NCIt Code of Subset Subset Preferred Term NCIt Code NCIt PT NCIt Definition INC Preferred Term INC Synonym INC Definition MedDRA Term MedDRA Code Relationship to MedDRA Term MedDRA Term Type MedDRA Version C154914 INC-MedDRA Neonatal Adverse Events Terminology C154919 Bronchopulmonary Dysplasia, AE An adverse event in a newborn characterized by a 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. Bronchopulmonary Dysplasia Bronchopulmonary dysplasia 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. Bronchopulmonary dysplasia 10006475 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154944 Feeding Intolerance, AE An adverse event in a newborn characterized by inability to achieve a full feeding volume. Feeding Intolerance Feeding intolerance Inability to achieve a full feeding volume. Feeding intolerance 10076042 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155227 Grade 1 Bronchopulmonary Dysplasia, AE An adverse event in a newborn characterized by the need for supplemental oxygen at 28 days AND breathing room air at 36 weeks postmenstrual age (PMA) in infants born less than 32 weeks' gestation; breathing room air by 56 days postnatal age in infants born greater than 32 weeks' gestation; breathing room air at discharge. Note: For conversion of oxygen administered by different modalities to fraction of inspired oxygen (FiO2): see http://nicutools.org/MediCalcs/ActualO2.php3. Grade 1 Bronchopulmonary Dysplasia Supplemental oxygen at 28 days AND breathing room air at 36 weeks PMA in infants born <32 weeks' gestation; breathing room air by 56 days postnatal age in infants born >32 weeks' gestation; breathing room air at discharge. Note: For conversion of oxygen administered by different modalities to FiO2: see http://nicutools.org/MediCalcs/ActualO2.php3. Bronchopulmonary dysplasia 10006475 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155245 Grade 1 Feeding Intolerance, AE An adverse event in a newborn characterized by mild feeding intolerance (e.g. increased gastric residual volume or abdominal distension); without discomfort; no change in care indicated. Grade 1 Feeding Intolerance Mild feeding intolerance (e.g. increased gastric residual volume or abdominal distension); without discomfort; no change in care indicated. Feeding intolerance 10076042 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155141 Grade 1 Hypoxic Ischemic Encephalopathy, AE An adverse event in a newborn clinically classified as perinatal asphyxia, but not resulting in encephalopathy. Grade 1 Hypoxic Ischemic Encephalopathy An event clinically classified as perinatal asphyxia, but not resulting in encephalopathy. Hypoxic-ischemic encephalopathy 10070512 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155149 Grade 1 Infant Irritability, AE An adverse event in a newborn characterized by mild, self-limiting, irritability, not affecting feeding and sleeping. Grade 1 Infant Irritability Mild, self-limiting, irritability, not affecting feeding and sleeping. Infant irritability 10082189 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155153 Grade 1 Infant Sedation, AE An adverse event in a newborn characterized by mild, self-limiting or transient sedation or sleepiness; transient loss of interactions; not requiring care change. Grade 1 Infant Sedation Mild, self-limiting or transient sedation or sleepiness; transient loss of interactions; not requiring care change. Infant sedation 10082187 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155197 Grade 1 Infantile Apnea, AE An adverse event in a newborn characterized by self-limiting apnea. Grade 1 Infantile Apnea Self-limiting apnea. Infantile apnea 10077322 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155240 Grade 1 Infantile Vomiting, AE An adverse event in a newborn characterized by an increase in vomiting over baseline, self limiting. Grade 1 Infantile Vomiting Increase in vomiting over baseline, self limiting. Infantile vomiting 10075315 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155277 Grade 1 Neonatal Administration Site Complication, AE An administration site complication adverse event in a newborn characterized by painless edema. Grade 1 Administration Site Complication Neonatal Painless edema. Administration site reaction neonatal 10082193 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155182 Grade 1 Neonatal Bradyarrhythmia, AE An adverse event in a newborn characterized by brief, self-limiting, episodes of asymptomatic bradyarrhythmia; no care changes. Grade 1 Neonatal Bradyarrhythmia Brief, self-limiting, episodes of asymptomatic bradyarrhythmia; no care changes. Neonatal bradyarrhythmia 10082054 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155192 Grade 1 Neonatal Coagulation Disorder, AE An adverse event in a newborn characterized by minor biochemical coagulation abnormalities without clinical signs; no care changes indicated. Grade 1 Coagulation Disorder Neonatal Minor biochemical coagulation abnormalities without clinical signs; no care changes indicated. Coagulation disorder neonatal 10009732 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155258 Grade 1 Neonatal Constipation, AE An adverse event in a newborn characterized by reduced number of stools or hard stools; no apparent discomfort. Grade 1 Constipation Neonatal Reduced number of stools or hard stools; no apparent discomfort. Constipation neonatal 10082190 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155121 Grade 1 Neonatal Convulsion, AE An adverse event in a newborn characterized by a single, self-limited suspected seizure requiring no treatment. Grade 1 Neonatal Convulsion Single, self-limited suspected seizure, no treatment. Neonatal convulsion 10028932 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155267 Grade 1 Neonatal Culture Positive Sepsis, AE An adverse event in a newborn characterized by a positive blood culture positive; no care change indicated (e.g. contamination suspected). Grade 1 Culture Positive Neonatal Sepsis Blood culture positive; no care change indicated (e.g. contamination suspected). Culture positive neonatal sepsis 10082058 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155235 Grade 1 Neonatal Diarrhea, AE An adverse event in a newborn characterized by an increase of 2-4 stools per day over baseline; mild increase in ostomy output compared to baseline. Grade 1 Diarrhea Neonatal Increase of 2-4 stools per day over baseline; mild increase in ostomy output compared to baseline. Diarrhea neonatal 10012731 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155187 Grade 1 Neonatal Edema, AE An adverse event in a newborn characterized by mild edema; no change in age appropriate behavior; no care changes indicated. Grade 1 Edema Neonatal Mild edema; no change in age appropriate behavior; no care changes indicated. Edema neonatal 10054497 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155126 Grade 1 Neonatal Epileptic Seizure, AE An adverse event in a newborn characterized by a single, self-limited electroencephalogram (EEG)-proven seizure requiring no treatment. Grade 1 Neonatal Epileptic Seizure Single, self-limited EEG-proven seizure*, no treatment. Note: *Electrographic confirmation required: can be electro-clinical or electrographic only. Neonatal epileptic seizure 10082068 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155282 Grade 1 Neonatal Fever, AE An adverse event in a newborn characterized by isolated, not sustained fever, no change in baseline age-appropriate behavior. Grade 1 Fever Neonatal Isolated, not sustained fever, no change in baseline age-appropriate behavior. Fever neonatal 10016562 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155250 Grade 1 Neonatal Gastrointestinal Bleeding, AE A gastrointestinal bleeding adverse event in a newborn characterized by mild, self-limiting, bleeding; no change in care required. Grade 1 Gastro-intestinal Bleeding Neonatal Mild, self-limiting, bleeding; no change in care required. Gastrointestinal bleeding neonatal 10082192 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155162 Grade 1 Neonatal Hypertension, AE An adverse event in a newborn characterized by systolic or diastolic blood pressure above the 90th percentile but below the 95th percentile; self-limiting. Grade 1 Neonatal Hypertension Systolic or diastolic BP >90th percentile but<95th percentile; self-limiting. Note: For percentile values: e.g. Dionne et al. Ped Nephrol 2012. Hypertension neonatal 10049781 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155157 Grade 1 Neonatal Hypotension, AE An adverse event in a newborn characterized by transient (less than 60 minutes), asymptomatic hypotension; not affecting perfusion; not requiring intervention. Grade 1 Neonatal Hypotension Transient (<60 min), asymptomatic hypotension; not affecting perfusion; not requiring intervention. Neonatal hypotension 10049223 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155131 Grade 1 Neonatal Intraventricular Hemorrhage, AE An adverse event in a newborn characterized by asymptomatic hemorrhage confined to the germinal matrix; minimal hemorrhage within the ventricle (less than 10% on parasagittal view). Grade 1 Intraventricular Hemorrhage neonatal Asymptomatic hemorrhage confined to the germinal matrix; minimal hemorrhage within the ventricle (<10% on parasagittal view). Intraventricular hemorrhage neonatal 10022844 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155222 Grade 1 Neonatal Pneumothorax, AE An adverse event in a newborn characterized by radiological evidence of pneumothorax; no clinical signs; no care change required. Grade 1 Neonatal Pneumothorax Radiological evidence of pneumothorax; no clinical signs; no care change required. Neonatal pneumothorax 10082056 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155212 Grade 1 Neonatal Pulmonary Hemorrhage, AE An adverse event in a newborn characterized by limited hemorrhagic secretion in an endotracheal (ET) tube. Grade 1 Neonatal Pulmonary Hemorrhage Limited hemorrhagic secretion in ET tube. Neonatal pulmonary hemorrhage 10082199 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155272 Grade 1 Neonatal Rash, AE An adverse event in a newborn characterized by localized rash. Grade 1 Rash Neonatal Localized rash. Rash neonatal 10037871 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155207 Grade 1 Neonatal Respiratory Distress Syndrome, AE An adverse event in a newborn characterized by radiological evidence without clinical signs; clinical evidence of mildly increased respiratory distress (e.g. increased work of breathing) without significant deterioration in gas exchange (increase in partial pressure of carbon dioxide (pCO2) or decrease in oxygenation); no supportive care required. Grade 1 Neonatal Respiratory Distress Syndrome Radiological evidence without clinical signs; clinical evidence of mildly increased respiratory distress (e.g. increased work of breathing) without significant deterioration in gas exchange (increase in pCO2 or decrease in oxygenation); no supportive care required. Neonatal respiratory distress syndrome 10028974 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155202 Grade 1 Neonatal Respiratory Insufficiency, AE An adverse event in a newborn characterized by clinical evidence of mildly increased respiratory distress (e.g. increased work of breathing) without significant deterioration in gas exchange (increase in partial pressure of carbon dioxide (pCO2) or decrease in oxygenation); no change in baseline functioning; no care changes required. Grade 1 Neonatal Respiratory Insufficiency Clinical evidence of mildly increased respiratory distress (e.g. increased work of breathing) without significant deterioration in gas exchange (increase in pCO2 or decrease in oxygenation); no change in baseline functioning; no care changes required. Neonatal respiratory insufficiency 10082057 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155172 Grade 1 Neonatal Sinus Bradycardia, AE An adverse event in a newborn characterized by brief, self-limiting, episodes of sinus bradycardia; no care changes. Grade 1 Neonatal Sinus Bradycardia Brief, self-limiting, episodes of bradycardia; no care changes. Neonatal sinus bradycardia 10082188 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155167 Grade 1 Neonatal Sinus Tachycardia, AE An adverse event in a newborn characterized by brief, self-limiting, episodes of sinus tachycardia; no care changes. Grade 1 Neonatal Sinus Tachycardia Brief, self-limiting, episodes of tachycardia; no care changes. Neonatal sinus tachycardia 10082191 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155177 Grade 1 Neonatal Tachyarrhythmia, AE An adverse event in a newborn characterized by brief, self-limiting, episodes of asymptomatic tachyarrhythmia (e.g. extra-systolic beats); no care changes. Grade 1 Neonatal Tachyarrhythmia Brief, self-limiting, episodes of asymptomatic tachyarrhythmia (e.g. extra systolic beats); no care changes. Neonatal tachyarrhythmia 10082055 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155146 Grade 1 Periventricular Leukomalacia, AE An adverse event in a newborn characterized by transient periventricular echodensities persisting greater than seven days and resolving completely. Grade 1 Periventricular Leukomalacia Transient periventricular echo densities persisting > 7 days and resolving completely. Periventricular leukomalacia 10052594 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155217 Grade 1 Persistent Pulmonary Hypertension of the Newborn, AE An adverse event in a newborn characterized by technical evidence of increased right ventricular pressures; no clinical symptoms. Grade 1 Persistent Pulmonary Hypertension of the Newborn Technical evidence of increased RV-pressures; no clinical symptoms. Persistent pulmonary hypertension of the newborn 10082195 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155136 Grade 1 Retinopathy of Prematurity, AE An adverse event in a newborn characterized by zone 2 International Classification of Retinopathy of Prematurity (ICROP) stage 1 with or without plus disease; zone 2 ICROP stage 2 without plus disease; zone 3 any ICROP stage; no care changes indicated. Grade 1 Retinopathy of Prematurity Zone 2 ICROP stage 1 with or without plus disease; zone 2 ICROP stage 2 without plus disease; zone 3 any ICROP stage; no care changes indicated. Retinopathy of prematurity 10038933 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155228 Grade 2 Bronchopulmonary Dysplasia, AE An adverse event in a newborn characterized by the need for supplemental oxygen at 28 days AND need for 22-30% oxygen at 36 weeks postmenstrual age (PMA) in infants born less than 32 weeks' gestation; need for 22-30% oxygen by 56 days postnatal age in infants born greater than 32 weeks' gestation; need for 22-30% oxygen at discharge. Note: For conversion of oxygen administered by different modalities to fraction of inspired oxygen (FiO2): see http://nicutools.org/MediCalcs/ActualO2.php3. Grade 2 Bronchopulmonary Dysplasia Supplemental oxygen at 28 days AND need for 22-30% oxygen at 36 weeks PMA in infants born <32 weeks' gestation; need for 22-30% oxygen by 56 days postnatal age in infants born >32 weeks' gestation; need for 22-30% oxygen at discharge. Note: For conversion of oxygen administered by different modalities to FiO2: see http://nicutools.org/MediCalcs/ActualO2.php3. Bronchopulmonary dysplasia 10006475 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155246 Grade 2 Feeding Intolerance, AE An adverse event in a newborn characterized by moderate feeding intolerance; resulting in minor discomfort or alteration of drinking behavior; minor care changes indicated (e.g. feeds withheld). Grade 2 Feeding Intolerance Moderate feeding intolerance; resulting in minor discomfort or alteration of drinking behavior; minor care changes indicated (e.g. feeds withheld). Feeding intolerance 10076042 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155142 Grade 2 Hypoxic Ischemic Encephalopathy, AE An adverse event in a newborn characterized by mild transient clinical signs (see Sarnat stages for further guidance on mild, moderate and severe clinical signs of encephalopathy) of encephalopathy resulting from a perinatal asphyxia event; necessitating observation and additional care. Grade 2 Hypoxic Ischemic Encephalopathy Mild transient clinical signs* of encephalopathy resulting from a perinatal asphyxia event; necessitating observation and additional care. Note: *see Sarnat stages for further guidance on mild, moderate and severe clinical signs of encephalopathy. Hypoxic-ischemic encephalopathy 10070512 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155150 Grade 2 Infant Irritability, AE An adverse event in a newborn characterized by moderate irritability, minor changes in feeding and sleeping behavior, requiring minor additional care (e.g. occasional analgesics). Grade 2 Infant Irritability Moderate irritability, minor changes in feeding and sleeping behavior, requiring minor additional care (e.g. occasional analgesics). Infant irritability 10082189 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155154 Grade 2 Infant Sedation, AE An adverse event in a newborn characterized by moderate sedation; limiting interactions and minor changes in feeding behavior; requiring increased monitoring. Grade 2 Infant Sedation Moderate sedation; limiting interactions and minor changes in feeding behavior; requiring increased monitoring. Infant sedation 10082187 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155198 Grade 2 Infantile Apnea, AE An adverse event in a newborn characterized by apnea responsive to stimulation or intermittent fraction of inspired oxygen (FiO2) increase. Grade 2 Infantile Apnea Apnea responsive to stimulation or intermittent FiO2-increase. Infantile apnea 10077322 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155241 Grade 2 Infantile Vomiting, AE An adverse event in a newborn characterized by a persistent increase in vomiting over baseline; no dehydration; minor changes in feeding support indicated. Grade 2 Infantile Vomiting Persistent increase in vomiting over baseline; no dehydration; minor changes in feeding support indicated. Infantile vomiting 10075315 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155278 Grade 2 Neonatal Administration Site Complication, AE An administration site complication adverse event in a newborn characterized by erythema with associated symptoms (e.g., edema, pain, induration, phlebitis). Grade 2 Administration Site Complication Neonatal Erythema with associated symptoms (e.g., edema, pain, induration, phlebitis). Administration site reaction neonatal 10082193 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155183 Grade 2 Neonatal Bradyarrhythmia, AE A bradyarrhythmia adverse event in a newborn characterized by no change in age-appropriate behavior; requiring minor care changes (e.g. increased monitoring). Grade 2 Neonatal Bradyarrhythmia No change in age-appropriate behavior; requiring minor care changes (e.g. increased monitoring). Neonatal bradyarrhythmia 10082054 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155193 Grade 2 Neonatal Coagulation Disorder, AE An adverse event in a newborn characterized by biochemical coagulation abnormalities with clinical signs; requiring increased monitoring. Grade 2 Coagulation Disorder Neonatal Biochemical coagulation abnormalities with clinical signs; requiring increased monitoring. Coagulation disorder neonatal 10009732 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155259 Grade 2 Neonatal Constipation, AE An adverse event in a newborn characterized by reduced number of stools or hard stools; apparent discomfort; minor care changes indicated. Grade 2 Constipation Neonatal Reduced number of stools or hard stools; apparent discomfort; minor care changes indicated. Constipation neonatal 10082190 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155122 Grade 2 Neonatal Convulsion, AE An adverse event in a newborn characterized by suspected seizures controlled with one anti-seizure drug (no recurrence within three days after treatment). Grade 2 Neonatal Convulsion Suspected seizures controlled with 1 anti-seizure drug (no recurrence within 3 days after treatment). Neonatal convulsion 10028932 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155263 Grade 2 Neonatal Culture Negative Sepsis, AE An adverse event in a newborn characterized by suspected sepsis with mild or ambiguous signs; anti-infectives initiated. Grade 2 Culture Negative Neonatal Sepsis Suspected sepsis with mild or ambiguous signs; anti-infectives initiated. Culture negative neonatal sepsis 10082059 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155268 Grade 2 Neonatal Culture Positive Sepsis, AE An adverse event in a newborn characterized by a positive blood culture positive with mild or ambiguous signs; anti-infectives initiated. Grade 2 Culture Positive Neonatal Sepsis Blood culture positive with mild or ambiguous signs; anti-infectives initiated. Culture positive neonatal sepsis 10082058 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155236 Grade 2 Neonatal Diarrhea, AE An adverse event in a newborn characterized by an increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline. Grade 2 Diarrhea Neonatal Increase of 4 - 6 stools per day over baseline; moderate increase in ostomy output compared to baseline. Diarrhea neonatal 10012731 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155188 Grade 2 Neonatal Edema, AE An adverse event in a newborn characterized by moderate edema; no change in age appropriate behavior; requiring minor care changes (e.g. alteration in fluid management). Grade 2 Edema Neonatal Moderate edema; no change in age appropriate behavior; requiring minor care changes (e.g. alteration in fluid management). Edema neonatal 10054497 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155127 Grade 2 Neonatal Epileptic Seizure, AE An adverse event in a newborn characterized by electroencephalogram (EEG)-proven seizures that are controlled with one anti-seizure drug (no recurrence within three days after treatment). Grade 2 Neonatal Epileptic Seizure EEG-proven seizures* controlled with 1 anti-seizure drug (no recurrence within 3 days after treatment). Note: *Electrographic confirmation required: can be electro-clinical or electrographic only. Neonatal epileptic seizure 10082068 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155283 Grade 2 Neonatal Fever, AE An adverse event in a newborn characterized by fever, minor change in baseline age-appropriate behavior; minor changes in care (e.g. environmental settings, symptomatic treatment). Grade 2 Fever Neonatal Fever, minor change in baseline age-appropriate behavior; minor changes in care (e.g. environmental settings, symptomatic treatment). Fever neonatal 10016562 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155251 Grade 2 Neonatal Gastrointestinal Bleeding, AE A gastrointestinal bleeding adverse event in a newborn characterized by moderate bleeding; minor change in care or monitoring required. Grade 2 Gastro-intestinal Bleeding Neonatal Moderate bleeding; minor change in care or monitoring required. Gastrointestinal bleeding neonatal 10082192 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155163 Grade 2 Neonatal Hypertension, AE An adverse event in a newborn characterized by persistent or recurrent hypertension, with systolic or diastolic blood pressure between the 95th percentile and the 99th percentile. Grade 2 Neonatal Hypertension Persistent or recurrent hypertension, with systolic or diastolic BP between the 95th percentile and the 99th percentile. Note: For percentile values: e.g. Dionne et al. Ped Nephrol 2012. Hypertension neonatal 10049781 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155158 Grade 2 Neonatal Hypotension, AE An adverse event in a newborn characterized by persistent (greater than 60 minutes) hypotension; not affecting perfusion; requiring minor care changes (e.g. additional fluids). Grade 2 Neonatal Hypotension Persistent (>60 min) hypotension; not affecting perfusion; requiring minor care changes (e.g. additional fluids). Neonatal hypotension 10049223 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155132 Grade 2 Neonatal Intraventricular Hemorrhage, AE An adverse event in a newborn characterized by hemorrhage occupying less than 50% of ventricular volume without ventricular dilatation greater than 4mm above the 97th percentile. Grade 2 Intraventricular Hemorrhage neonatal Moderate hemorrhage occupying <50% of ventricular volume without ventricular dilatation > 4mm above the 97th percentile. Intraventricular hemorrhage neonatal 10022844 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155223 Grade 2 Neonatal Pneumothorax, AE An adverse event in a newborn characterized by radiological evidence of pneumothorax; minor clinical signs; minor care change required (e.g. oxygen, increased monitoring). Grade 2 Neonatal Pneumothorax Radiological evidence of pneumothorax; minor clinical signs; minor care change required (e.g. oxygen, increased monitoring). Neonatal pneumothorax 10082056 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155213 Grade 2 Neonatal Pulmonary Hemorrhage, AE An adverse event in a newborn characterized by hemorrhagic secretion in an endotracheal (ET) tube; without relevant increase in partial pressure of carbon dioxide (pCO2) or decrease in oxygenation; requiring minor changes in care (e.g. increase in positive end-expiration pressure (PEEP)). Grade 2 Neonatal Pulmonary Hemorrhage Hemorrhagic secretion in ET tube; without relevant increase in PCO2 or decrease in oxygenation; requiring minor changes in care (e.g. increase PEEP). Neonatal pulmonary hemorrhage 10082199 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155273 Grade 2 Neonatal Rash, AE An adverse event in a newborn characterized by diffuse rash or target lesions. Grade 2 Rash Neonatal Diffuse rash or target lesions. Rash neonatal 10037871 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155208 Grade 2 Neonatal Respiratory Distress Syndrome, AE An adverse event in a newborn characterized by clinical evidence of increased respiratory distress without significant deterioration in gas exchange (increase in partial pressure of carbon dioxide (pCO2) or decrease in oxygenation); corrected by minor adjustments in current ventilatory support, supplemental oxygen or non-invasive support. Grade 2 Neonatal Respiratory Distress Syndrome Clinical evidence of increased respiratory distress without significant deterioration in gas exchange (increase in pCO2 or decrease in oxygenation); corrected by minor adjustments in current ventilatory support, supplemental oxygen or non-invasive support. Neonatal respiratory distress syndrome 10028974 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155203 Grade 2 Neonatal Respiratory Insufficiency, AE An adverse event in a newborn characterized by clinical evidence of increased respiratory distress without significant deterioration in gas exchange (increase in partial pressure of carbon dioxide (pCO2) or decrease in oxygenation); corrected by minor adjustments in current ventilatory support, supplemental oxygen or non-invasive support. Grade 2 Neonatal Respiratory Insufficiency Clinical evidence of increased respiratory distress without significant deterioration in gas exchange (increase in pCO2 or decrease in oxygenation); corrected by minor adjustments in current ventilatory support, supplemental oxygen or non-invasive support. Neonatal respiratory insufficiency 10082057 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155173 Grade 2 Neonatal Sinus Bradycardia, AE An adverse event in a newborn characterized by persistent sinus bradycardia; no change in age-appropriate behavior; requiring minor care changes (e.g. concomitant medication adapted, intermittent increase of fraction of inspired oxygen (FiO2)). Grade 2 Neonatal Sinus Bradycardia Persistent bradycardia; no change in age-appropriate behavior; requiring minor care changes (e.g. concomitant medication adapted, intermittent increase FiO2). Neonatal sinus bradycardia 10082188 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155168 Grade 2 Neonatal Sinus Tachycardia, AE An adverse event in a newborn characterized by persistent sinus tachycardia; no change in age appropriate behavior; requiring minor care changes (e.g. concomitant medication changed). Grade 2 Neonatal Sinus Tachycardia Persistent tachycardia; no change in age appropriate behavior; requiring minor care changes (e.g. concomitant medication changed). Neonatal sinus tachycardia 10082191 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155178 Grade 2 Neonatal Tachyarrhythmia, AE A tachyarrhythmia adverse event in a newborn characterized by no change in age-appropriate behavior; requiring minor care changes (e.g. increased monitoring). Grade 2 Neonatal Tachyarrhythmia No change in age-appropriate behavior; requiring minor care changes (e.g. increased monitoring). Neonatal tachyarrhythmia 10082055 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155147 Grade 2 Periventricular Leukomalacia, AE An adverse event in a newborn characterized by transient periventricular echodensities evolving in to small localized fronto-parietal cysts or persistent diffuse echodensities. Grade 2 Periventricular Leukomalacia Transient periventricular echo densities evolving in to small localized fronto-parietal cysts or persistent diffuse echo densities. Periventricular leukomalacia 10052594 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155218 Grade 2 Persistent Pulmonary Hypertension of the Newborn, AE An adverse event in a newborn characterized by increased estimated right ventricular pressures; with moderate clinical symptoms; oxygenation index less than 25; minor care changes required. Grade 2 Persistent Pulmonary Hypertension of the Newborn Increased estimated RV-pressures; with moderate clinical symptoms; oxygenation index <25; minor care changes required. Persistent pulmonary hypertension of the newborn 10082195 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155137 Grade 2 Retinopathy of Prematurity, AE An adverse event in a newborn characterized by type 2 prethreshold retinopathy of prematurity (ROP) (zone 1 International Classification of Retinopathy of Prematurity (ICROP) stage 1 or 2 without plus disease; zone 2 ICROP stage 3 without plus disease); requiring more frequent ophthalmic monitoring. Grade 2 Retinopathy of Prematurity Type 2 prethreshold ROP (zone 1 ICROP stage 1 or 2 without plus disease; zone 2 ICROP stage 3 without plus disease); requiring more frequent ophthalmic monitoring. Retinopathy of prematurity 10038933 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155229 Grade 3 Bronchopulmonary Dysplasia, AE An adverse event in a newborn characterized by the need for supplemental oxygen at 28 days AND need for greater than 30% oxygen or positive pressure at 36 weeks postmenstrual age (PMA) in infants born less than 32 weeks' gestation; need for greater than 30% oxygen or positive pressure by 56 days postnatal age in infants born greater than 32 weeks' gestation; need for greater than 30% oxygen and/or positive pressure at discharge. Note: For conversion of oxygen administered by different modalities to fraction of inspired oxygen (FiO2): see http://nicutools.org/MediCalcs/ActualO2.php3. Grade 3 Bronchopulmonary Dysplasia Supplemental oxygen at 28 days AND need for >30% oxygen or positive pressure at 36 weeks PMA in infants born <32 weeks' gestation; need for >30% oxygen or positive pressure by 56 days postnatal age in infants born >32 weeks' gestation; need for >30% oxygen and/or positive pressure at discharge. Note: For conversion of oxygen administered by different modalities to FiO2: see http://nicutools.org/MediCalcs/ActualO2.php3. Bronchopulmonary dysplasia 10006475 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155247 Grade 3 Feeding Intolerance, AE An adverse event in a newborn characterized by severe feeding intolerance; requiring major changes in feeding support indicated (e.g. change to total parenteral nutrition (TPN) or gavage). Grade 3 Feeding Intolerance Severe feeding intolerance; requiring major changes in feeding support indicated (e.g. change to TPN or gavage). Feeding intolerance 10076042 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155143 Grade 3 Hypoxic Ischemic Encephalopathy, AE An adverse event in a newborn characterized by moderate clinical signs (see Sarnat stages for further guidance on mild, moderate and severe clinical signs of encephalopathy) of encephalopathy resulting from a perinatal asphyxia event; meeting criteria for therapeutic hypothermia. Grade 3 Hypoxic Ischemic Encephalopathy Moderate clinical signs* of encephalopathy resulting from a perinatal asphyxia event; meeting criteria for therapeutic hypothermia. Note: *see Sarnat stages for further guidance on mild, moderate and severe clinical signs of encephalopathy. Hypoxic-ischemic encephalopathy 10070512 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155151 Grade 3 Infant Irritability, AE An adverse event in a newborn characterized by severe irritability, major changes in feeding behavior, requiring support other than oral feeding; requiring long term medical treatment (e.g. sedatives). Grade 3 Infant Irritability Severe irritability, major changes in feeding behavior, requiring support other than oral feeding; requiring long term medical treatment (e.g. sedatives). Infant irritability 10082189 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155155 Grade 3 Infant Sedation, AE An adverse event in a newborn characterized by severe sedation, major changes in feeding behavior; requiring support other than oral feeding (e.g. tube feeding). Grade 3 Infant Sedation Severe sedation, major changes in feeding behavior; requiring support other than oral feeding (e.g. tube feeding). Infant sedation 10082187 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155199 Grade 3 Infantile Apnea, AE An adverse event in a newborn characterized by apnea requiring stimulation and sustained fraction of inspired oxygen (FiO2) increase; requiring non-invasive ventilation; reoccurrences requiring start of or relevant increase in dose of respiratory stimulants or other major care changes. Grade 3 Infantile Apnea Apnea requiring stimulation and sustained FiO2 increase; requiring non-invasive ventilation; reoccurrences requiring start of or relevant increase in dose of respiratory stimulants or other major care changes. Infantile apnea 10077322 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155242 Grade 3 Infantile Vomiting, AE An adverse event in a newborn characterized by a persistent increase in vomiting over baseline; signs of dehydration; major changes in feeding support indicated (e.g. change to total parenteral nutrition (TPN) or gavage). Grade 3 Infantile Vomiting Persistent increase in vomiting over baseline; signs of dehydration; major changes in feeding support indicated (e.g. change to TPN or gavage). Infantile vomiting 10075315 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155232 Grade 3 Necrotizing Enterocolitis, AE An adverse event in a newborn characterized by confirmed necrotizing enterocolitis; major care change indicated (e.g. NPO, antibiotics, non-urgent surgery). Grade 3 Necrotizing Enterocolitis NEC confirmed; major care change indicated (e.g. NPO, antibiotics, non-urgent surgery). Note: If NEC is not confirmed (Bell stages I): please record severity of individual symptoms (e.g. feeding intolerance). Necrotizing enterocolitis neonatal 10052818 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155279 Grade 3 Neonatal Administration Site Complication, AE An administration site complication adverse event in a newborn characterized by ulceration or necrosis; severe tissue damage; operative intervention indicated. Grade 3 Administration Site Complication Neonatal Ulceration or necrosis; severe tissue damage; operative intervention indicated. Administration site reaction neonatal 10082193 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155184 Grade 3 Neonatal Bradyarrhythmia, AE A bradyarrhythmia adverse event in a newborn resulting in non-life threatening hemodynamic compromise; requiring major care changes (e.g. new medication or intervention). Grade 3 Neonatal Bradyarrhythmia Resulting in non-life threatening hemodynamic compromise; requiring major care changes (e.g. new medication or intervention). Neonatal bradyarrhythmia 10082054 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155194 Grade 3 Neonatal Coagulation Disorder, AE An adverse event in a newborn characterized by biochemical or clinical coagulation abnormalities; requiring intervention. Grade 3 Coagulation Disorder Neonatal Biochemical or clinical coagulation abnormalities; requiring intervention. Coagulation disorder neonatal 10009732 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155260 Grade 3 Neonatal Constipation, AE An adverse event in a newborn characterized by reduced number of stools or hard stools; signs of obstruction; apparent discomfort or affecting feeding; major care changes indicated (e.g. long term medical treatment, enema). Grade 3 Constipation Neonatal Reduced number of stools or hard stools; signs of obstruction; apparent discomfort or affecting feeding; major care changes indicated (e.g. long term medical treatment, enema). Constipation neonatal 10082190 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155123 Grade 3 Neonatal Convulsion, AE An adverse event in a newborn characterized by suspected seizures uncontrolled with one anti-seizure drug (recurrence within three days after treatment or requiring two or more anti-seizure drugs). Grade 3 Neonatal Convulsion Suspected seizures uncontrolled with 1 anti-seizure drug (recurrence within 3 days after treatment or requiring 2 or more anti-seizure drugs). Neonatal convulsion 10028932 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155264 Grade 3 Neonatal Culture Negative Sepsis, AE An adverse event in a newborn characterized by suspected sepsis with severe signs (e.g. fever, grunting); supportive treatment escalated or initiated. Grade 3 Culture Negative Neonatal Sepsis Suspected sepsis with severe signs (e.g. fever, grunting); support treatment escalated or initiated. Culture negative neonatal sepsis 10082059 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155269 Grade 3 Neonatal Culture Positive Sepsis, AE An adverse event in a newborn characterized by a positive blood culture positive with severe signs; supportive treatment escalated or initiated. Grade 3 Culture Positive Neonatal Sepsis Blood culture positive with severe signs; support treatment escalated or initiated. Culture positive neonatal sepsis 10082058 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155237 Grade 3 Neonatal Diarrhea, AE An adverse event in a newborn characterized by an increase of 7 stools or more per day over baseline; severe increase in ostomy output compared to baseline; signs of dehydration. Grade 3 Diarrhea Neonatal Increase of >=7 stools per day over baseline; severe increase in ostomy output compared to baseline; signs of dehydration. Diarrhea neonatal 10012731 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155189 Grade 3 Neonatal Edema, AE An adverse event in a newborn characterized by severe edema; limiting age appropriate behavior; requiring major care changes (e.g. diuretics). Grade 3 Edema Neonatal Severe edema; limiting age appropriate behavior; requiring major care changes (e.g. diuretics). Edema neonatal 10054497 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155128 Grade 3 Neonatal Epileptic Seizure, AE An adverse event in a newborn characterized by electroencephalogram (EEG)-proven seizures uncontrolled with one anti-seizure drug (recurrence within three days after treatment or requiring two or more anti-seizure drugs). Grade 3 Neonatal Epileptic Seizure EEG-proven seizures* uncontrolled with 1 anti-seizure drug (recurrence within 3 days after treatment or requiring 2 or more anti-seizure drugs). Note: *Electrographic confirmation required: can be electro-clinical or electrographic only. Neonatal epileptic seizure 10082068 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155284 Grade 3 Neonatal Fever, AE An adverse event in a newborn characterized by fever, major change in baseline age-appropriate behavior and without resolution to symptomatic treatment. Grade 3 Fever Neonatal Fever, major change in baseline age-appropriate behavior and without resolution to symptomatic treatment. Fever neonatal 10016562 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155252 Grade 3 Neonatal Gastrointestinal Bleeding, AE A gastrointestinal bleeding adverse event in a newborn characterized by severe bleeding; non-life threatening hemodynamic consequences; major care change required (e.g. invasive intervention, transfusion, long term medical treatment). Grade 3 Gastro-intestinal Bleeding Neonatal Severe bleeding; non-life threatening hemodynamic consequences; major care change required (e.g. invasive intervention, transfusion, long term medical treatment). Gastrointestinal bleeding neonatal 10082192 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155164 Grade 3 Neonatal Hypertension, AE An adverse event in a newborn characterized by persistent or recurrent hypertension, with systolic or diastolic blood pressure above the 99th percentile; need for antihypertensive medication. Grade 3 Neonatal Hypertension Persistent or recurrent hypertension, with systolic or diastolic above the 99th percentile; need for antihypertensive medication. Note: For percentile values: e.g. Dionne et al. Ped Nephrol 2012. Hypertension neonatal 10049781 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155159 Grade 3 Neonatal Hypotension, AE An adverse event in a newborn characterized by persistent hypotension affecting perfusion; requiring major care change (e.g. vaso-active drugs or hydrocortisone). Grade 3 Neonatal Hypotension Persistent hypotension affecting perfusion; requiring major care change (e.g. vaso-active drugs or hydrocortisone). Neonatal hypotension 10049223 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155133 Grade 3 Neonatal Intraventricular Hemorrhage, AE An adverse event in a newborn characterized by hemorrhage occupying greater than 50% of the ventricle volume; ventricular dilatation greater than 4mm above the 97th percentile; parenchymal venous infarction; requiring temporizing neurosurgical procedure (drain, shunt or reservoir). Grade 3 Intraventricular Hemorrhage neonatal Hemorrhage occupying >50% of the ventricle volume; ventricular dilatation > 4mm above the 97th percentile; parenchymal venous infarction; requiring temporizing neurosurgical procedure (drain, shunt or reservoir). Intraventricular hemorrhage neonatal 10022844 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155224 Grade 3 Neonatal Pneumothorax, AE An adverse event in a newborn characterized by radiological evidence of pneumothorax; with clinical signs; major care change required (e.g. chest drainage). Grade 3 Neonatal Pneumothorax Radiological evidence of pneumothorax; with clinical signs; major care change required (e.g. chest drainage). Neonatal pneumothorax 10082056 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155214 Grade 3 Neonatal Pulmonary Hemorrhage, AE An adverse event in a newborn characterized by hemorrhagic secretion in an endotracheal (ET) tube; with relevant increase in partial pressure of carbon dioxide (pCO2) or decrease in oxygenation; requiring major change in ventilatory support or transfusion. Grade 3 Neonatal Pulmonary Hemorrhage Hemorrhagic secretion in ET tube; with relevant increase in PCO2 or decrease in oxygenation; requiring major change in ventilatory support or transfusion. Neonatal pulmonary hemorrhage 10082199 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155274 Grade 3 Neonatal Rash, AE An adverse event in a newborn characterized by diffuse rash and vesicles or limited number of bullae or superficial ulcerations of mucous membranes limited to one site. Grade 3 Rash Neonatal Diffuse rash and vesicles or limited number of bullae or superficial ulcerations of mucous membrane limited to one site. Rash neonatal 10037871 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155209 Grade 3 Neonatal Respiratory Distress Syndrome, AE An adverse event in a newborn characterized by clinical evidence of increased respiratory distress with relevant deterioration in gas exchange (increase in partial pressure of carbon dioxide (pCO2) or decrease in oxygenation); requiring major care change (e.g. starting invasive support). Grade 3 Neonatal Respiratory Distress Syndrome Clinical evidence of increased respiratory distress with relevant deterioration in gas exchange (increase in pCO2 or decrease in oxygenation); requiring major care change (e.g. start invasive support). Neonatal respiratory distress syndrome 10028974 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155204 Grade 3 Neonatal Respiratory Insufficiency, AE An adverse event in a newborn characterized by clinical evidence of increased respiratory distress with relevant deterioration in gas exchange (increase in partial pressure of carbon dioxide (pCO2) or decrease in oxygenation); requiring major care change (e.g. starting invasive support). Grade 3 Neonatal Respiratory Insufficiency Clinical evidence of increased respiratory distress with relevant deterioration in gas exchange (increase in pCO2 or decrease in oxygenation); requiring major care change (e.g. start invasive support). Neonatal respiratory insufficiency 10082057 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155174 Grade 3 Neonatal Sinus Bradycardia, AE An adverse event in a newborn characterized by persistent sinus bradycardia; resulting in non-life threatening hemodynamic compromise; requiring major care changes (e.g. new medication or intervention). Grade 3 Neonatal Sinus Bradycardia Persistent bradycardia; resulting in non-life threatening hemodynamic compromise; requiring major care changes (e.g. new medication or intervention). Neonatal sinus bradycardia 10082188 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155169 Grade 3 Neonatal Sinus Tachycardia, AE An adverse event in a newborn characterized by persistent sinus tachycardia; resulting in non-life threatening hemodynamic compromise; requiring major care changes (e.g. new medication or intervention). Grade 3 Neonatal Sinus Tachycardia Persistent tachycardia; resulting in non-life threatening hemodynamic compromise; requiring major care changes (e.g. new medication or intervention). Neonatal sinus tachycardia 10082191 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155255 Grade 3 Neonatal Spontaneous Intestinal Perforation, AE An adverse event in a newborn characterized by presence of spontaneous intestinal perforation (SIP), non-urgent medical stabilization and surgical intervention indicated. Grade 3 Neonatal Spontaneous Intestinal Perforation Presence of SIP, non-urgent medical stabilization and surgical intervention indicated. Neonatal spontaneous intestinal perforation 10082196 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155179 Grade 3 Neonatal Tachyarrhythmia, AE A tachyarrhythmia adverse event in a newborn resulting in non-life threatening hemodynamic compromise or changes in age-appropriate behavior; requiring major care changes (e.g. new medication or intervention). Grade 3 Neonatal Tachyarrhythmia Resulting in non-life threatening hemodynamic compromise or changes in age-appropriate behavior; requiring major care changes (e.g. new medication or intervention). Neonatal tachyarrhythmia 10082055 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155148 Grade 3 Periventricular Leukomalacia, AE An adverse event in a newborn characterized by periventricular echodensities, evolving in to extensive cystic periventricular lesions; or densities extending in to the deep white matter. Grade 3 Periventricular Leukomalacia Periventricular echo densities, evolving in to extensive cystic periventricular lesions; or densities extending in to the deep white matter. Periventricular leukomalacia 10052594 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155219 Grade 3 Persistent Pulmonary Hypertension of the Newborn, AE An adverse event in a newborn characterized by Increased estimated right ventricular pressures; with severe clinical symptoms; oxygenation index greater than 25; major care changes required (e.g. inhaled nitric oxide (iNO)). Grade 3 Persistent Pulmonary Hypertension of the Newborn Increased estimated RV-pressures; with severe clinical symptoms; oxygenation index >25; major care changes required (e.g. iNO). Persistent pulmonary hypertension of the newborn 10082195 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155138 Grade 3 Retinopathy of Prematurity, AE An adverse event in a newborn characterized by type 1 prethreshold retinopathy of prematurity (ROP) (zone 1 any stage with plus disease; zone 1 International Classification of Retinopathy of Prematurity (ICROP) stage 3 without plus disease; zone 2 ICROP stage 2 or 3 with plus disease); threshold ROP; requiring major care changes (e.g. laser intervention, intravitreal anti-VEGF therapy or operative management). Grade 3 Retinopathy of Prematurity Type 1 prethreshold ROP (zone 1 any stage with plus disease; zone 1 ICROP stage 3 without plus disease; zone 2 ICROP stage 2 or 3 with plus disease); threshold ROP; requiring major care changes (e.g. laser intervention, intravitreal anti-VEGF or operative management). Retinopathy of prematurity 10038933 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155230 Grade 4 Bronchopulmonary Dysplasia, AE An adverse event in a newborn characterized by the need for supplemental oxygen at 28 days AND need for greater than 30% oxygen AND positive pressure at 36 weeks postmenstrual age (PMA) in infants born less than 32 weeks' gestation; need for greater than 30% oxygen AND positive pressure by 56 days postnatal age in infants born greater than 32 weeks' gestation; need for greater than 30% oxygen AND positive pressure at discharge. Note: For conversion of oxygen administered by different modalities to fraction of inspired oxygen (FiO2): see http://nicutools.org/MediCalcs/ActualO2.php3. Grade 4 Bronchopulmonary Dysplasia Supplemental oxygen at 28 days AND need for >30% oxygen AND positive pressure at 36 weeks PMA in infants born <32 weeks' gestation; need for >30% oxygen AND positive pressure by 56 days postnatal age in infants born >32 weeks' gestation; need for >30% oxygen AND positive pressure at discharge. Note: For conversion of oxygen administered by different modalities to FiO2: see http://nicutools.org/MediCalcs/ActualO2.php3. Bronchopulmonary dysplasia 10006475 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155248 Grade 4 Feeding Intolerance, AE A feeding intolerance adverse event in a newborn characterized by life-threatening consequences. Grade 4 Feeding Intolerance Life-threatening consequences. Feeding intolerance 10076042 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155144 Grade 4 Hypoxic Ischemic Encephalopathy, AE An adverse event in a newborn characterized by severe clinical signs (see Sarnat stages for further guidance on mild, moderate and severe clinical signs of encephalopathy) of encephalopathy resulting from a perinatal asphyxia event with life-threatening consequences (e.g. respiratory depression, refractory seizures). Grade 4 Hypoxic Ischemic Encephalopathy Severe clinical signs* of encephalopathy resulting from a perinatal asphyxia event with life-threatening consequences (e.g. respiratory depression, refractory seizures). Note: *see Sarnat stages for further guidance on mild, moderate and severe clinical signs of encephalopathy. Hypoxic-ischemic encephalopathy 10070512 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155152 Grade 4 Infant Irritability, AE An adverse event in a newborn characterized by life threatening irritability, with loss of autonomic control of temperature or heart rate; requiring urgent care change. Grade 4 Infant Irritability Life threatening irritability, with loss of autonomic control of temperature or heart rate; requiring urgent care change. Infant irritability 10082189 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155156 Grade 4 Infant Sedation, AE An adverse event in a newborn characterized by life-threatening sedation with cardiorespiratory instability; requiring urgent care change. Grade 4 Infant Sedation Life-threatening sedation with cardiorespiratory instability; requiring urgent care change. Infant sedation 10082187 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155200 Grade 4 Infantile Apnea, AE An apneic adverse event in a newborn characterized by life-threatening respiratory and/or hemodynamic compromise; (semi-)urgent intubation required. Grade 4 Infantile Apnea Life-threatening respiratory and/or hemodynamic compromise; (semi-)urgent intubation required. Infantile apnea 10077322 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155243 Grade 4 Infantile Vomiting, AE A vomiting adverse event in a newborn characterized by life-threatening consequences (e. g. severe dehydration). Grade 4 Infantile Vomiting Life-threatening consequences (e. g. severe dehydration). Infantile vomiting 10075315 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155233 Grade 4 Necrotizing Enterocolitis, AE A necrotizing enterocolitis adverse event in a newborn characterized by bowel perforation (pneumoperitoneum)(modified Bell stage IIIB); shock, disseminated intravascular coagulation (DIC), combined respiratory and metabolic acidosis (modified Bell stage IIIA); urgent major care change indicated. Grade 4 Necrotizing Enterocolitis Bowel perforation (pneumoperitoneum)(Bell IIIB); shock, DIC, combined respiratory and metabolic acidosis (Bell IIIA); urgent major care change indicated. Note: If NEC is not confirmed (Bell stages I): please record severity of individual symptoms (e.g. feeding intolerance). Necrotizing enterocolitis neonatal 10052818 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155280 Grade 4 Neonatal Administration Site Complication, AE An administration site complication adverse event in a newborn characterized by life-threatening consequences; urgent intervention indicated. Grade 4 Administration Site Complication Neonatal Life-threatening consequences; urgent intervention indicated. Administration site reaction neonatal 10082193 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155185 Grade 4 Neonatal Bradyarrhythmia, AE A bradyarrhythmia adverse event in a newborn characterized by life-threatening consequences (e.g. shock); requiring urgent major care changes. Grade 4 Neonatal Bradyarrhythmia Life-threatening consequences (e.g. shock); requiring urgent major care changes. Neonatal bradyarrhythmia 10082054 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155195 Grade 4 Neonatal Coagulation Disorder, AE A coagulation disorder adverse event in a newborn characterized by life threatening consequences (e.g. severe pulmonary embolism, limb ischemia, hemorrhagic shock, disseminated intravascular coagulation (DIC)); requiring urgent major care changes. Grade 4 Coagulation Disorder Neonatal Life threatening consequences (e.g. severe pulmonary embolism, limb ischemia, hemorrhagic shock, DIC); requiring urgent major care changes. Coagulation disorder neonatal 10009732 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155261 Grade 4 Neonatal Constipation, AE A constipation adverse event in a newborn characterized by life-threatening consequences. Grade 4 Constipation Neonatal Life-threatening consequences. Constipation neonatal 10082190 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155124 Grade 4 Neonatal Convulsion, AE An adverse event in a newborn characterized by suspected seizures with life-threatening consequences (e.g. need for ventilation); suspected status epilepticus (greater than 30 minutes of convulsions within any 60 minute period) despite multiple anti-seizure drugs. Grade 4 Neonatal Convulsion Suspected seizures with life-threatening consequences (e.g. need for ventilation); suspected status epilepticus* despite multiple anti-seizure drugs. Note: *>30min of convulsions within any 60-minute period. Neonatal convulsion 10028932 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155265 Grade 4 Neonatal Culture Negative Sepsis, AE A culture negative neonatal sepsis adverse event in a newborn characterized by life-threatening consequences (e.g. shock, disseminated intravascular coagulation (DIC)); urgent major care change required. Grade 4 Culture Negative Neonatal Sepsis Life-threatening consequences (e.g. state of shock, DIC); urgent major care change required. Culture negative neonatal sepsis 10082059 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155270 Grade 4 Neonatal Culture Positive Sepsis, AE A culture positive sepsis adverse event in a newborn characterized by life-threatening consequences (e. g. shock, disseminated intravascular coagulation (DIC)); urgent major care change required. Grade 4 Culture Positive Neonatal Sepsis Life-threatening consequences (e. g. state of shock, DIC); urgent major care change required. Culture positive neonatal sepsis 10082058 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155238 Grade 4 Neonatal Diarrhea, AE A diarrhea adverse event in a newborn characterized by life-threatening consequences (e.g. severe dehydration). Grade 4 Diarrhea Neonatal Life-threatening consequences (e.g. severe dehydration). Diarrhea neonatal 10012731 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155190 Grade 4 Neonatal Edema, AE An edema adverse event in a newborn characterized by life threatening consequences (e.g. respiratory failure, shock); requiring urgent major care changes (e.g. intubation, dialysis). Grade 4 Edema Neonatal Life threatening consequences (e.g. respiratory failure, shock); requiring urgent major care changes (e.g. intubation, dialysis). Edema neonatal 10054497 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155129 Grade 4 Neonatal Epileptic Seizure, AE An adverse event in a newborn characterized by electroencephalogram (EEG)- proven seizures with life-threatening consequences (e.g. need for ventilation); status epilepticus (greater than 30 minutes of seizure activity within any 60 minute period) despite multiple anti-seizure drugs. Grade 4 Neonatal Epileptic Seizure EEG- proven seizures* with life-threatening consequences (e.g. need for ventilation); status epilepticus**despite multiple anti-seizure drugs. Note: *Electrographic confirmation required: can be electro-clinical or electrographic only.**>30min of seizure activity within any 60-minute period. Neonatal epileptic seizure 10082068 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155285 Grade 4 Neonatal Fever, AE A febrile adverse event in a newborn characterized by life-threatening consequences. Grade 4 Fever Neonatal Life-threatening consequences. Fever neonatal 10016562 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155253 Grade 4 Neonatal Gastrointestinal Bleeding, AE A gastrointestinal bleeding adverse event in a newborn characterized by life-threatening consequences (e.g. hemorrhagic shock); urgent major care change required. Grade 4 Gastro-intestinal Bleeding Neonatal Life-threatening consequences (e.g. hemorrhagic shock); urgent major care change required. Gastrointestinal bleeding neonatal 10082192 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155165 Grade 4 Neonatal Hypertension, AE A hypertensive adverse event in a newborn characterized by life-threatening consequences (e.g. malignant hypertension: shock, cardiac failure or neonatal encephalopathy). Grade 4 Neonatal Hypertension Life-threatening consequences (e.g. malignant hypertension: shock, cardiac failure or neonatal encephalopathy). Note: For percentile values: e.g. Dionne et al. Ped Nephrol 2012. Hypertension neonatal 10049781 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155160 Grade 4 Neonatal Hypotension, AE A hypotensive adverse event in a newborn characterized by life-threatening consequences (e.g. shock, organ failure). Grade 4 Neonatal Hypotension Life-threatening consequences (e.g. shock, organ failure). Neonatal hypotension 10049223 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155134 Grade 4 Neonatal Intraventricular Hemorrhage, AE An adverse event in a newborn characterized by intraventricular hemorrhage with parenchymal venous infarction; resulting in life threatening consequences (e.g. refractory seizures, hypotension, respiratory depression); requiring urgent stabilization or surgical decompression. Grade 4 Intraventricular Hemorrhage neonatal Hemorrhage with parenchymal venous infarction; resulting in life threatening consequences (e.g. refractory seizures, hypotension, respiratory depression); requiring urgent stabilization or surgical decompression. Intraventricular hemorrhage neonatal 10022844 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155225 Grade 4 Neonatal Pneumothorax, AE A pneumothorax adverse event in a newborn characterized by life-threatening respiratory and/or hemodynamic compromise (e.g. tension pneumothorax); urgent major care change required. Grade 4 Neonatal Pneumothorax Life-threatening respiratory and/or hemodynamic compromise (e.g. tension pneumothorax); urgent major care change required. Neonatal pneumothorax 10082056 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155215 Grade 4 Neonatal Pulmonary Hemorrhage, AE A pulmonary hemorrhage adverse event in a newborn characterized by life-threatening respiratory and/or hemodynamic compromise. Grade 4 Neonatal Pulmonary Hemorrhage Life-threatening respiratory and/or hemodynamic compromise. Neonatal pulmonary hemorrhage 10082199 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155275 Grade 4 Neonatal Rash, AE An adverse event in a newborn characterized by extensive or generalized bullous lesions or ulceration of mucous membranes involving two or more distinct mucosal sites or Stevens-Johnson syndrome or toxic epidermal necrosis. Grade 4 Rash Neonatal Extensive or generalized bullous lesions or ulceration of mucous membrane involving 2 or more distinct mucosal sites or Stevens-Johnson syndrome or toxic epidermal necrosis. Rash neonatal 10037871 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155210 Grade 4 Neonatal Respiratory Distress Syndrome, AE A respiratory distress adverse event in a newborn characterized by life-threatening respiratory and/or hemodynamic compromise; requiring urgent care change (e.g. urgent intubation). Grade 4 Neonatal Respiratory Distress Syndrome Life-threatening respiratory and/or hemodynamic compromise; requiring urgent care change (e.g. urgent intubation). Neonatal respiratory distress syndrome 10028974 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155205 Grade 4 Neonatal Respiratory Insufficiency, AE A respiratory insufficiency adverse event in a newborn characterized by life-threatening respiratory and/or hemodynamic compromise; requiring urgent care change (e.g. urgent intubation). Grade 4 Neonatal Respiratory Insufficiency Life-threatening respiratory and/or hemodynamic compromise; requiring urgent care change (e.g. urgent intubation). Neonatal respiratory insufficiency 10082057 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155175 Grade 4 Neonatal Sinus Bradycardia, AE A sinus bradycardia adverse event in a newborn characterized by life-threatening consequences (e.g. shock); requiring urgent major care changes. Grade 4 Neonatal Sinus Bradycardia Life-threatening consequences (e.g. shock); requiring urgent major care changes. Neonatal sinus bradycardia 10082188 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155170 Grade 4 Neonatal Sinus Tachycardia, AE A sinus tachycardia adverse event in a newborn characterized by life-threatening consequences; requiring urgent major care changes. Grade 4 Neonatal Sinus Tachycardia Life-threatening consequences; requiring urgent major care changes. Neonatal sinus tachycardia 10082191 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155256 Grade 4 Neonatal Spontaneous Intestinal Perforation, AE A spontaneous intestinal perforation (SIP) adverse event in a newborn characterized by life-threatening consequences (e.g. shock, organ failure); urgent intervention indicated. Grade 4 Neonatal Spontaneous Intestinal Perforation Life-threatening consequences (e.g. shock, organ failure); urgent intervention indicated. Neonatal spontaneous intestinal perforation 10082196 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155180 Grade 4 Neonatal Tachyarrhythmia, AE A tachyarrhythmia adverse event in a newborn characterized by life-threatening consequences (e.g. shock); requiring urgent major care changes. Grade 4 Neonatal Tachyarrhythmia Life-threatening consequences (e.g. shock); requiring urgent major care changes. Neonatal tachyarrhythmia 10082055 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155220 Grade 4 Persistent Pulmonary Hypertension of the Newborn, AE A persistent pulmonary hypertension adverse event in a newborn characterized by life-threatening respiratory and/or hemodynamic compromise; extracorporeal membrane oxygenation (ECMO) required; oxygenation index greater than 40. Grade 4 Persistent Pulmonary Hypertension of the Newborn Life-threatening respiratory and/or hemodynamic compromise; ECMO required; oxygenation index >40. Persistent pulmonary hypertension of the newborn 10082195 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155139 Grade 4 Retinopathy of Prematurity, AE An adverse event in a newborn characterized by unilateral retinal detachment. Grade 4 Retinopathy of Prematurity Unilateral retinal detachment. Retinopathy of prematurity 10038933 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155231 Grade 5 Bronchopulmonary Dysplasia, AE A bronchopulmonary dysplasia adverse event in a newborn which results in death. Grade 5 Bronchopulmonary Dysplasia Death. Bronchopulmonary dysplasia 10006475 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155249 Grade 5 Feeding Intolerance, AE A feeding intolerance adverse event in a newborn which results in death. Grade 5 Feeding Intolerance Death. Feeding intolerance 10076042 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155145 Grade 5 Hypoxic Ischemic Encephalopathy, AE An hypoxic ischemic encephalopathy adverse event in a newborn which results in death. Grade 5 Hypoxic Ischemic Encephalopathy Death. Hypoxic-ischemic encephalopathy 10070512 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155201 Grade 5 Infantile Apnea, AE An apneic adverse event in a newborn which results in death. Grade 5 Infantile Apnea Death. Infantile apnea 10077322 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155244 Grade 5 Infantile Vomiting, AE A vomiting adverse event in a newborn which results in death. Grade 5 Infantile Vomiting Death. Infantile vomiting 10075315 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155234 Grade 5 Necrotizing Enterocolitis, AE A necrotizing enterocolitis adverse event in a newborn which results in death. Grade 5 Necrotizing Enterocolitis Death. Note: If NEC is not confirmed (Bell stages I): please record severity of individual symptoms (e.g. feeding intolerance). Necrotizing enterocolitis neonatal 10052818 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155281 Grade 5 Neonatal Administration Site Complication, AE An administration site complication adverse event in a newborn which results in death. Grade 5 Administration Site Complication Neonatal Death. Administration site reaction neonatal 10082193 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155186 Grade 5 Neonatal Bradyarrhythmia, AE A bradyarrhythmia adverse event in a newborn which results in death. Grade 5 Neonatal Bradyarrhythmia Death. Neonatal bradyarrhythmia 10082054 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155196 Grade 5 Neonatal Coagulation Disorder, AE A coagulation disorder adverse event in a newborn which results in death. Grade 5 Coagulation Disorder Neonatal Death. Coagulation disorder neonatal 10009732 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155262 Grade 5 Neonatal Constipation, AE A constipation adverse event in a newborn which results in death. Grade 5 Constipation Neonatal Death. Constipation neonatal 10082190 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155125 Grade 5 Neonatal Convulsion, AE An adverse event in a newborn characterized by death related to suspected seizures. Grade 5 Neonatal Convulsion Death related to suspected seizures. Neonatal convulsion 10028932 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155266 Grade 5 Neonatal Culture Negative Sepsis, AE A culture negative neonatal sepsis adverse event in a newborn which results in death. Grade 5 Culture Negative Neonatal Sepsis Death. Culture negative neonatal sepsis 10082059 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155271 Grade 5 Neonatal Culture Positive Sepsis, AE A culture positive sepsis adverse event in a newborn which results in death. Grade 5 Culture Positive Neonatal Sepsis Death. Culture positive neonatal sepsis 10082058 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155239 Grade 5 Neonatal Diarrhea, AE A diarrhea adverse event in a newborn which results in death. Grade 5 Diarrhea Neonatal Death. Diarrhea neonatal 10012731 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155191 Grade 5 Neonatal Edema, AE An edema adverse event in a newborn which results in death. Grade 5 Edema Neonatal Death. Edema neonatal 10054497 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155130 Grade 5 Neonatal Epileptic Seizure, AE An adverse event in a newborn characterized by death related to electroencephalogram (EEG)-proven seizures. Grade 5 Neonatal Epileptic Seizure Death related to seizures*. Note: *Electrographic confirmation required: can be electro-clinical or electrographic only. Neonatal epileptic seizure 10082068 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155286 Grade 5 Neonatal Fever, AE A febrile adverse event in a newborn which results in death. Grade 5 Fever Neonatal Death. Fever neonatal 10016562 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155254 Grade 5 Neonatal Gastrointestinal Bleeding, AE A gastrointestinal bleeding adverse event in a newborn which results in death. Grade 5 Gastro-intestinal Bleeding Neonatal Death. Gastrointestinal bleeding neonatal 10082192 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155166 Grade 5 Neonatal Hypertension, AE A hypertensive adverse event in a newborn which results in death. Grade 5 Neonatal Hypertension Death. Hypertension neonatal 10049781 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155161 Grade 5 Neonatal Hypotension, AE A hypotensive adverse event in a newborn which results in death. Grade 5 Neonatal Hypotension Death. Neonatal hypotension 10049223 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155135 Grade 5 Neonatal Intraventricular Hemorrhage, AE An intraventricular hemorrhage adverse event in a newborn which results in death. Grade 5 Intraventricular Hemorrhage neonatal Death. Intraventricular hemorrhage neonatal 10022844 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155226 Grade 5 Neonatal Pneumothorax, AE A pneumothorax adverse event in a newborn which results in death. Grade 5 Neonatal Pneumothorax Death. Neonatal pneumothorax 10082056 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155216 Grade 5 Neonatal Pulmonary Hemorrhage, AE A pulmonary hemorrhage adverse event in a newborn which results in death. Grade 5 Neonatal Pulmonary Hemorrhage Death. Neonatal pulmonary hemorrhage 10082199 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155276 Grade 5 Neonatal Rash, AE A rash adverse event in a newborn which results in death. Grade 5 Rash Neonatal Death. Rash neonatal 10037871 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155211 Grade 5 Neonatal Respiratory Distress Syndrome, AE A respiratory distress adverse event in a newborn which results in death. Grade 5 Neonatal Respiratory Distress Syndrome Death. Neonatal respiratory distress syndrome 10028974 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155206 Grade 5 Neonatal Respiratory Insufficiency, AE A respiratory insufficiency adverse event in a newborn which results in death. Grade 5 Neonatal Respiratory Insufficiency Death. Neonatal respiratory insufficiency 10082057 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155176 Grade 5 Neonatal Sinus Bradycardia, AE A sinus bradycardia adverse event in a newborn which results in death. Grade 5 Neonatal Sinus Bradycardia Death. Neonatal sinus bradycardia 10082188 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155171 Grade 5 Neonatal Sinus Tachycardia, AE A sinus tachycardia adverse event in a newborn which results in death. Grade 5 Neonatal Sinus Tachycardia Death. Neonatal sinus tachycardia 10082191 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155257 Grade 5 Neonatal Spontaneous Intestinal Perforation, AE A spontaneous intestinal perforation (SIP) adverse event in a newborn which results in death. Grade 5 Neonatal Spontaneous Intestinal Perforation Death. Neonatal spontaneous intestinal perforation 10082196 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155181 Grade 5 Neonatal Tachyarrhythmia, AE A tachyarrhythmia adverse event in a newborn which results in death. Grade 5 Neonatal Tachyarrhythmia Death. Neonatal tachyarrhythmia 10082055 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155221 Grade 5 Persistent Pulmonary Hypertension of the Newborn, AE A persistent pulmonary hypertension adverse event in a newborn which results in death. Grade 5 Persistent Pulmonary Hypertension of the Newborn Death. Persistent pulmonary hypertension of the newborn 10082195 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C155140 Grade 5 Retinopathy of Prematurity, AE An adverse event in a newborn characterized by bilateral retinal detachment and blindness. Grade 5 Retinopathy of Prematurity Blindness (bilateral retinal detachment). Retinopathy of prematurity 10038933 Narrower Than LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154945 Hypoxic Ischemic Encephalopathy, AE An adverse event in a newborn characterized by injury to the central nervous system that occurs when there is insufficient delivery of oxygen to all or part of the brain. Hypoxic Ischemic Encephalopathy Hypoxic-ischemic encephalopathy Injury to the central nervous system that occurs when there is insufficient delivery of oxygen to all or part of the brain. Hypoxic-ischemic encephalopathy 10070512 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154939 Infant Irritability, AE An adverse event in a newborn characterized by crying easily and difficulty consoling. Infant Irritability Infant irritability Crying easily, difficult to console. Infant irritability 10082189 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154926 Infant Sedation, AE An adverse event in a newborn characterized by a state of a lowered level of consciousness. Infant Sedation Infant sedation A state of a lowered level of consciousness. Infant sedation 10082187 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154938 Infantile Apnea, AE An adverse event in a newborn characterized by cessation of air flow. Infantile Apnea Infantile apnea Cessation of air flow. Infantile apnea 10077322 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154942 Infantile Vomiting, AE An adverse event in a newborn characterized by expulsion of the contents of the stomach through the mouth. Infantile Vomiting Infantile vomiting Expulsion of the contents of the stomach through the mouth. Infantile vomiting 10075315 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154922 Necrotizing Enterocolitis, AE An adverse event in newborns characterized by extensive mucosal ulceration, pseudomembrane formation, submucosal hemorrhage, and necrosis in the intestines . Necrotizing Enterocolitis Necrotizing enterocolitis neonatal A disease of neonates in which there is extensive mucosal ulceration, pseudomembrane formation, submucosal hemorrhage, and necrosis. Necrotizing enterocolitis neonatal 10052818 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154947 Neonatal Administration Site Complication, AE An adverse event in a newborn characterized by local irritation or a complication at the administration site of a drug. Administration Site Complication Neonatal Administration site reaction neonatal Local irritation or complication at the administration site of a drug. Administration site reaction neonatal 10082193 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154949 Neonatal Bradyarrhythmia, AE An adverse event in a newborn characterized by non-sinus rhythm with an abnormally low heart rate for age. Neonatal Bradyarrhythmia Neonatal bradyarrhythmia Non sinus rhythm with an abnormally low heart rate for age. Neonatal bradyarrhythmia 10082054 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154921 Neonatal Coagulation Disorder, AE An adverse event in a newborn characterized by abnormal blood clotting or bleeding. Coagulation Disorder Neonatal Coagulation disorder neonatal A condition of abnormal blood clotting or bleeding. Coagulation disorder neonatal 10009732 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154946 Neonatal Constipation, AE An adverse event in a newborn characterized by irregular and infrequent or difficult evacuation of the bowels. Constipation Neonatal Constipation neonatal Irregular and infrequent or difficult evacuation of the bowels. Constipation neonatal 10082190 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154952 Neonatal Convulsion, AE An adverse event in a newborn characterized by sudden, involuntary, rapid rhythmic or stereotyped skeletal muscular contraction. Neonatal Convulsion Neonatal convulsion Sudden, involuntary, rapid rhythmic or stereotyped skeletal muscular contraction in a newborn. Neonatal convulsion 10028932 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154928 Neonatal Culture Negative Sepsis, AE An adverse event in a newborn characterized by a systemic inflammatory response without identifiable cause. Culture Negative Neonatal Sepsis Culture negative neonatal sepsis A systemic inflammatory response without identifiable cause. Culture negative neonatal sepsis 10082059 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154927 Neonatal Culture Positive Sepsis, AE An adverse event in a newborn characterized by a systemic inflammatory response to an infection with an identifiable cause. Culture Positive Neonatal Sepsis Culture positive neonatal sepsis A systemic inflammatory response to an infection. Culture positive neonatal sepsis 10082058 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154953 Neonatal Diarrhea, AE An adverse event in a newborn characterized by watery bowel movements. Diarrhea Neonatal Diarrhea neonatal Watery bowel movements. Diarrhea neonatal 10012731 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154931 Neonatal Edema, AE An adverse event in a newborn characterized by accumulation of an excessive amount of fluid in cells or intercellular tissues. Edema Neonatal Edema neonatal Accumulation of an excessive amount of fluid in cells or intercellular tissues. Edema neonatal 10054497 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154934 Neonatal Epileptic Seizure, AE An adverse event in a newborn characterized by an electroencephalogram (EEG) confirmed paroxysmal surge of electrical activity in the brain that may result in physical or behavioral changes. Neonatal Epileptic Seizure Neonatal epileptic seizure An EEG confirmed paroxysmal surge of electrical activity in the brain that may result in physical or behavioral changes in a neonate. Neonatal epileptic seizure 10082068 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154941 Neonatal Fever, AE An adverse event in a newborn characterized by elevation of body temperature above normal due to the production of more heat than the body is able to dissipate. Fever Neonatal Fever neonatal Elevation of body temperature above normal due to the production of more heat than the body is able to dissipate. Fever neonatal 10016562 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154943 Neonatal Gastrointestinal Bleeding, AE An adverse event in a newborn characterized by hemorrhage originating at any site located within the gastrointestinal tract. Gastro-intestinal Bleeding Neonatal Gastrointestinal bleeding neonatal Hemorrhage originating at any site located within the gastrointestinal tract. Gastrointestinal bleeding neonatal 10082192 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154929 Neonatal Hypertension, AE An adverse event in a newborn characterized by abnormally high blood pressure. Neonatal Hypertension Hypertension neonatal Abnormal high blood pressure. Hypertension neonatal 10049781 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154930 Neonatal Hypotension, AE An adverse event in a newborn characterized by abnormally low blood pressure, which is usually symptomatic. Neonatal Hypotension Neonatal hypotension Abnormally low blood pressure, which is usually symptomatic. Neonatal hypotension 10049223 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154937 Neonatal Intraventricular Hemorrhage, AE An adverse event in a newborn characterized by bleeding into the lateral cerebral ventricles. Intraventricular Hemorrhage neonatal Intraventricular hemorrhage neonatal Bleeding into the lateral cerebral ventricles in a newborn infant. Intraventricular hemorrhage neonatal 10022844 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154920 Neonatal Pneumothorax, AE An adverse event in a newborn characterized by a collection of air or other gas between the visceral and parietal pleura. Neonatal Pneumothorax Neonatal pneumothorax A collection of air or other gas between the visceral and parietal pleura. Neonatal pneumothorax 10082056 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154936 Neonatal Pulmonary Hemorrhage, AE An adverse event in a newborn characterized by bleeding in the respiratory tract of a neonate. Neonatal Pulmonary Hemorrhage Neonatal pulmonary hemorrhage Bleeding in the respiratory tract of a neonate. Neonatal pulmonary hemorrhage 10082199 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154935 Neonatal Rash, AE An adverse event in a newborn characterized by an eruption in the skin which affects its appearance and/or texture. Rash Neonatal Rash neonatal An eruption in the skin which affects its appearance and/or texture. Rash neonatal 10037871 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154950 Neonatal Respiratory Distress Syndrome, AE An adverse event in a newborn characterized by 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. Neonatal Respiratory Distress Syndrome Neonatal respiratory distress syndrome 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. Neonatal respiratory distress syndrome 10028974 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154951 Neonatal Respiratory Insufficiency, AE An adverse event in a newborn characterized by significant impairment of gas exchange resulting in compensatory breathing efforts and eventually hypoxia and/or hypercarbia. Note: Consider this adverse event for any patient whose respiratory condition deteriorates from baseline. If any specific diagnosis is identified: use diagnosis-specific scale (e.g. respiratory distress syndrome (RDS), pulmonary hemorrhage). Neonatal Respiratory Insufficiency Neonatal respiratory insufficiency Significant impairment of gas exchange resulting in compensatory breathing efforts and eventually hypoxia and/or hypercarbia.* Note: *Consider this adverse event for any patient whose respiratory condition deteriorates from baseline. If any specific diagnosis is identified: use diagnosis specific scale (e.g. RDS, pulmonary hemorrhage). Neonatal respiratory insufficiency 10082057 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154933 Neonatal Sinus Bradycardia, AE An adverse event in a newborn characterized by an abnormally low heart rate for age. Neonatal Sinus Bradycardia Neonatal sinus bradycardia An abnormally low heart rate for age. Neonatal sinus bradycardia 10082188 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154932 Neonatal Sinus Tachycardia, AE An adverse event in a newborn characterized by an abnormally high heart rate for age. Neonatal Sinus Tachycardia Neonatal sinus tachycardia An abnormally high heart rate for age. Neonatal sinus tachycardia 10082191 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154924 Neonatal Spontaneous Intestinal Perforation, AE An adverse event in a newborn characterized by a perforation in the gastrointestinal tract of a newborn with no demonstrable cause. Neonatal Spontaneous Intestinal Perforation Neonatal spontaneous intestinal perforation A perforation in the gastrointestinal tract of a newborn with no demonstrable cause. Neonatal spontaneous intestinal perforation 10082196 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154948 Neonatal Tachyarrhythmia, AE An adverse event in a newborn characterized by non-sinus rhythm with an abnormally high heart rate for age. Neonatal Tachyarrhythmia Neonatal tachyarrhythmia Non sinus rhythm with an abnormally high heart rate for age. Neonatal tachyarrhythmia 10082055 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154923 Periventricular Leukomalacia, AE An adverse event in a newborn characterized by 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. Periventricular Leukomalacia Periventricular leukomalacia 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. Periventricular leukomalacia 10052594 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154940 Persistent Pulmonary Hypertension of the Newborn, AE An adverse event in a newborn characterized by elevated pulmonary vascular pressure in a neonate. Persistent Pulmonary Hypertension of the Newborn Persistent pulmonary hypertension of the newborn Elevated pulmonary vascular pressure in a neonate. Persistent pulmonary hypertension of the newborn 10082195 Has Synonym LLT 22.0 C154914 INC-MedDRA Neonatal Adverse Events Terminology C154925 Retinopathy of Prematurity, AE An adverse event characterized by a retinal condition of very immature infants that may be characterized by non-vascularized retinae that may lead to neovascularization, scarring, retinal detachment, and blindness. Retinopathy of Prematurity Retinopathy of prematurity 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. Retinopathy of prematurity 10038933 Has Synonym LLT 22.0