four limbs. Paralysis of all four limbs, or of the entire body below the neck. C2934 Central Nervous System Disorder C118464 Pediatric Adverse Events Terminology Quadriplegia Has Synonym LLT 10037714 MedDRA C117265 Racing Thoughts Racing Thoughts Abnormally rapid thoughts with or without abrupt changes from one topic to another. Abnormally rapid thoughts with or without abrupt changes from one topic to another. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Racing thoughts Has Synonym LLT 10067192 MedDRA C114472 Radiation Damage Radiation Damage Injury resulting from exposure to ionizing radiation. Injury resulting from exposure to ionizing radiation. C3671 Injury C118464 Pediatric Adverse Events Terminology Radiation injury Has Synonym LLT 10037760 MedDRA C3349 Radiation-Induced Dermatitis Radiation Dermatitis A cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation. A cutaneous inflammatory reaction occurring as a result of exposure to ionizing radiation. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Dermatitis radiation Has Synonym LLT 10061103 MedDRA C78580 Radiation-Recall Dermatitis Radiation Recall Dermatitis Acute skin inflammatory reaction caused by drugs, especially chemotherapeutic agents, weeks or months following radiotherapy. The inflammatory reaction is confined to the previously irradiated skin and the symptoms disappear after the removal of the pharmacologic agent. Skin inflammatory reaction caused by drugs, during the weeks or months following radiotherapy. The inflammatory reaction is confined to the previously irradiated skin and the symptoms disappear after the removal of the pharmacologic agent. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Radiation recall reaction (dermatologic) Has Synonym LLT 10037767 MedDRA C78581 Radiculitis Radiculitis An inflammatory process affecting a nerve root. Patients experience pain radiating along a nerve path because of spinal pressure on the nerve root that connects to the nerve path. Inflammation of the nerve root. C27580 Peripheral Nervous System Disorder C118464 Pediatric Adverse Events Terminology Radiculitis Has Synonym LLT 10061928 MedDRA C113673 Reactive Airway Disease Reactive Airway Disease (AQ) Coughing, wheezing, or shortness of breath that is triggered by allergens, infection, or other irritants. A term describing any condition in which the airways are hyperreactive to stimulation. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Reactive airways disease Has Synonym LLT 10037993 MedDRA C118190 Reactive Attachment Disorder of Infancy or Early Childhood Reactive Attachment Disorder of Infancy or Early Childhood A condition in which the failure to establish healthy bonds with caregivers in early childhood leads to lifelong impairment of social interactions. A condition in which the failure to establish healthy bonds with caregivers in early childhood leads to lifelong impairment of social interactions. C92190 Pediatric Psychiatric Disorder C118464 Pediatric Adverse Events Terminology Reactive attachment disorder of infancy or early childhood Has Synonym LLT 10037996 MedDRA C34973 Rectal Prolapse Rectal Prolapse Protrusion of the rectum through the anus. Protrusion of the anus through the rectum. C36173 Prolapse C118464 Pediatric Adverse Events Terminology Rectal prolapse Has Synonym LLT 10038077 MedDRA C92866 Recurrent Deceleration Recurrent Fetal Heart Rate Deceleration Recurrent Deceleration Fetal heart rate decelerations that occur with greater than or equal to 50 percent of uterine contractions within a 20 minute timeframe. Applies to early, late or variable decelerations. Fetal heart rate decelerations that occur with greater than or equal to 50 percent of uterine contractions within a 20 minute timeframe. Applies to early, late or variable decelerations. C92789 Fetal Heart Deceleration C118464 Pediatric Adverse Events Terminology Recurrent fetal heart rate deceleration Has Synonym LLT 10074659 MedDRA C78592 Recurrent Laryngeal Nerve Paralysis Recurrent Laryngeal Nerve Palsy Recurrent Laryngeal Nerve Paralysis|Vagus Nerve Laryngeal Paralysis Paralysis of the recurrent laryngeal nerve. Causes include surgical and non-surgical traumas, neoplasms (e.g., lung carcinoma), and inflammatory neuritis. Paralysis of the recurrent laryngeal nerve. C26733 Cranial Nerve Disorder C103171 Recurrent Laryngeal Nerve Injury C118464 Pediatric Adverse Events Terminology Recurrent laryngeal nerve palsy Has Synonym LLT 10038130 MedDRA C111778 Recurrent Variable Fetal Heart Rate Deceleration Recurrent Variable Fetal Heart Rate Decelerations Variable decelerations that occur with greater than or equal to 50 percent of uterine contractions. They are usually associated with umbilical cord compression. Variable decelerations that occur with greater than or equal to 50 percent of uterine contractions. They are usually associated with umbilical cord compression. C92790 Fetal Heart Rate Variability C118464 Pediatric Adverse Events Terminology Recurrent variable fetal heart rate deceleration Has Synonym LLT 10074661 MedDRA C112202 Red Man Syndrome Red Man Syndrome An abrupt onset drug reaction characterized by a red rash that involves the face, neck, and upper torso. An abrupt onset drug reaction characterized by a red rash that involves the face, neck, and upper torso. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Red man syndrome Has Synonym LLT 10038192 MedDRA C122416 Refusal to Bear Weight Refusal to Bear Weight A reluctance to place any body weight on a limb, which is most commonly secondary to pain or discomfort. A reluctance to place any body weight on a limb, which is most commonly secondary to pain or discomfort. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Weight bearing difficulty Narrower Than LLT 10066454 MedDRA C118200 Developmental Regression Regression Reversion to an earlier stage of development. Reversion to an earlier stage of development. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Developmental regression Has Synonym LLT 10076709 MedDRA C78593 Renal Colic Renal Colic Paroxysmal and severe flank pain radiating to the inguinal area. It is caused by the passage of a kidney stone through the ureter. Paroxysmal and severe flank or abdominal pain that is associated with obstruction of urine flow. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Renal colic Has Synonym LLT 10038419 MedDRA C4376 Renal Failure Renal Failure Renal Failure Syndrome An acute or chronic condition that is characterized by the inability of the kidneys to adequately filter the blood. An acute or chronic condition that is characterized by the inability of the kidneys to adequately filter the blood. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Renal failure Has Synonym LLT 10038435 MedDRA C114851 Renal Lymphocele Renal Lymphocele Kidney Lymphocele Encapsulated collection of lymphatic fluid around a transplanted kidney. Encapsulated collection of lymphatic fluid around a transplanted kidney. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Renal lymphocele Has Synonym LLT 10059668 MedDRA C114827 Renal Osteodystrophy Renal Osteodystrophy Abnormalities of bone mineral metabolism associated with chronic kidney disease. Abnormalities of bone mineral metabolism associated with chronic kidney disease. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Renal osteodystrophy Has Synonym LLT 10038489 MedDRA C28129 Renal Tubular Acidosis Renal Tubular Acidosis The inability of the kidneys to maintain acid-base homeostasis. The inability of the kidneys to maintain acid-base homeostasis. C27120 Electrolyte Disorder C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Renal tubular acidosis Has Synonym LLT 10038535 MedDRA C99042 Renal Vein Thrombosis Renal Vein Thrombosis The formation of a thrombus in the renal vein. The formation of a thrombus in the renal vein. C99107 Venous Thrombosis C118464 Pediatric Adverse Events Terminology Renal vein thrombosis Has Synonym LLT 10038548 MedDRA C117193 Repetitive Behavior Repetitive Behaviors Recurring actions that are often non-purposeful. Recurring actions that are often non-purposeful. C5039 Motor Manifestations C118464 Pediatric Adverse Events Terminology Stereotypy Narrower Than LLT 10042008 MedDRA C50728 Respiratory Acidosis Respiratory Acidosis A condition in which the blood pH is less than normal, secondary to impaired gas exchange. A condition in which the blood pH is less than normal, secondary to impaired gas exchange. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Respiratory acidosis Has Synonym LLT 10038661 MedDRA C50729 Respiratory Alkalosis Respiratory Alkalosis A condition in which the blood pH is greater than normal, secondary to impaired gas exchange. A condition in which the blood pH is greater than normal, secondary to impaired gas exchange. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Respiratory alkalosis Has Synonym LLT 10038664 MedDRA C101772 Respiratory Arrest Respiratory Arrest Pulmonary Arrest Cessation of breathing function. Cessation of respiratory function. C26872 Respiratory Failure C118464 Pediatric Adverse Events Terminology Respiratory arrest Has Synonym LLT 10038669 MedDRA C116314 Respiratory Depression Respiratory Depression A decrease in ventilation secondary to impaired signals from the central nervous system. A decrease in ventilation secondary to impaired signals from the central nervous system. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Respiratory depression Has Synonym LLT 10038678 MedDRA C27165 Respiratory Distress Respiratory Distress A pathological increase in the effort and frequency of breathing movements. Increased work of breathing with tachypnea and retractions. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Respiratory distress Has Synonym LLT 10038687 MedDRA C27560 Respiratory Distress Syndrome Respiratory Distress Syndrome Neonatal Respiratory Distress|Neonatal Respiratory Distress Syndrome|RDS|Respiratory Distress Syndrome in the Newborn A condition beginning in the first day of life that results from inadequate surfactant production, causing increased work of breathing and impaired gas exchange. Progressive alveolar atelectasis from birth due to an abnormality of synthesis, function or metabolism of surfactant, characterized by respiratory failure and an abnormal chest radiograph showing diffuse reticulogranular densities and air bronchograms. C97173 Congenital Respiratory System Disorder C99232 Neonatal Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Acute respiratory distress syndrome Related To LLT 10001052 MedDRA C26872 Respiratory Failure Respiratory Failure The significant impairment of gas exchange within the lungs resulting in hypoxia, hypercarbia, or both, to the extent that organ tissue perfusion is severely compromised. Causes include chronic obstructive pulmonary disease, asthma, emphysema, acute respiratory distress syndrome, pneumonia, pulmonary edema, pneumothorax, and congestive heart failure. Treatment requires intubation and mechanical ventilation until the time the lungs recover sufficient function. The significant impairment of gas exchange resulting in hypoxia and/or hypercarbia, to the extent that tissue oxygenation is severely compromised. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Respiratory failure Has Synonym LLT 10038695 MedDRA C3354 Respiratory Syncytial Virus Infection Respiratory Syncytial Virus Infection Infection with the respiratory syncytial virus, an RNA virus of the genus Pneumovirus, in the family Paramyxoviridae, which is characterized by the formation of syncytia in tissue culture. It causes minor respiratory infection with rhinitis and cough in adults, but is capable of causing severe bronchitis and bronchopneumonia in young children. Infection with the respiratory syncytial virus, an RNA virus of the genus Pneumovirus, in the family Paramyxoviridae, which is characterized by the formation of syncytia in tissue culture. It causes minor respiratory infection with rhinitis and cough in adults, but is capable of causing severe bronchitis and bronchopneumonia in young children. C3439 Viral Infection C118464 Pediatric Adverse Events Terminology Respiratory syncytial virus infection Has Synonym LLT 10061603 MedDRA C84501 Restless Leg Syndrome Restless Leg Syndrome A condition that occurs while resting or lying in bed; it is characterized by an irresistible urgency to move the legs to obtain relief from a strange and uncomfortable sensation in the legs. Uncomfortable or painful sensation associated with an irresistible urge to move the limbs, usually triggered by relaxation or lying down. C26835 Nervous System Disorder C118464 Pediatric Adverse Events Terminology Restless leg syndrome Has Synonym LLT 10038741 MedDRA C74533 Restlessness Restlessness An inability to rest, relax, or be still. A feeling of unrest or the need to move, and/or an inability to feel calm, relaxed, or be still. C5039 Motor Manifestations C118464 Pediatric Adverse Events Terminology Restlessness Has Synonym LLT 10038743 MedDRA C94475 Retching Retching Involuntary spasms of the stomach and esophagus resulting in vomiting or dry heaving. Involuntary spasms of the stomach and esophagus resulting in vomiting or dry heaving. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Retching Has Synonym LLT 10038776 MedDRA C113710 Reticulocytopenia Reticulocytopenia Abnormally low level of immature red blood cells in the blood. Abnormally low level of immature red blood cells in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Reticulocytopenia Has Synonym LLT 10038795 MedDRA C26874 Retinal Detachment Retinal Detachment An eye emergency condition which may lead to blindness if left untreated. It is characterized by the separation of the inner retina layers from the underlying pigment epithelium. Causes include trauma, advanced diabetes mellitus, high myopia, and choroid tumors. Symptoms include sudden appearance of floaters, sudden light flushes, and blurred vision. Separation of neurosensory retina from the retinal pigment epithelium. C26875 Retinal Disorder C118464 Pediatric Adverse Events Terminology Retinal detachment Has Synonym LLT 10038848 MedDRA C50732 Retinal Tear Retinal Tear A usually small tearing of the retina occurring when the vitreous separates from the retina. It may lead to retinal detachment. Symptoms include flashes and floaters. A break or hole in the retina. C26875 Retinal Disorder C118464 Pediatric Adverse Events Terminology Retinal tear Has Synonym LLT 10038897 MedDRA C115993 Retinitis Retinitis Inflammation of the retina. Inflammation of the retina. C26875 Retinal Disorder C118464 Pediatric Adverse Events Terminology Retinitis Has Synonym LLT 10038910 MedDRA C7541 Retinoblastoma Retinoblastoma A malignant tumor that originates in the nuclear layer of the retina. As the most common primary tumor of the eye in children, retinoblastoma is still relatively uncommon, accounting for only 1% of all malignant tumors in pediatric patients. Approximately 95% of cases are diagnosed before age 5. These tumors may be multifocal, bilateral, congenital, inherited, or acquired. Seventy-five percent of retinoblastomas are unilateral; 60% occur sporadically. A predisposition to retinoblastoma has been associated with 13q14 cytogenetic abnormalities. Patients with the inherited form also appear to be at increased risk for secondary nonocular malignancies such as osteosarcoma, malignant fibrous histiocytoma, and fibrosarcoma. A malignant tumor that originates in the nuclear layer of the retina. As the most common primary tumor of the eye in children, retinoblastoma is still relatively uncommon, accounting for only 1% of all malignant tumors in pediatric patients. Approximately 95% of cases are diagnosed before age 5. These tumors may be multifocal, bilateral, congenital, inherited, or acquired. Seventy-five percent of retinoblastomas are unilateral; 60% occur sporadically. A predisposition to retinoblastoma has been associated with 13q14 cytogenetic abnormalities. Patients with the inherited form also appear to be at increased risk for secondary nonocular malignancies such as osteosarcoma, malignant fibrous histiocytoma, and fibrosarcoma. C9305 Cancer C118464 Pediatric Adverse Events Terminology Retinoblastoma Has Synonym LLT 10038916 MedDRA C78597 APL Differentiation Syndrome Retinoic Acid Syndrome Differentiation Syndrome A syndrome observed in patients with acute promyelocytic leukemia treated with all-trans retinoic acid. It is characterized by weight gain, dyspnea, pleural and pericardial effusions, leukocytosis, and renal failure. A disorder manifesting with fever, leukocytosis, hypotension, and possible cardiac and renal failure as a result of treatment with all-trans retinoic acid or arsenic trioxide. C9229 Systemic Disorder C118464 Pediatric Adverse Events Terminology Retinoic acid syndrome Has Synonym LLT 10038921 MedDRA C62601 Retinopathy Retinopathy Any non-neoplastic pathologic conditions of the retina, including non-neoplastic structural anomalies. A disease or disorder of the retina. C26875 Retinal Disorder C118464 Pediatric Adverse Events Terminology Retinopathy Has Synonym LLT 10038923 MedDRA C34982 Retinopathy of Prematurity Retinopathy of Prematurity Retrolental Fibroplasia|Terry Syndrome A bilateral retinopathy characterized by neovascularization, scarring, retinal detachment, and eventually blindness. It may be mild or severe. It occurs in babies born prematurely. Causes include oxygen toxicity and hypoxia. A retinal condition of very immature infants that may be characterized by non-vascularized retina that may lead to neovascularization, scarring, retinal detachment, and blindness. C62601 Retinopathy C98996 Neonatal Disorder C118464 Pediatric Adverse Events Terminology Retinopathy of prematurity Has Synonym LLT 10038933 MedDRA C116770 Retinopathy of Prematurity Stage 0 Retinopathy of Prematurity Stage 0 Prior to the development of ROP in the premature infant, vascularization of the retina is incomplete or immature. In Stage 0, there is no clear demarcation line between vascularized and non-vascularized retina. Prior to the development of ROP in the premature infant, vascularization of the retina is incomplete or immature. In Stage 0, there is no clear demarcation line between vascularized and non-vascularized retina. C34982 Retinopathy of Prematurity C118464 Pediatric Adverse Events Terminology Retinopathy of prematurity Narrower Than LLT 10038933 MedDRA C99047 Retinopathy of Prematurity Stage 1 Demarcation Line Retinopathy of Prematurity Stage 1 Retinopathy of Prematurity Stage 1 - Demarcation Line An ophthalmoscopic finding that refers to retinopathy of prematurity characterized by the presence of a faint demarcation line. A vasoproliferative condition of the retina seen in very immature newborn infants. Stage 1 is defined by a demarcation line, a thin but definite structure that separates the avascular retina anteriorly from the vascularized retina posteriorly. There is abnormal branching or arcading of vessels leading up to the demarcation line that is relatively flat, white, and lies within the plane of the retina. C34982 Retinopathy of Prematurity C118464 Pediatric Adverse Events Terminology Retinopathy of prematurity Narrower Than LLT 10038933 MedDRA C99048 Retinopathy of Prematurity Stage 2 Intraretinal Ridge Retinopathy of Prematurity Stage 2 Retinopathy of Prematurity Stage 2 - Intraretinal Ridge An ophthalmoscopic finding that references retinopathy of prematurity characterized by the presence of an elevated ridge. A vasoproliferative condition of the retina seen in very immature newborn infants. Stage 2 is defined by an intraretinal ridge, the ridge arises from the demarcation line and has height and width, which extends above the plane of the retina. The ridge may change from white to pink and vessels may leave the plane of the retina posterior to the ridge to enter it. C34982 Retinopathy of Prematurity C118464 Pediatric Adverse Events Terminology Retinopathy of prematurity Narrower Than LLT 10038933 MedDRA C99049 Retinopathy of Prematurity Stage 3 Ridge with Extraretinal Fibroblastic Proliferation Retinopathy of Prematurity Stage 3 Retinopathy of Prematurity Stage 3 - Ridge with Extraretinal Fibrovascular Proliferation An ophthalmoscopic finding that references retinopathy of prematurity characterized by the presence of extraretinal fibrovascular tissue. A vasoproliferative condition of the retina seen in very immature newborn infants. Stage 3 is defined by a ridge with extraretinal fibrovascular proliferation, the neovascularization extends from the ridge into the vitreous. This extraretinal proliferating tissue is continuous with the posterior aspect of the ridge, causing a ragged appearance as the proliferation becomes more extensive. C34982 Retinopathy of Prematurity C118464 Pediatric Adverse Events Terminology Retinopathy of prematurity Narrower Than LLT 10038933 MedDRA C99050 Retinopathy of Prematurity Stage 4 Subtotal Retinal Detachment Retinopathy of Prematurity Stage 4 Retinopathy of Prematurity Stage 4 - Subtotal Retinal Detachment An ophthalmoscopic finding that references retinopathy of prematurity characterized by the presence of subtotal retinal detachment. A vasoproliferative condition of the retina seen in very immature newborn infants. Stage 4 is defined by subtotal retinal detachment. The retinal detachments are generally concave and most are circumferentially oriented. Retinal detachments usually begin at the point of fibrovascular attachment to the vascularized retina and the extent of detachment depends on the amount of neovascularization present. Stage 4A is defined by retinal detachment which spares the macula. Stage 4B is defined by retinal detachment involving the macula. C34982 Retinopathy of Prematurity C118464 Pediatric Adverse Events Terminology Retinopathy of prematurity Narrower Than LLT 10038933 MedDRA C99051 Retinopathy of Prematurity Stage 5 Total Retinal Detachment Retinopathy of Prematurity Stage 5 Retinopathy of Prematurity Stage 5 - Total Retinal Detachment An ophthalmoscopic finding that references retinopathy of prematurity characterized by the presence of total retinal detachment. A vasoproliferative condition of the retina seen in very immature newborn infants. Stage 5 is defined by total retinal detachment. The retinal detachments are generally tractional and usually funnel shaped. The configuration of the funnel itself is used for subdivision of this stage depending if the anterior and posterior portions are open or narrowed. C34982 Retinopathy of Prematurity C118464 Pediatric Adverse Events Terminology Retinopathy of prematurity Narrower Than LLT 10038933 MedDRA C118745 Retrobulbar Hemorrhage Retrobulbar Hemorrhage Bleeding in the orbital cavity that results in compression of orbital structures, resulting in ischemia of the optic nerve, and possible loss of vision. Accumulation of blood posterior to the globe. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Ocular retrobulbar haemorrhage Has Synonym LLT 10057571 MedDRA C118318 Rhabdomyolysis Rhabdomyolysis A clinical syndrome resulting from direct or indirect muscle injury and subsequent release of myoglobin into the plasma. A clinical syndrome resulting from direct or indirect muscle injury and subsequent release of myoglobin into the plasma. C107377 Musculoskeletal System Disorder C118464 Pediatric Adverse Events Terminology Rhabdomyolysis Has Synonym LLT 10039020 MedDRA C3359 Rhabdomyosarcoma Rhabdomyosarcoma A rare aggressive malignant mesenchymal neoplasm arising from skeletal muscle. It usually occurs in children and young adults. Only a small percentage of tumors arise in the skeletal muscle of the extremities. The majority arise in other anatomical sites. A malignant neoplasm arising from skeletal myocytes. C9306 Soft Tissue Sarcoma C118464 Pediatric Adverse Events Terminology Rhabdomyosarcoma Has Synonym LLT 10039022 MedDRA C118755 Rhegmatogenous Retinal Detachment Rhegmatogenous Retinal Detachment Retinal detachment secondary to retinal tear or break. Retinal detachment secondary to retinal tear or break. C26874 Retinal Detachment C118464 Pediatric Adverse Events Terminology Rhegmatogenous retinal detachment Has Synonym LLT 10065569 MedDRA C34986 Rhinitis Rhinitis An inflammation of the mucous membrane lining the nose, usually associated with nasal discharge. Inflammation of the mucous membrane lining the nose. C118420 Otolaryngologic Disorder C118464 Pediatric Adverse Events Terminology Rhinitis Has Synonym LLT 10039083 MedDRA C54282 Rhinorrhea Rhinorrhea A discharge of fluid from the nose. A discharge of fluid from the nose. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Rhinorrhea Has Synonym LLT 10039100 MedDRA C122572 Rhinovirus Infection Rhinovirus Infection An infectious process caused by rhinovirus. The virus usually causes upper respiratory infections, but can infect the lower tract as well. An infectious process caused by rhinovirus. The virus usually causes upper respiratory infections, but can infect the lower tract as well. C3439 Viral Infection C118464 Pediatric Adverse Events Terminology Rhinovirus infection Has Synonym LLT 10061494 MedDRA C26878 Rickets Rickets Bone softening and weakening usually caused by deficiency or impaired metabolism of vitamin D. Deficiency of calcium, magnesium, or phosphorus may also cause rickets. It predominantly affects children who suffer from severe malnutrition. It manifests with bone pain, fractures, muscle weakness, and skeletal deformities. A disorder of defective chondrocyte differentiation and mineralization of the epiphyseal plate due to deficiency of calcium, phosphate, or vitamin D. Rickets can manifest clinically with features such as craniotabes, costrochondral junction enlargement, widening of the wrists and ankles, lower extremity bowing, and failure to thrive. This condition is diagnosed radiographically, and is characterized by growth plate widening as well as metaphyseal cupping and fraying. C26836 Nutritional Disorder C118464 Pediatric Adverse Events Terminology Rickets Has Synonym LLT 10039119 MedDRA C114849 Right Atrial Thrombus Right Atrial Thrombus A blood clot in the right atrium of the heart. A blood clot in the right atrium of the heart. C111118 Atrial Thrombus C118464 Pediatric Adverse Events Terminology Right atrial thrombosis Has Synonym LLT 10076725 MedDRA C50733 Right Ventricular Dysfunction Right Ventricular Dysfunction Impairment of the right ventricular function associated with low ejection fraction and decreased motility of the right ventricular wall. Impairment of the right ventricle to either fill or eject adequately. C111655 Ventricular Dysfunction C118464 Pediatric Adverse Events Terminology Right ventricular dysfunction Has Synonym LLT 10058597 MedDRA C111658 Rigor Rigor Severe chills accompanied by vigorous shaking. Severe chills accompanied by vigorous shaking. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Rigors Has Synonym LLT 10039177 MedDRA C97136 Rosacea Rosacea Acne Rosacea A chronic erythematous skin disorder that affects the face. It is characterized by the development of redness in the cheeks, nose, and/or forehead and telangiectasia. Sometimes, the erythematous changes may involve the eyelids. A chronic dermatitis characterized by redness, flushing, pustules and papules on the face. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Rosacea Has Synonym LLT 10039218 MedDRA C92567 Rumination Disorder Rumination An eating disorder most commonly observed in infants characterized by the repeated regurgitation and rechewing of food for a period of at least one month; this behavior is not associated with a gastrointestinal or other medical reason. Unintentional and reflexive regurgitation and rechewing of undigested food. C92190 Pediatric Psychiatric Disorder C118464 Pediatric Adverse Events Terminology Ruminations Has Synonym LLT 10039294 MedDRA C50804 Blood Vessel Perforation Rupture of Vessel Damage to a blood vessel resulting from a full thickness disruption in the integrity of the vessel wall. Full thickness disruption in the integrity of a blood vessel wall. C35117 Vascular Disorder C118464 Pediatric Adverse Events Terminology Vascular rupture Has Synonym LLT 10053649 MedDRA C118871 Ruptured Globe Ruptured Globe Full thickness wound of the eyewall (cornea and/or sclera) due to blunt trauma. (adapted from the Birmingham Eye Trauma Terminology System (BETTS)) Full thickness wound of the eyewall (cornea and/or sclera) due to blunt trauma. (adapted from the International Society of Ocular Trauma-Birmingham Eye Trauma Terminology System (BETTS)) C118748 Open Globe Injury C118464 Pediatric Adverse Events Terminology Eyeball rupture Has Synonym LLT 10015973 MedDRA C74534 Sadness Sadness Feelings of grief or unhappiness. An emotional state characterized by feelings of unhappiness or grief. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Feeling sad Has Synonym LLT 10016364 MedDRA C113397 Sandifer's Syndrome Sandifer's Syndrome Sandifer Syndrome A condition associated with gastro-esophageal reflux disease that presents in infancy and early childhood and is characterized by spastic torticollis and dystonic body movements. A condition associated with gastro-esophageal reflux disease that presents in infancy and early childhood and is characterized by spastic torticollis and dystonic body movements. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Sandifer's syndrome Has Synonym LLT 10066142 MedDRA C34483 Scar Scar A permanent mark left on the skin in the process of wound healing. A permanent mark left on the skin in the process of wound healing. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Scar Has Synonym LLT 10039580 MedDRA C35000 Schistosomiasis Schistosomiasis Bilharzia|Snail Fever A parasitic infection caused by flukes of the genus Schistosoma. Signs and symptoms include fever, abdominal pain, eosinophilia and hepatosplenomegaly. If left untreated it may eventually cause liver damage leading to cirrhosis, bladder cancer and kidney failure. Schistosoma parasite infection that is commonly seen in tropical and subtropical regions and may be transmitted through skin contact with contaminated freshwater. C27864 Parasitic Infection C118464 Pediatric Adverse Events Terminology Schistosomiasis Has Synonym LLT 10039603 MedDRA C122411 Scleral Icterus Scleral Icterus Yellowing of the white part of the eyes, often due to a rise in bilirubin levels. Yellowing of the white part of the eyes, often due to a rise in bilirubin levels. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Scleral icterus Has Synonym LLT 10057488 MedDRA C26746 Scleroderma Scleroderma A localized or systemic chronic and progressive autoimmune disorder characterized by thickening of the skin and the connective tissues. Localized scleroderma affects only the skin. Systemic scleroderma affects internal organs, including the heart, lungs, gastrointestinal tract, and kidneys. A chronic and progressive autoimmune disorder characterized by thickening of the skin and the connective tissues. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Scleroderma Has Synonym LLT 10039710 MedDRA C61429 Sclerosing Peritonitis Sclerosing Peritonitis A rare peritoneal cavity disorder that is characterized by the development of dense fibrous tissue in the peritoneum and the creation of severe adhesions in the abdomen that result in partial or complete small bowel obstruction. It may be idiopathic or develop in patients who receive peritoneal dialysis treatment. Patients present with abdominal distention and pain. Severe scarring resulting from an inflamed peritoneum. C26849 Peritonitis C118464 Pediatric Adverse Events Terminology Sclerosing peritonitis Has Synonym LLT 10039719 MedDRA C118737 Scotoma Scotoma An area of impaired sight within the normal visual field. An area of impaired sight within the normal visual field. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Scotoma Has Synonym LLT 10039729 MedDRA C122573 Screaming Screaming A loud, vociferous cry or yell; it can be the result of many emotions, including pain, excitement, or fear. A loud, vociferous cry or yell; it can be the result of many emotions, including pain, excitement, or fear. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Screaming Has Synonym LLT 10039740 MedDRA C111888 Seborrheic Dermatitis Seborrheic Dermatitis Cradle Cap|Seborrhea|Seborrheic Eczema A chronic, inflammatory skin disorder that affects the scalp, central face and skin folds; it is characterized by scaling and itching. A chronic, inflammatory skin disorder that affects the scalp, central face and skin folds; it is characterized by scaling and itching. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Seborrheic dermatitis Has Synonym LLT 10039788 MedDRA C76131 Second-Degree Burn Second Degree Burn An injury that includes the entire epidermis and upper layers of the dermis due to a chemical, friction, radiation or thermal exposure. The affected area appears as moist red or white skin that does not blanch. Often it is painful with the presence of blisters. A burn that involves the full thickness of the epidermis characterized by blisters. C34441 Burn C118464 Pediatric Adverse Events Terminology Burns second degree Has Synonym LLT 10006802 MedDRA C113340 Secondary Amenorrhea Secondary Amenorrhea The cessation of menstruation for six months or more in a female that is not pregnant, breastfeeding or menopausal. Amenorrhea in the setting of the following factors: occurring after the onset of menarche; persisting for six months or more; occurring in the absence of pregnancy, breastfeeding, or menopause. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Secondary amenorrhoea Has Synonym LLT 10039809 MedDRA C113335 Secondary Hyperparathyroidism Secondary Hyperparathyroidism Overproduction of parathyroid hormone in response to influence external to the parathyroid glands. Overproduction of parathyroid hormone in response to a condition originating extrinsic to the parathyroid glands. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Hyperparathyroidism secondary Has Synonym LLT 10020708 MedDRA C26725 Common Variable Immunodeficiency Secondary Hypogammaglobulinemia Acquired Hypogammaglobulinemia A primary immunodeficiency characterized by low levels or absence of all the immunoglobulin classes and lack of B-lymphocytes or plasma cells. It results in recurrent bacterial infections. Complications include autoimmune phenomena and cancer development. Abnormally low level of functional immunoglobulins in the blood that is not associated with a primary immunodeficiency. C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Secondary acquired hypogammaglobulinaemia Has Synonym LLT 10039805 MedDRA C118302 Sedated Sedation A state of a lowered level of consciousness. A state of a lowered level of consciousness. C36280 Nervous System Finding C118464 Pediatric Adverse Events Terminology Sedation Has Synonym LLT 10039897 MedDRA C2962 Seizure Seizure Convulsion Sudden, involuntary skeletal muscular contractions of cerebral or brain stem origin. A paroxysmal surge of electrical activity in the brain that may result in physical or behavioral changes. C87124 Central Nervous System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Seizure Has Synonym LLT 10039906 MedDRA C118206 Self-Injury Self-Injury Self-Harm Self-inflicted harm without the intent to die. Self-inflicted harm without the intent to die. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Intentional self-injury Has Synonym LLT 10022524 MedDRA C26739 Sensorineural Hearing Loss Sensorineural Hearing Loss SNHL Hearing loss resulting from damage to the cochlea, auditory nerve and/or brainstem. Hearing loss resulting from damage to the cochlea, auditory nerve and/or brainstem. C35731 Hearing Loss C118464 Pediatric Adverse Events Terminology Sensorineural hearing loss Has Synonym LLT 10040016 MedDRA C3364 Septicemia Sepsis Sepsis Syndrome|Septicemia The presence of pathogenic microorganisms in the blood stream causing a rapidly progressing systemic reaction that may lead to shock. Symptoms include fever, chills, tachycardia, and increased respiratory rate. It is a medical emergency that requires urgent medical attention. A systemic inflammatory response to an infection. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Sepsis Has Synonym LLT 10040047 MedDRA C26700 Infective Arthritis Septic Arthritis The inflammation of one or more joints caused by any infectious pathogen within the joint space. Symptoms include pain, stiffness, and decreased range of motion in the affected joint. Infection of one or more joints. C2883 Arthritis C118464 Pediatric Adverse Events Terminology Septic arthritis Has Synonym LLT 10040057 MedDRA C50739 Seroma Seroma A collection of serum in the body. A collection of serous fluid within the body. C36287 Congenital or Acquired Anatomic Abnormality C118464 Pediatric Adverse Events Terminology Seroma Has Synonym LLT 10040102 MedDRA C118756 Serous Retinal Detachment Serous Retinal Detachment Retinal detachment secondary to fluid accumulation under the neurosensory retina without a retinal tear or break. Retinal detachment secondary to fluid accumulation under the neurosensory retina without a retinal tear or break. C26874 Retinal Detachment C118464 Pediatric Adverse Events Terminology Serous retinal detachment Has Synonym LLT 10040114 MedDRA C79718 Serum Sickness Serum Sickness Delayed-type hypersensitivity reaction to foreign proteins derived from an animal serum. It occurs approximately six to twenty one days following the administration of the foreign antigen. Symptoms include fever, arthralgias, myalgias, skin eruptions, lymphadenopathy, chest pain, and dyspnea. Certain drugs (e.g., antibiotics, anticancer agents, and anti-inflammatory medications) and infectious disorders (e.g., hepatitis B) may also cause serum sickness-like reaction. A systemic, immune complex mediated hypersensitivity reaction to injected foreign or autologous protein that usually presents four to ten days after exposure and resolves on its own. Manifestations may include fever, joint pain, rash, and swollen lymph nodes. C3114 Hypersensitivity Reaction C118464 Pediatric Adverse Events Terminology Serum sickness Has Synonym LLT 10040400 MedDRA C3472 Severe Combined Immunodeficiency Severe Combined Immunodeficiency X-linked or autosomal recessive disorder characterized by defects of both humoral and cell mediated immunity, resulting in low or absent antibody levels, leukopenia, marked susceptibility to infections, and early death.--2004 X-linked or autosomal recessive disorder characterized by defects of both humoral and cell mediated immunity, resulting in low or absent antibody levels, leukopenia, marked susceptibility to infections, and early death.--2004 C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Severe combined immunodeficiency syndrome Has Synonym LLT 10069566 MedDRA C3347 Sexual Dysfunction Sexual Dysfunction Disturbances in sexual desire or performance. Disturbances in sexual desire or performance. C36284 Reproductive System Finding C118464 Pediatric Adverse Events Terminology Sexual dysfunction Has Synonym LLT 10040477 MedDRA C111815 Shakes Shakiness Unsteadiness or trembling movements of the whole body or a body part. Unsteadiness or trembling movements of the whole body or a body part. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Shakiness Has Synonym LLT 10040527 MedDRA C35016 Shock Shock A life-threatening condition that requires immediate medical intervention. It is characterized by reduced blood flow that may result in damage of multiple organs. Types of shock include cardiogenic, hemorrhagic, septic, anaphylactic, and traumatic shock. Profoundly reduced blood flow that results in impaired tissue perfusion and possible end organ damage. C2931 Cardiovascular Disorder C118464 Pediatric Adverse Events Terminology Shock Has Synonym LLT 10040560 MedDRA C99059 Short Bowel Syndrome Short Bowel Syndrome Malabsorption that results from the removal of a large segment of the small intestine or, less frequently, from the complete dysfunction of a large portion of the small intestine. Signs and symptoms include diarrhea, steatorrhea, and weigh loss. Malabsorption that results from the removal of a large segment of the small intestine or, less frequently, from the complete dysfunction of a large portion of the small intestine. Signs and symptoms include diarrhea, steatorrhea, and weigh loss. C97171 Congenital Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Short-bowel syndrome Has Synonym PT 10049416 MedDRA C111652 Vascular Shunt Thrombosis Shunt Thrombosis The presence of a thrombus within a vascular shunt. Presence of a thrombus within a vascular shunt. C26891 Thrombosis C118464 Pediatric Adverse Events Terminology Shunt thrombosis Has Synonym LLT 10059054 MedDRA C115165 Sialitis Sialitis Sialadenitis Inflammation of the salivary glands. Inflammation of the salivary glands. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Salivary gland inflammation Has Synonym LLT 10075244 MedDRA C118301 Sialorrhea Sialorrhea Hypersalivation An increase in saliva secretion. An increase in saliva secretion. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Sialorrhea Has Synonym LLT 10059826 MedDRA C113170 Sick Euthyroid Syndrome Sick Euthyroid Syndrome Euthyroid Sick Syndrome Abnormal thyroid function tests, low triiodothyronine with elevated reverse triiodothyronine, in the setting of non-thyroidal illness. A pattern of thyroid function tests associated with a non-thyroidal illness in which triiodothyronine is low while reverse triiodothyronine is elevated. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Euthyroid sick syndrome Has Synonym LLT 10015549 MedDRA C116761 Simple Tic Simple Tic A tic that involves one muscle or muscle group, or non-word sounds. A tic that involves one muscle or muscle group, or non-word sounds. C116758 Tic C118464 Pediatric Adverse Events Terminology Tic Narrower Than LLT 10043833 MedDRA C35024 Sinusitis Sinusitis An acute or chronic inflammatory process affecting the mucous membranes of any sinus cavity. Inflammation of the mucous membranes lining a sinus cavity. C118420 Otolaryngologic Disorder C26726 Infectious Disorder C118464 Pediatric Adverse Events Terminology Sinusitis Has Synonym LLT 10040753 MedDRA C111768 Sinusoidal Fetal Heart Rate Pattern Sinusoidal Fetal Heart Rate Pattern A fetal heart rate pattern characterized by a smooth, sine wave-like undulating pattern with a cycle frequency of 3 to 5 beats per minute that continues for at least 20 minutes or more. A fetal heart rate pattern characterized by a smooth, sine wave-like undulating pattern with a cycle frequency of 3 to 5 beats per minute that continues for at least 20 minutes or more. C92715 Fetal Heart Finding C118464 Pediatric Adverse Events Terminology Sinusoidal fetal heart rate pattern Has Synonym LLT 10074663 MedDRA C118455 Sirenomelia Sirenomelia A disorder characterized by the malformation of the legs into a single lower limb. A disorder characterized by the malformation of the legs into a single lower limb. C89337 Congenital Musculoskeletal Defect C118464 Pediatric Adverse Events Terminology Sirenomelia Has Synonym LLT 10072457 MedDRA C35163 Skin Atrophy Skin Atrophy Atrophic Skin The degeneration and thinning of the epidermis and dermis. It is usually a manifestation of aging. Thin, mechanically weak skin. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Skin atrophy Has Synonym LLT 10040799 MedDRA C96218 Skin Eschar Skin Eschar A crust that covers necrotic tissue in the skin that is caused by a burn or gangrene. A crust that covers necrotic tissue in the skin that is caused by a burn or gangrene. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Eschar Has Synonym LLT 10051814 MedDRA C112114 Skin Necrosis Skin Necrosis Death of one or more layers of skin. Death of one or more layers of skin. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Skin necrosis Has Synonym LLT 10040893 MedDRA C38004 Skin Photosensitivity Skin Photosensitivity Increased sensitivity of the skin to light exposure. Increased skin reactivity to light exposure. C36281 Integumentary System Finding C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Photosensitivity Has Synonym LLT 10034966 MedDRA C39594 Skin Rash Skin Rash Rash|Skin Eruption Any change in the skin which affects its appearance or texture. A rash may be localized to one part of the body, or affect all the skin. Rashes may cause the skin to change color, itch, become warm, bumpy, dry, cracked or blistered, swell and may be painful. An eruption in the skin which affects its appearance and/or texture. C36281 Integumentary System Finding C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Rash Narrower Than LLT 10037844 MedDRA C112110 Skin Sloughing Skin Sloughing Peeling or shedding of skin in sheets. Peeling or shedding of skin in sheets. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Sloughing Has Synonym LLT 10041036 MedDRA C54247 Skin Ulcer Skin Ulceration Skin Ulcer A circumscribed and often suppurating skin crater which usually includes loss of skin integrity of the superficial skin or the mucous membranes. A circumscribed and often suppurating skin crater which usually includes loss of skin integrity of the superficial skin or the mucous membranes. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Skin ulceration Has Synonym LLT 10040947 MedDRA C26884 Sleep Apnea Sleep Apnea Cessation of breathing for short periods during sleep. It is classified as obstructive, central, or mixed obstructive-central. It can occur at any age but it is more frequent in people over forty. Risk factors include male sex and obesity. The cessation of breathing for periods of time during sleep. C26698 Apnea C118464 Pediatric Adverse Events Terminology Sleep apnea Has Synonym LLT 10040975 MedDRA C3376 Sleep Disorder Sleep Disorder A change from the patient's baseline sleeping pattern, in the hours slept and/or an alteration/dysfunction in the stages of sleep. A change from the patient's baseline sleeping pattern, in the hours slept and/or an alteration/dysfunction in the stages of sleep. C26835 Nervous System Disorder C118464 Pediatric Adverse Events Terminology Sleep disorder Has Synonym LLT 10040984 MedDRA C118171 Sleep Paralysis Sleep Paralysis Temporary inability to speak or move while waking up or falling asleep. Temporary inability to speak or move while waking up or falling asleep. C3376 Sleep Disorder C118464 Pediatric Adverse Events Terminology Sleep paralysis Has Synonym LLT 10041002 MedDRA C118188 Sleep Related Eating Disorder Sleep Related Eating Disorder Eating during sleep. Eating during sleep. C89332 Eating Disorder C118464 Pediatric Adverse Events Terminology Sleep-related eating disorder Has Synonym LLT 10067315 MedDRA C118384 Slipped Capital Femoral Epiphysis Slipped Capital Femoral Epiphysis Separation of the femoral head and neck through the epiphyseal plate. Separation of the femoral head and neck through the epiphyseal plate. C107377 Musculoskeletal System Disorder C118464 Pediatric Adverse Events Terminology Slipped femoral capital epiphysis Has Synonym LLT 10041027 MedDRA C118867 Slipped Extraocular Muscle Slipped Extraocular Muscle Weakness of extraocular muscle function as a result of inadequate securing of the muscle to the sclera during strabismus surgery. Weakness of extraocular muscle function as a result of inadequate securing of the muscle to the sclera during strabismus surgery. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Slipped extraocular muscle Has Synonym LLT 10076710 MedDRA C50746 Sneezing Sneezing A symptom consisting of the involuntary expulsion of air from the nose. The involuntary expulsion of air from the nose. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Sneezing Has Synonym LLT 10041232 MedDRA C116315 Snoring Snoring A harsh inspiratory sound during sleep. A harsh inspiratory sound during sleep. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Snoring Has Synonym LLT 10041235 MedDRA C9306 Soft Tissue Sarcoma Soft Tissue Sarcoma A malignant neoplasm arising from muscle tissue, adipose tissue, blood vessels, fibrous tissue, or other supportive tissues excluding the bones. A solid, malignant neoplasm originating in muscle, tendon, fat, blood vessels, nerves, connective or joint tissue. C9118 Sarcoma C118464 Pediatric Adverse Events Terminology Soft tissue sarcoma Has Synonym LLT 10075333 MedDRA C95078 Sleepwalking Somnambulism Sleepwalking Repeated episodes of rising from bed and walking about during sleep; while sleepwalking, the individual has a blank stare and can be awakened only with great difficulty. On awakening, the individual has amnesia for the episode. Amnestic episodes of ambulation during sleep, during which the individual may unconsciously engage in other activities. C3376 Sleep Disorder C118464 Pediatric Adverse Events Terminology Somnambulism Has Synonym LLT 10041347 MedDRA C26754 Somnolence Somnolence A sleep disorder characterized by excessive sleepiness and drowsiness. Excessive sleepiness and drowsiness. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Somnolence Has Synonym LLT 10041349 MedDRA C79750 Spasticity Spasticity Spastic Increased involuntary muscle tone caused by central nervous system disorders that affect the regions interfering with voluntary movement. It results in gait, movement, and speech disturbances. Representative examples of disorders causing spasticity include brain or spinal cord injury, and multiple sclerosis. Excessive muscle contraction and reflex hyperexcitability caused by lesions involving the upper motor neurons of the corticospinal tract. C110937 Musculoskeletal Finding C118464 Pediatric Adverse Events Terminology Spasticity Has Synonym LLT 10041416 MedDRA C101201 Myelomeningocele Spina Bifida Cystica Myelomeningocele A congenital abnormality in which the spinal cord and meninges protrude through a defect in the spinal column. The protrusion is above the skin surface. Incomplete closure of the spinal column during central nervous system development with protrusion of a hernial cyst containing meninges, spinal cord, or both. C101214 Spina Bifida C118464 Pediatric Adverse Events Terminology Spina bifida cystica Has Synonym LLT 10071011 MedDRA C3381 Spinal Cord Neoplasm Spinal Cord Tumor A primary or metastatic neoplasm affecting the spinal cord. A neoplasm arising within the spinal cord. C3268 Nervous System Neoplasm C118464 Pediatric Adverse Events Terminology Spinal cord neoplasm Has Synonym LLT 10062261 MedDRA C50751 Spinal Injury Spinal Injury Damage to the spine that results in impaired function. Damage to the spinal cord that results in impaired motor, sensory, or autonomic function. C3671 Injury C118464 Pediatric Adverse Events Terminology Spinal cord injury Has Synonym LLT 10041552 MedDRA C34336 Spontaneous Abortion Spontaneous Abortion Miscarriage Fetal loss at less than 20 weeks of gestation. Fetal loss at less than 20 weeks of gestation. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Spontaneous abortion Has Synonym LLT 10041687 MedDRA C115168 Spontaneous Bladder Rupture Spontaneous Bladder Perforation Rupture in the bladder wall due to a pathologic process, in the absence of trauma. Rupture in the bladder wall due to a pathologic process, in the absence of trauma. C36286 Urinary System Finding C118464 Pediatric Adverse Events Terminology Rupture of bladder, non-traumatic Has Synonym LLT 10057741 MedDRA C117011 Sporadic Hemiplegic Migraine Sporadic Hemiplegic Migraine A migraine disorder characterized by an aura that includes motor weakness and the absence of family history. A migraine disorder characterized by an aura that includes motor weakness and the absence of family history. C89715 Migraine C118464 Pediatric Adverse Events Terminology Hemiplegic migraine Narrower Than LLT 10019476 MedDRA C122576 Staphylococcus Aureus Infection Staphylococcus aureus Infection An infectious process in which the bacteria Staphylococcus aureus is present. An infectious process in which the bacteria Staphylococcus aureus is present. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Staphylococcus aureus infection Has Synonym LLT 10075981 MedDRA C122577 Status Asthmaticus Status Asthmaticus An acute exacerbation of asthma, characterized by inadequate response to initial bronchodilators. An acute exacerbation of asthma, characterized by an inadequate response to the initial use of bronchodilators and the progressive worsening of bronchial obstruction and shortness of breath, which can result in the need for mechanical ventilation and/or possibly death. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Status asthmaticus Has Synonym LLT 10041961 MedDRA C85079 Status Epilepticus Status Epilepticus A life-threatening situation in which the brain is in a continuous state of seizure. A prolonged seizure, or two or more discrete seizures without complete recovery of consciousness between seizures. C3020 Epilepsy C118464 Pediatric Adverse Events Terminology Status epilepticus Has Synonym LLT 10041962 MedDRA C117022 Status Migranosus Status Migrainosus An episode of migraine that persists for more than 72 hours. An episode of migraine that persists for more than 72 hours. C89715 Migraine C118464 Pediatric Adverse Events Terminology Status migrainosus Has Synonym LLT 10052945 MedDRA C115787 Vascular Access Steal Syndrome Steal Syndrome Shunting of blood flow from the arterial to the venous side of a hemodialysis access. Shunting of blood flow from the arterial to the venous side of a hemodialysis access. C116081 Dialysis Access Complication C118464 Pediatric Adverse Events Terminology Steal syndrome Has Synonym LLT 10063900 MedDRA C50754 Stenosis Stenosis Narrowing or stricture of a vessel, duct or canal. Narrowing of the luminal diameter in a tubular organ or structure. C36287 Congenital or Acquired Anatomic Abnormality C118464 Pediatric Adverse Events Terminology Stenosis Has Synonym LLT 10076711 MedDRA C116731 Stereotypy Stereotypy Persistent repetition of non-purposeful speech or movement. Persistent repetition of non-purposeful speech or movement. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Stereotypy Has Synonym LLT 10042008 MedDRA C116312 Stertor Stertor The sound produced by tissue vibrations in the nasopharynx and pharynx secondary to partial obstruction of the upper airway. The sound produced by tissue vibrations in the nasopharynx and pharynx secondary to partial obstruction of the upper airway. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Stertor Has Synonym LLT 10076712 MedDRA C79484 Stevens-Johnson Syndrome Stevens Johnson Syndrome Erythema Multiforme Major A systemic, serious, and life-threatening disorder characterized by lesions in the skin and mucous membranes that may lead to necrosis. The lesions may appear anywhere in the body but they occur more commonly in the palms, soles, dorsum of the hands, and extensor surfaces. The lesions are vesicular or necrotic in the center, surrounded by an erythematous zone and occupy less than 10% of the body surfaces. The appearance of the mucocutaneous lesions is preceded by an upper respiratory tract infection. It is an immune complex hypersensitivity reaction usually caused by drugs (e.g., sulfa, phenytoin, penicillin), viruses (e.g., herpes simplex, influenza, hepatitis), and malignancies (e.g., carcinoma and lymphoma). Drug or microbial induced exanthem characterized by papular or target-like lesions that involve less than 30% of the skin surface and at least two mucous membranes associated with systemic symptoms and may result in variable areas of skin necrosis. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Stevens Johnson syndrome Has Synonym LLT 10042030 MedDRA C49151 Stillbirth Stillbirth A fetus of at least 20 weeks gestation, or of a birth weight of at least 350 grams if the gestational age is unknown, that is born without signs of life at the time of delivery, and with an Apgar score of zero at both one and five minutes. A fetus of at least 20 weeks gestation, or of a birth weight of 350 grams or greater when the gestational age is not known, with no signs of life at the time of delivery, with Apgar scores of 0 at 1 and 5 minutes. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Stillbirth Has Synonym LLT 10042062 MedDRA C26887 Stomatitis Stomatitis Oral Mucositis Inflammation of the oral mucosa due to local or systemic factors. Inflammation of the oral mucous membranes. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Stomatitis Has Synonym LLT 10042128 MedDRA C116003 Streptococcal Pharyngitis Streptococcal Pharyngitis Strep Throat Inflammation of the throat due to Streptococcus pyogenes. Inflammation of the throat due to Streptococcus pyogenes. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Streptococcal pharyngitis Has Synonym LLT 10042182 MedDRA C78632 Stridor Stridor A symptom resulting from laryngeal obstruction. It is characterized by a high pitched breathing sound. A high-pitched breath sound secondary to obstruction and turbulent air flow at the level of the larynx. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Stridor Has Synonym LLT 10042241 MedDRA C35043 Stutter Stutter A speech disorder characterized by frequent sound or syllable repetitions, sound prolongations, or other dysfluencies that are inappropriate for the individual's age. A speech disorder characterized by frequent sound or syllable repetitions, sound prolongations, or other dysfluencies that are inappropriate for the individual's age. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Stutter Has Synonym LLT 10042266 MedDRA C118722 Stye Stye An infection of one or more of the glands surrounding the eye. An infection of one or more of the glands surrounding the eye. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Stye Has Synonym LLT 10042269 MedDRA C34583 Subacute Bacterial Endocarditis Subacute Bacterial Endocarditis Subacute inflammation of the endocardium. Streptococcus viridans is the usual etiologic agent of subacute bacterial endocarditis. The distinction between "acute" and "subacute" endocarditis has traditionally been made based on the pathogenic organism and clinical presentation. Chronic infection of the endocardium or heart valves. C34582 Endocarditis C118464 Pediatric Adverse Events Terminology Subacute bacterial endocarditis Has Synonym LLT 10042271 MedDRA C85171 Subacute Sclerosing Panencephalitis Subacute Sclerosing Panencephalitis SSPE A rare, slowly progressive post-infectious neurological disorder affecting the central nervous system. It is characterized by seizures, ataxia, myoclonus, personality changes, spasticity, and coma. The symptoms appear several years following measles infection at an early age. An encephalitic disorder that occurs following a measles infection. The disease initially manifests as personality changes, and then progresses to muscle spasms and seizures, possibly death. C26760 Encephalitis C118464 Pediatric Adverse Events Terminology Subacute sclerosing panencephalitis Has Synonym LLT 10042297 MedDRA C116583 Subarachnoid Hematoma Subarachnoid Hematoma A collection of blood into the space between the pia membrane and arachnoid membrane. A collection of blood into the space between the pia membrane and arachnoid membrane. C50579 Hematoma C118464 Pediatric Adverse Events Terminology Subarachnoid hematoma Has Synonym LLT 10076726 MedDRA C115788 Subcapsular Renal Hematoma Subcapsular Hematoma A collection of blood between the renal capsule and the renal parenchyma. A collection of blood between the renal capsule and the renal parenchyma. C50579 Hematoma C118464 Pediatric Adverse Events Terminology Renal haematoma Narrower Than LLT 10038459 MedDRA C114850 Subclavian Vein Stenosis Subclavian Vein Stenosis Narrowing of the lumen of the subclavian vein. Narrowing of the lumen of the subclavian vein. C35117 Vascular Disorder C118464 Pediatric Adverse Events Terminology Subclavian vein stenosis Has Synonym LLT 10076713 MedDRA C35045 Subconjunctival Hemorrhage Subconjunctival Hemorrhage Blood between the conjunctiva and sclera. Blood between the conjunctiva and sclera. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Subconjunctival hemorrhage Has Synonym LLT 10055345 MedDRA C116585 Subdural Hematoma Subdural Hematoma A collection of blood between the dura mater and the brain. A collection of blood into the space between the dura mater and the brain. C50579 Hematoma C118464 Pediatric Adverse Events Terminology Subdural hematoma Has Synonym LLT 10042380 MedDRA C116591 Subgaleal Hematoma Subgaleal Hematoma A collection of blood between the scalp and the skull periosteum. A collection of blood in the space between the scalp and the periosteum. C50579 Hematoma C118464 Pediatric Adverse Events Terminology Subgaleal hematoma Has Synonym LLT 10069514 MedDRA C50911 Sudden Cardiac Death Sudden Cardiac Death An unexpected natural death from a cardiac cause within a short time period from the onset of symptoms. An unexpected death from a cardiac cause within a short time period from the onset of symptoms. C50483 Cardiopulmonary Arrest C118464 Pediatric Adverse Events Terminology Sudden cardiac death Has Synonym PT 10049418 MedDRA C85173 Sudden Infant Death Syndrome Sudden Infant Death Syndrome SIDS Unexpected death in infancy which remains unexplained following autopsy, review of the medical history, and investigation of the death circumstances and death scene. The unexpected death of an infant less than 1 year of age that cannot be explained after a thorough investigation is conducted, including a complete autopsy, examination of the death scene, and review of the clinical history. C28554 Death C118464 Pediatric Adverse Events Terminology Sudden infant death syndrome Has Synonym LLT 10042440 MedDRA C111854 Sudden Unexplained Death in Childhood Sudden Unexplained Death in Childhood Unexpected death of a child over one year of age, which remains unexplained when all known and possible causes of death have been ruled out. Unexpected death of a child over one year of age, which remains unexplained when all known and possible causes of death have been ruled out. C89328 Pediatric Disorder C118464 Pediatric Adverse Events Terminology Sudden death unexplained Narrower Than LLT 10042436 MedDRA C111853 Sudden Unexplained Infant Death Sudden Unexplained Infant Death Unexpected death of an infant less than one year of age, whose cause of death is not immediately obvious prior to investigation. Unexpected death of an infant less than one year of age, whose cause of death is not immediately obvious prior to investigation. C89328 Pediatric Disorder C118464 Pediatric Adverse Events Terminology Sudden death unexplained Narrower Than LLT 10042436 MedDRA C80102 Suicidal Ideation Suicidal Ideation Thoughts of taking one's own life. Thinking about ending or making plans to end one's own life. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Suicidal ideation Has Synonym LLT 10042458 MedDRA C3394 Suicide Suicide The act of ending one's own life. Death caused by intentionally inflicted self harm. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Suicide Has Synonym LLT 10042462 MedDRA C80111 Suicide Attempt Suicide Attempt Self-inflicted harm in an attempt to end one's own life. Self-inflicted harm with the intent to end one's own life. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Suicide attempt Has Synonym LLT 10042464 MedDRA C3395 Sunburn Sunburn An inflammatory reaction from ultraviolet radiation characterized by transient redness, tenderness and occasional blistering. An inflammatory reaction from ultraviolet radiation characterized by transient redness, tenderness and occasional blistering. C34441 Burn C118464 Pediatric Adverse Events Terminology Sunburn Has Synonym LLT 10042496 MedDRA C36065 Superior Vena Cava Occlusion Superior Vena Cava Occlusion Blockage of the lumen of the superior vena cava. Blockage of the lumen of the superior vena cava. C99137 Great Vessels Abnormality C118464 Pediatric Adverse Events Terminology Superior vena cava occlusion Has Synonym LLT 10058988 MedDRA C111653 Superior Vena Cava Stenosis Superior Vena Cava Stenosis Abnormal narrowing of the lumen of the superior vena cava. Abnormal narrowing of the lumen of the superior vena cava. C99137 Great Vessels Abnormality C118464 Pediatric Adverse Events Terminology Superior vena cava stenosis Has Synonym LLT 10064771 MedDRA C3396 Superior Vena Cava Syndrome Superior Vena Cava Syndrome Obstruction of the blood flow in the superior vena cava caused by a malignant neoplasm, thrombosis, or aneurysm. It is a medical emergency requiring immediate treatment. Signs and symptoms include swelling and cyanosis of the face, neck, and upper arms, cough, orthopnea, and headache. Elevated pressure in the superior vena cava causing a constellation of recognized symptoms such as swelling and cyanosis of the face, neck, and upper arms, cough, orthopnea and headache. C99137 Great Vessels Abnormality C118464 Pediatric Adverse Events Terminology Superior vena cava syndrome Has Synonym LLT 10042569 MedDRA C118475 Suppurative Arthritis Suppurative Arthritis Pyogenic Arthritis Acute inflammation of one or more joints caused by the presence of pus within the joint cavity. Acute inflammation of one or more joints caused by the presence of pus within the joint cavity. C2883 Arthritis C118464 Pediatric Adverse Events Terminology Arthritis pyogenic Has Synonym LLT 10003266 MedDRA C35061 Supraventricular Tachycardia Supraventricular Tachycardia A disorder characterized by an electrocardiographic finding of a tachycardia which does not originate in the ventricles or His Purkinje system. There is an abnormally high heart rate and QRS complexes are typically narrow, but aberration or preexcitation may be present. (CDISC) A tachycardia originating in the atria of the heart. C110938 Tachyarrhythmia C118464 Pediatric Adverse Events Terminology Supraventricular tachycardia Has Synonym LLT 10042604 MedDRA C35050 Surgical Wound Infection Surgical Wound Infection Infection of a surgical incision. Infection of a surgical incision. C128320 Infection C2959 Complication C118464 Pediatric Adverse Events Terminology Surgical wound infection Has Synonym LLT 10053562 MedDRA C116363 Susac Syndrome Susac Syndrome An autoimmune microvascular disease that is characterized by the clinical triad of encephalopathy, branch retinal artery occlusions, and hearing loss. An autoimmune microvascular disease that is characterized by the clinical triad of encephalopathy, branch retinal artery occlusions, and hearing loss. C2889 Autoimmune Disease C118464 Pediatric Adverse Events Terminology Susac's syndrome Has Synonym LLT 10071573 MedDRA C13280 Sweat Sweat Perspiration|Sweats The liquid secreted by the sweat glands, having a salty taste and a pH that varies from 4.5 to 7.5. Sweat produced by the eccrine sweat glands is clear with a faint characteristic odor, and contains water, sodium chloride, and traces of albumin, urea, and other compounds. Its composition varies with many factors, e.g., fluid intake, external temperature and humidity, and some hormonal activity. Sweat produced by the larger, deeper, apocrine sweat glands of the axillae contains, in addition, organic material which on bacterial decomposition produces an offensive odor. The secretion by the sweat glands that is primarily composed of water and salt. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Sweating Has Synonym LLT 10042661 MedDRA C35053 Syncope Syncope Fainting A spontaneous loss of consciousness caused by insufficient blood supply to the brain. Transitory loss of consciousness and postural tone. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Syncope Has Synonym LLT 10042772 MedDRA C3988 Syndrome of Inappropriate Antidiuretic Hormone Secretion Syndrome of Inappropriate Antidiuretic Hormone Inappropriate ADH Secretion|Inappropriate Arginine Vasopressin Secretion|SIADH|Syndrome of Inappropriate Antidiuretic Hormone Secretion|Syndrome of Inappropriate Vasopressin Secretion A syndrome characterized by abnormal secretion of antidiuretic hormone in conjunction with neoplastic growth occurring anywhere in the body. A syndrome characterized by elevated concentrations of antidiuretic hormone (ADH) or ADH-like peptides, in the setting of hyponatremia and hypoosmolality. Causes include surgical damage to the pituitary stalk, drugs that stimulate release of, or mimic ADH, including psychotropic drugs, ectopic production of ADH, and pulmonary disease. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Syndrome inappropriate ADH Has Synonym LLT 10042818 MedDRA C94832 Systemic Inflammatory Response Syndrome Systemic Inflammatory Response Syndrome SIRS A generalized state of dysregulated inflammation induced by noninfectious processes. It is characterized by two or more of the following signs and symptoms: fever or hypothermia, increased heart rate, increased respiratory rate, and abnormal white blood cell count. A generalized state of dysregulated inflammation characterized by two or more of the following signs and symptoms: fever or hypothermia, increased heart rate, increased respiratory rate, and abnormal white blood cell count. C9229 Systemic Disorder C118464 Pediatric Adverse Events Terminology Systemic inflammatory response syndrome Has Synonym LLT 10051379 MedDRA C38029 Tachycardia Tachycardia An abnormally rapid heart rate. Thresholds for different age, gender, and patient populations exist. An abnormally high heart rate for age. C35552 Cardiovascular System Finding C118464 Pediatric Adverse Events Terminology Tachycardia Has Synonym LLT 10043071 MedDRA C50767 Tachypnea Tachypnea Fast Breathing Abnormal increase of rate of breathing. An increased rate of respiration. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Tachypnea Has Synonym LLT 10043088 MedDRA C118176 Tactile Hallucination Tactile Hallucination Perception of pressure or touch in the absence of a corresponding stimulus. Perception of pressure or touch in the absence of a corresponding stimulus. C37961 Hallucination C118464 Pediatric Adverse Events Terminology Hallucination, tactile Has Synonym LLT 10019074 MedDRA C84641 Clubfoot Talipes Club Foot|Clubfoot|Talipes Equinovarus The most common congenital deformation of the foot, occurring in 1 of 1,000 live births. The most common form is talipes equinovarus, where the deformed foot is turned downward and inward sharply. A congenital malformation involving one or both feet, in which the affected foot is rotated inward and downward. C84978 Osteochondrodysplasia C118464 Pediatric Adverse Events Terminology Talipes Has Synonym LLT 10043101 MedDRA C111972 Targetoid Lesion Targetoid Lesion Iris Lesion A red, edematous ring skin finding that may have a central dusky disk and an erythematous halo. A red, edematous ring skin finding that may have a central dusky disk and an erythematous halo. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Skin lesion Narrower Than LLT 10040882 MedDRA C117198 Tearfulness Tearfulness Excessive crying. Excessive crying. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Tearfulness Has Synonym LLT 10043169 MedDRA C112200 Telogen Effluvium Telogen Effluvium A scalp hair loss condition characterized by excessive shedding of hair in the resting phase of growth, usually following a fever or major body stress. A scalp hair loss condition characterized by excessive shedding of hair in the resting phase of growth, usually following a fever or major body stress. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Telogen effluvium Has Synonym LLT 10043200 MedDRA C117070 Tension Headache Tension-type Headache Stress Headache|Tension Headache A headache associated with muscle tightness which may radiate to other parts of the body. A headache associated with muscle tightness which may radiate to other parts of the body. C34661 Headache C118464 Pediatric Adverse Events Terminology Tension headache Has Synonym LLT 10043269 MedDRA C114821 Tertiary Hyperparathyroidism Tertiary Hyperparathyroidism An overproduction of parathyroid hormone that is autonomous and often associated with chronic secondary hyperparathyroidism. Unregulated secretion of parathyroid hormone following prolonged secondary hyperparathyroidism. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Hyperparathyroidism tertiary Has Synonym LLT 10020709 MedDRA C8591 Testicular Germ Cell Tumor Testicular Germ Cell Tumor A germ cell tumor arising from the testis. Representative examples include teratoma, seminoma, embryonal carcinoma, and yolk sac tumor. A neoplasm arising from gonadal tissue within the testes. C114801 Childhood Gonadal Germ Cell Tumor C118464 Pediatric Adverse Events Terminology Testicular germ cell tumor Has Synonym LLT 10075819 MedDRA C113349 Testosterone Excess Testosterone Excess Abnormally high level of testosterone. Abnormally high level of testosterone. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Testosterone excess Has Synonym LLT 10075906 MedDRA C114789 Tetany Tetany Sudden and involuntary contraction of a muscle of group of muscles due to hypocalcemia. Sudden and involuntary contraction of a muscle or group of muscles due to hypocalcemia. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Tetany Has Synonym LLT 10043380 MedDRA C80683 Therapy-Related Leukemia Therapy Related Leukemia Treatment Induced Leukemia|Treatment Related Leukemia A leukemia arising as a result of the mutagenic effect of chemotherapy agents that are used for the treatment of a malignant tumor or exposure to ionizing radiation. Leukemia arising as a result of the mutagenic effect of prior therapy. C3161 Leukemia C118464 Pediatric Adverse Events Terminology Treatment related leukemia Has Synonym LLT 10075814 MedDRA C76132 Third-Degree Burn Third Degree Burn An injury that includes all skin layers into the subcutaneous tissue due to chemical, friction, radiation or thermal exposure. The affected area appears dry and thickened; damage to nerve endings usually renders the wound painless. A burn that involves the full thickness of the epidermis and dermis characterized by exposure of subcutaneous tissues. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Burns third degree Has Synonym LLT 10006803 MedDRA C122578 Throat Tightening Throat Tightening The sensation of constriction or contraction in the throat area. The sensation of constriction or contraction in the throat area. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Throat tightness Has Synonym LLT 10043528 MedDRA C3408 Thrombocytopenia Thrombocytopenia Thrombocytopenic Disorder A laboratory test result indicating that there is an abnormally small number of platelets in the circulating blood. Abnormally low level of platelets in the blood. C26323 Hematologic Disorder C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Thrombocytopenia Has Synonym PT 10043554 MedDRA C35530 Thrombocytosis Thrombocytosis A hematology test result that indicates the presence of higher than normal platelet counts in the peripheral blood. Abnormally high level of platelets in the blood. C26323 Hematologic Disorder C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Thrombocytosis Has Synonym LLT 10043563 MedDRA C28195 Thromboembolism Thromboembolism Occlusion of the lumen of a vessel by a thrombus that has migrated from a distal site via the blood stream. Occlusion of the lumen of a vessel by a thrombus. C35117 Vascular Disorder C118464 Pediatric Adverse Events Terminology Thromboembolism Has Synonym LLT 10043566 MedDRA C84479 Thrombophilia Thrombophilia Hypercoagulability|Hypercoagulability State|Hypercoagulable A condition characterized by an abnormally high level of thrombi. Causes include thrombotic thrombocytopenic purpura, disseminated intravascular coagulation, bone marrow disorders, and antiphospholipid antibody syndrome. Abnormally increased tendency of the blood to form clots. C2902 Coagulation Disorder C118464 Pediatric Adverse Events Terminology Hypercoagulability Has Synonym LLT 10075816 MedDRA C3410 Thrombophlebitis Thrombophlebitis Inflammation of the veins associated with the presence of a thrombus. Inflammation of the veins associated with the presence of a thrombus. C99107 Venous Thrombosis C118464 Pediatric Adverse Events Terminology Thrombophlebitis Has Synonym LLT 10043570 MedDRA C26891 Thrombosis Thrombosis The formation of a blood clot in the lumen of a vessel or heart chamber; causes include coagulation disorders and vascular endothelial injury. Formation of a blood clot within a blood vessel or the heart. C35117 Vascular Disorder C118464 Pediatric Adverse Events Terminology Thrombosis Has Synonym LLT 10043607 MedDRA C78797 Thrombotic Thrombocytopenic Purpura Thrombotic Thrombocytopenic Purpura TTP A coagulation disorder characterized by extensive formation of thrombi in small blood vessels throughout the body due to low levels of ADAMTS13 protein, and resulting in consumption of circulating platelets, which is characterized by thrombocytopenia, anemia, neurologic changes, and sometimes fever and renal dysfunction. A coagulation disorder characterized by extensive formation of thrombi in small blood vessels throughout the body due to low levels of ADAMTS13 protein, and resulting in consumption of circulating platelets, which is characterized by thrombocytopenia, anemia, neurologic changes, and sometimes fever and renal dysfunction. C78787 Purpura C62605 Thrombotic Microangiopathy C118464 Pediatric Adverse Events Terminology Thrombotic thrombocytopenic purpura Has Synonym LLT 10043648 MedDRA C27083 Blood Clot Thrombus Blood Clot An aggregation of blood factors, primarily platelets and fibrin with entrapment of cellular elements, frequently causing vascular obstruction at the point of its formation. An aggregation of platelets and fibrin within the cardiovascular system. C35117 Vascular Disorder C118464 Pediatric Adverse Events Terminology Clot blood Has Synonym LLT 10009667 MedDRA C118258 Thymic Damage Thymic Damage Anatomic injury or physiologic dysfunction of the thymus gland. Anatomic injury or physiologic dysfunction of the thymus gland. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Thymus disorder Related To LLT 10061381 MedDRA C4815 Thyroid Gland Carcinoma Thyroid Carcinoma Thyroid Cancer A carcinoma arising from the thyroid gland. It is usually an adenocarcinoma and includes the following main subtypes: follicular, papillary, medullary, poorly differentiated, and anaplastic. A malignant tumor arising from the epithelial cells of the thyroid gland. C9305 Cancer C118464 Pediatric Adverse Events Terminology Thyroid cancer Has Synonym LLT 10066474 MedDRA C112836 Thyroid Storm Thyroid Storm Acute onset of severe, life-threatening hyperthyroidism caused by a sudden release of excessive thyroid hormone. An acute complication of hyperthyroidism characterized by fever, tachycardia, nausea, agitation and/or coma that may result in death. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Thyroid storm Has Synonym LLT 10043773 MedDRA C26894 Thyroiditis Thyroiditis Inflammation of the thyroid gland. This category includes Hashimoto thyroiditis, Riedel thyroiditis, acute thyroiditis, subacute thyroiditis, and radiation-induced thyroiditis. Inflammation of the thyroid gland. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Thyroiditis Has Synonym LLT 10043778 MedDRA C61469 Thyrotoxicosis Thyrotoxicosis A hypermetabolic syndrome caused by the elevation of thyroid hormone levels in the serum. Signs and symptoms include tachycardia, palpitations, tremor, weight loss, warm weather intolerance, and moist skin. Causes include Graves disease, toxic nodular goiter, toxic thyroid nodule, and lymphocytic thyroiditis. A syndrome caused by excessive levels of thyroid hormone due to overproduction or excessive release of stored thyroid hormone. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Thyrotoxicosis Has Synonym LLT 10043789 MedDRA C116758 Tic Tic Involuntary sudden, rapid, recurrent, nonrhythmic, stereotyped motor movement or vocalization. Involuntary sudden, rapid, recurrent, nonrhythmic, stereotyped motor movement or vocalization. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Tic Has Synonym LLT 10043833 MedDRA C112181 Tinea Infection Tinea Infection A skin infection caused by a fungus. A skin infection caused by a fungus. C3371 Skin Disorder C26726 Infectious Disorder C118464 Pediatric Adverse Events Terminology Tinea Has Synonym LLT 10043864 MedDRA C112833 Tinea Versicolor Tinea Versicolor A skin condition characterized by hypopigmented, pink or tan, confetti-like, discrete and confluent scaly macules distributed on the chest, shoulders and upper back. A skin condition characterized by hypopigmented, pink or tan, confetti-like, discrete and confluent scaly macules distributed on the chest, shoulders and upper back. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Tinea versicolor Has Synonym LLT 10043875 MedDRA C50772 Tinnitus Tinnitus Abnormal perception of sounds experienced by an individual in the absence of auditory stimulation. Abnormal perception of sounds experienced by an individual in the absence of auditory stimulation. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Tinnitus Has Synonym LLT 10043882 MedDRA C54685 Tissue Adhesion Tissue Adhesion A fibrous band of tissue that connects normally separate body regions. A fibrous band of tissue that connects normally separate body regions. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Adhesion Has Synonym LLT 10059837 MedDRA C116006 Tonsillitis Tonsillitis Inflammation of the tonsillar tissue. Inflammation of the tonsillar tissue. C118420 Otolaryngologic Disorder C118464 Pediatric Adverse Events Terminology Tonsillitis Has Synonym LLT 10044008 MedDRA C35596 Dental Developmental Disorder Tooth Development Disorder A disorder of the teeth arising during odontogenesis. A disorder of the teeth arising during odontogenesis. C89330 Developmental Disorder C118464 Pediatric Adverse Events Terminology Tooth development disorder Has Synonym LLT 10044030 MedDRA C80112 Tooth Discoloration Tooth Discoloration A change in tooth color. Causes may be local or systemic and include tobacco use, foods, dental plaques, caries, restorative filling materials, trauma, medications, infections, hereditary diseases, and nutritional deficiencies. Abnormal tooth color. C35077 Dental Disorder C118464 Pediatric Adverse Events Terminology Tooth discoloration Has Synonym LLT 10044031 MedDRA C78639 Tooth Infection Tooth Infection An infectious process affecting a tooth. An infectious process affecting a tooth. C26726 Infectious Disorder C118464 Pediatric Adverse Events Terminology Tooth infection Has Synonym LLT 10048762 MedDRA C118306 Tooth Malformation Tooth Malformation Any abnormality in the growth or formation of one or more teeth. Any abnormality in the growth or formation of one or more teeth. C35596 Tooth Development Disorder C118464 Pediatric Adverse Events Terminology Tooth malformation Has Synonym LLT 10044046 MedDRA C50779 Torsades De Pointes by ECG Finding Torsades de Pointes An electrocardiographic finding of an atypical rapid polymorphic ventricular tachycardia with a characteristic rotation of the QRS complex around the isoelectric baseline, occurring in the setting of a prolonged QT interval. In addition, the QRS complex displays a periodic waxing and waning of amplitude on the electrocardiogram. An atypical polymorphic ventricular tachycardia that is characterized by fluctuation of the QRS complexes around the baseline. C110938 Tachyarrhythmia C118464 Pediatric Adverse Events Terminology Torsades de pointes Has Synonym LLT 10044067 MedDRA C35078 Tourette Syndrome Tourette Syndrome Gilles de la Tourette syndrome|Tourette's Syndrome A neurologic disorder caused by defective metabolism of the neurotransmitters in the brain. It is characterized by repeated involuntary movements (motor tics) and uncontrollable vocal sounds (vocal tics). The symptoms are usually manifested before the age of eighteen. A neurological disorder presenting in childhood that is characterized by both motor and phonic tics that occur daily or nearly daily for at least a year and are not attributed to an identifiable cause. C96412 Brain Development Abnormality C116757 Movement Disorders C118464 Pediatric Adverse Events Terminology Tourette's syndrome Has Synonym LLT 10044127 MedDRA C116766 Tourettism Tourettism Tics that are secondary to an identifiable cause. Tics that are secondary to an identifiable cause. C116757 Movement Disorders C118464 Pediatric Adverse Events Terminology Tourettism Has Synonym LLT 10076727 MedDRA C79777 Toxic Epidermal Necrolysis Toxic Epidermal Necrolysis Lyell's Syndrome A systemic, serious, and life-threatening disorder characterized by erythematous and necrotic lesions in the skin and mucous membranes that are associated with bullous detachment of the epidermis. The epidermal and mucous membranes detachment leads to sepsis and may be fatal. The lesions appear throughout the body and occupy more than 30% of the body surfaces. It is a hypersensitivity reaction usually caused by drugs (e.g., sulfonamides, nonsteroidal anti-inflammatory drugs, anticonvulsants, and antiretroviral drugs). Drug-induced rapidly evolving cutaneous reaction resulting in areas of painful skin sloughing of greater than 30% body surface area. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Toxic epidermal necrolysis Has Synonym LLT 10044223 MedDRA C112182 Toxic Erythema of Chemotherapy Toxic Erythema of Chemotherapy Painful red or purple patches, edematous plaques or blisters on the hands, feet, extremities or intertriginous regions; the onset can occur days to months after receiving chemotherapy. Painful red or purple patches, edematous plaques or blisters on the hands, feet, extremities or intertriginous regions; the onset can occur days to months after receiving chemotherapy. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Toxic erythema of chemotherapy Has Synonym LLT 10074982 MedDRA C35498 Toxic Shock Syndrome Toxic Shock Syndrome TSS A rare acute life-threatening systemic bacterial noncontagious illness caused by any of several related staphylococcal exotoxins. It is characterized by high fever, hypotension, rash, multi-organ dysfunction, and cutaneous desquamation during the early convalescent period. The toxins affect the host immune system, causing an exuberant and pathological host inflammatory response. Laboratory findings include leukocytosis, elevated prothrombin time, hypoalbuminemia, hypocalcemia, and pyuria. Profoundly reduced blood flow that results in impaired tissue perfusion and possible end organ damage resulting from an exotoxin released from certain bacteria, most often Staphylococcus aureus, or Streptococcus pyogenes. C9229 Systemic Disorder C118464 Pediatric Adverse Events Terminology Toxic shock syndrome Has Synonym LLT 10044248 MedDRA C78643 Tracheitis Tracheitis An inflammatory process affecting the wall of the trachea. Inflammation of the trachea. C35079 Tracheal Disorder C118464 Pediatric Adverse Events Terminology Tracheitis Has Synonym LLT 10044302 MedDRA C122784 Tracheobronchitis Tracheobronchitis Inflammation of the tracheobronchial tree. Inflammation of the tracheobronchial tree. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Tracheobronchitis Has Synonym LLT 10044314 MedDRA C122643 Tracheostomy Site Tracheostomy Site A surgically created external opening into the trachea. A surgically created external opening into the trachea. C122638 Ostomy Site C118464 Pediatric Adverse Events Terminology C118759 Tractional Retinal Detachment Tractional Retinal Detachment Retinal detachment secondary to vasoproliferative changes in the retina and/or vitreous. Retinal detachment secondary to vasoproliferative changes in the retina and/or vitreous. C26874 Retinal Detachment C118464 Pediatric Adverse Events Terminology Traction detachment of retina Has Synonym LLT 10044331 MedDRA C113751 Transaminitis Transaminitis Elevated Transaminases|Hypertransaminasemia Abnormally high levels of alanine transaminase (ALT) and/or aspartate transaminase (AST) in the blood. Abnormally high levels of alanine transaminase (ALT) and/or aspartate transaminase (AST) in the blood. C36292 Laboratory Test Result C118464 Pediatric Adverse Events Terminology Transaminitis Has Synonym LLT 10054969 MedDRA C27071 Transient Hypogammaglobulinemia of Infancy Transient Hypogammaglobulinemia of Infancy A rare, primary humoral immunodeficiency of childhood characterized by decreasing serum levels of immunoglobulin G (IgG) as maternal antibodies clear the circulation while serum levels of immunoglobulin A and immunoglobulin M remain normal or are slightly decreased. Diagnosis may be suspected after the age of six months when a child's own synthesis of IgG should accelerate but it must be confirmed retrospectively after normalization of all serum immunoglobulin levels is seen by ages 2-6. This disorder may be caused by inadequate activation of progenitor B cells, defective class-switching or may even represent a maturational variant. Typically, a normal response to protein antigens is found while there is a notably diminished response to viral and bacterial polysaccharide antigens. Clinical presentation may include recurrent infections especially those of the respiratory tract. Despite increased susceptibility to infection in childhood, this disorder is self-limited with minimal implications for a normal life span. Transitory decrease in the concentration of IgG below established reference ranges, in an infant or child less than 6 months of age. IgA and IgM concentrations may be decreased as well. C3507 Immune System Disorder C118464 Pediatric Adverse Events Terminology Transient hypogammaglobulinemia of infancy Has Synonym LLT 10054672 MedDRA C113171 Transient Hypothyroxinemia of Prematurity Transient Hypothyroxinemia of Prematurity Hypothyroxinemia of Prematurity|THOP|Transient Congenital Hypothyroidism A common, self-limiting thyroid disorder seen in preterm infants that is characterized by abnormally low serum levels of thyroxine and free thyroxine with normal serum levels of thyroid stimulating hormone. A congenital condition in which the function of the thyroid gland is transiently impaired, resulting in a subnormal concentration(s) of thyroid hormone(s) in the neonatal period. C3009 Endocrine System Disorder C118464 Pediatric Adverse Events Terminology Transient hypothyroxinemia of prematurity Has Synonym LLT 10075915 MedDRA C50781 Transient Ischemic Attack Transient Ischemic Attacks A brief attack (from a few minutes to an hour) of cerebral dysfunction of vascular origin, with no persistent neurological deficit. A transient episode of cerebral dysfunction of vascular origin with no persistent neurological deficit. C3390 Cerebrovascular Accident C118464 Pediatric Adverse Events Terminology Transient ischemic attacks Has Synonym LLT 10044391 MedDRA C116767 Transient Tic Disorder Transient Tic Disorder Benign Tic Disorder of Childhood A neurological disorder presenting in childhood that is characterized by motor and/or phonic tics that occur daily or nearly daily for one to twelve months and are not attributed to an identifiable cause. A neurological disorder presenting in childhood that is characterized by motor and/or phonic tics that occur daily or nearly daily for one to twelve months and are not attributed to an identifiable cause. C116757 Movement Disorders C118464 Pediatric Adverse Events Terminology Transient tic disorder of childhood Has Synonym LLT 10044404 MedDRA C35082 Traumatic Subcutaneous Emphysema Traumatic Subcutaneous Emphysema The infiltration of air into the skin tissue secondary to traumatic tissue disruption. The infiltration of air into the skin tissue secondary to traumatic tissue disruption. C3671 Injury C118464 Pediatric Adverse Events Terminology Traumatic subcutaneous emphysema Has Synonym LLT 10044544 MedDRA C38038 Tremor Tremor The shaking movement of the whole body or just a certain part of it, often caused by problems of the neurons responsible for muscle action. Unintentional trembling or shaking of one or more body parts. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Tremor Has Synonym LLT 10044565 MedDRA C117074 Trigeminal Autonomic Cephalalgia Trigeminal Autonomic Cephalalgia A headache disorder characterized by episodes of unilateral, short lasting pain and associated ipsilateral cranial autonomic symptoms. A headache disorder characterized by episodes of unilateral, short lasting pain and associated ipsilateral cranial autonomic symptoms. C26733 Cranial Nerve Disorder C118464 Pediatric Adverse Events Terminology Cephalalgia Narrower Than LLT 10008011 MedDRA C3423 Tuberculosis Tuberculosis Active Tuberculosis|TB|Tuberculosis|Tuberculosis Disease A chronic, recurrent infection caused by the bacterium Mycobacterium tuberculosis. Tuberculosis (TB) may affect almost any tissue or organ of the body with the lungs being the most common site of infection. The clinical stages of TB are primary or initial infection, latent or dormant infection, and recrudescent or adult-type TB. Ninety to 95% of primary TB infections may go unrecognized. Histopathologically, tissue lesions consist of granulomas which usually undergo central caseation necrosis. Local symptoms of TB vary according to the part affected; acute symptoms include hectic fever, sweats, and emaciation; serious complications include granulomatous erosion of pulmonary bronchi associated with hemoptysis. If untreated, progressive TB may be associated with a high degree of mortality. This infection is frequently observed in immunocompromised individuals with AIDS or a history of illicit IV drug use. A disease caused by Mycobacterium tuberculosis infection that is characterized by the growth of nodules in body tissues, most commonly the lungs, and may be transmitted through droplets from the throat or lungs of individuals with the active respiratory disease. C2890 Bacterial Infection C118464 Pediatric Adverse Events Terminology Tuberculosis Has Synonym LLT 10044755 MedDRA C26834 Interstitial Nephritis Tubulointerstitial Nephritis Inflammation of the renal tubules and supporting tissues of the kidney. Inflammation of the renal tubules and supporting tissues of the kidney. C3149 Kidney Disease C118464 Pediatric Adverse Events Terminology Tubulointerstitial nephritis Has Synonym LLT 10048302 MedDRA C3425 Tumor Lysis Syndrome Tumor Lysis Syndrome A condition of metabolic abnormalities that result from a spontaneous or therapy-related cytolysis of tumor cells. Tumor lysis syndrome typically occurs in aggressive, rapidly proliferating lymphoproliferative disorders. Burkitt lymphoma and T cell acute lymphoblastic leukemia are commonly associated with this syndrome. Metabolic abnormalities include hyperuricemia, lactic acidosis, hyperkalemia, hyperphosphatemia and hypocalcemia and may result in renal failure, multiple organ failure, and death. Multiple metabolic abnormalities resulting from tumor cell cytolysis characterized typically by hyperkalemia, hyperphosphatemia, hyperuricemia, and impaired renal function. C3235 Metabolic Disease C118464 Pediatric Adverse Events Terminology Tumor lysis syndrome Has Synonym LLT 10045152 MedDRA C2986 Type 1 Diabetes Mellitus Type 1 Diabetes Mellitus Immune Mediated Diabetes|Insulin Dependent Diabetes|Juvenile Diabetes|Type 1 Diabetes|Type I Diabetes A chronic condition characterized by minimal or absent production of insulin by the pancreas. Diabetes mellitus caused by cell-mediated autoimmune destruction of pancreatic beta cells. C2985 Diabetes Mellitus C118464 Pediatric Adverse Events Terminology Insulin Dependent Diabetes|Type I Diabetes Type I diabetes mellitus Has Synonym LLT 10045228 MedDRA C26747 Type 2 Diabetes Mellitus Type 2 Diabetes Mellitus Adult Onset Diabetes|Noninsulin Dependent Diabetes|Type 2 Diabetes A type of diabetes mellitus that is characterized by insulin resistance or desensitization and increased blood glucose levels. This is a chronic disease that can develop gradually over the life of a patient and can be linked to both environmental factors and heredity. Diabetes mellitus caused by decreased insulin action in target tissues and insufficient production of insulin by pancreatic beta cells. C2985 Diabetes Mellitus C118464 Pediatric Adverse Events Terminology Adult Onset Diabetes|Noninsulin Dependent Diabetes|Type II Diabetes Type II diabetes mellitus Has Synonym LLT 10045242 MedDRA C3116 Type I Hypersensitivity Type I Immediate Hypersensitivity Reaction Type 1 Hypersensitivity|Type 1 Hypersensitivity Reaction Immediate hypersensitivity reaction - type I reaction, involves immunoglobulin E (IgE)-mediated release of chemical mediators from mast cells and basophils. Th2 cells produce IL-4 and IL-13, which then act on B cells to promote the production of antigen-specific IgE. Reexposure to the antigen can then result in the antigen binding to and cross-linking the bound IgE antibodies on the mast cells and basophils. This causes the release of preformed mediators (histamine, tryptase, tryptase, chemotactic factors), newly synthesized mediators (leukotrienes, prostaglandin, thromboxane, platelet-activating factor, adenosine, bradykinin), and cytokines from these cells that results in structural and functional changes to the affected tissue. An immunoglobulin E (IgE) mediated hypersensitivity reaction. These usually occur within an hour of exposure to an allergen. C3114 Hypersensitivity Reaction C118464 Pediatric Adverse Events Terminology Immediate hypersensitivity reaction Broader Than LLT 10021414 MedDRA C114345 Type II Hypersensitivity Type II Hypersensitivity Reaction Type 2 Hypersensitivity Reaction A hypersensitivity reaction mediated by antibodies formed against cell surface antigens. A hypersensitivity reaction mediated by antibodies formed against cell surface antigens. C3114 Hypersensitivity Reaction C118464 Pediatric Adverse Events Terminology Type II hypersensitivity Has Synonym LLT 10054000 MedDRA C114346 Type III Hypersensitivity Type III Hypersensitivity Reaction Type 3 Hypersensitivity Reaction A hypersensitivity reaction resulting from the deposition of antigen-antibody immune complexes in tissues, which trigger activation of the complement system. A hypersensitivity reaction resulting from the deposition of antigen-antibody immune complexes in tissues, which trigger activation of the complement system. C3114 Hypersensitivity Reaction C118464 Pediatric Adverse Events Terminology Type III hypersensitivity reaction Has Synonym LLT 10045265 MedDRA C3115 Type IV Hypersensitivity Type IV Hypersensitivity Reaction Type 4 Hypersensitivity Reaction Delayed hypersensitivity reaction (DTH) - type IV reaction, an inflammatory response that develops 24 to 72 hours after exposure to an antigen that the immune system recognizes as foreign. DTH is mediated by T cells rather than by antibodies. Th1 cells produce interferon gamma, interleukin (IL)-2, and tumor necrosis factor-beta and promote a cell-mediated immune response. A hypersensitivity reaction triggered by sensitized T lymphocytes encountering antigens. These reactions usually develop 18 to 24 hours after exposure. C3114 Hypersensitivity Reaction C118464 Pediatric Adverse Events Terminology Type IV hypersensitivity reaction Has Synonym LLT 10053613 MedDRA C38043 Typhlitis Typhlitis Neutropenic Colitis Inflammation of the cecum, usually accompanied by neutropenia. Inflammation of the cecum, usually in the presence of neutropenia. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Typhlitis Has Synonym LLT 10045271 MedDRA C3426 Ulcer Ulcer Ulceration A circumscribed inflammatory and often suppurating lesion on the skin or an internal mucous surface resulting in necrosis of tissue. A circumscribed loss of integrity of the skin or mucous membrane. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Ulcer Has Synonym LLT 10045285 MedDRA C2952 Ulcerative Colitis Ulcerative Colitis Colitis Ulcerative An inflammatory bowel disease involving the mucosal surface of the large intestine and rectum. It may present with an acute or slow onset and follows an intermittent or continuous course. Signs and symptoms include abdominal pain, diarrhea, fever, weight loss, and intestinal hemorrhage. A chronic inflammatory disease affecting the mucosal surface of the colon and rectum. C26723 Colitis C118464 Pediatric Adverse Events Terminology Ulcerative colitis Has Synonym LLT 10045365 MedDRA C122413 Ulcerative Colitis Flare Ulcerative Colitis Flare An exacerbation of ulcerative colitis. An exacerbation of ulcerative colitis. C2990 Gastrointestinal Disorder C118464 Pediatric Adverse Events Terminology Colitis ulcerative acute episode Has Synonym LLT 10058816 MedDRA C92902 Umbilical Cord Compression Umbilical Cord Compression A situation in utero, when there is increased pressure on the umbilical cord, which constricts blood supply to the fetus. A situation in utero, when there is increased pressure on the umbilical cord, which constricts blood supply to the fetus. C81236 Birth Complication C118464 Pediatric Adverse Events Terminology Umbilical cord compression Has Synonym LLT 10045451 MedDRA C113154 Umbilical Cord Occlusion Umbilical Cord Occlusion Blockage of blood flow in the umbilical vessels. Blockage of blood flow in the umbilical vessels. C81236 Birth Complication C118464 Pediatric Adverse Events Terminology Umbilical cord occlusion Has Synonym LLT 10076714 MedDRA C87126 Umbilical Cord Prolapse Umbilical Cord Prolapse Prolapsed Cord A situation in which the umbilical cord is ahead of the presenting fetal part. If the cord becomes compressed it may cut off the flow of blood to the baby. Passage of the umbilical cord through the cervix before the fetus during delivery. C81236 Birth Complication C118464 Pediatric Adverse Events Terminology Umbilical cord prolapse Has Synonym LLT 10045452 MedDRA C112119 Umbilical Granuloma Umbilical Granuloma Excessive granulation tissue at the base of the umbilicus after separation. Excessive granulation tissue at the base of the umbilicus after separation. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Umbilical granuloma Has Synonym LLT 10067731 MedDRA C118375 Umbilical Hernia Umbilical Hernia Protrusion of the abdominal cavity contents through the abdominal wall at the umbilicus. Protrusion of the abdominal cavity contents through the abdominal wall at the umbilicus. C34685 Hernia C118464 Pediatric Adverse Events Terminology Umbilical hernia Has Synonym LLT 10045458 MedDRA C113785 Indirect Hyperbilirubinemia Unconjugated Hyperbilirubinemia Indirect Hyperbilirubinemia Abnormally high level of unconjugated bilirubin in the blood. Abnormally high level of unconjugated bilirubin in the blood. C27088 Hyperbilirubinemia C118464 Pediatric Adverse Events Terminology Unconjugated bilirubinemia Has Synonym LLT 10075817 MedDRA C122529 Unresponsive to Stimuli Unresponsive to Stimuli An individual whose level of consciousness is such that he is not responsive to any stimulus. An individual whose level of consciousness is such that he is not responsive to any stimulus. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Unresponsive to stimuli Has Synonym LLT 10045555 MedDRA C35650 Upper Respiratory Tract Infection Upper Respiratory Infection Cold|URI|Upper Respiratory Tract Infection An infectious process affecting the upper respiratory tract (nose, paranasal sinuses, pharynx, larynx, or trachea). Symptoms include congestion, sneezing, coughing, fever, and sore throat. Infection of the nose, pharynx, larynx, or any combination thereof. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Upper respiratory infection Has Synonym LLT 10046300 MedDRA C114837 Uremic Pericarditis Uremic Pericarditis Inflammation of the pericardium associated with chronic kidney failure. Inflammation of the pericardium associated with chronic kidney failure. C34915 Pericarditis C118464 Pediatric Adverse Events Terminology Uremic pericarditis Has Synonym LLT 10046373 MedDRA C78662 Ureteric Anastomotic Leakage Ureteral Anastomotic Leak Leakage due to breakdown of a ureteral anastomosis. Urinary leak specific to a reimplanted ureter. C2959 Complication C118464 Pediatric Adverse Events Terminology Ureteric anastomotic leak Has Synonym LLT 10065814 MedDRA C114479 Ureter Compression Ureteral Compression Narrowing of the luminal diameter of one or both ureters due to extrinsic pressure. Narrowing of the luminal diameter of one or both ureters due to extrinsic pressure. C36286 Urinary System Finding C118464 Pediatric Adverse Events Terminology Ureteric compression Has Synonym LLT 10076715 MedDRA C79802 Ureter Obstruction Ureteral Obstruction Blockage of the normal flow of urine in the ureter. A blockage in one or both ureters. C79805 Urinary Tract Obstruction C118464 Pediatric Adverse Events Terminology Ureteric obstruction Has Synonym LLT 10046406 MedDRA C78665 Ureteric Perforation Ureteral Perforation A rupture in the wall of the ureter due to traumatic or pathologic processes. A rupture in the ureter. C36286 Urinary System Finding C118464 Pediatric Adverse Events Terminology Ureteric perforation Has Synonym LLT 10065809 MedDRA C115958 Ureteral Stenosis Ureteral Stenosis Narrowing of the luminal diameter of one or both ureters due to intrinsic factors. An intrinsic narrowing of the lumen of the ureter. C36286 Urinary System Finding C118464 Pediatric Adverse Events Terminology Stenosis ureteral Has Synonym LLT 10041998 MedDRA C26904 Urethritis Urethritis Inflammation of the urethra. Inflammation of the urethra. C3430 Urinary System Disorder C118464 Pediatric Adverse Events Terminology Urethritis Has Synonym LLT 10046480 MedDRA C26906 Urinary Frequency Urinary Frequency Urination at short intervals; it may result from increased urine formation, decreased bladder capacity, or lower urinary tract irritation. Urination occurring more often than normal. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Urinary frequency Has Synonym LLT 10046539 MedDRA C78497 Urinary Incontinence Urinary Incontinence Enuresis Involuntary passage of urine outside the body. Involuntary passage of urine outside the body. C123162 Voiding Disorders C118464 Pediatric Adverse Events Terminology Urinary incontinence Has Synonym LLT 10046543 MedDRA C118167 Urinary Leakage Urinary Leak Extravasation of urine outside the urinary collecting system. Extravasation of urine outside the urinary collecting system. C36286 Urinary System Finding C118464 Pediatric Adverse Events Terminology Extravasation of urine Has Synonym LLT 10015869 MedDRA C50790 Urinary Retention Urinary Retention Accumulation of urine within the bladder because of the inability to urinate. Inability to completely empty the bladder with urination. C36286 Urinary System Finding C118464 Pediatric Adverse Events Terminology Urinary retention Has Synonym LLT 10046555 MedDRA C50791 Urinary Tract Infection Urinary Tract Infection UTI|Urinary Tract Infectious Disease A bacterial infectious process affecting any part of the urinary tract, most commonly the bladder and the urethra. Symptoms include urinary urgency and frequency, burning sensation during urination, lower abdominal discomfort, and cloudy urine. An infection of the kidneys, ureters, bladder and/or urethra. C3430 Urinary System Disorder C26726 Infectious Disorder C118464 Pediatric Adverse Events Terminology Urinary tract infection Has Synonym LLT 10046571 MedDRA C50792 Urinary Urgency Urinary Urgency An acute and compelling urge to urinate. An acute and compelling urge to urinate. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Urinary urgency Has Synonym LLT 10046593 MedDRA C80522 Urine Output Decreased Urine Output Decreased A finding indicating that the urine production is less than 500 milliliters during a 24 hour period. A finding indicating that the urine production is less than 500 milliliters during a 24 hour period. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Urine output decreased Has Synonym LLT 10059895 MedDRA C114688 Urolithiasis Urolithiasis Urinary Stones Stone(s) within the urinary tract. Stone(s) within the urinary tract. C3430 Urinary System Disorder C118464 Pediatric Adverse Events Terminology Urolithiasis Has Synonym LLT 10046707 MedDRA C122644 Urostomy Site Urostomy Site A surgically created external opening into the urinary tract. A surgically created external opening into the urinary tract. C122638 Ostomy Site C118464 Pediatric Adverse Events Terminology C3432 Urticaria Urticaria Hives A transient, itchy skin eruption characterized by wheals with pale interiors and red margins. A transient, itchy skin eruption characterized by wheals with pale interiors and red margins. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Urticaria Has Synonym LLT 10046735 MedDRA C118754 Uveal Prolapse Uveal Prolapse The protrusion of uveal tissue through an opening in the sclera. The protrusion of uveal tissue through an opening in the sclera and/or cornea. C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Uveal prolapse Has Synonym LLT 10063605 MedDRA C26909 Uveitis Uveitis An inflammatory process affecting a part of or the entire uvea. Causes include inflammatory agents (e.g., herpes simplex, herpes zoster, leptospirosis) and systemic diseases (e.g., inflammatory bowel disease, multiple sclerosis, systemic lupus erythematosus, ankylosing spondylitis). Patients present with pain and redness in the eye, light sensitivity, and blurred and decreased vision. Inflammation of the iris, ciliary body, and/or choroid (uveal tract). C26767 Eye Disorder C118464 Pediatric Adverse Events Terminology Uveitis Has Synonym LLT 10046851 MedDRA C113671 Vaccine-Associated Paralytic Poliomyelitis Vaccine-Associated Paralytic Poliomyelitis OPV associated Paralytic Poliomyelitis|VAPP A rare, paralytic poliomyelitis associated with the orally administered live attenuated strain of the poliovirus, OPV. A paralytic poliomyelitis syndrome associated with the orally administered live attenuated strain of the poliovirus, OPV. C2959 Complication C118464 Pediatric Adverse Events Terminology Vaccine associated paralytic poliomyelitis Has Synonym LLT 10076716 MedDRA C50795 Vaginal Discharge Vaginal Discharge Normal or abnormal secretions from the vagina. Mucus produced by the cervical glands is discharged from the vagina naturally, especially during the childbearing years. Causes of abnormal vaginal discharge include infectious agents (e.g., Neisseria gonorrhea, Chlamydia trachomatis, Trichomonas, and Candida albicans), the presence of foreign bodies, and cervical or vaginal cancer. Normal or abnormal secretions from the vagina. Mucus produced by the cervical glands is discharged from the vagina naturally, especially during the childbearing years. Causes of abnormal vaginal discharge include infectious agents (e.g., Neisseria gonorrhea, Chlamydia trachomatis, Trichomonas, and Candida albicans), the presence of foreign bodies, and cervical or vaginal cancer. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Vaginal discharge Has Synonym LLT 10046901 MedDRA C26911 Vaginitis Vaginitis A non-infectious or infectious inflammatory process affecting the vagina. Inflammation of the vagina. C27020 Female Reproductive System Disorder C118464 Pediatric Adverse Events Terminology Vaginitis Has Synonym LLT 10046950 MedDRA C92914 Variable Deceleration Variable Fetal Heart Rate Deceleration Finding of Variable Deceleration|Variable Deceleration An abrupt decrease in the fetal heart rate below baseline that lasts 15 seconds to less than two minutes. The decrease from baseline fetal heart rate is greater than or equal to 15 beats per minute, and the time from onset to nadir of the deceleration is less than 30 seconds. Variable fetal heart rate decelerations that are associated with successive uterine contractions commonly have varying onsets, depths, and durations. An abrupt decrease in the fetal heart rate below baseline that lasts 15 seconds to less than two minutes. The decrease from baseline fetal heart rate is greater than or equal to 15 beats per minute, and the time from onset to nadir of the deceleration is less than 30 seconds. Variable fetal heart rate decelerations that are associated with successive uterine contractions commonly have varying onsets, depths, and durations. C92789 Fetal Heart Deceleration C118464 Pediatric Adverse Events Terminology Variable deceleration Has Synonym LLT 10058345 MedDRA C114846 Vascular Calcification Vascular Calcification Deposition of calcium in vascular structures. Deposition of calcium in vascular structures. C35552 Cardiovascular System Finding C118464 Pediatric Adverse Events Terminology Vascular calcification Has Synonym LLT 10051753 MedDRA C112117 Vascular Malformation Vascular Malformation A congenital abnormality of the arteries and veins, lymph vessels or veins and lymph vessels. A non-neoplastic anatomic abnormality involving blood vessels. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Vascular malformation Has Synonym LLT 10074979 MedDRA C115152 Vascular Stenosis Vascular Stenosis Narrowing of the lumen of an artery or vein. Narrowing of the lumen of an artery or vein. C35552 Cardiovascular System Finding C118464 Pediatric Adverse Events Terminology Vascular stenosis Has Synonym LLT 10057469 MedDRA C122412 Vaso-Occlusive Crisis Vaso-Occlusive Crisis An exacerbation of sickle cell disease. An exacerbation of sickle cell disease. C35117 Vascular Disorder C118464 Pediatric Adverse Events Terminology Vaso-occlusive crisis Has Synonym LLT 10072397 MedDRA C50798 Vasovagal Reaction Vasovagal Reaction Sudden drop of the blood pressure, bradycardia, and peripheral vasodilation that may lead to loss of consciousness. It results from an increase in the activity of the vagus nerve. It may be triggered by emotions of fear or pain or gastrointestinal upset and may be relieved by lying down while keeping the legs elevated. Sudden onset of decreased blood pressure, bradycardia, and peripheral vasodilation resulting from increased activity of the vagus nerve. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Vasovagal reaction Has Synonym LLT 10047166 MedDRA C111654 Venous Embolism Venous Embolism The passage of an embolus from its site of formation to another location within the venous system. The passage of an embolus from its site of formation to another location within the venous system. C26759 Embolism C118464 Pediatric Adverse Events Terminology Embolism venous Has Synonym LLT 10014522 MedDRA C116715 Venous Stroke Venous Stroke Cerebral Thrombotic Stroke|Cerebral Venous Stroke Ischemic or hemorrhagic stroke resulting from cerebral venous thrombosis. Ischemic or hemorrhagic stroke resulting from cerebral venous thrombosis. C3390 Cerebrovascular Accident C118464 Pediatric Adverse Events Terminology Thrombotic stroke Related To LLT 10043647 MedDRA C99537 Venous Thromboembolism Venous Thromboembolism Occlusion of the lumen of a vein by a thrombus that has migrated from a distal site via the blood stream. The migration of a blood clot formed within a vein to a site distant from the formation. C35117 Vascular Disorder C118464 Pediatric Adverse Events Terminology Venous thromboembolism Has Synonym LLT 10066899 MedDRA C99107 Venous Thrombosis Venous Thrombosis The formation of a blood clot (thrombus) in the lumen of a vein. Partial or complete occlusion of the lumen of a vein by a thrombus. C26891 Thrombosis C118464 Pediatric Adverse Events Terminology Venous thrombosis Has Synonym LLT 10047249 MedDRA C118313 Ventral Hernia Ventral Hernia The protrusion of abdominal cavity contents through the anterior abdominal wall. The protrusion of abdominal cavity contents through the anterior abdominal wall. C34685 Hernia C118464 Pediatric Adverse Events Terminology Ventral hernia Has Synonym LLT 10047272 MedDRA C111655 Ventricular Dysfunction Ventricular Dysfunction Impairment of the ventricle to either fill or eject adequately. Impairment of the ventricle to either fill or eject adequately. C3079 Heart Disorder C118464 Pediatric Adverse Events Terminology Ventricular dysfunction Has Synonym LLT 10059056 MedDRA C50799 Ventricular Fibrillation Ventricular Fibrillation A disorder characterized by an electrocardiographic finding of a rapid grossly irregular ventricular rhythm with marked variability in QRS cycle length, morphology, and amplitude. The rate is typically greater than 300 bpm. (CDISC) An irregular heart rhythm, usually associated with a rapid rate, that is caused by abnormal electrical activity within the ventricles. C26924 Ventricular Arrhythmia C118464 Pediatric Adverse Events Terminology Ventricular fibrillation Has Synonym LLT 10047290 MedDRA C84506 Ventricular Septal Defect Ventricular Septal Defect The presence of a defect (opening) in the septum that separates the two ventricles of the heart. It can be congenital or acquired. The presence of a defect (opening) in the septum that separates the two ventricles of the heart. The VSD can be congenital or acquired. C84482 Congenital Septal Defect C118464 Pediatric Adverse Events Terminology Ventricular septal defect Has Synonym LLT 10047298 MedDRA C50802 Ventricular Tachycardia Ventricular Tachycardia A disorder characterized by an electrocardiographic finding of three or more consecutive complexes of ventricular origin with a rate greater than a certain threshold (100 or 120 beats per minute are commonly used). The QRS complexes are wide and have an abnormal morphology. (CDISC) A tachycardia originating in the ventricles of the heart. C26924 Ventricular Arrhythmia C118464 Pediatric Adverse Events Terminology Ventricular tachycardia Has Synonym LLT 10047302 MedDRA C38057 Vertigo Vertigo A feeling of movement, a sensation as if the external world were revolving around the patient (objective vertigo) or as if he himself were revolving in space (subjective vertigo). Vertigo is medically distinct from dizziness, lightheadedness, and unsteadiness. A type of dizziness with a sensation of spinning. C87124 Central Nervous System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Vertigo Has Synonym LLT 10047340 MedDRA C118677 Very Preterm Infant Very Preterm Infant A newborn infant greater than 28 weeks, 0 days and less than 34 weeks, 0 days. A newborn infant greater than 28 weeks, 0 days and less than 34 weeks, 0 days. C16731 Newborn C118464 Pediatric Adverse Events Terminology Very preterm infant Has Synonym LLT 10076729 MedDRA C111969 Skin Vesicle Vesicle A small (less than 5-10 mm) intraepidermal/subepidermal cavity filled with clear, serosanguineous or cloudy fluid. A small (less than 5 - 10 mm) intraepidermal/subepidermal cavity filled with clear, serosanguineous or turbid fluid. C36281 Integumentary System Finding C118464 Pediatric Adverse Events Terminology Vesicle Has Synonym LLT 10047367 MedDRA C122528 Violent Behavior Violent Behavior Any action that results in intimidation, harm, damage, or destruction of someone or something. Any action that results in intimidation, harm, damage, or destruction of someone or something. C3858 Mental and Behavioral Signs and Symptoms C118464 Pediatric Adverse Events Terminology Violent behavior Has Synonym LLT 10057073 MedDRA C3439 Viral Infection Viral Infection Viral Disease Any disease caused by a virus. Any disease caused by a virus. C128320 Infection C118464 Pediatric Adverse Events Terminology Viral infection Has Synonym LLT 10047461 MedDRA C118298 Viral Meningitis Viral Meningitis Inflammation of the membranes surrounding the brain and spinal cord due to a viral infection. Inflammation of the membranes surrounding the brain and spinal cord due to a viral infection. C26828 Meningitis C118464 Pediatric Adverse Events Terminology Viral meningitis Has Synonym LLT 10047469 MedDRA C79859 Abnormal Virilization Virilization Virilism The abnormal development of male secondary sexual characteristics due to excessive androgens. The abnormal development of male secondary sexual characteristics due to excessive androgens. C36285 Endocrine System Finding C118464 Pediatric Adverse Events Terminology Virilization Has Synonym LLT 10047488 MedDRA C118727 Visual Field Defect Visual Field Defect An absolute or relative reduction in the extent of the normal field of vision. An absolute or relative reduction in the extent of the normal field of vision. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Visual field defect Has Synonym LLT 10047555 MedDRA C118179 Visual Hallucination Visual Hallucination Optical perception of an object, person or event in the absence of a corresponding stimulus. Optical perception of an object, person or event in the absence of a corresponding stimulus. C37961 Hallucination C118464 Pediatric Adverse Events Terminology Hallucination visual Has Synonym LLT 10019068 MedDRA C114830 Vitamin D Deficiency Vitamin D Deficiency Abnormally low level of 25-hydroxyvitamin D in the blood. Abnormally low level of 25-hydroxyvitamin D in the blood. C35772 Vitamin Deficiency Disorder C118464 Pediatric Adverse Events Terminology Vitamin D deficiency Has Synonym LLT 10047626 MedDRA C26915 Vitiligo Vitiligo Generalized well circumscribed patches of leukoderma that are generally distributed over symmetric body locations and is due to autoimmune destruction of melanocytes. Generalized well circumscribed patches of leukoderma that is generally distributed over symmetric body locations and is due to autoimmune destruction of melanocytes. C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Vitiligo Has Synonym LLT 10047642 MedDRA C50469 Vitreous Hemorrhage Vitreous Hemorrhage Blood extravasation in the vitreous humor. Causes include neovascularization, retinal tear, retinal detachment, and rupture of a blood vessel aneurysm in the eye. Blood in the vitreous. C99208 Eye Finding C118464 Pediatric Adverse Events Terminology Vitreous hemorrhage Has Synonym LLT 10047656 MedDRA C47814 Vocal Cord Paralysis Vocal Cord Paralysis Vocal Cord Palsy Paralysis of the muscles of one or both vocal cords. Signs and symptoms include hoarseness, weak voice, dyspnea, and coughing. Affected individuals are at risk for aspiration pneumonia. Nerve injury that results in inability to move the vocal cords. C26835 Nervous System Disorder C118420 Otolaryngologic Disorder C118464 Pediatric Adverse Events Terminology Vocal cord paralysis Has Synonym LLT 10047674 MedDRA C3442 Vomiting Vomiting Emesis Forceful ejection of the contents of the stomach through the mouth. Expulsion of the contents of the stomach through the mouth. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Vomiting Has Synonym LLT 10047700 MedDRA C5028 Verrucous Lesion Wart Verruca|Verrucous Lesion A papillomavirus related epithelial overgrowth. It can be located anywhere on the body though when it involves the perineal region it is generally referred to as condyloma acuminata. A growth on the skin with a thickened, rough surface. C3262 Neoplasm C3371 Skin Disorder C118464 Pediatric Adverse Events Terminology Wart Has Synonym LLT 10047825 MedDRA C78717 Watering Eyes Watering Eyes Tearing eyes; a condition caused either by tear overproduction or impaired drainage of the tear duct. Causes of tear overproduction include eye irritation (e.g., eye infection, foreign body in the eye), headache, pain reaction, allergies, sinusitis, and injury to the eye. Overflow of tears from the eye. C99208 Eye Finding C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Watering eyes Has Synonym LLT 10047848 MedDRA C50809 Weakness Weakness The property of lacking physical strength. Lacking physical strength. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Weakness Has Synonym LLT 10047862 MedDRA C62754 Weight Gain Weight Gain Weight Increase An increase in total body weight. An increase in total body weight. C92720 Pregnancy Finding C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Weight gain Has Synonym LLT 10047896 MedDRA C3445 Weight Loss Weight Loss Weight Decrease A reduction in total body weight. A reduction in total body weight. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Weight loss Has Synonym LLT 10047900 MedDRA C84788 West Syndrome West Syndrome A rare autosomal recessive inherited neurodegenerative disorder caused by mutations in the PLA2G6 gene. It is characterized by the development of swellings called spheroids along the axons of the central nervous system. Signs and symptoms appear early in life and include movement difficulties, muscle hypotonia and spasticity, and cognitive dysfunction. A form of epilepsy presenting in the first years of life that is characterized by infantile spasms; a distinct high-voltage and disorganized electroencephalogram pattern called hypsarrhythmia; and cognitive dysfunction. C26835 Nervous System Disorder C3020 Epilepsy C118464 Pediatric Adverse Events Terminology West's syndrome Has Synonym LLT 10058893 MedDRA C78718 Wheezing Wheezing A symptom and a finding during physical examination, characterized by a high-pitched, whistling sound during breathing. It results from the narrowing or obstruction of the respiratory airways. The most common causes of wheezing are asthma, chronic obstructive pulmonary disease, tracheobronchitis, and pulmonary edema. A high-pitched breath sound resulting from a narrowing or obstruction of the small airways. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Wheezing Has Synonym LLT 10047924 MedDRA C85231 Whooping Cough Whooping Cough Pertussis A contagious bacterial respiratory infection caused by Bordetella pertussis. It is characterized by severe and uncontrollable cough, resulting in a whooping sound during breathing following the cough. A bacterial respiratory infection caused by Bordetella pertussis, which is characterized by severe and uncontrollable cough, resulting in a whooping sound during breathing following the cough. C26871 Respiratory System Disorder C118464 Pediatric Adverse Events Terminology Whooping cough Has Synonym LLT 10047974 MedDRA C3267 Wilms Tumor Wilms Tumor An embryonal neoplasm characterized by the presence of epithelial, mesenchymal, and blastema components. The vast majority of cases arise from the kidney. A small number of cases with morphologic features resembling Wilms tumor of the kidney have been reported arising from the ovary and the cervix. A malignant neoplasm of embryonal origin arising within the kidney. C9305 Cancer C118464 Pediatric Adverse Events Terminology Wilms tumor Has Synonym LLT 10047985 MedDRA C121616 Wound Discharge Wound Discharge The material exuded from a wound, either surgical or traumatic. The material exuded from a wound, either surgical or traumatic. C100104 Sign or Symptom C118464 Pediatric Adverse Events Terminology Wound secretion Has Synonym LLT 10048629 MedDRA C50863 Wound Dehiscence Wound Disruption Wound Dehiscence Splitting of the sutured margins of a surgical wound. Risk factors include diabetes mellitus, obesity, and advanced age. The separation of the tissues along the healing edges of a surgical repair. C2959 Complication C118464 Pediatric Adverse Events Terminology Open wound Narrower Than LLT 10058834 MedDRA C45234 Wound Infection Wound Infection Infection of a break in the skin or other tissue. Infection of a break in the skin or other tissue due to injury. C128320 Infection C26726 Infectious Disorder C118464 Pediatric Adverse Events Terminology Wound infection Has Synonym LLT 10048038 MedDRA C26917 Xerostomia Xerostomia Dry Mouth Dryness of the oral mucosa secondary to a decrease in saliva production, or a change in saliva composition. Dryness of the oral mucosa. C3368 Gastrointestinal System Signs and Symptoms C118464 Pediatric Adverse Events Terminology Xerostomia Has Synonym LLT 10048223 MedDRA