Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Preferred Term CDISC Synonym(s) CDISC Definition NCI Preferred Term Pre-release/ Production C66767 C66767 No Action Taken with Study Treatment ACN ACN Action Taken with Study Treatment The reason that changes were made to the therapy under study. (NCI) CDISC SDTM Action Taken with Study Treatment Terminology Production C49503 C66767 Action Taken with Study Treatment DOSE INCREASED DOSE INCREASED An indication that a medication schedule was modified by addition; either by changing the frequency, strength or amount. (NCI) Dose Increased Production C49504 C66767 Action Taken with Study Treatment DOSE NOT CHANGED DOSE NOT CHANGED An indication that a medication schedule was maintained. (NCI) Dose Not Changed Production C49505 C66767 Action Taken with Study Treatment DOSE REDUCED DOSE REDUCED An indication that a medication schedule was modified by subtraction, either by changing the frequency, strength or amount. (NCI) Dose Reduced Production C49501 C66767 Action Taken with Study Treatment DRUG INTERRUPTED DRUG INTERRUPTED An indication that a medication schedule was modified by temporarily terminating a prescribed regimen of medication. (NCI) Drug Interrupted Production C49502 C66767 Action Taken with Study Treatment DRUG WITHDRAWN DRUG WITHDRAWN An indication that a medication schedule was modified through termination of a prescribed regimen of medication. (NCI) Drug Withdrawn Production C48660 C66767 Action Taken with Study Treatment NOT APPLICABLE NOT APPLICABLE NA Determination of a value is not relevant in the current context. (NCI) Not Applicable Production C17998 C66767 Action Taken with Study Treatment UNKNOWN UNKNOWN U; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown Production C66768 C66768 No Outcome of Event OUT OUT Outcome of Event A condition or event that is attributed to the adverse event and is the result or conclusion of the adverse event. (NCI) CDISC SDTM Adverse Event Outcome Terminology Production C48275 C66768 Outcome of Event FATAL FATAL Grade 5; 5 The termination of life as a result of an adverse event. (NCI) Death Related to Adverse Event Production C49494 C66768 Outcome of Event NOT RECOVERED/NOT RESOLVED NOT RECOVERED/NOT RESOLVED One of the possible results of an adverse event outcome that indicates that the event has not improved or recuperated. (NCI) Not Recovered or Not Resolved Production C49498 C66768 Outcome of Event RECOVERED/RESOLVED RECOVERED/RESOLVED One of the possible results of an adverse event outcome that indicates that the event has improved or recuperated. (NCI) Recovered or Resolved Production C49495 C66768 Outcome of Event RECOVERED/RESOLVED WITH SEQUELAE RECOVERED/RESOLVED WITH SEQUELAE One of the possible results of an adverse event outcome where the subject recuperated but retained pathological conditions resulting from the prior disease or injury. (NCI) Recovered or Resolved with Sequelae Production C49496 C66768 Outcome of Event RECOVERING/RESOLVING RECOVERING/RESOLVING One of the possible results of an adverse event outcome that indicates that the event is improving. (NCI) Recovering or Resolving Production C17998 C66768 Outcome of Event UNKNOWN UNKNOWN U; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown Production C66780 C66780 Yes Age Span AGESPAN AGESPAN Age Span Subgroups of populations based on age. (NCI) CDISC SDTM Age GroupTerminology Production C27954 C66780 Age Span ADOLESCENT (12-17 YEARS) ADOLESCENT (12-17 YEARS) A juvenile between the onset of puberty and maturity; in the state of development between puberty and maturity. (NCI) Adolescent Production C49685 C66780 Age Span ADULT (18-65) ADULT (18-65) A person from 18 years to 65 years of age. (NCI) Adult 18-65 Years Old Production C49683 C66780 Age Span CHILDREN (2-11 YEARS) CHILDREN (2-11 YEARS) A person from 2 years to 11 years of age. (NCI) Children 2-11 Years Old Production C16268 C66780 Age Span ELDERLY (> 65) ELDERLY (> 65) An age group comprised by people 65 years of age and older. (NCI) Elderly Production C49641 C66780 Age Span IN UTERO IN UTERO The period of time during which the embryo or foetus is present in the uterus of the female. Also describes the location of the embryo or foetus as being in the uterus in contrast to outside the uterus (ex utero). (NCI) In Utero Production C49643 C66780 Age Span INFANT AND TODDLER (28 DAYS - 23 MONTHS) INFANT AND TODDLER (28 DAYS - 23 MONTHS) A person from 28 days to 23 months of age. (NCI) Infant And Toddler Production C16731 C66780 Age Span NEWBORN (0-27 DAYS) NEWBORN (0-27 DAYS) An infant during the first month after birth. (NCI) Newborn Production C49642 C66780 Age Span PRETERM NEWBORN INFANTS PRETERM NEWBORN INFANTS An infant born prior to completion of the normal gestation period. (NCI) Preterm Newborn Infant Production C66781 C66781 No Age Unit AGEU AGEU Age Unit Those units of time that are routinely used to express the age of a person. (NCI) CDISC SDTM Age UnitTerminology Production C25301 C66781 Age Unit DAYS DAYS The time for Earth to make a complete rotation on its axis; ordinarily divided into twenty-four hours. This also refers to a specific day. (NCI) Day Production C25529 C66781 Age Unit HOURS HOURS A unit measure of time equal to 3,600 seconds or 60 minutes. It is approximately 1/24 of a median day. (NCI) Hour Production C29846 C66781 Age Unit MONTHS MONTHS One of the 12 divisions of a year as determined by a calendar. It corresponds to the unit of time of approximately to one cycle of the moon's phases, about 30 days or 4 weeks. (NCI) Month Production C29844 C66781 Age Unit WEEKS WEEKS Any period of seven consecutive days. (NCI) Week Production C29848 C66781 Age Unit YEARS YEARS The period of time that it takes for Earth to make a complete revolution around the sun, approximately 365 days; a specific one year period. (NCI) Year Production C66797 C66797 No Category for Inclusion/Exclusion IECAT IECAT Category for Inclusion/Exclusion A collection of criteria on which subjects are evaluated and that must be met by all study subjects. (NCI) CDISC SDTM Category of Inclusion And Or ExclusionTerminology Production C25370 C66797 Category for Inclusion/Exclusion EXCLUSION EXCLUSION List of characteristics in a protocol, any one of which may exclude a potential subject from participation in a study. (CDISC glossary) Exclusion Production C25532 C66797 Category for Inclusion/Exclusion INCLUSION INCLUSION The criteria in a protocol that prospective subjects must meet to be eligible for participation in a study. NOTE: Exclusion and inclusion criteria define the study population. See also exclusion criteria. (CDISC glossary) Inclusion Production C66783 C66783 No CDISC System Organ Class SOC SOC CDISC System Organ Class Terms at the highest level of the CDISC system organ class terminology. CDISC SDTM System Organ Class Terminology Production C35814 C66783 CDISC System Organ Class BLOOD AND LYMPHATIC SYSTEM DISORDERS BLOOD AND LYMPHATIC SYSTEM DISORDERS Any deviation from the normal structure or function of the blood or lymphatic system that is manifested by a characteristic set of symptoms and signs. (NCI) Hematopoietic and Lymphoid System Disorder Production C3079 C66783 CDISC System Organ Class CARDIAC DISORDERS CARDIAC DISORDERS Any deviation from the normal structure or function of the cardiac system that is manifested by a characteristic set of symptoms and signs. (NCI) Heart Disorder Production C49399 C66783 CDISC System Organ Class CONGENITAL, FAMILIAL AND GENETIC DISORDERS CONGENITAL, FAMILIAL AND GENETIC DISORDERS A class of disorders that encompasses conditions resulting from a congenital, familial hereditary trait or genetic abnormality as is manifested by a characterstic set of symptoms and signs. (NCI) Congenital, Familial and Genetic Disorder Class Production C49400 C66783 CDISC System Organ Class EAR AND LABYRINTH DISORDERS EAR AND LABYRINTH DISORDERS Any deviation from the normal structure or function of the ear or labyrinth that is manifested by a characteristic set of symptoms and signs. (NCI) Ear and Labyrinth Disorder Class Production C3009 C66783 CDISC System Organ Class ENDOCRINE DISORDERS ENDOCRINE DISORDERS Any deviation from the normal structure or function of the endocrine system that is manifested by a characteristic set of symptoms and signs. (NCI) Endocrine Disorder Production C26767 C66783 CDISC System Organ Class EYE DISORDERS EYE DISORDERS Any deviation from the normal structure or function of the eye that is manifested by a characteristic set of symptoms and signs. (NCI) Eye Disorder Production C2990 C66783 CDISC System Organ Class GASTROINTESTINAL DISORDERS GASTROINTESTINAL DISORDERS Diseases of the digestive tract (oral cavity to anus) and associated organs (salivary glands, liver, pancreas). (NCI) Gastrointestinal Disorder Production C49401 C66783 CDISC System Organ Class GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS A class of disorders that encompasses conditions of a general kind that result from a disease, the treatment of disease or administration of treatment at a particular site and are manifested by a characteristic set of symptoms and signs. (NCI) General Disorders and Administration Site Conditions Class Production C3959 C66783 CDISC System Organ Class HEPATOBILIARY DISORDERS HEPATOBILIARY DISORDERS Any deviation from the normal structure or function of the liver or biliary tract that is manifested by a characteristic set of symptoms and signs. (NCI) Liver and Biliary Tract Disorder Production C3507 C66783 CDISC System Organ Class IMMUNE SYSTEM DISORDERS IMMUNE SYSTEM DISORDERS A disorder resulting from an abnormality in the immune system. -- 2003 (NCI) Immune System Disorder Production C26726 C66783 CDISC System Organ Class INFECTIONS AND INFESTATIONS INFECTIONS AND INFESTATIONS A disorder resulting from the presence and activity of a microbial, viral, or parasitic agent. It can be transmitted by direct or indirect contact. -- 2003 (NCI) Infectious Disorder Production C49402 C66783 CDISC System Organ Class INJURY, POISONING AND PROCEDURAL COMPLICATIONS INJURY, POISONING AND PROCEDURAL COMPLICATIONS A class of disorders that encompasses conditions resulting from an injury, poisoning or procedure. (NCI) Injury, Poisoning and Procedural Complication Class Production C41198 C66783 CDISC System Organ Class INVESTIGATIONS INVESTIGATIONS The act or process of a systematic and thorough examination; research, study; the process of inquiring into or following up, intended to develop facts. (NCI) Investigation Production C49403 C66783 CDISC System Organ Class METABOLISM AND NUTRITION DISORDERS METABOLISM AND NUTRITION DISORDERS A class of disorders that encompasses conditions occurring as a result of metabolic dysfunction or deviation from the normal nutritional requirements. (NCI) Metabolism and Nutrition Disorder Class Production C27574 C66783 CDISC System Organ Class MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Any deviation from the normal structure or function of the musculoskeletal or connective tissue that is manifested by a characteristic set of symptoms and signs. (NCI) Connective and Soft Tissue Disorder Production C3262 C66783 CDISC System Organ Class NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) An abnormal tissue growth resulted from uncontrolled cell proliferation. Benign neoplastic cells resemble normal cells without exhibiting significant cytologic atypia, while malignant ones exhibit overt signs such as dysplastic features, atypical mitotic figures, necrosis, nuclear pleomorphism, and anaplasia. Representative examples of benign neoplasms include papillomas, cystadenomas, and lipomas; malignant neoplasms include carcinomas, sarcomas, lymphomas, and leukemias. -- 2004 (NCI) Neoplasm Production C26835 C66783 CDISC System Organ Class NERVOUS SYSTEM DISORDERS NERVOUS SYSTEM DISORDERS Any deviation from the normal structure or function of the nervous system that is manifested by a characteristic set of symptoms and signs. (NCI) Nervous System Disorder Production C49404 C66783 CDISC System Organ Class PREGNANCY, PUERPERIUM AND PERINATAL CONDITIONS PREGNANCY, PUERPERIUM AND PERINATAL CONDITIONS A class of conditions associated with pregnancy, puerperium and perinatal status. (NCI) Pregnancy, Puerperium and Perinatal Condition Class Production C2893 C66783 CDISC System Organ Class PSYCHIATRIC DISORDERS PSYCHIATRIC DISORDERS Any deviation from the normal structure or function of the brain and a psychiatric condition, that results in an impairment of an individual's normal cognitive, emotional, or behavioral functioning, and is caused by physiological or psychosocial factors. (NCI) Psychiatric Disorder Production C3430 C66783 CDISC System Organ Class RENAL AND URINARY DISORDERS RENAL AND URINARY DISORDERS Disorders of any part of the urologic system. (NCI) Urinary System Disorder Production C49405 C66783 CDISC System Organ Class REPRODUCTIVE SYSTEM AND BREAST DISORDERS REPRODUCTIVE SYSTEM AND BREAST DISORDERS Any deviation from the normal structure or function of the reproductive system or breast that is manifested by a characteristic set of symptoms and signs. (NCI) Reproductive System and Breast Disorder Class Production C27669 C66783 CDISC System Organ Class RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Any deviation from the normal structure or function of the respiratory system including the thorax and mediastinum that is manifested by a characteristic set of symptoms and signs. (NCI) Respiratory and Thoracic Disorder Production C3371 C66783 CDISC System Organ Class SKIN AND SUBCUTANEOUS TISSUE DISORDERS SKIN AND SUBCUTANEOUS TISSUE DISORDERS Any deviation from the normal structure or function of the skin or subcutaneous tissue that is manifested by a characteristic set of symptoms and signs.(NCI) Skin Disorder Production C20188 C66783 CDISC System Organ Class SOCIAL CIRCUMSTANCES SOCIAL CIRCUMSTANCES A set of concepts that results from or is influenced by criteria or activities associated with the social environment of a person. (NCI) Social Circumstances Production C25218 C66783 CDISC System Organ Class SURGICAL AND MEDICAL PROCEDURES SURGICAL AND MEDICAL PROCEDURES A particular course of action intended to achieve a result. (NCI) Procedure Production C35117 C66783 CDISC System Organ Class VASCULAR DISORDERS VASCULAR DISORDERS Any deviation from the normal structure or function of the vascular system that is manifested by a characteristic set of symptoms and signs. (NCI) Vascular Disorder Production C66784 C66784 No Common Terminology Criteria for Adverse Events TOXGR TOXGR Common Terminology Criteria for Adverse Events A standard terminology developed to report adverse events occurring in cancer clinical trials. Common terminology criteria for adverse events (CTCAE) are used in study adverse event summaries and Investigational New Drug reports to the Food and Drug Administration. The CTCAE contain a grading scale for each adverse event term representing the severity of the event. (NCI) CDISC SDTM CommonTerminology Criteria for Adverse Event Grade Terminology Production C41338 C66784 Common Terminology Criteria for Adverse Events 1 MILD Grade 1; 1 A type of adverse event that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Mild Adverse Event Production C41339 C66784 Common Terminology Criteria for Adverse Events 2 MODERATE Grade 2; 2 A type of adverse event that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Moderate Adverse Event Production C41340 C66784 Common Terminology Criteria for Adverse Events 3 SEVERE Grade 3; 3 A type of adverse event that requires intensive therapeutic intervention. The event interrupts usual activities of daily living, or significantly affects clinical status. The event possesses a significant risk of harm to the research participant and hospitalization may be required. Severe Adverse Event Production C41337 C66784 Common Terminology Criteria for Adverse Events 4 LIFE THREATENING Grade 4; 4 An adverse event, and/or its immediate sequelae, which is associated with an imminent risk of death or which is associated with physical or mental disabilities that affect or limit the ability of a person to perform activities of daily living (eating, ambulation, toileting, etc.) See NCI Common Terminology Criteria for Adverse Events. Life Threatening or Disabling Adverse Event Production C48275 C66784 Common Terminology Criteria for Adverse Events 5 FATAL Grade 5; 5 The termination of life as a result of an adverse event. (NCI) Death Related to Adverse Event Production C66785 C66785 Yes Control Type TCNTRL TCNTRL Control Type; Type of Control Comparator against which the study treatment is evaluated (e.g., concurrent (placebo, no treatment, dose-response, active), external (historical, published literature). CDISC SDTM Control Type Terminology Production C49649 C66785 Control Type ACTIVE ACTIVE A type of control, which has a demonstrated effect, administered as a comparator, to subjects in a clinical trial. [From ICH E10]. Active Control Production C41132 C66785 Control Type NONE NONE No person or thing, nobody, not any. (NCI) None Production C49648 C66785 Control Type PLACEBO PLACEBO Use of an inactive compound identical in appearance to drug or treatment being tested in experimental research, which may or may not be known to the physician and/or subject, administered to distinguish between drug action and suggestive effect of the drug or treatment under study. The effects of the active drug or treatment are compared to the effects of the placebo. (NCI) Placebo Control Production C66786 C66786 No Country COUNTRY COUNTRY Country A collective generic term that refers here to a wide variety of dependencies, areas of special sovereignty, uninhabited islands, and other entities in addition to the traditional countries or independent states. (NCI) CDISC SDTM Country Terminology Production C17884 C66786 Country ABW ABW ARUBA Island in the Caribbean Sea, north of Venezuela. Aruba Production C16267 C66786 Country AFG AFG AFGHANISTAN A country in Southern Asia, north and west of Pakistan, east of Iran. Afghanistan Production C16292 C66786 Country AGO AGO ANGOLA A country in Southern Africa, bordering the South Atlantic Ocean, between Namibia and Democratic Republic of the Congo. Angola Production C20133 C66786 Country AIA AIA ANGUILLA An island in the Caribbean Sea, east of Puerto Rico. Anguilla Production C44481 C66786 Country ALA ALA ALAND ISLANDS An archipelago in the Baltic Sea at the entrance to the Gulf of Bothnia between Sweden and Finland. Aland Islands Production C16271 C66786 Country ALB ALB ALBANIA A country in Southeastern Europe, bordering the Adriatic Sea and Ionian Sea, between Greece and Serbia and Montenegro. Albania Production C16289 C66786 Country AND AND ANDORRA A country in Southwestern Europe, between France and Spain. Andorra Production C16904 C66786 Country ANT ANT NETHERLANDS ANTILLES A country in the Caribbean, comprising two island groups in the Caribbean Sea - one includes Curacao and Bonaire north of Venezuela; the other is east of the Virgin Islands. Netherlands Antilles Production C17232 C66786 Country ARE ARE UNITED ARAB EMIRATES A country in the Middle East, bordering the Gulf of Oman and the Persian Gulf, between Oman and Saudi Arabia. United Arab Emirates Production C16305 C66786 Country ARG ARG ARGENTINA A country in Southern South America, bordering the South Atlantic Ocean, between Chile and Uruguay. Argentina Production C16306 C66786 Country ARM ARM ARMENIA A country in Southwestern Asia, east of Turkey. Armenia Production C17739 C66786 Country ASM ASM AMERICAN SAMOA A group of islands in the South Pacific Ocean, about half way between Hawaii and New Zealand. American Samoa Production C18007 C66786 Country ATA ATA ANTARCTICA The continent lying mostly south of the Antarctic Circle. Antarctica Production C20105 C66786 Country ATF ATF FRENCH SOUTHERN TERRITORIES Islands in the southern Indian Ocean, south of Africa, about equidistant between Africa, Antarctica, and Australia. French Southern Territories Production C16303 C66786 Country ATG ATG ANTIGUA AND BARBUDA Islands between the Caribbean Sea and the North Atlantic Ocean, east-southeast of Puerto Rico. Antigua and Barbuda Production C16311 C66786 Country AUS AUS AUSTRALIA The continent between the Indian Ocean and the South Pacific Ocean. Australia Production C16312 C66786 Country AUT AUT AUSTRIA A country in Central Europe, north of Italy and Slovenia. Austria Production C16316 C66786 Country AZE AZE AZERBAIJAN A country in Southwestern Asia, bordering the Caspian Sea, between Iran and Russia. Azerbaijan Production C16371 C66786 Country BDI BDI BURUNDI A country in Central Africa, east of Democratic Republic of the Congo. Burundi Production C16329 C66786 Country BEL BEL BELGIUM A country in Western Europe, bordering the North Sea, between France and the Netherlands. Belgium Production C16333 C66786 Country BEN BEN BENIN REPUBLIC A country in Western Africa, bordering the North Atlantic Ocean, between Nigeria and Togo. Benin Republic Production C16369 C66786 Country BFA BFA BURKINA FASO A country in Western Africa, north of Ghana. Burkina Faso Production C16323 C66786 Country BGD BGD BANGLADESH A country in Southern Asia, bordering the Bay of Bengal, between Burma and India. Bangladesh Production C16368 C66786 Country BGR BGR BULGARIA A country in Southeastern Europe, bordering the Black Sea, between Romania and Turkey. Bulgaria Production C16322 C66786 Country BHR BHR BAHRAIN An archipelago in the Persian Gulf, east of Saudi Arabia. Bahrain Production C16321 C66786 Country BHS BHS BAHAMAS A chain of islands in the North Atlantic Ocean, southeast of Florida. Bahamas Production C16361 C66786 Country BIH BIH BOSNIA-HERZEGOVINA A country in Southeastern Europe, bordering the Adriatic Sea and Croatia. Bosnia-Herzegovina Production C16372 C66786 Country BLR BLR BELARUS A country in Eastern Europe, east of Poland. Belarus Production C16331 C66786 Country BLZ BLZ BELIZE A country in Central America, bordering the Caribbean Sea, between Guatemala and Mexico. Belize Production C16334 C66786 Country BMU BMU BERMUDA No Definition Bermuda Production C16359 C66786 Country BOL BOL BOLIVIA A country in Central South America, southwest of Brazil. Bolivia Production C16364 C66786 Country BRA BRA BRAZIL A country in Eastern South America, bordering the Atlantic Ocean. Brazil Production C16324 C66786 Country BRB BRB BARBADOS An island between the Caribbean Sea and the North Atlantic Ocean, northeast of Venezuela. Barbados Production C16367 C66786 Country BRN BRN BRUNEI A country in Southeastern Asia, bordering the South China Sea and Malaysia. Brunei Darussalam Production C16336 C66786 Country BTN BTN BHUTAN A country in Southern Asia, between China and India. Bhutan Production C20104 C66786 Country BVT BVT BOUVET ISLAND An island in the South Atlantic Ocean, south-southwest of the Cape of Good Hope (South Africa). Bouvet Island Production C16363 C66786 Country BWA BWA BOTSWANA A country in Southern Africa, north of South Africa. Botswana Production C16409 C66786 Country CAF CAF CENTRAL AFRICAN REPUBLIC A country in Central Africa, north of Democratic Republic of the Congo. Central African Republic Production C16380 C66786 Country CAN CAN CANADA A country in Northern North America, bordering the North Atlantic Ocean on the east, North Pacific Ocean on the west, and the Arctic Ocean on the north, north of the conterminous US. Canada Production C16445 C66786 Country CCK CCK COCOS (KEELING) ISLANDS A group of islands in the Indian Ocean, south of Indonesia, about halfway from Australia to Sri Lanka. Cocos (Keeling) Islands Production C17181 C66786 Country CHE CHE SWITZERLAND A country in Central Europe, east of France, north of Italy. Switzerland Production C16427 C66786 Country CHL CHL CHILE A country in Southern South America, bordering the South Atlantic Ocean and South Pacific Ocean, between Argentina and Peru. Chile Production C16428 C66786 Country CHN CHN CHINA A country in Eastern Asia, bordering the East China Sea, Korea Bay, Yellow Sea, and South China Sea, between North Korea and Vietnam. China Production C16762 C66786 Country CIV CIV COTE D'IVOIRE A country in Western Africa, bordering the North Atlantic Ocean, between Ghana and Liberia. Cote d'Ivoire Production C16379 C66786 Country CMR CMR CAMEROON A country in Western Africa, bordering the Bight of Biafra, between Equatorial Guinea and Nigeria. Cameroon Production C17266 C66786 Country COD COD DEMOCRATIC REPUBLIC OF THE CONGO A country in Central Africa, northeast of Angola. Democratic Republic of the Congo Production C16467 C66786 Country COG COG CONGO A country in Western Africa, bordering the South Atlantic Ocean, between Angola and Gabon. Congo Production C16469 C66786 Country COK COK COOK ISLANDS A group of islands in the South Pacific Ocean, about one-half of the way from Hawaii to New Zealand. Cook Islands Production C16449 C66786 Country COL COL COLOMBIA A country in Northern South America, bordering the Caribbean Sea, between Panama and Venezuela, and bordering the North Pacific Ocean, between Ecuador and Panama. Colombia Production C16458 C66786 Country COM COM COMOROS A group of islands in the Mozambique Channel, about two-thirds of the way between northern Madagascar and northern Mozambique. Comoros Production C16382 C66786 Country CPV CPV CAPE VERDE A group of islands in the North Atlantic Ocean, west of Senegal. Cape Verde Production C16470 C66786 Country CRI CRI COSTA RICA A country in Central America, bordering both the Caribbean Sea and the North Pacific Ocean, between Nicaragua and Panama. Costa Rica Production C16477 C66786 Country CUB CUB CUBA An island between the Caribbean Sea and the North Atlantic Ocean, 150 km south of Key West, Florida. Cuba Production C44482 C66786 Country CXR CXR CHRISTMAS ISLAND An Australian-administered island in the eastern Indian Ocean south of Java, Indonesia. Christmas Island Production C16391 C66786 Country CYM CYM CAYMAN ISLANDS An island group in the Caribbean Sea, nearly one-half of the way from Cuba to Honduras. Cayman Islands Production C16480 C66786 Country CYP CYP CYPRUS An island in the Mediterranean Sea, south of Turkey. Cyprus Production C17668 C66786 Country CZE CZE CZECH REPUBLIC A country in Central Europe, southeast of Germany. Czech Republic Production C16636 C66786 Country DEU DEU GERMANY A country in Central Europe, bordering the Baltic Sea and the North Sea, between the Netherlands and Poland, south of Denmark. Germany Production C16506 C66786 Country DJI DJI DJIBOUTI A country in Eastern Africa, bordering the Gulf of Aden and the Red Sea, between Eritrea and Somalia. Djibouti Production C16519 C66786 Country DMA DMA DOMINICA An island between the Caribbean Sea and the North Atlantic Ocean, about one-half of the way from Puerto Rico to Trinidad and Tobago. Dominica Production C16496 C66786 Country DNK DNK DENMARK A country in Northern Europe, bordering the Baltic Sea and the North Sea, on a peninsula north of Germany (Jutland); also includes two major islands (Sjaelland and Fyn). Denmark Production C16520 C66786 Country DOM DOM DOMINICAN REPUBLIC A country comprising the eastern two-thirds of the island of Hispaniola, between the Caribbean Sea and the North Atlantic Ocean, east of Haiti. Dominican Republic Production C16274 C66786 Country DZA DZA ALGERIA A country in Northern Africa, bordering the Mediterranean Sea, between Morocco and Tunisia. Algeria Production C16528 C66786 Country ECU ECU ECUADOR A country in Western South America, bordering the Pacific Ocean at the Equator, between Colombia and Peru. Ecuador Production C16530 C66786 Country EGY EGY EGYPT A country in Northern Africa, bordering the Mediterranean Sea, between Libya and the Gaza Strip. Egypt Production C16558 C66786 Country ERI ERI ERITREA A country in Eastern Africa, bordering the Red Sea, between Djibouti and Sudan. Eritrea Production C20113 C66786 Country ESH ESH WESTERN SAHARA A country in Northern Africa, bordering the North Atlantic Ocean, between Mauritania and Morocco. Western Sahara Production C17152 C66786 Country ESP ESP SPAIN A country in Southwestern Europe, bordering the Bay of Biscay, Mediterranean Sea, North Atlantic Ocean, and Pyrenees Mountains, southwest of France. Spain Production C16562 C66786 Country EST EST ESTONIA A country in Eastern Europe, bordering the Baltic Sea and Gulf of Finland, between Latvia and Russia. Estonia Production C16563 C66786 Country ETH ETH ETHIOPIA A country in Eastern Africa, west of Somalia. Ethiopia Production C16584 C66786 Country FIN FIN FINLAND A country in Northern Europe, bordering the Baltic Sea, Gulf of Bothnia, and Gulf of Finland, between Sweden and Russia. Finland Production C16582 C66786 Country FJI FJI FIJI An island group in the South Pacific Ocean, about two-thirds of the way from Hawaii to New Zealand. Fiji Production C17954 C66786 Country FLK FLK FALKLAND ISLANDS Islands in the South Atlantic Ocean, east of southern Argentina. Falkland Islands Production C16592 C66786 Country FRA FRA FRANCE A country in Western Europe, bordering the Bay of Biscay and English Channel, between Belgium and Spain, southeast of the UK; bordering the Mediterranean Sea, between Italy and Spain. France Production C16573 C66786 Country FRO FRO FAROE ISLANDS An island group between the Norwegian Sea and the North Atlantic Ocean, about one-half of the way from Iceland to Norway. Faroe Islands Production C17881 C66786 Country FSM FSM MICRONESIA, FEDERATED STATES OF An island group in the North Pacific Ocean, about three-quarters of the way from Hawaii to Indonesia. Federated States of Micronesia Production C16596 C66786 Country GAB GAB GABON A country in Western Africa, bordering the Atlantic Ocean at the Equator, between Republic of the Congo and Equatorial Guinea. Gabon Production C17233 C66786 Country GBR GBR UNITED KINGDOM A country in Western Europe, comprising islands, including the northern one-sixth of the island of Ireland, between the North Atlantic Ocean and the North Sea, northwest of France. United Kingdom Production C16634 C66786 Country GEO GEO GEORGIA A country in Southwestern Asia, bordering the Black Sea, between Turkey and Russia. Georgia Production C64375 C66786 Country GGY GGY GUERNSEY The island of Guernsey and the other Channel Islands represent the last remnants of the medieval Dukedom of Normandy, which held sway in both France and England. Guernsey is a British crown dependency, but is not part of the UK. Guernsey Production C26330 C66786 Country GHA GHA GHANA A country in Western Africa, bordering the Gulf of Guinea, between Cote d'Ivoire and Togo. Ghana Production C16638 C66786 Country GIB GIB GIBRALTAR A dependency in Southwestern Europe, bordering the Strait of Gibraltar, on the southern coast of Spain. Gibraltar Production C16655 C66786 Country GIN GIN GUINEA A country in Western Africa, bordering the North Atlantic Ocean, between Guinea-Bissau and Sierra Leone. Guinea Production C16651 C66786 Country GLP GLP GUADELOUPE Islands in the eastern Caribbean Sea, southeast of Puerto Rico. Guadeloupe Production C16598 C66786 Country GMB GMB GAMBIA A country in Western Africa, bordering the North Atlantic Ocean and Senegal. Gambia Production C16656 C66786 Country GNB GNB GUINEA-BISSAU A country in Western Africa, bordering the North Atlantic Ocean, between Guinea and Senegal. Guinea-Bissau Production C16557 C66786 Country GNQ GNQ EQUATORIAL GUINEA A country in Western Africa, bordering the Bight of Biafra, between Cameroon and Gabon; composed of a mainland portion and five inhabited islands. Equatorial Guinea Production C16645 C66786 Country GRC GRC GREECE A country in Southern Europe, bordering the Aegean Sea, Ionian Sea, and the Mediterranean Sea, between Albania and Turkey. Greece Production C16647 C66786 Country GRD GRD GRENADA An island between the Caribbean Sea and Atlantic Ocean, north of Trinidad and Tobago. Grenada Production C16646 C66786 Country GRL GRL GREENLAND An island between the Arctic Ocean and the North Atlantic Ocean, northeast of Canada. Greenland Production C16654 C66786 Country GTM GTM GUATEMALA A country in Central America, bordering the Caribbean Sea, between Honduras and Belize and bordering the North Pacific Ocean, between El Salvador and Mexico. Guatemala Production C16593 C66786 Country GUF GUF FRENCH GUIANA A country in Northern South America, bordering the North Atlantic Ocean, between Brazil and Suriname. French Guiana Production C16652 C66786 Country GUM GUM GUAM Island in the North Pacific Ocean, about three-quarters of the way from Hawaii to the Philippines. Guam Production C16657 C66786 Country GUY GUY GUYANA A country in Northern South America, bordering the North Atlantic Ocean, between Suriname and Venezuela. Guyana Production C16695 C66786 Country HKG HKG HKG; HONG KONG A special administrative region of China, bordering the South China Sea and China. Hong Kong Production C20106 C66786 Country HMD HMD HEARD ISLAND AND MCDONALD ISLANDS Islands in the Indian Ocean, about two-thirds of the way from Madagascar to Antarctica. Heard Island and McDonald Islands Production C16694 C66786 Country HND HND HONDURAS A country in Central America, bordering the Caribbean Sea, between Guatemala and Nicaragua and bordering the North Pacific Ocean, between El Salvador and Nicaragua. Honduras Production C16474 C66786 Country HRV HRV CROATIA A country in Southeastern Europe, bordering the Adriatic Sea, between Bosnia and Herzegovina and Slovenia. Croatia Production C16660 C66786 Country HTI HTI HAITI A country comprising the western one-third of the island of Hispaniola, between the Caribbean Sea and the North Atlantic Ocean, west of the Dominican Republic. Haiti Production C16699 C66786 Country HUN HUN HUNGARY A country in Central Europe, northwest of Romania. Hungary Production C16728 C66786 Country IDN IDN INDONESIA A country in Southeastern Asia, comprising the archipelago between the Indian Ocean and the Pacific Ocean. Indonesia Production C16727 C66786 Country IND IND INDIA A country in Southern Asia, bordering the Arabian Sea and the Bay of Bengal, between Burma and Pakistan. India Production C16365 C66786 Country IOT IOT BRITISH INDIAN OCEAN TERRITORY An archipelago in the Indian Ocean, about one-half the way from Africa to Indonesia. British Indian Ocean Territory Production C16757 C66786 Country IRL IRL IRELAND A country in Western Europe, occupying five-sixths of the island of Ireland in the North Atlantic Ocean, west of Great Britain. Ireland Production C16755 C66786 Country IRN IRN IRAN A country in the Middle East, bordering the Gulf of Oman, the Persian Gulf, and the Caspian Sea, between Iraq and Pakistan. Iran Production C16756 C66786 Country IRQ IRQ IRAQ A country in the Middle East, bordering the Persian Gulf, between Iran and Kuwait. Iraq Production C16704 C66786 Country ISL ISL ICELAND A country in Northern Europe, island between the Greenland Sea and the North Atlantic Ocean, northwest of the UK. Iceland Production C16760 C66786 Country ISR ISR ISRAEL A country in the Middle East, bordering the Mediterranean Sea, between Egypt and Lebanon. Israel Production C16761 C66786 Country ITA ITA ITALY A country in Southern Europe, occupying a peninsula extending into the central Mediterranean Sea, northeast of Tunisia. Italy Production C16763 C66786 Country JAM JAM JAMAICA An island in the Caribbean Sea, south of Cuba. Jamaica Production C16765 C66786 Country JOR JOR JORDAN A country in the Middle East, northwest of Saudi Arabia. Jordan Production C16764 C66786 Country JPN JPN JAPAN A country in Eastern Asia, occupying an island chain between the North Pacific Ocean and the Sea of Japan, east of the Korean Peninsula. Japan Production C64374 C66786 Country JRE JRE JERSEY Jersey and the other Channel Islands represent the last remnants of the medieval Dukedom of Normandy that held sway in both France and England. Jersey is a British crown dependency, but is not part of the UK. Jersey Production C20107 C66786 Country KAZ KAZ KAZAKHSTAN A country in Central Asia, northwest of China. Kazakhstan Production C16769 C66786 Country KEN KEN KENYA A country in Eastern Africa, bordering the Indian Ocean, between Somalia and Tanzania. Kenya Production C16771 C66786 Country KGZ KGZ KYRGYZSTAN A country in Central Asia, west of China. Kyrgyzstan Production C16378 C66786 Country KHM KHM CAMBODIA A country in Southeastern Asia, bordering the Gulf of Thailand, between Thailand, Vietnam, and Laos. Cambodia Production C16639 C66786 Country KIR KIR KIRIBATI A group of 33 coral atolls in the Pacific Ocean, straddling the equator; the capital Tarawa is about one-half of the way from Hawaii to Australia. Kiribati Production C17885 C66786 Country KNA KNA SAINT KITTS AND NEVIS Islands in the Caribbean Sea, about one-third of the way from Puerto Rico to Trinidad and Tobago. Saint Kitts and Nevis Production C16774 C66786 Country KOR KOR SOUTH KOREA A country in Eastern Asia, occupying the southern half of the Korean Peninsula, bordering the Sea of Japan and the Yellow Sea. South Korea Production C16775 C66786 Country KWT KWT KUWAIT A country in the Middle East, bordering the Persian Gulf, between Iraq and Saudi Arabia. Kuwait Production C16780 C66786 Country LAO LAO LAO PEOPLE'S DEMOCRATIC REPUBLIC A country in Southeastern Asia, northeast of Thailand, west of Vietnam. Lao People's Democratic Republic Production C16784 C66786 Country LBN LBN LEBANON A country in the Middle East, bordering the Mediterranean Sea, between Israel and Syria. Lebanon Production C16791 C66786 Country LBR LBR LIBERIA A country in Western Africa, bordering the North Atlantic Ocean, between Cote d'Ivoire and Sierra Leone. Liberia Production C16793 C66786 Country LBY LBY LIBYAN ARAB JAMAHIRIYA A country in Northern Africa, bordering the Mediterranean Sea, between Egypt and Tunisia. Libyan Arab Jamahiriya Production C17113 C66786 Country LCA LCA SAINT LUCIA A country in the Caribbean, occupying an island between the Caribbean Sea and North Atlantic Ocean, north of Trinidad and Tobago. Saint Lucia Production C16794 C66786 Country LIE LIE LIECHTENSTEIN A country in Central Europe, between Austria and Switzerland. Liechtenstein Production C17163 C66786 Country LKA LKA SRI LANKA A country in Southern Asia, occupying an island in the Indian Ocean, south of India. Sri Lanka Production C16787 C66786 Country LSO LSO LESOTHO A country in Southern Africa, an enclave of South Africa. Lesotho Production C16799 C66786 Country LTU LTU LITHUANIA A country in Eastern Europe, bordering the Baltic Sea, between Latvia and Russia. Lithuania Production C16803 C66786 Country LUX LUX LUXEMBOURG A country in Western Europe, between France, Belgium, and Germany. Luxembourg Production C16783 C66786 Country LVA LVA LATVIA A country in Eastern Europe, bordering the Baltic Sea, between Estonia and Lithuania. Latvia Production C16807 C66786 Country MAC MAC MACAO A country in Eastern Asia, bordering the South China Sea and China. Macao Production C16878 C66786 Country MAR MAR MOROCCO A country in Northern Africa, bordering the North Atlantic Ocean and the Mediterranean Sea, between Algeria and Western Sahara. Morocco Production C16874 C66786 Country MCO MCO MONACO A country in Western Europe, bordering the Mediterranean Sea on the southern coast of France, near the border with Italy. Monaco Production C16871 C66786 Country MDA MDA MOLDOVA, REPUBLIC OF A country in Eastern Europe, northeast of Romania. Moldova Production C16808 C66786 Country MDG MDG MADAGASCAR A country in Southern Africa, occupying an island in the Indian Ocean, east of Mozambique. Madagascar Production C16815 C66786 Country MDV MDV MALDIVES A country in Southern Asia, occupying a group of atolls in the Indian Ocean, south-southwest of India. Maldives Production C16850 C66786 Country MEX MEX MEXICO A country in Central America, bordering the Caribbean Sea and the Gulf of Mexico, between Belize and the US and bordering the North Pacific Ocean, between Guatemala and the US. Mexico Production C16822 C66786 Country MHL MHL MARSHALL ISLANDS A group of atolls and reefs in the North Pacific Ocean, about one-half of the way from Hawaii to Australia. Marshall Islands Production C17654 C66786 Country MKD MKD REPUBLIC OF MACEDONIA A country in Southeastern Europe, north of Greece. Republic of Macedonia Production C16816 C66786 Country MLI MLI MALI A country in Western Africa, southwest of Algeria. Mali Production C16817 C66786 Country MLT MLT MALTA A country in Southern Europe, occupying islands in the Mediterranean Sea, south of Sicily (Italy). Malta Production C16370 C66786 Country MMR MMR MYANMAR A country in Southeastern Asia, bordering the Andaman Sea and the Bay of Bengal, between Bangladesh and Thailand. Myanmar Production C64378 C66786 Country MNE MNE MONTENEGRO A republic in Southeastern Europe, bordering the Adriatic Sea, between Albania and Bosnia and Herzegovina. Formerly part of Serbia and Montenegro (Federation Republic of Yugoslavia). Montenegro Production C16875 C66786 Country MNG MNG MONGOLIA A country in Northern Asia, between China and Russia. Mongolia Production C17882 C66786 Country MNP MNP NORTHERN MARIANA ISLANDS A country in the Pacific, comprising islands in the North Pacific Ocean, about three-quarters of the way from Hawaii to the Philippines. Northern Mariana Islands Production C16882 C66786 Country MOZ MOZ MOZAMBIQUE A country in Southern Africa, bordering the Mozambique Channel, between South Africa and Tanzania. Mozambique Production C16826 C66786 Country MRT MRT MAURITANIA A country in Northern Africa, bordering the North Atlantic Ocean, between Senegal and Western Sahara. Mauritania Production C16876 C66786 Country MSR MSR MONTSERRAT A country in the Caribbean, occupying an island in the Caribbean Sea, southeast of Puerto Rico. Montserrat Production C16823 C66786 Country MTQ MTQ MARTINIQUE An island in the Caribbean Sea, north of Trinidad and Tobago. Martinique Production C16827 C66786 Country MUS MUS MAURITIUS A country in Southern Africa, occupying an island in the Indian Ocean, east of Madagascar. Mauritius Production C16813 C66786 Country MWI MWI MALAWI A country in Southern Africa, east of Zambia. Malawi Production C16814 C66786 Country MYS MYS MALAYSIA A country in Southeastern Asia, occupying a peninsula and the northern one-third of the island of Borneo, bordering Indonesia and the South China Sea, south of Vietnam. Malaysia Production C16828 C66786 Country MYT MYT MAYOTTE A country in Southern Africa, occupying an island in the Mozambique Channel, about one-half of the way from northern Madagascar to northern Mozambique. Mayotte Production C16891 C66786 Country NAM NAM NAMIBIA A country in Southern Africa, bordering the South Atlantic Ocean, between Angola and South Africa. Namibia Production C16913 C66786 Country NCL NCL NEW CALEDONIA A country in the Pacific, comprised of islands in the South Pacific Ocean, east of Australia. New Caledonia Production C16916 C66786 Country NER NER NIGER A country in Western Africa, southeast of Algeria. Niger Production C16919 C66786 Country NFK NFK NORFOLK ISLAND A country in the Pacific, occupying an island in the South Pacific Ocean, east of Australia. Norfolk Island Production C16917 C66786 Country NGA NGA NIGERIA A country in Western Africa, bordering the Gulf of Guinea, between Benin and Cameroon. Nigeria Production C16915 C66786 Country NIC NIC NICARAGUA A country in Central America, bordering both the Caribbean Sea and the North Pacific Ocean, between Costa Rica and Honduras. Nicaragua Production C16918 C66786 Country NIU NIU NIUE A country in the Pacific, occupying an island in the South Pacific Ocean, east of Tonga. Niue Production C16903 C66786 Country NLD NLD NETHERLANDS A country in Western Europe, bordering the North Sea, between Belgium and Germany. Netherlands Production C16920 C66786 Country NOR NOR NORWAY A country in Northern Europe, bordering the North Sea and the North Atlantic Ocean, west of Sweden. Norway Production C16901 C66786 Country NPL NPL NEPAL A country in Southern Asia, between China and India. Nepal Production C16896 C66786 Country NRU NRU NAURU A country in Oceania, occupying an island in the South Pacific Ocean, south of the Marshall Islands. Nauru Production C16914 C66786 Country NZL NZL NEW ZEALAND A country in the Pacific, comprised of islands in the South Pacific Ocean, southeast of Australia. New Zealand Production C16933 C66786 Country OMN OMN OMAN A country in the Middle East, bordering the Arabian Sea, Gulf of Oman, and Persian Gulf, between Yemen and the United Arab Emirates. Oman Production C16949 C66786 Country PAK PAK PAKISTAN A country in Southern Asia, bordering the Arabian Sea, between India on the east and Iran and Afghanistan on the west and China in the north. Pakistan Production C16951 C66786 Country PAN PAN PANAMA A country in Central America, bordering both the Caribbean Sea and the North Pacific Ocean, between Colombia and Costa Rica. Panama Production C16993 C66786 Country PCN PCN PITCAIRN A country in the Pacific, comprised of islands in the South Pacific Ocean, about midway between Peru and New Zealand. Pitcairn Island Production C16972 C66786 Country PER PER PERU A country in Western South America, bordering the South Pacific Ocean, between Chile and Ecuador. Peru Production C16978 C66786 Country PHL PHL PHILIPPINES A country in Southeastern Asia, comprised of an archipelago between the Philippine Sea and the South China Sea, east of Vietnam. Philippines Production C17733 C66786 Country PLW PLW PALAU A country in the Pacific, comprising a group of islands in the North Pacific Ocean, southeast of the Philippines. Palau Production C16952 C66786 Country PNG PNG PAPUA NEW GUINEA A country in Southeastern Asia, comprising a group of islands and including the eastern half of the island of New Guinea, between the Coral Sea and the South Pacific Ocean, east of Indonesia. Papua New Guinea Production C17002 C66786 Country POL POL POLAND A country in Central Europe, east of Germany. Poland Production C17043 C66786 Country PRI PRI PUERTO RICO An island between the Caribbean Sea and the North Atlantic Ocean, east of the Dominican Republic. Puerto Rico Production C16773 C66786 Country PRK PRK NORTH KOREA A country in Eastern Asia, occupying the northern half of the Korean Peninsula, bordering the Korea Bay and the Sea of Japan, between China and South Korea. North Korea Production C17006 C66786 Country PRT PRT PORTUGAL A country in Southwestern Europe, bordering the North Atlantic Ocean, west of Spain. Portugal Production C16953 C66786 Country PRY PRY PARAGUAY A country in Central South America, northeast of Argentina. Paraguay Production C20110 C66786 Country PSE PSE PALESTINIAN TERRITORY, OCCUPIED A collective name for the West Bank and the Gaza Strip, two territories in Palestine. Palestinian Territory, Occupied Production C16594 C66786 Country PYF PYF FRENCH POLYNESIA An archipelago in the South Pacific Ocean, about one-half of the way from South America to Australia. French Polynesia Production C17045 C66786 Country QAT QAT QATAR A country in the Middle East, occupying a peninsula bordering the Persian Gulf and Saudi Arabia. Qatar Production C17095 C66786 Country REU REU REUNION An Southern Africa, occupying an island in the Indian Ocean, east of Madagascar. Reunion Production C17108 C66786 Country ROU ROU ROMANIA A country in Southeastern Europe, bordering the Black Sea, between Bulgaria and Ukraine. Romania Production C17111 C66786 Country RUS RUS RUSSIAN FEDERATION A country in Northern Asia (that part west of the Urals is sometimes included with Europe), bordering the Arctic Ocean, between Europe and the North Pacific Ocean. Russia Production C17112 C66786 Country RWA RWA RWANDA A country in Central Africa, east of Democratic Republic of the Congo. Rwanda Production C17117 C66786 Country SAU SAU SAUDI ARABIA A country in the Middle East, bordering the Persian Gulf and the Red Sea, north of Yemen. Saudi Arabia Production C64377 C66786 Country SCG SCG SERBIA A republic in Southeastern Europe, bordering the Adriatic Sea, between Albania and Bosnia and Herzegovina. Formerly part of Serbia and Montenegro (Federation Republic of Yugoslavia). Serbia Production C17170 C66786 Country SDN SDN SUDAN A country in Northern Africa, bordering the Red Sea, between Egypt and Eritrea. Sudan Production C17121 C66786 Country SEN SEN SENEGAL A country in Western Africa, bordering the North Atlantic Ocean, between Guinea-Bissau and Mauritania. Senegal Production C17134 C66786 Country SGP SGP SINGAPORE A country in Southeastern Asia, comprised of islands between Malaysia and Indonesia. Singapore Production C20111 C66786 Country SGS SGS SOUTH GEORGIA AND THE SOUTH SANDWICH ISLANDS A group of islands in the South Atlantic Ocean, east of the tip of South America. South Georgia and the South Sandwich Islands Production C17164 C66786 Country SHN SHN SAINT HELENA Islands in the South Atlantic Ocean, about midway between South America and Africa. Saint Helena Production C17178 C66786 Country SJM SJM SVALBARD AND JAN MAYEN Islands between the Arctic Ocean, Barents Sea, Greenland Sea, and Norwegian Sea, northeast of Iceland and north of Norway. Svalbard and Jan Mayen Production C17148 C66786 Country SLB SLB SOLOMON ISLANDS A group of islands in the South Pacific Ocean, east of Papua New Guinea. Solomon Islands Production C17130 C66786 Country SLE SLE SIERRA LEONE A country in Western Africa, bordering the North Atlantic Ocean, between Guinea and Liberia. Sierra Leone Production C16532 C66786 Country SLV SLV EL SALVADOR A country in Central America, bordering the North Pacific Ocean, between Guatemala and Honduras. El Salvador Production C17115 C66786 Country SMR SMR SAN MARINO A country in Southern Europe, an enclave in central Italy. San Marino Production C17149 C66786 Country SOM SOM SOMALIA A country in Eastern Africa, bordering the Gulf of Aden and the Indian Ocean, east of Ethiopia. Somalia Production C17165 C66786 Country SPM SPM SAINT PIERRE AND MIQUELON A country in Northern North America, comprised of islands in the North Atlantic Ocean, south of Newfoundland (Canada). Saint Pierre and Miquelon Production C17116 C66786 Country STP STP SAO TOME AND PRINCIPE A country in Western Africa, comprised of islands in the Gulf of Guinea, straddling the Equator, west of Gabon. Sao Tome and Principe Production C17175 C66786 Country SUR SUR SURINAME A country in Northern South America, bordering the North Atlantic Ocean, between French Guiana and Guyana. Suriname Production C17669 C66786 Country SVK SVK SLOVAKIA A country in Central Europe, south of Poland. Slovakia Production C17138 C66786 Country SVN SVN SLOVENIA A country in Central Europe, bordering the Adriatic Sea, between Austria and Croatia. Slovenia Production C17180 C66786 Country SWE SWE SWEDEN A country in Northern Europe, bordering the Baltic Sea, Gulf of Bothnia, Kattegat, and Skagerrak, between Finland and Norway. Sweden Production C17179 C66786 Country SWZ SWZ SWAZILAND A country in Southern Africa, between Mozambique and South Africa. Swaziland Production C17129 C66786 Country SYC SYC SEYCHELLES A country in Eastern Africa, comprised of a group of islands in the Indian Ocean, northeast of Madagascar. Seychelles Production C17182 C66786 Country SYR SYR SYRIAN ARAB REPUBLIC A country in the Middle East, bordering the Mediterranean Sea, between Lebanon and Turkey. Syria Production C17224 C66786 Country TCA TCA TURKS AND CAICOS ISLANDS Two island groups in the North Atlantic Ocean, southeast of The Bahamas. Turks and Caicos Islands Production C16412 C66786 Country TCD TCD CHAD A country in Central Africa, south of Libya. Chad Production C17202 C66786 Country TGO TGO TOGO A country in Western Africa, bordering the Bight of Benin, between Benin and Ghana. Togo Production C17192 C66786 Country THA THA THAILAND A country in Southeastern Asia, bordering the Andaman Sea and the Gulf of Thailand, southeast of Burma. Thailand Production C17183 C66786 Country TJK TJK TAJIKISTAN A country in Central Asia, west of China. Tajikistan Production C17704 C66786 Country TKL TKL TOKELAU A group of three atolls in the South Pacific Ocean, about one-half of the way from Hawaii to New Zealand. Tokelau Production C17223 C66786 Country TKM TKM TURKMENISTAN A country in Central Asia, bordering the Caspian Sea, between Iran and Kazakhstan. Turkmenistan Production C17200 C66786 Country TLS TLS TIMOR-LESTE A country in Southeastern Asia, northwest of Australia in the Lesser Sunda Islands at the eastern end of the Indonesian archipelago. East Timor includes the eastern half of the island of Timor, the Oecussi (Ambeno) region on the northwest portion of the island of Timor, and the islands of Pulau Atauro and Pulau Jaco. Timor-Leste Production C17205 C66786 Country TON TON TONGA An archipelago in the South Pacific Ocean, about two-thirds of the way from Hawaii to New Zealand. Tonga Production C17217 C66786 Country TTO TTO TRINIDAD AND TOBAGO Islands between the Caribbean Sea and the North Atlantic Ocean, northeast of Venezuela. Trinidad and Tobago Production C17221 C66786 Country TUN TUN TUNISIA A country in Northern Africa, bordering the Mediterranean Sea, between Algeria and Libya. Tunisia Production C17222 C66786 Country TUR TUR TURKEY A country in southeastern Europe and southwestern Asia (that portion of Turkey west of the Bosporus is geographically part of Europe), bordering the Black Sea, between Bulgaria and Georgia, and bordering the Aegean Sea and the Mediterranean Sea, between Greece and Syria. Turkey Production C17225 C66786 Country TUV TUV TUVALU An island group consisting of nine coral atolls in the South Pacific Ocean, about one-half of the way from Hawaii to Australia. Tuvalu Production C17184 C66786 Country TWN TWN TAIWAN A group of islands bordering the East China Sea, Philippine Sea, South China Sea, and Taiwan Strait, north of the Philippines, off the southeastern coast of China. Taiwan Production C17185 C66786 Country TZA TZA TANZANIA, UNITED REPUBLIC OF A country in Eastern Africa, bordering the Indian Ocean, between Kenya and Mozambique. Tanzania Production C17228 C66786 Country UGA UGA UGANDA A country in Eastern Africa, west of Kenya. Uganda Production C17229 C66786 Country UKR UKR UKRAINE A country in Eastern Europe, bordering the Black Sea, between Poland and Russia. Ukraine Production C20112 C66786 Country UMI UMI UNITED STATES MINOR OUTLYING ISLANDS The U.S. Minor Outlying Islands consist of Baker Island, Howland Island, Jarvis Island, Johnston Atoll, Kingman Reef, Midway Island, Navassa Island, Palmyra Atoll, and Wake Island (Wake Atoll). United States Minor Outlying Islands Production C17244 C66786 Country URY URY URUGUAY A country in Southern South America, bordering the South Atlantic Ocean, between Argentina and Brazil. Uruguay Production C17234 C66786 Country USA USA UNITED STATES A country in North America, bordering both the North Atlantic Ocean and the North Pacific Ocean, between Canada and Mexico. United States Production C17246 C66786 Country UZB UZB UZBEKISTAN A country in Central Asia, north of Afghanistan. Uzbekistan Production C17249 C66786 Country VAT VAT VATICAN CITY STATE An enclave of Rome (Italy). Holy See Production C17114 C66786 Country VCT VCT SAINT VINCENT AND THE GRENADINES A country in the Caribbean, comprised of islands in the Caribbean Sea, north of Trinidad and Tobago. Saint Vincent and the Grenadines Production C17250 C66786 Country VEN VEN VENEZUELA A country in Northern South America, bordering the Caribbean Sea and the North Atlantic Ocean, between Colombia and Guyana. Venezuela Production C17653 C66786 Country VGB VGB VIRGIN ISLANDS,BRITISH Islands between the Caribbean Sea and the North Atlantic Ocean, east of Puerto Rico. British Virgin Islands Production C17255 C66786 Country VIR VIR VIRGIN ISLANDS, U.S. Islands between the Caribbean Sea and the North Atlantic Ocean, east of Puerto Rico. United States Virgin Islands Production C17252 C66786 Country VNM VNM VIETNAM A country in Southeastern Asia, bordering the Gulf of Thailand, Gulf of Tonkin, and South China Sea, alongside China, Laos, and Cambodia. Vietnam Production C17247 C66786 Country VUT VUT VANUATU A group of islands in the South Pacific Ocean, about three-quarters of the way from Hawaii to Australia. Vanuatu Production C17259 C66786 Country WLF WLF WALLIS AND FUTUNA Islands in the South Pacific Ocean, about two-thirds of the way from Hawaii to New Zealand. Wallis and Futuna Islands Production C17740 C66786 Country WSM WSM SAMOA A group of islands in the South Pacific Ocean, about one-half of the way from Hawaii to New Zealand. Samoa Production C17264 C66786 Country YEM YEM YEMEN A country in the Middle East, bordering the Arabian Sea, Gulf of Aden, and Red Sea, between Oman and Saudi Arabia. Yemen Production C17151 C66786 Country ZAF ZAF SOUTH AFRICA A country in Southern Africa, at the southern tip of the continent of Africa. South Africa Production C17267 C66786 Country ZMB ZMB ZAMBIA A country in Southern Africa, east of Angola. Zambia Production C17268 C66786 Country ZWE ZWE ZIMBABWE A country in Southern Africa, between South Africa and Zambia. Zimbabwe Production C66787 C66787 Yes Diagnosis Group TDIGRP TDIGRP Diagnosis Group A grouping of individuals on the basis of a shared procedure or disease, or lack thereof (e.g. healthy volunteers, type 2 diabetic subjects, subjects with renal cell cancer). Standardized naming systems are available that define the groups within which a subject should be placed. (NCI) CDISC SDTM Diagnosis Group Terminology Production C49651 C66787 Diagnosis Group HEALTHY SUBJECTS HEALTHY SUBJECTS An individual who is or becomes a participant in a research study and has no significant health-related issues. (NCI) Healthy Subject Production C66788 C66788 Yes Dictionary Name DICTNAM DICTNAM Dictionary Name; Name of Dictionary A name given to a reference source that lists words and gives their meaning. (NCI) CDISC SDTM Dictionary Name Terminology Production C49471 C66788 Dictionary Name COSTART COSTART Coding Symbols for a Thesaurus of Adverse Reaction Terms A terminology developed and used by the Food and Drug Administration (FDA) for the coding, filing and retrieving of post marketing adverse reaction reports. (NCI) Thesaurus of Adverse Reaction Term Coding Symbols Production C49474 C66788 Dictionary Name ICD ICD International Classification of Diseases A system of categories to which morbid entries are assigned according to established criteria. Included is the entire range of conditions in a manageable number of categories, grouped to facilitate mortality reporting. It is produced by the World Health Organization (from ICD-10, p1). The Clinical Modifications, produced by the United States Dept. of Health and Human Services, are larger extensions used for morbidity and general epidemiological purposes, primarily in the U.S. (MSH2005_2004_10_12) International Classification of Diseases Production C49476 C66788 Dictionary Name LOINC LOINC Logical Observation Identifiers Names and Codes Published by the The Regenstrief Institute, the Logical Observation Identifiers Names and Codes covers clinical and clinical laboratory terminology. (NCI) Logical Observation Identifiers Names and Codes Production C43820 C66788 Dictionary Name MedDRA MedDRA Medical Dictionary for Regulatory Activities MedDRA is an international medical terminology designed to support the classification, retrieval, presentation, and communication of medical information throughout the medical product regulatory cycle. MedDRA was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The MedDRA Maintenance and Support Services Organization (MSSO) holds a contract with the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) to maintain and support the implementation of the terminology. (NCI) MedDRA Production C53489 C66788 Dictionary Name SNOMED SNOMED Systematized Nomenclature of Medicine A multiaxial, hierarchical classification system for diseases in man developed by the College of American Pathologists. (NCI) Systematized Nomenclature of Medicine Production C49468 C66788 Dictionary Name WHOART WHOART World Health Organization Adverse Reaction Terms A terminology implemented by the World Health Organization to describe adverse reactions to a prescribed medication or treatment regimen. (NCI) World Health Organization Adverse Reaction Terminology Production C49475 C66788 Dictionary Name WHODD WHODD World Health Organization Drug Dictionary A reference source of drugs and drug associated information maintained by the World Health Organization. (NCI) World Health Organization Drug Dictionary Production C66789 C66789 No Not Done ND ND Not Done Indicates a task, process or examination that has either not been initiated or completed. (NCI) CDISC SDTM Not DoneTerminology Production C49484 C66789 Not Done NOT DONE NOT DONE Indicates a task, process or examination that has either not been initiated or completed. (NCI) Not Done Production C66790 C66790 Yes Patient Ethnic Group ETHNIC ETHNIC Patient Ethnic Group A social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences and often a common genetic heritage; these features may be reflected in their experience of health and disease. (NCI) CDISC SDTM Patient Ethnic GroupTerminology Production C17459 C66790 Patient Ethnic Group HISPANIC OR LATINO HISPANIC OR LATINO A person of Mexican, Puerto Rican, Cuban, Central or South American or other Spanish culture or origin, regardless of race. (NCI) Hispanic or Latino Production C41222 C66790 Patient Ethnic Group NOT HISPANIC OR LATINO NOT HISPANIC OR LATINO A person not of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. An arbitrary ethnic classification. (NCI) Not Hispanic or Latino Production C43234 C66790 Patient Ethnic Group NOT REPORTED NOT REPORTED Not reported Not provided or available Not Stated Production C17998 C66790 Patient Ethnic Group UNKNOWN UNKNOWN U; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown Production C66726 C66726 Yes Pharmaceutical Dosage Form FRM FRM Pharmaceutical Dosage Form; Dose Form The form of the completed pharmaceutical product, e.g. tablet, capsule, injection, elixir, suppository. Dosage form can have a significant effect on the onset, duration and intensity of the pharmacological action of a drug. A pharmaceutical dosage form controls the rate at which the drug is released into the biological fluids. This release rate affects its intrinsic absorption pattern and therefore, the bioavailability of the drug. CDISC SDTM Pharmaceutical Dosage FormTerminology Production C42887 C66726 Pharmaceutical Dosage Form AEROSOL AEROSOL A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols). (FDA) Aerosol Dosage Form Production C42888 C66726 Pharmaceutical Dosage Form AEROSOL, FOAM AEROSOL, FOAM A dosage form containing one or more active ingredients, surfactants, aqueous or non-aqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged. (FDA) Aerosol Foam Dosage Form Production C42960 C66726 Pharmaceutical Dosage Form AEROSOL, METERED AEROSOL, METERED A pressurized dosage form consisting of metered dose valves which allow for the delivery of a uniform quantity of spray upon each activation. (NCI) Metered Aerosol Dosage Form Production C42971 C66726 Pharmaceutical Dosage Form AEROSOL, POWDER AEROSOL, POWDER A product that is packaged under pressure and contains therapeutically active ingredients, in the form of a powder, that are released upon activation of an appropriate valve system. (NCI) Powder Aerosol Dosage Form Production C42889 C66726 Pharmaceutical Dosage Form AEROSOL, SPRAY AEROSOL, SPRAY An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents. (NCI) Aerosol Spray Dosage Form Production C42892 C66726 Pharmaceutical Dosage Form BAR, CHEWABLE BAR, CHEWABLE A solid dosage form usually in the form of a rectangle that is meant to be chewed. (NCI) Chewable Bar Dosage Form Production C42890 C66726 Pharmaceutical Dosage Form BEAD BEAD A solid dosage form in the shape of a small ball. (NCI) Bead Dosage Form Production C43451 C66726 Pharmaceutical Dosage Form BEAD, IMPLANT, EXTENDED RELEASE BEAD, IMPLANT, EXTENDED RELEASE A small sterile solid mass consisting of a highly purified drug intended for implantation in the body which would allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form. (NCI) Extended Release Bead Implant Dosage Form Production C42891 C66726 Pharmaceutical Dosage Form BLOCK BLOCK Solid dosage form, usually in the shape of a square or rectangle. (NCI) Block Dosage Form Production C25158 C66726 Pharmaceutical Dosage Form CAPSULE CAPSULE A solid pharmaceutical dosage form that contains medicinal agent within either a hard or soft soluble container or shell, usually used for the oral administration of medicine. The shells are made of a suitable form of gelatin or other substance. (NCI) Capsule Dosage Form Production C42895 C66726 Pharmaceutical Dosage Form CAPSULE, COATED CAPSULE, COATED A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated coating. (NCI) Coated Capsule Dosage Form Production C42896 C66726 Pharmaceutical Dosage Form CAPSULE, COATED PELLETS CAPSULE, COATED PELLETS A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which varying amounts of coating have been applied. (NCI) Coated Pellets in Capsule Dosage Form Production C42917 C66726 Pharmaceutical Dosage Form CAPSULE, COATED, EXTENDED RELEASE CAPSULE, COATED, EXTENDED RELEASE A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated coating, and which releases a drug (or drugs) in such a manner to allow at least a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. (NCI) Extended Release Coated Capsule Dosage Form Production C42902 C66726 Pharmaceutical Dosage Form CAPSULE, DELAYED RELEASE CAPSULE, DELAYED RELEASE A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms. (NCI) Delayed Release Capsule Dosage Form Production C42904 C66726 Pharmaceutical Dosage Form CAPSULE, DELAYED RELEASE PELLETS CAPSULE, DELAYED RELEASE PELLETS A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines. (NCI) Delayed Release Pellets in Capsule Dosage Form Production C42916 C66726 Pharmaceutical Dosage Form CAPSULE, EXTENDED RELEASE CAPSULE, EXTENDED RELEASE A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. (NCI) Extended Release Capsule Dosage Form Production C42928 C66726 Pharmaceutical Dosage Form CAPSULE, FILM COATED, EXTENDED RELEASE CAPSULE, FILM COATED, EXTENDED RELEASE A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; additionally, the capsule is covered in a designated film coating, and which releases a drug (or drugs) in such a manner to allow at least a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. (NCI) Extended Release Film Coated Capsule Dosage Form Production C42936 C66726 Pharmaceutical Dosage Form CAPSULE, GELATIN COATED CAPSULE, GELATIN COATED A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal. (NCI) Gelatin Coated Capsule Dosage Form Production C42954 C66726 Pharmaceutical Dosage Form CAPSULE, LIQUID FILLED CAPSULE, LIQUID FILLED A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle. (NCI) Liquid Filled Capsule Dosage Form Production C45414 C66726 Pharmaceutical Dosage Form CEMENT CEMENT A substance that serves to produce solid union between two surfaces. (NCI) Cement Dosage Form Production C42678 C66726 Pharmaceutical Dosage Form CIGARETTE CIGARETTE A narrow tube filled with material that is capable to burn with release of therapeutically-active substance(s) during the process of smoking. Cigarette is a very efficient drug-delivery inhaler system for fast-acting substances.(FDA) Cigarette Dosage Form Production C60884 C66726 Pharmaceutical Dosage Form CLOTH CLOTH A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing. (FDA) Cloth Dosage Form Production C60891 C66726 Pharmaceutical Dosage Form CONCENTRATE CONCENTRATE A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration. (NCI) Concentrate Dosage Form Production C42900 C66726 Pharmaceutical Dosage Form CONE CONE A solid dosage form bounded by a circular base and the surface formed by line segments joining every point of the boundary of the base to a common vertex. A cone (usually containing antibiotics) is normally placed below the gingiva after a dental extraction. (NCI) Cone Dosage Form Production C42919 C66726 Pharmaceutical Dosage Form CORE, EXTENDED RELEASE CORE, EXTENDED RELEASE An ocular system placed in the eye from which the drug diffuses through a membrane at a constant rate over a specified period. (NCI) Extended Release Core Dosage Form Production C28944 C66726 Pharmaceutical Dosage Form CREAM CREAM A semisolid emulsion of either the oil-in-water or the water-in-oil type, ordinarily intended for topical use. (NCI) Cream Dosage Form Production C60897 C66726 Pharmaceutical Dosage Form CREAM, AUGMENTED CREAM, AUGMENTED A cream dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered augmented. (FDA) Augmented Cream Dosage Form Production C42901 C66726 Pharmaceutical Dosage Form CRYSTAL CRYSTAL A naturally produced angular solid of definite form in which the ultimate units from which it is built up are systematically arranged; they are usually evenly spaced on a regular space lattice. Crystal Dosage Form Production C45415 C66726 Pharmaceutical Dosage Form CULTURE CULTURE The propagation of microorganisms or of living tissue cells in special media conducive to their growth. (NCI) Culture Dosage Form Production C47890 C66726 Pharmaceutical Dosage Form DIAPHRAGM DIAPHRAGM A device usually dome-shaped, worn during copulation over the cervical mouth for prevention of conception or infection. (NCI) Diaphragm Dosage Form Production C43525 C66726 Pharmaceutical Dosage Form DISC DISC A circular plate-like organ or structure. (FDA) Disc Dosage Form Production C42679 C66726 Pharmaceutical Dosage Form DOUCHE DOUCHE A liquid preparation, intended for the irrigative cleansing of the vagina, that is prepared from powders, liquid solutions, or liquid concentrates and contains one or more chemical substances dissolved in a suitable solvent or mutually miscible solvents. (NCI) Douche Dosage Form Production C42763 C66726 Pharmaceutical Dosage Form DRESSING DRESSING The application of various materials for protecting a wound.(FDA) Dressing Dosage Form Production C17423 C66726 Pharmaceutical Dosage Form DRUG DELIVERY SYSTEM DRUG DELIVERY SYSTEM Modern technology, distributed with or as a part of a drug product that allows for the uniform release or targeting of drugs to the body. (FDA) Drug Delivery System Production C42912 C66726 Pharmaceutical Dosage Form ELIXIR ELIXIR A clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use. (NCI) Elixir Dosage Form Production C42913 C66726 Pharmaceutical Dosage Form EMULSION EMULSION A dosage form consisting of a two-phase system comprised of at least two immiscible liquids (1), one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. Note 1: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. Note 2: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment. (NCI) Emulsion Dosage Form Production C42915 C66726 Pharmaceutical Dosage Form ENEMA ENEMA A rectal preparation for therapeutic, diagnostic, or nutritive purposes. (NCI) Enema Dosage Form Production C42929 C66726 Pharmaceutical Dosage Form EXTRACT EXTRACT A concentrated preparation of vegetable or animal drugs obtained by removal of the active constituents of the respective drugs with a suitable menstrua, evaporation of all or nearly all of the solvent, and adjustment of the residual masses or powders to the prescribed standards. (NCI) Extract Dosage Form Production C60926 C66726 Pharmaceutical Dosage Form FIBER, EXTENDED RELEASE FIBER, EXTENDED RELEASE A slender and elongated solid thread-like substance that delivers drug in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. (FDA) Extended Release Fiber Dosage Form Production C42932 C66726 Pharmaceutical Dosage Form FILM FILM A thin layer or coating. (NCI) Film Dosage Form Production C42920 C66726 Pharmaceutical Dosage Form FILM, EXTENDED RELEASE FILM, EXTENDED RELEASE A drug delivery system in the form of a film that releases the drug over an extended period in such a way as to maintain constant drug levels in the blood or target tissue. (NCI) Extended Release Film Dosage Form Production C42984 C66726 Pharmaceutical Dosage Form FILM, SOLUBLE FILM, SOLUBLE A thin layer or coating which is susceptible to being dissolved when in contact with a liquid. (NCI) Soluble Film Dosage Form Production C60927 C66726 Pharmaceutical Dosage Form FOR SOLUTION FOR SOLUTION A product, usually a solid, intended for solution prior to administration. (FDA) Dosage Form For Solution Production C60928 C66726 Pharmaceutical Dosage Form FOR SUSPENSION FOR SUSPENSION A product, usually a solid, intended for suspension prior to administration. (FDA) Dosage Form For Suspension Production C60929 C66726 Pharmaceutical Dosage Form FOR SUSPENSION, EXTENDED RELEASE FOR SUSPENSION, EXTENDED RELEASE A product, usually a solid, intended for suspension prior to administration; once the suspension is administered, the drug will be released at a constant rate over a specified period. (FDA) Extended Release Dosage Form For Suspension Production C42933 C66726 Pharmaceutical Dosage Form GAS GAS Any elastic aeriform fluid in which the molecules are separated from one another and have free paths. (NCI) Gas Dosage Form Production C42934 C66726 Pharmaceutical Dosage Form GEL GEL A semisolid (1) dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion (2). A gel may contain suspended particles. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: A colloidal dispersion is a system in which particles of colloidal dimension (i.e., typically between 1 nm and 1 micrometer) are distributed uniformly throughout a liquid. (NCI) Gel Dosage Form Production C42906 C66726 Pharmaceutical Dosage Form GEL, DENTIFRICE GEL, DENTIFRICE A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth. (NCI) Dentifrice Gel Dosage Form Production C60930 C66726 Pharmaceutical Dosage Form GEL, METERED GEL, METERED A gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity of gel upon each activation. (FDA) Metered Gel Dosage Form Production C48193 C66726 Pharmaceutical Dosage Form GENERATOR GENERATOR An apparatus for the formation of vapor or gas from a liquid or solid by heat or chemical action. The term GENERATOR also applies to radioactive columns from which radionuclides are provided. (NCI) Generator Dosage Form Production C42937 C66726 Pharmaceutical Dosage Form GLOBULE GLOBULE Also called pellets or pilules, are made of pure sucrose, lactose, or other polysaccharides. They are formed into small globular masses of various sizes, and are medicated by placing them in a vial and adding the liquid drug attenuation in the proportion not less than one percent (v/w). After shaking, the medicated globules are dried at temperatures not to exceed 40 degrees Centigrade. (NCI) Globule Dosage Form Production C45416 C66726 Pharmaceutical Dosage Form GRAFT GRAFT A slip of skin or of other tissue for implantation. (NCI) Graft Dosage Form Production C42938 C66726 Pharmaceutical Dosage Form GRANULE GRANULE A small particle or grain. (NCI) Granule Dosage Form Production C42903 C66726 Pharmaceutical Dosage Form GRANULE, DELAYED RELEASE GRANULE, DELAYED RELEASE A small medicinal particle or grain to which an enteric or other coating has been applied, thus delaying release of the drug until its passage into the intestines. (NCI) Delayed Release Granule Dosage Form Production C42909 C66726 Pharmaceutical Dosage Form GRANULE, EFFERVESCENT GRANULE, EFFERVESCENT A small particle or grain containing a medicinal agent in a dry mixture usually composed of sodium bicarbonate, citric acid, and tartaric acid which, when in contact with water, has the capability to release gas, resulting in effervescence. (NCI) Effervescent Granule Dosage Form Production C42939 C66726 Pharmaceutical Dosage Form GRANULE, FOR SOLUTION GRANULE, FOR SOLUTION A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient. (NCI) Granule For Solution Dosage Form Production C42940 C66726 Pharmaceutical Dosage Form GRANULE, FOR SUSPENSION GRANULE, FOR SUSPENSION A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing to form a suspension; the granules are so prepared to contain not only the medicinal agent, but the colorants, flavorants, and any other desired pharmaceutic ingredient. (NCI) Granule For Suspension Dosage Form Production C42921 C66726 Pharmaceutical Dosage Form GRANULE, FOR SUSPENSION, EXTENDED RELEASE GRANULE, FOR SUSPENSION, EXTENDED RELEASE A small medicinal particle or grain made available in its more stable dry form, to be reconstituted with solvent just before dispensing to form a suspension; the extended release system achieves slow release of the drug over an extended period of time and maintains constant drug levels in the blood or target tissue. (NCI) Extended Release Granule For Suspension Dosage Form Production C42941 C66726 Pharmaceutical Dosage Form GUM GUM A mucilaginous excretion from various plants. (NCI) Gum Dosage Form Production C42894 C66726 Pharmaceutical Dosage Form GUM, CHEWING GUM, CHEWING A sweetened and flavored insoluble plastic material of various shapes which when chewed, releases a drug substance into the oral cavity. (NCI) Chewing Gum Dosage Form Production C42978 C66726 Pharmaceutical Dosage Form GUM, RESIN GUM, RESIN Natural mixture of gum and resin, usually obtained as exudations from plants. (NCI) Resin Gum Dosage Form Production C42942 C66726 Pharmaceutical Dosage Form IMPLANT IMPLANT A material containing drug intended to be inserted securely and deeply in a living site for growth, slow release, or formation of an organic union. (NCI) Implant Dosage Form Production C42944 C66726 Pharmaceutical Dosage Form INHALANT INHALANT A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure, can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler. (NCI) Inhalant Dosage Form Production C60931 C66726 Pharmaceutical Dosage Form INJECTABLE, LIPOSOMAL INJECTABLE, LIPOSOMAL An injection, which either consists of or forms liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance). (FDA) Liposomal Injection Dosage Form Production C42946 C66726 Pharmaceutical Dosage Form INJECTION INJECTION A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP. (NCI) Injectable Dosage Form Production C42914 C66726 Pharmaceutical Dosage Form INJECTION, EMULSION INJECTION, EMULSION An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally.(FDA) Emulsion for Injection Dosage Form Production C42950 C66726 Pharmaceutical Dosage Form INJECTION, LIPID COMPLEX INJECTION, LIPID COMPLEX [definition pending](FDA) Injectable Lipid Complex Dosage Form Production C42974 C66726 Pharmaceutical Dosage Form INJECTION, POWDER, FOR SOLUTION INJECTION, POWDER, FOR SOLUTION A sterile preparation intended for reconstitution to form a solution for parenteral use. (NCI) Powder For Injectable Solution Dosage Form Production C42976 C66726 Pharmaceutical Dosage Form INJECTION, POWDER, FOR SUSPENSION INJECTION, POWDER, FOR SUSPENSION A sterile preparation intended for reconstitution to form a suspension for parenteral use. (NCI) Powder For Injectable Suspension Dosage Form Production C42977 C66726 Pharmaceutical Dosage Form INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE A dried preparation intended for reconstitution to form a suspension for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution).(FDA) Powder For Injectable Extended Release Suspension Dosage Form Production C42959 C66726 Pharmaceutical Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION A sterile freeze dried preparation intended for reconstitution for parenteral use which has been formulated in a manner that would allow liposomes (a lipid bilayer vesicle usually composed of phospholipids which is used to encapsulate an active drug substance, either within a lipid bilayer or in an aqueous space) to be formed upon reconstitution. (NCI) Lyophilized Powder For Injectable Liposomal Suspension Dosage Form Production C42957 C66726 Pharmaceutical Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION A dosage form intended for the solution prepared by lyophilization ('freeze drying'), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections. (NCI) Lyophilized Powder For Injectable Solution Dosage Form Production C42958 C66726 Pharmaceutical Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION A liquid preparation, intended for parenteral use, that contains solids suspended in a suitable fluid medium and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension are prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures. (NCI) Lyophilized Powder For Injectable Suspension Dosage Form Production C42956 C66726 Pharmaceutical Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION A sterile freeze dried preparation intended for reconstitution for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution). (NCI) Lyophilized Powder For Extended Release Injectable Suspension Dosage Form Production C42945 C66726 Pharmaceutical Dosage Form INJECTION, SOLUTION INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection. (NCI) Injectable Solution Dosage Form Production C42899 C66726 Pharmaceutical Dosage Form INJECTION, SOLUTION, CONCENTRATE INJECTION, SOLUTION A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections. (NCI) Concentrate for Injectable Solution Dosage Form Production C42995 C66726 Pharmaceutical Dosage Form INJECTION, SUSPENSION INJECTION, SOLUTION, CONCENTRATE A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa. (NCI) Injectable Suspension Dosage Form Production C42926 C66726 Pharmaceutical Dosage Form INJECTION, SUSPENSION, EXTENDED RELEASE INJECTION, SUSPENSION A sterile preparation intended for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form). (NCI) Injectable Extended Release Suspension Dosage Form Production C42951 C66726 Pharmaceutical Dosage Form INJECTION, SUSPENSION, LIPOSOMAL INJECTION, SUSPENSION, EXTENDED RELEASE A liquid parenteral pharmaceutical dosage form structured as a multilamellar composition of concentric phospholipid spheres that encapsulate the drug (drug delivery systems) separated by layers of water. Drug release is facilitated and controlled by in vivo erosion of the liposomes. To further increase the in vivo circulation time, liposomes in some preparations are covalently derivatized with PEG to produce PEGylated or stealth liposomes. Covalent attachment of drugs to the outer surface of liposomes can potentially serve as a delayed-release product. (NCI) Injectable Liposomal Suspension Dosage Form Production C42988 C66726 Pharmaceutical Dosage Form INJECTION, SUSPENSION, SONICATED INJECTION, SUSPENSION, SONICATED A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. In addition, the product is sonicated while a gas is bubbled through the suspension, and this results in the formation of microspheres by the solid particles. (NCI) Injectable Sonicated Suspension Dosage Form Production C60933 C66726 Pharmaceutical Dosage Form INSERT INSERT A specially formulated and shaped non-encapsulated solid preparation intended to be placed into a non-rectal orifice of the body, where drug is released, generally for localized effects. (FDA) Insert Dosage Form Production C42922 C66726 Pharmaceutical Dosage Form INSERT, EXTENDED RELEASE INSERT, EXTENDED RELEASE A specially formulated and shaped solid preparation (e.g., ring, tablet, or stick) intended to be placed in the vagina by special inserters, where the medication is released, generally for localized effects; the extended release preparation is designed to allow a reduction in dosing frequency. (NCI) Extended Release Insert Dosage Form Production C47915 C66726 Pharmaceutical Dosage Form INTRAUTERINE DEVICE INTRAUTERINE DEVICE A device inserted and left in the uterus to prevent effective conception. (NCI) Intrauterine Device Dosage Form Production C42947 C66726 Pharmaceutical Dosage Form IRRIGANT IRRIGANT A sterile solution intended to bathe or flush open wounds or body cavities; they're used topically, never parenterally. (NCI) Irrigant Dosage Form Production C42948 C66726 Pharmaceutical Dosage Form JELLY JELLY A class of gels--semisolid systems which consist of suspensions made up of either small inorganic particles or large organic molecules interpenetrated by a liquid--in which the structural coherent matrix contains a high portion of liquid, usually water. (NCI) Jelly Dosage Form Production C47916 C66726 Pharmaceutical Dosage Form KIT KIT A packaged collection of related material. (NCI) Kit Dosage Form Production C45413 C66726 Pharmaceutical Dosage Form LINER, DENTAL LINER, DENTAL A material applied to the inside of the dental cavity, for protection or insulation of the surface.(FDA) Dental Liner Dosage Form Production C42949 C66726 Pharmaceutical Dosage Form LINIMENT LINIMENT A solution or mixture of various substances in oil, alcoholic solutions of soap, or emulsions intended for external application. (NCI) Liniment Dosage Form Production C42952 C66726 Pharmaceutical Dosage Form LIPSTICK LIPSTICK A waxy solid, usually colored cosmetic, in stick form for the lips. (NCI) Lipstick Dosage Form Production C42953 C66726 Pharmaceutical Dosage Form LIQUID LIQUID A dosage form consisting of a pure chemical in its liquid state. This dosage form term should not be applied to solutions. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior.(FDA) Liquid Dosage Form Production C60934 C66726 Pharmaceutical Dosage Form LIQUID, EXTENDED RELEASE LIQUID, EXTENDED RELEASE A liquid that delivers a drug in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. (FDA) Extended Release Liquid Dosage Form Production C29167 C66726 Pharmaceutical Dosage Form LOTION LOTION An emulsion, liquid (1) dosage form. This dosage form is generally for external application to the skin (2). Note 1: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. Note 2: Previously the definition of a lotion was: The term lotion has been used to categorize many topical suspensions, solutions, and emulsions intended for application to the skin. The current definition of a lotion is restricted to an emulsion. (FDA) Lotion Dosage Form Production C60957 C66726 Pharmaceutical Dosage Form LOTION. AUGMENTED LOTION. AUGMENTED A lotion dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered augmented. (FDA) Augmented Lotion Dosage Form Production C60958 C66726 Pharmaceutical Dosage Form LOTION/SHAMPOO LOTION/SHAMPOO A lotion dosage form which has a soap or detergent that is usually used to clean the hair and scalp; it is often used as a vehicle for dermatologic agents. (FDA) Lotion Shampoo Dosage Form Production C42955 C66726 Pharmaceutical Dosage Form LOZENGE LOZENGE A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.(FDA) Lozenge Dosage Form Production C29269 C66726 Pharmaceutical Dosage Form MOUTHWASH MOUTHWASH An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect. (NCI) Mouthwash Dosage Form Production C48624 C66726 Pharmaceutical Dosage Form NOT APPLICABLE NOT APPLICABLE The use of a dosage form term is not relevant or appropriate. (NCI) Dosage Form Not Applicable Production C42965 C66726 Pharmaceutical Dosage Form OIL OIL An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils. (NCI) Oil Dosage Form Production C42966 C66726 Pharmaceutical Dosage Form OINTMENT OINTMENT A suspension or emulsion, semisolid (1) dosage form, usually containing < 20% water and volatiles (2) and > 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: Percent water and volatiles are measured by a loss on drying test in which the sample is heated at 105 degrees C until constant weight is achieved. (NCI) Ointment Dosage Form Production C60984 C66726 Pharmaceutical Dosage Form OINTMENT, AUGMENTED OINTMENT, AUGMENTED An ointment dosage form that enhances drug delivery. Augmentation does not refer to the strength of the drug in the dosage form. NOTE: CDER has decided to refrain from expanding the use of this dosage form due to difficulties in setting specific criteria that must be met to be considered augmented. (FDA) Augmented Ointment Dosage Form Production C47887 C66726 Pharmaceutical Dosage Form PACKING PACKING A material, usually covered by or impregnated with a drug, that is inserted into a body cavity or between the tooth enamel and the gingival margin.(FDA) Packing Dosage Form Production C42967 C66726 Pharmaceutical Dosage Form PASTE PASTE A semisolid dosage form, containing a large proportion (20 - 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes. Note: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. (NCI) Paste Dosage Form Production C42907 C66726 Pharmaceutical Dosage Form PASTE, DENTIFRICE PASTE, DENTIFRICE A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents. (NCI) Dentifrice Paste Dosage Form Production C60985 C66726 Pharmaceutical Dosage Form PASTILLE PASTILLE An aromatic preparation, often with a pleasing flavor, usually intended to dissolve in the mouth. (FDA) Pastille Dosage Form Production C42968 C66726 Pharmaceutical Dosage Form PATCH PATCH A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms Extended Release Film and System. (NCI) Patch Dosage Form Production C42923 C66726 Pharmaceutical Dosage Form PATCH, EXTENDED RELEASE PATCH, EXTENDED RELEASE A drug delivery system in the form of a patch that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form). (NCI) Extended Release Patch Dosage Form Production C42911 C66726 Pharmaceutical Dosage Form PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLED PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLED A drug delivery system in the form of a patch which is controlled by an electric current that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form). (NCI) Electrically Controlled Extended Release Patch Dosage Form Production C42969 C66726 Pharmaceutical Dosage Form PELLET PELLET A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding. (NCI) Pellet Dosage Form Production C42943 C66726 Pharmaceutical Dosage Form PELLET, IMPLANTABLE PELLET, IMPLANTABLE A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding; they are intended for implantation in the body (usually subcutaneously) for the purpose of providing continuous release of the drug over long periods of time. (NCI) Implantable Pellet Dosage Form Production C42918 C66726 Pharmaceutical Dosage Form PELLETS, COATED, EXTENDED RELEASE PELLETS, COATED, EXTENDED RELEASE A solid dosage form in which the drug itself is in the form of granules to which varying amounts of coating have been applied, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form. (NCI) Extended Release Coated Pellets Dosage Form Production C25394 C66726 Pharmaceutical Dosage Form PILL PILL A dose of medicine in the form of a small pellet. (NCI) Pill Dosage Form Production C42970 C66726 Pharmaceutical Dosage Form PLASTER PLASTER Substance intended for external application made of such materials and of such consistency as to adhere to the skin and attach to a dressing; plasters are intended to afford protection and support and/or to furnish an occlusion and macerating action and to bring medication into close contact with the skin. (NCI) Plaster Dosage Form Production C47913 C66726 Pharmaceutical Dosage Form POULTICE POULTICE A soft, moist mass of meal, herbs, seed, etc., usually applied hot in cloth that consists of gruel-like consistency. (NCI) Poultice Dosage Form Production C42972 C66726 Pharmaceutical Dosage Form POWDER POWDER An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. (NCI) Powder Dosage Form Production C42908 C66726 Pharmaceutical Dosage Form POWDER, DENTIFRICE POWDER, DENTIFRICE A powder formulation intended to clean and/or polish the teeth, and which may contain certain additional agents. (NCI) Dentifrice Powder Dosage Form Production C42973 C66726 Pharmaceutical Dosage Form POWDER, FOR SOLUTION POWDER, FOR SOLUTION An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution. (NCI) Powder for Solution Dosage Form Production C42975 C66726 Pharmaceutical Dosage Form POWDER, FOR SUSPENSION POWDER, FOR SUSPENSION An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle). (NCI) Powder for Suspension Dosage Form Production C42961 C66726 Pharmaceutical Dosage Form POWDER, METERED POWDER, METERED A powder dosage form that is situated inside a container that has a mechanism to deliver a specified quantity. (NCI) Metered Powder Dosage Form Production C60988 C66726 Pharmaceutical Dosage Form RING RING A small circular object with a vacant circular center that is usually intended to be placed in the body by special inserters, where the medication is released, generally for localized effects. (FDA) Ring Dosage Form Production C42979 C66726 Pharmaceutical Dosage Form RINSE RINSE A liquid used to cleanse by flushing. (NCI) Rinse Dosage Form Production C42980 C66726 Pharmaceutical Dosage Form SALVE SALVE A thick ointment or cerate (a fat or wax based preparation with a consistency between an ointment and a plaster). (NCI) Salve Dosage Form Production C42981 C66726 Pharmaceutical Dosage Form SHAMPOO SHAMPOO A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents. (NCI) Shampoo Dosage Form Production C42982 C66726 Pharmaceutical Dosage Form SHAMPOO, SUSPENSION SHAMPOO, SUSPENSION A liquid soap or detergent containing one or more solid, insoluble substances dispersed in a liquid vehicle that is used to clean the hair and scalp and is often used as a vehicle for dermatologic agents. (NCI) Shampoo Suspension Dosage Form Production C42983 C66726 Pharmaceutical Dosage Form SOAP SOAP Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic. (NCI) Soap Dosage Form Production C42986 C66726 Pharmaceutical Dosage Form SOLUTION SOLUTION A clear, homogeneous liquid dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. (NCI) Solution Dosage Form Production C42898 C66726 Pharmaceutical Dosage Form SOLUTION, CONCENTRATE SOLUTION, CONCENTRATE A liquid preparation (i.e., a substance that flows readily in its natural state) that contains a drug dissolved in a suitable solvent or mixture of mutually miscible solvents; the drug has been strengthened by the evaporation of its non-active parts. (NCI) Concentrate for Solution Dosage Form Production C42987 C66726 Pharmaceutical Dosage Form SOLUTION, FOR SLUSH SOLUTION, FOR SLUSH A solution for the preparation of an iced saline slush, which is administered by irrigation and used to induce regional hypothermia (in conditions such as certain open heart and kidney surgical procedures) by its direct application. (NCI) Solution For Slush Dosage Form Production C60994 C66726 Pharmaceutical Dosage Form SOLUTION, GEL FORMING / DROPS SOLUTION, GEL FORMING / DROPS A solution, which after usually being administered in a drop-wise fashion, forms a gel. (FDA) Gel Forming Drops Solution Dosage Form Production C42935 C66726 Pharmaceutical Dosage Form SOLUTION, GEL FORMING, EXTENDED RELEASE SOLUTION, GEL FORMING, EXTENDED RELEASE A solution that forms a gel when it comes in contact with ocular fluid, and which allows at least a reduction in dosing frequency Extended Release Gel Forming Solution Dosage Form Production C60992 C66726 Pharmaceutical Dosage Form SOLUTION/ DROPS SOLUTION/ DROPS A solution which is usually administered in a drop-wise fashion. (FDA) Drops Solution Dosage Form Production C47912 C66726 Pharmaceutical Dosage Form SPONGE SPONGE A porous, interlacing, absorbent material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape.(FDA) Sponge Dosage Form Production C42989 C66726 Pharmaceutical Dosage Form SPRAY SPRAY A liquid minutely divided as by a jet of air or steam. (NCI) Spray Dosage Form Production C42962 C66726 Pharmaceutical Dosage Form SPRAY, METERED SPRAY, METERED A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation. (NCI) Metered Spray Dosage Form Production C42990 C66726 Pharmaceutical Dosage Form SPRAY, SUSPENSION SPRAY, SUSPENSION A liquid preparation containing solid particles dispersed in a liquid vehicle and in the form of coarse droplets or as finely divided solids to be applied locally, most usually to the nasal-pharyngeal tract, or topically to the skin. (NCI) Spray Suspension Dosage Form Production C42991 C66726 Pharmaceutical Dosage Form STICK STICK A dosage form prepared in a relatively long and slender often cylindrical form. (NCI) Stick Dosage Form Production C47914 C66726 Pharmaceutical Dosage Form STRIP STRIP A long narrow piece of material. Strip Dosage Form Production C42993 C66726 Pharmaceutical Dosage Form SUPPOSITORY SUPPOSITORY A solid body of various weights and shapes, adapted for introduction into the rectal, vaginal, or urethral orifice of the human body; they usually melt, soften, or dissolve at body temperature. (NCI) Suppository Dosage Form Production C42924 C66726 Pharmaceutical Dosage Form SUPPOSITORY, EXTENDED RELEASE SUPPOSITORY, EXTENDED RELEASE A drug delivery system in the form of a suppository that allows at least a reduction in dosing frequency. (NCI) Extended Release Suppository Dosage Form Production C42994 C66726 Pharmaceutical Dosage Form SUSPENSION SUSPENSION A liquid dosage form that contains solid particles dispersed in a liquid vehicle. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior.(FDA) Suspension Dosage Form Production C42925 C66726 Pharmaceutical Dosage Form SUSPENSION, EXTENDED RELEASE SUSPENSION, EXTENDED RELEASE A liquid preparation consisting of solid particles dispersed throughout a liquid phase in which the particles are not soluble; the suspension has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form). (NCI) Extended Release Suspension Dosage Form Production C60995 C66726 Pharmaceutical Dosage Form SUSPENSION/DROPS SUSPENSION/DROPS A suspension which is usually administered in a dropwise fashion. (FDA) Drops Suspension Dosage Form Production C47889 C66726 Pharmaceutical Dosage Form SUTURE SUTURE A strand or fiber used to hold wound edges in apposition during healing. (NCI) Suture Dosage Form Production C47898 C66726 Pharmaceutical Dosage Form SWAB SWAB A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing. (NCI) Swab Dosage Form Production C42996 C66726 Pharmaceutical Dosage Form SYRUP SYRUP An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions. (NCI) Syrup Dosage Form Production C42998 C66726 Pharmaceutical Dosage Form TABLET TABLET A solid dosage form containing medicinal substances with or without suitable diluents. (NCI) Tablet Dosage Form Production C42893 C66726 Pharmaceutical Dosage Form TABLET, CHEWABLE TABLET, CHEWABLE A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste. (NCI) Chewable Tablet Dosage Form Production C42897 C66726 Pharmaceutical Dosage Form TABLET, COATED TABLET, COATED A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating. (NCI) Coated Tablet Dosage Form Production C60997 C66726 Pharmaceutical Dosage Form TABLET, COATED PARTICLES TABLET, COATED PARTICLES A solid dosage form containing a conglomerate of medicinal particles that have each been covered with a coating. (FDA) Tablet Coated Particles Dosage Form Production C42905 C66726 Pharmaceutical Dosage Form TABLET, DELAYED RELEASE TABLET, DELAYED RELEASE A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms. (NCI) Delayed Release Tablet Dosage Form Production C42997 C66726 Pharmaceutical Dosage Form TABLET, DELAYED RELEASE PARTICLES TABLET, DELAYED RELEASE PARTICLES A solid dosage form containing a conglomerate of medicinal particles that have been covered with a coating which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms. (NCI) Delayed Release Particles Tablet Dosage Form Production C42910 C66726 Pharmaceutical Dosage Form TABLET, EFFERVESCENT TABLET, EFFERVESCENT A solid dosage form containing mixtures of acids (e.g., citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water; it is intended to be dissolved or dispersed in water before administration.(FDA) Effervescent Tablet Dosage Form Production C42927 C66726 Pharmaceutical Dosage Form TABLET, EXTENDED RELEASE TABLET, EXTENDED RELEASE A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form. (NCI) Extended Release Tablet Dosage Form Production C42931 C66726 Pharmaceutical Dosage Form TABLET, FILM COATED TABLET, FILM COATED A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer. (NCI) Film Coated Tablet Dosage Form Production C42930 C66726 Pharmaceutical Dosage Form TABLET, FILM COATED, EXTENDED RELEASE TABLET, FILM COATED, EXTENDED RELEASE A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion. (NCI) Film Coated Extended Release Tablet Dosage Form Production C61004 C66726 Pharmaceutical Dosage Form TABLET, FOR SOLUTION TABLET, FOR SOLUTION A tablet that forms a solution when placed in a liquid. (FDA) Tablet For Solution Dosage Form Production C61005 C66726 Pharmaceutical Dosage Form TABLET, FOR SUSPENSION TABLET, FOR SUSPENSION; TABLET, DISPERSIBLE A tablet that forms a suspension when placed in a liquid (formerly referred to as a Dispersible Tablet). Tablet For Suspension Dosage Form Production C42964 C66726 Pharmaceutical Dosage Form TABLET, MULTILAYER TABLET, MULTILAYER A solid dosage form containing medicinal substances that have been compressed to form a multiple-layered tablet or a tablet-within-a-tablet, the inner tablet being the core and the outer portion being the shell. (NCI) Multilayered Tablet Dosage Form Production C42963 C66726 Pharmaceutical Dosage Form TABLET, MULTILAYER, EXTENDED RELEASE TABLET, MULTILAYER, EXTENDED RELEASE A solid dosage form containing medicinal substances that have been compressed to form a multiple-layered tablet or a tablet-within-a-tablet, the inner tablet being the core and the outer portion being the shell, which, additionally, is covered in a designated coating; the tablet is formulated in such manner as to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form. (NCI) Multilayered Extended Release Tablet Dosage Form Production C42999 C66726 Pharmaceutical Dosage Form TABLET, ORALLY DISINTEGRATING TABLET, ORALLY DISINTEGRATING A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue. (NCI) Orally Disintegrating Tablet Dosage Form Production C61006 C66726 Pharmaceutical Dosage Form TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue, but which releases a drug (or drugs) at a time other than promptly after administration. (FDA) Tablet Orally Disintegrating Delayed Release Dosage Form Production C42985 C66726 Pharmaceutical Dosage Form TABLET, SOLUBLE TABLET, SOLUBLE A solid dosage form that contains medicinal substances with or without suitable diluents and possesses the ability to dissolve in fluids. (NCI) Soluble Tablet Dosage Form Production C42992 C66726 Pharmaceutical Dosage Form TABLET, SUGAR COATED TABLET, SUGAR COATED A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a colored or an uncolored water-soluble sugar. (NCI) Sugar Coated Tablet Dosage Form Production C47892 C66726 Pharmaceutical Dosage Form TAMPON TAMPON A plug made of cotton, sponge, or oakum variously used in surgery to plug the nose, vagina, etc., for the control of hemorrhage or the absorption of secretions. (NCI) Tampon Dosage Form Production C47897 C66726 Pharmaceutical Dosage Form TAPE TAPE A narrow woven fabric, or a narrow extruded synthetic (such as plastic), usually with an adhesive on one or both sides. (NCI) Tape Dosage Form Production C43000 C66726 Pharmaceutical Dosage Form TINCTURE TINCTURE An alcoholic or hydroalcoholic solution prepared from vegetable materials or from chemical substances. (NCI) Tincture Dosage Form Production C43001 C66726 Pharmaceutical Dosage Form TROCHE TROCHE A discoid-shaped solid containing the medicinal agent in a suitably flavored base; troches are placed in the mouth where they slowly dissolve, liberating the active ingredients. (NCI) Troche Dosage Form Production C43002 C66726 Pharmaceutical Dosage Form UNASSIGNED UNASSIGNED A dosage form has yet to be assigned. (NCI) Unassigned Dosage Form Production C43003 C66726 Pharmaceutical Dosage Form WAFER WAFER A thin slice of material containing a medicinal agent. (NCI) Wafer Dosage Form Production C66727 C66727 Yes Completion/Reason for Non-Completion NCOMPLT NCOMPLT Completion/Reason for Non-Completion The reason that a subject was discontinued from a clinical trial. CDISC SDTM Reason for Non-Completion Terminology Production C41331 C66727 Completion/Reason for Non-Completion ADVERSE EVENT ADVERSE EVENT Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom,or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. NOTE: For further information, see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. “[Modified from ICH E2A]” Synonyms: side effect, adverse experience. See also serious adverse event, serious adverse experience. (CDISC glossary) Adverse Event Production C25250 C66727 Completion/Reason for Non-Completion COMPLETED COMPLETED To possess every necessary or normal part or component or step; having come or been brought to a conclusion. (NCI) Complete Production C28554 C66727 Completion/Reason for Non-Completion DEATH DEATH The absence of life or state of being dead. (NCI) Death Production C48226 C66727 Completion/Reason for Non-Completion LACK OF EFFICACY LACK OF EFFICACY The lack of expected or desired effect related to a therapy. (NCI) Lack of Efficacy Production C48227 C66727 Completion/Reason for Non-Completion LOST TO FOLLOW-UP LOST TO FOLLOW-UP The loss or lack of continuation of follow-up after a study has officially closed. See Follow-up. (NCI) Lost To Follow-up Production C49631 C66727 Completion/Reason for Non-Completion NON-COMPLIANCE WITH STUDY DRUG NON-COMPLIANCE WITH STUDY DRUG An indication that a subject has not agreed with or followed the instructions related to the study medication. (NCI) Non-Compliance With Study Drug Production C17649 C66727 Completion/Reason for Non-Completion OTHER OTHER Other Different than the one(s) previously specified or mentioned. (NCI) Other Production C48250 C66727 Completion/Reason for Non-Completion PHYSICIAN DECISION PHYSICIAN DECISION A position, opinion or judgment reached after consideration by a physician with reference to subject. (NCI) Physician Decision Production C25742 C66727 Completion/Reason for Non-Completion PREGNANCY PREGNANCY Pregnancy is the state or condition of having a developing embryo or fetus in the body (uterus), after union of an ovum and spermatozoon, during the period from conception to birth. (NCI) Pregnancy Production C35571 C66727 Completion/Reason for Non-Completion PROGRESSIVE DISEASE PROGRESSIVE DISEASE A disease process that is increasing in scope or severity. (NCI) Progressive Disease Production C48251 C66727 Completion/Reason for Non-Completion PROTOCOL VIOLATION PROTOCOL VIOLATION An event or decision that stands in contrast to the guidelines set out by the protocol. (NCI) Protocol Violation Production C25746 C66727 Completion/Reason for Non-Completion RECOVERY RECOVERY A healing process and/or an outcome implying relative health. The term is typically used in the context of direct and indirect effects of sickness or injury. (NCI) Recovery Production C49628 C66727 Completion/Reason for Non-Completion SCREEN FAILURE SCREEN FAILURE The potential subject who does not meet one or more criteria required for participation in a trial. Trial Screen Failure Production C49632 C66727 Completion/Reason for Non-Completion STUDY TERMINATED BY SPONSOR STUDY TERMINATED BY SPONSOR An indication that a clinical study was stopped by its sponsor. (NCI) Study Terminated By Sponsor Production C49633 C66727 Completion/Reason for Non-Completion TECHNICAL PROBLEMS TECHNICAL PROBLEMS A problem with some technical aspect of a clinical study, usually related to an instrument. (NCI) Technical Problem Production C49634 C66727 Completion/Reason for Non-Completion WITHDRAWAL BY SUBJECT WITHDRAWAL BY SUBJECT An indication that a study participant has removed itself from the study. (NCI) Withdrawal by Subject Production C66728 C66728 No Relation to Reference Period STENRF STENRF Relation to Reference Period The name of a code list that contains terms that reference timepoints within and without a defined time period. CDISC SDTM Relation to Reference Period Terminology Production C38008 C66728 Relation to Reference Period AFTER AFTER The time period following a point or another period of time. (NCI) Status Post Production C25629 C66728 Relation to Reference Period BEFORE BEFORE Earlier in time or order. (NCI) Prior Production C25490 C66728 Relation to Reference Period DURING DURING At some point in a given period of time. (NCI) During Production C49640 C66728 Relation to Reference Period DURING/AFTER DURING/AFTER Within a certain period of time or after a certain point or period in time. (NCI) During Or After Production C17998 C66728 Relation to Reference Period U UNKNOWN U; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown Production C66729 C66729 Yes Route of Administration ROUTE ROUTE Route of Administration The course by which a substance was administered in order to reach the site of action in the body. CDISC SDTM Route of Administration Terminology Production C38192 C66729 Route of Administration AURICULAR (OTIC) AURICULAR (OTIC) Administration to or by way of the ear.(FDA) Auricular Route of Administration Production C38193 C66729 Route of Administration BUCCAL BUCCAL Administration directed toward the cheek, generally from within the mouth.(FDA) Buccal Route of Administration Production C38194 C66729 Route of Administration CONJUNCTIVAL CONJUNCTIVAL Administration to the conjunctiva, the delicate membrane that lines the eyelids and covers the exposed surface of the eyeball.(FDA) Conjunctival Route of Administration Production C38675 C66729 Route of Administration CUTANEOUS CUTANEOUS Administration to the skin.(FDA) Cutaneous Route of Administration Production C38197 C66729 Route of Administration DENTAL DENTAL Administration to a tooth or teeth.(FDA) Dental Route of Administration Production C38633 C66729 Route of Administration ELECTRO-OSMOSIS ELECTRO-OSMOSIS Administration of through the diffusion of substance through a membrane in an electric field.(FDA) Electro-osmosis Route of Administration Production C38205 C66729 Route of Administration ENDOCERVICAL ENDOCERVICAL Administration within the canal of the cervix uteri. Synonymous with the term intracervical.(FDA) Endocervical Route of Administration Production C38206 C66729 Route of Administration ENDOSINUSIAL ENDOSINUSIAL Administration within the nasal sinuses of the head.(FDA) Endosinusial Route of Administration Production C38208 C66729 Route of Administration ENDOTRACHEAL ENDOTRACHEAL Administration directly into the trachea. Synonymous with the term intratracheal.(FDA) Endotracheal Route of Administration Production C38209 C66729 Route of Administration ENTERAL ENTERAL Administration directly into the intestines.(FDA) Enteral Route of Administration Production C38210 C66729 Route of Administration EPIDURAL EPIDURAL Administration upon or over the dura mater.(FDA) Epidural Route of Administration Production C38211 C66729 Route of Administration EXTRA-AMNIOTIC EXTRA-AMNIOTIC Administration to the outside of the membrane enveloping the fetus.(FDA) Extraamniotic Route of Administration Production C38212 C66729 Route of Administration EXTRACORPOREAL EXTRACORPOREAL Administration outside of the body.(FDA) Extracorporeal Circulation Route of Administration Production C38200 C66729 Route of Administration HEMODIALYSIS HEMODIALYSIS Administration through hemodialysate fluid.(FDA) Administration Via Hemodialysis Production C38215 C66729 Route of Administration INFILTRATION INFILTRATION Administration that results in substances passing into tissue spaces or into cells.(FDA) Infiltration Route of Administration Production C38219 C66729 Route of Administration INTERSTITIAL INTERSTITIAL Administration to or in the interstices of a tissue.(FDA) Interstitial Route of Administration Production C38220 C66729 Route of Administration INTRA-ABDOMINAL INTRA-ABDOMINAL Administration within the abdomen.(FDA) Intraabdominal Route of Administration Production C38221 C66729 Route of Administration INTRA-AMNIOTIC INTRA-AMNIOTIC Administration within the amnion.(FDA) Intraamniotic Route of Administration Production C38222 C66729 Route of Administration INTRA-ARTERIAL INTRA-ARTERIAL Administration within an artery or arteries.(FDA) Intraarterial Route of Administration Production C38223 C66729 Route of Administration INTRA-ARTICULAR INTRA-ARTICULAR Administration within a joint.(FDA) Intraarticular Route of Administration Production C38224 C66729 Route of Administration INTRABILIARY INTRABILIARY Administration within the bile, bile ducts or gallbladder.(FDA) Intrabiliary Route of Administration Production C38225 C66729 Route of Administration INTRABRONCHIAL INTRABRONCHIAL Administration within a bronchus.(FDA) Intrabronchial Route of Administration Production C38226 C66729 Route of Administration INTRABURSAL INTRABURSAL Administration within a bursa.(FDA) Intrabursal Route of Administration Production C38227 C66729 Route of Administration INTRACARDIAC INTRACARDIAC Administration within the heart.(FDA) Intracardiac Route of Administration Production C38228 C66729 Route of Administration INTRACARTILAGINOUS INTRACARTILAGINOUS Administration within a cartilage; endochondral.(FDA) Intracartilaginous Route of Administration Production C38229 C66729 Route of Administration INTRACAUDAL INTRACAUDAL Administration within the cauda equina.(FDA) Intracaudal Route of Administration Production C38230 C66729 Route of Administration INTRACAVERNOUS INTRACAVERNOUS Administration within a pathologic cavity, such as occurs in the lung in tuberculosis.(FDA) Intracavernous Route of Administration Production C38231 C66729 Route of Administration INTRACAVITARY INTRACAVITARY Administration within a non-pathologic cavity, such as that of the cervix, uterus, or penis, or such as that is formed as the result of a wound.(FDA) Intracavitary Route of Administration Production C38232 C66729 Route of Administration INTRACEREBRAL INTRACEREBRAL Administration within the cerebrum.(FDA) Intracerebral Route of Administration Production C38233 C66729 Route of Administration INTRACISTERNAL INTRACISTERNAL Administration within the cisterna magna cerebellomedularis.(FDA) Intracisternal Route of Administration Production C38234 C66729 Route of Administration INTRACORNEAL INTRACORNEAL Administration within the cornea (the transparent structure forming the anterior part of the fibrous tunic of the eye).(FDA) Intracorneal Route of Administration Production C38217 C66729 Route of Administration INTRACORONAL, DENTAL INTRACORONAL, DENTAL Administration of a drug within a portion of a tooth which is covered by enamel and which is separated from the roots by a slightly constricted region known as the neck.(FDA) Intracoronal Dental Route of Administration Production C38218 C66729 Route of Administration INTRACORONARY INTRACORONARY Administration within the coronary arteries.(FDA) Intracoronary Route of Administration Production C38235 C66729 Route of Administration INTRACORPORUS CAVERNOSUM INTRACORPORUS CAVERNOSUM Administration within the dilatable spaces of the corporus cavernosa of the penis.(FDA) Intracorporus Cavernosum Route of Administration Production C38238 C66729 Route of Administration INTRADERMAL INTRADERMAL Administration within the dermis.(FDA) Intradermal Route of Administration Production C38239 C66729 Route of Administration INTRADISCAL INTRADISCAL Administration within a disc.(FDA) Intradiscal Route of Administration Production C38240 C66729 Route of Administration INTRADUCTAL INTRADUCTAL Administration within the duct of a gland.(FDA) Intraductal Route of Administration Production C38241 C66729 Route of Administration INTRADUODENAL INTRADUODENAL Administration within the duodenum.(FDA) Intraduodenal Route of Administration Production C38242 C66729 Route of Administration INTRADURAL INTRADURAL Administration within or beneath the dura.(FDA) Intradural Route of Administration Production C38243 C66729 Route of Administration INTRAEPIDERMAL INTRAEPIDERMAL Administration within the epidermis.(FDA) Intraepidermal Route of Administration Production C38245 C66729 Route of Administration INTRAESOPHAGEAL INTRAESOPHAGEAL Administration within the esophagus.(FDA) Intraesophageal Route of Administration Production C38246 C66729 Route of Administration INTRAGASTRIC INTRAGASTRIC Administration within the stomach.(FDA) Intragastric Route of Administration Production C38247 C66729 Route of Administration INTRAGINGIVAL INTRAGINGIVAL Administration within the gingivae.(FDA) Intragingival Route of Administration Production C38249 C66729 Route of Administration INTRAILEAL INTRAILEAL Administration within the distal portion of the small intestine, from the jejunum to the cecum.(FDA) Intraileal Route of Administration Production C38250 C66729 Route of Administration INTRALESIONAL INTRALESIONAL Administration within or introduced directly into a localized lesion.(FDA) Intralesional Route of Administration Production C38251 C66729 Route of Administration INTRALUMINAL INTRALUMINAL Administration within the lumen of a tube.(FDA) Intraluminal Route of Administration Production C38252 C66729 Route of Administration INTRALYMPHATIC INTRALYMPHATIC Administration within the lymph.(FDA) Intralymphatic Route of Administration Production C38253 C66729 Route of Administration INTRAMEDULLARY INTRAMEDULLARY Administration within the marrow cavity of a bone.(FDA) Intramedullary Route of Administration Production C38254 C66729 Route of Administration INTRAMENINGEAL INTRAMENINGEAL Administration within the meninges (the three membranes that envelope the brain and spinal cord).(FDA) Intrameningeal Route of Administration Production C28161 C66729 Route of Administration INTRAMUSCULAR INTRAMUSCULAR Administration within a muscle. (FDA) Intramuscular Route of Administration Production C38255 C66729 Route of Administration INTRAOCULAR INTRAOCULAR Administration within the eye.(FDA) Intraocular Route of Administration Production C38256 C66729 Route of Administration INTRAOVARIAN INTRAOVARIAN Administration within the ovary.(FDA) Intraovarian Route of Administration Production C38257 C66729 Route of Administration INTRAPERICARDIAL INTRAPERICARDIAL Administration within the pericardium.(FDA) Intrapericardial Route of Administration Production C38258 C66729 Route of Administration INTRAPERITONEAL INTRAPERITONEAL Administration within the peritoneal cavity.(FDA) Intraperitoneal Route of Administration Production C38259 C66729 Route of Administration INTRAPLEURAL INTRAPLEURAL Administration within the pleura.(FDA) Intrapleural Route of Administration Production C38260 C66729 Route of Administration INTRAPROSTATIC INTRAPROSTATIC Administration within the prostate gland.(FDA) Intraprostatic Route of Administration Production C38261 C66729 Route of Administration INTRAPULMONARY INTRAPULMONARY Administration within the lungs or its bronchi.(FDA) Intrapulmonary Route of Administration Production C38262 C66729 Route of Administration INTRASINAL INTRASINAL Administration within the nasal or periorbital sinuses.(FDA) Intrasinal Route of Administration Production C38263 C66729 Route of Administration INTRASPINAL INTRASPINAL Administration within the vertebral column.(FDA) Intraspinal Route of Administration Production C38264 C66729 Route of Administration INTRASYNOVIAL INTRASYNOVIAL Administration within the synovial cavity of a joint.(FDA) Intrasynovial Route of Administration Production C38265 C66729 Route of Administration INTRATENDINOUS INTRATENDINOUS Administration within a tendon.(FDA) Intratendinous Route of Administration Production C38266 C66729 Route of Administration INTRATESTICULAR INTRATESTICULAR Administration within the testicle.(FDA) Intratesticular Route of Administration Production C38267 C66729 Route of Administration INTRATHECAL INTRATHECAL Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.(FDA) Intrathecal Route of Administration Production C38207 C66729 Route of Administration INTRATHORACIC INTRATHORACIC Administration within the thorax (internal to the ribs); synonymous with the term endothoracic.(FDA) Endothoracic Route of Administration Production C38268 C66729 Route of Administration INTRATUBULAR INTRATUBULAR Administration within the tubules of an organ.(FDA) Intratubular Route of Administration Production C38269 C66729 Route of Administration INTRATUMOR INTRATUMOR Intratumor Route of Administration Administration within a tumor.(FDA) Intratumoral Route of Administration Production C38270 C66729 Route of Administration INTRATYMPANIC INTRATYMPANIC Administration within the auris media.(FDA) Intratympanic Route of Administration Production C38272 C66729 Route of Administration INTRAUTERINE INTRAUTERINE Administration within the uterus.(FDA) Intrauterine Route of Administration Production C38273 C66729 Route of Administration INTRAVASCULAR INTRAVASCULAR Administration within a vessel or vessels.(FDA) Intravascular Route of Administration Production C38276 C66729 Route of Administration INTRAVENOUS INTRAVENOUS Administration within or into a vein or veins.(FDA) Intravenous Route of Administration Production C38274 C66729 Route of Administration INTRAVENOUS BOLUS INTRAVENOUS BOLUS Administration within or into a vein or veins all at once.(FDA) Intravenous Bolus Production C38279 C66729 Route of Administration INTRAVENOUS DRIP INTRAVENOUS DRIP Administration within or into a vein or veins over a sustained period of time.(FDA) Intravenous Drip Production C38277 C66729 Route of Administration INTRAVENTRICULAR INTRAVENTRICULAR Administration within a ventricle.(FDA) Intraventricular Route of Administration Production C38278 C66729 Route of Administration INTRAVESICAL INTRAVESICAL Administration within the bladder.(FDA) Intravesical Route of Administration Production C38280 C66729 Route of Administration INTRAVITREAL INTRAVITREAL Administration within the vitreous body of the eye.(FDA) Intravitreal Route of Administration Production C38203 C66729 Route of Administration IONTOPHORESIS IONTOPHORESIS Administration by means of an electric current where ions of soluble salts migrate into the tissues of the body.(FDA) Iontophoresis Route of Administration Production C38281 C66729 Route of Administration IRRIGATION IRRIGATION Administration to bathe or flush open wounds or body cavities.(FDA) Irrigation-Route of Administration Production C38282 C66729 Route of Administration LARYNGEAL LARYNGEAL Administration directly upon the larynx.(FDA) Laryngeal Route of Administration Production C38284 C66729 Route of Administration NASAL NASAL Administration to the nose; administered by way of the nose.(FDA) Nasal Route of Administration Production C38285 C66729 Route of Administration NASOGASTRIC NASOGASTRIC Administration through the nose and into the stomach, usually by means of a tube.(FDA) Nasogastric Route of Administration Production C48623 C66729 Route of Administration NOT APPLICABLE NOT APPLICABLE Routes of administration are not applicable.(FDA) Route of Administration Not Applicable Production C38286 C66729 Route of Administration OCCLUSIVE DRESSING TECHNIQUE OCCLUSIVE DRESSING TECHNIQUE Administration by the topical route which is then covered by a dressing which occludes the area.(FDA) Occlusive Dressing Technique Production C38287 C66729 Route of Administration OPHTHALMIC OPHTHALMIC Administration to the external eye.(FDA) Ophthalmic Route of Administration Production C38288 C66729 Route of Administration ORAL ORAL Administration to or by way of the mouth.(FDA) Oral Route of Administration Production C38289 C66729 Route of Administration OROPHARYNGEAL OROPHARYNGEAL Administration directly to the mouth and pharynx.(FDA) Oropharyngeal Route of Administration Production C38290 C66729 Route of Administration OTHER OTHER Administration is different from others on this list.(FDA) Other Route of Administration Production C38291 C66729 Route of Administration PARENTERAL PARENTERAL Administration by injection, infusion, or implantation.(FDA) Parenteral Route of Administration Production C38676 C66729 Route of Administration PERCUTANEOUS PERCUTANEOUS Administration through the skin.(FDA) Percutaneous Route of Administration Production C38292 C66729 Route of Administration PERIARTICULAR PERIARTICULAR Administration around a joint.(FDA) Periarticular Route of Administration Production C38677 C66729 Route of Administration PERIDURAL PERIDURAL Administration to the outside of the dura mater of the spinal cord.(FDA) Peridural Route of Administration Production C38293 C66729 Route of Administration PERINEURAL PERINEURAL Administration surrounding a nerve or nerves.(FDA) Perineural Route of Administration Production C38294 C66729 Route of Administration PERIODONTAL PERIODONTAL Administration around a tooth.(FDA) Periodontal Route of Administration Production C38295 C66729 Route of Administration RECTAL RECTAL Administration to the rectum.(FDA) Rectal Route of Administration Production C38216 C66729 Route of Administration RESPIRATORY (INHALATION) RESPIRATORY (INHALATION) Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.(FDA) Inhalation Route of Administration Production C38296 C66729 Route of Administration RETROBULBAR RETROBULBAR Administration behind the pons or behind the eyeball.(FDA) Retrobulbar Route of Administration Production C38198 C66729 Route of Administration SOFT TISSUE SOFT TISSUE Administration into any soft tissue.(FDA) Soft Tissue Route Of Administration Production C38297 C66729 Route of Administration SUBARACHNOID SUBARACHNOID Administration beneath the arachnoid.(FDA) Subarachnoid Route of Administration Production C38298 C66729 Route of Administration SUBCONJUNCTIVAL SUBCONJUNCTIVAL Administration beneath the conjunctiva.(FDA) Subconjunctival Route of Administration Production C38299 C66729 Route of Administration SUBCUTANEOUS SUBCUTANEOUS Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.(FDA) Subcutaneous Route of Administration Production C38300 C66729 Route of Administration SUBLINGUAL SUBLINGUAL Administration beneath the tongue.(FDA) Sublingual Route of Administration Production C38301 C66729 Route of Administration SUBMUCOSAL SUBMUCOSAL Administration beneath the mucous membrane.(FDA) Submucosal Route of Administration Production C38304 C66729 Route of Administration TOPICAL TOPICAL Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.(FDA) Topical Route of Administration Production C38305 C66729 Route of Administration TRANSDERMAL TRANSDERMAL Administration through the dermal layer of the skin to the systemic circulation by diffusion.(FDA) Transdermal Route of Administration Production C38283 C66729 Route of Administration TRANSMUCOSAL TRANSMUCOSAL Administration across the mucosa.(FDA) Mucosal Route of Administration Production C38307 C66729 Route of Administration TRANSPLACENTAL TRANSPLACENTAL Administration through or across the placenta.(FDA) Transplacental Route of Administration Production C38308 C66729 Route of Administration TRANSTRACHEAL TRANSTRACHEAL Administration through the wall of the trachea.(FDA) Transtracheal Route of Administration Production C38309 C66729 Route of Administration TRANSTYMPANIC TRANSTYMPANIC Administration across or through the tympanic cavity.(FDA) Transtympanic Route of Administration Production C38310 C66729 Route of Administration UNASSIGNED UNASSIGNED Route of administration has not yet been assigned.(FDA) Unassigned Route of Administration Production C38311 C66729 Route of Administration UNKNOWN UNKNOWN Route of administration is unknown.(FDA) Unknown Route of Administration Production C38312 C66729 Route of Administration URETERAL URETERAL Administration into the ureter.(FDA) Ureteral Route of Administration Production C38271 C66729 Route of Administration URETHRAL URETHRAL Administration into the urethra.(FDA) Intraurethral Route of Administration Production C38313 C66729 Route of Administration VAGINAL VAGINAL Administration into the vagina.(FDA) Vaginal Route of Administration Production C66769 C66769 No Severity/Intensity Scale for Adverse Events AESEV AESEV Severity/Intensity Scale for Adverse Events A scale that defines the degree or state of disease existing in a patient as a result of the occurrence of an adverse event. (NCI) CDISC SDTM Severity Intensity Scale for Adverse Event Terminology Production C41338 C66769 Severity/Intensity Scale for Adverse Events MILD MILD Grade 1; 1 A type of adverse event that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Mild Adverse Event Production C41339 C66769 Severity/Intensity Scale for Adverse Events MODERATE MODERATE Grade 2; 2 A type of adverse event that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. Moderate Adverse Event Production C41340 C66769 Severity/Intensity Scale for Adverse Events SEVERE SEVERE Grade 3; 3 A type of adverse event that requires intensive therapeutic intervention. The event interrupts usual activities of daily living, or significantly affects clinical status. The event possesses a significant risk of harm to the research participant and hospitalization may be required. Severe Adverse Event Production C66731 C66731 No Sex SEX SEX Sex The assemblage of physical properties or qualities by which male is distinguished from female; the physical difference between male and female; the distinguishing peculiarity of male or female. (NCI) CDISC SDTM Sex of Individual Terminology Production C16576 C66731 Sex F F Female A person who belongs to the sex that normally produces ova. The term is used to indicate biological sex distinctions, or cultural gender role distinctions, or both. (NCI) Female Production C20197 C66731 Sex M M Male A person who belongs to the sex that normally produces sperm. The term is used to indicate biological sex distinctions, cultural gender role distinctions, or both. (NCI) Male Production C17998 C66731 Sex U UNKNOWN U; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown Production C45908 C66731 Sex UN UN Undifferentiated A person (one of unisexual specimens) who is born with genitalia and/or secondary sexual characteristics of indeterminate sex, or which combine features of both sexes. (NCI) Intersex Production C66732 C66732 No Sex of Participants SEXPOP SEXPOP Sex of Participants The specific sex, either male, female, or mixed of the subject group being studied. (NCI) CDISC SDTM Sex of Study Group Terminology Production C49636 C66732 Sex of Participants BOTH BOTH One and the other; relating to or being two in conjunction. (NCI) Both Production C16576 C66732 Sex of Participants F F Female A person who belongs to the sex that normally produces ova. The term is used to indicate biological sex distinctions, or cultural gender role distinctions, or both. (NCI) Female Production C20197 C66732 Sex of Participants M M Male A person who belongs to the sex that normally produces sperm. The term is used to indicate biological sex distinctions, cultural gender role distinctions, or both. (NCI) Male Production C66733 C66733 Yes Size SIZE SIZE Size The physical magnitude of something. (NCI) CDISC SDTM Size Terminology Production C49508 C66733 Size LARGE LARGE Of considerable or relatively great size, extent, or capacity. (NCI) Large Production C49507 C66733 Size MEDIUM MEDIUM Mid-way between small and large in number, quantity, magnitude or extent. (NCI) Medium Production C25376 C66733 Size SMALL SMALL Limited in number, quantity, magnitude or extent. (NCI) Small Production C66734 C66734 Yes Domain Abbreviation DOMAIN DOMAIN Domain Abbreviation A unique, 2-character domain code used in the regulatory submission process. The domain abbreviation is used consistently throughout the submission, i.e. in the dataset name, as the value of the domain variable within the dataset, and as a prefix for most variable names in the dataset. (CDISC Glossary) CDISC SDTM Submission Domain Abbreviation Terminology Production C49563 C66734 Domain Abbreviation AD AD Analysis Dataset Datasets used for statistical analysis and reporting by the sponsor. These are submitted in addition to the data tabulation datasets. Analysis Dataset Domain Production C49562 C66734 Domain Abbreviation AE AE Adverse Events Adverse events may be captured either as free text or a pre-specified list of terms. Adverse Event Domain Production C49565 C66734 Domain Abbreviation AU AU Autopsy Additional data about deaths, specific to findings from autopsies. Autopsy Domain Production C49566 C66734 Domain Abbreviation BM BM Bone Mineral Density (BMD) Data Findings resulting from evaluations of bone mineral density. Bone Mineral Density Data Domain Production C49567 C66734 Domain Abbreviation BR BR Biopsy Findings resulting from biopsies. Biopsy Domain Production C49568 C66734 Domain Abbreviation CM CM Concomitant Meds Case report form (CRF) data that captures the Concomitant and Prior Medications/Therapies used by the subject. Examples are the Concomitant Medications/Therapies given on an as needed basis and the usual Background Medications/Therapies given for a condition. Concomitant Medication Domain Production C49569 C66734 Domain Abbreviation CO CO Comments The Comments dataset accommodates two sources of comments: 1) those collected alongside other data on topical case report form (CRF) pages such as Adverse Events and 2) those collected on a separate page specifically dedicated to comments. Comment Domain Production C49578 C66734 Domain Abbreviation DA DA Drug Accountability Data regarding the accountability of study drug, such as information on the receipt, dispensing, return, and packaging. Drug Accountability Domain Production C49570 C66734 Domain Abbreviation DC DC Disease Characteristics Data related to the characteristics of a specific disease state under study for a subject. Disease Characteristics Domain Production C49572 C66734 Domain Abbreviation DM DM Demographics The Demographics domain includes a set of essential standard variables that describe each subject in a clinical study. It is the parent domain for all other observations for human clinical subjects Demographics Domain Production C49576 C66734 Domain Abbreviation DS DS Disposition A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to disposition. (NCI) Disposition Domain Production C49585 C66734 Domain Abbreviation DV DV Protocol Deviations The intent of the domain is to capture protocol violations and deviations during the course of the study and will store only those criteria violation by or deviated from by the subject and not a response to each violation or deviation. Protocol Deviations Domain Production C49625 C66734 Domain Abbreviation EE EE Electroencephalogram Findings resulting from electroencephalogram (EEG) tests. Electroencephalogram Domain Production C49626 C66734 Domain Abbreviation EG EG Electrocardiogram Findings related to the collection of ECG data, including position of the subject, method of evaluation, all cycle measurements and all findings from the ECG including an overall interpretation if collected or derived. Electrocardiogram Domain Production C49587 C66734 Domain Abbreviation EX EX Exposure The Exposure domain model records the details of a subject's exposure to protocol-specified study treatment. Study treatment may be any intervention that is prospectively defined as a test material within a study, and is typically but not always supplied to the subject. Exposure Domain Production C49588 C66734 Domain Abbreviation FH FH Family History A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to family history. (NCI) Family History Domain Production C49589 C66734 Domain Abbreviation HU HU Healthcare Resource Utilization Healthcare resource utilization data such as subject visits to physicians, hospitalizations, and nursing home stays. Healthcare Resource Utilization Domain Production C61536 C66734 Domain Abbreviation IE IE Inclusion/Exclusion The intent of the domain model is to only collect those criteria that cause the subject to be in violation of the inclusion/exclusion criteria not a response to each criterion. Inclusion Exclusion Domain Production C49592 C66734 Domain Abbreviation LB LB Laboratory Data Laboratory test findings including, but is not limited to hematology, clinical chemistry and urinalysis data. This domain does not include microbiology or pharmacokinetic data, which are stored in separate domains. Laboratory Data Domain Production C49602 C66734 Domain Abbreviation MB MB Microbiology Microbiology specimen findings, including gram stain results, and organisms found. Microbiology Specimen Domain Production C49603 C66734 Domain Abbreviation MH MH Medical History The medical history dataset includes the subject's prior history at the start of the trial. Examples of subject medical history information could include general medical history, gynecological history, and primary diagnosis. Medical History Domain Production C49604 C66734 Domain Abbreviation ML ML Meal Data Information regarding the subject's meal consumption, such as fluid intake, amounts, form (solid or liquid state), frequency, etc., typically used for pharmacokinetic analysis. Meal Data Domain Production C61531 C66734 Domain Abbreviation MS MS Microbiology Susceptibility This includes microbiology susceptibility test results, plus results of any other organism-related tests. Microbiology Susceptibility Domain Production C49605 C66734 Domain Abbreviation OM OM Organ Measurements Findings from organ measurement evaluations. Organ Measurement Domain Production C49606 C66734 Domain Abbreviation PC PC Pharmacokinetic Concentration Concentrations of drugs/metabolites in fluids or tissues as a function of time. Pharmacokinetic Concentration Domain Production C49608 C66734 Domain Abbreviation PE PE Physical Exam Findings collected during a physical examination of the subject. It has findings that are discovered that are related to body systems. Does not include vital signs measurements, which are stored in the vital signs domain. Physical Exam Domain Production C61529 C66734 Domain Abbreviation PG PG Pharmacogenomics Pharmacogenomics findings that initially focus on genotype and gene expression data. Pharmacogenomics Domain Production C49607 C66734 Domain Abbreviation PP PP Pharmacokinetic Parameters Pharmacokinetic parameters derived from pharmacokinetic concentration-time (PC) data. Pharmacokinetic Parameters Domain Production C49609 C66734 Domain Abbreviation QS QS Questionnaires Questionnaire data may include, but are not limited to the following: subject reported outcomes, validated or non-validated questionnaires, and validated or non-validated diaries (i.e. data with a common topicality). Questionnaire Domain Production C49610 C66734 Domain Abbreviation SC SC Subject Characteristics The subject characteristics domain is for data not collected in other domains that is subject-related. Examples: subject initials, other race details, eye color, childbearing status, etc. Subject Characteristics Domain Production C49616 C66734 Domain Abbreviation SE SE Subject Element The subject element table describes the actual order of elements followed by the subject, together with the start date/time and end date/time for each element. Subject Element Domain Production C49611 C66734 Domain Abbreviation SG SG Surgery Surgical information. Surgery Domain Production C49612 C66734 Domain Abbreviation SK SK Skin Test Findings from diagnostic skin tests. Skin Test Domain Production C49613 C66734 Domain Abbreviation SL SL Sleep Polysomnography Data Findings from diagnostic sleep tests (polysomnography). Sleep Polysomnography Domain Production C49614 C66734 Domain Abbreviation ST ST Stress (Exercise) Test Data Findings from exercise stress tests. Stress Exercise Test Data Domain Production C49615 C66734 Domain Abbreviation SU SU Substance Use The intent of the domain is to capture substance use information that may be used to assess the efficacy and/or safety of therapies that look to mitigate the effects of chronic substance use. Substance Use Domain Production C49617 C66734 Domain Abbreviation SV SV Subject Visits The subject visits table describes the actual start and end data/time for each visit of each individual subject. Subject Visits Domain Production C49618 C66734 Domain Abbreviation TA TA Trial Arms The trial arms table describes each planned arm in the trial. An arm is described as an ordered sequence of elements. Trial Arms Domain Production C49619 C66734 Domain Abbreviation TE TE TE; Trial Elements The trial elements table describes the element code that is unique for each element, the element description, and the rules for starting and ending an element. Trial Elements Domain Production C49620 C66734 Domain Abbreviation TI TI Trial Inclusion/Exclusion Criteria The trial summary information domain is not subject oriented. It contains one record for each of the inclusion and exclusion criteria for the trial. Trial Inclusion and Exclusion Criteria Domain Production C53483 C66734 Domain Abbreviation TS TS Trial Summary The trial summary information domain is not subject oriented. It contains one record for each trial summary characteristic. Trial Summary Domain Production C49621 C66734 Domain Abbreviation TV TV Trial Visits The trial visits table describes the planned order and number of visits in the study within each arm. Trial Visits Domain Production C49622 C66734 Domain Abbreviation VS VS Vital Signs Measurements including but not limited to blood pressure, temperature, respiration, body surface area, BMI, height and weight. Vital Signs Domain Production C66735 C66735 Yes Trial Blinding Schema TBLIND TBLIND Trial Blinding Schema The name of a code list that contains terms to define the type of blinding for the trial. (NCI) CDISC SDTM Trial Blinding Schema Terminology Production C15228 C66735 Trial Blinding Schema DOUBLE BLIND DOUBLE BLIND A study in which neither the subject nor the investigator nor the research team interacting with the subject or data during the trial knows what treatment a subject is receiving. (CDISC glossary) Double Blind Study Production C49659 C66735 Trial Blinding Schema OPEN LABEL OPEN LABEL A trial in which subjects and investigators know which product each subject is receiving; opposite of a blinded or double-blind study. (CDISC glossary) Open Label Study Production C28233 C66735 Trial Blinding Schema SINGLE BLIND SINGLE BLIND A study in which one party, either the investigator or the subject, does not know which medication or placebo is administered to the subject; also called singlemasked study. (CDISC glossary) Single Blind Study Production C66736 C66736 Yes Trial Indication Type TINDTP TINDTP Trial Indication Type The name of a code list that contains terms to define the type of trial, e.g. cure or prevention. (NCI) CDISC SDTM Trial Indication Type Terminology Production C49654 C66736 Trial Indication Type CURE CURE A type of study protocol designed to evaluate intervention(s) aimed to cure a disease or condition. (NCI) Cure Study Production C49653 C66736 Trial Indication Type DIAGNOSIS DIAGNOSIS A type of study protocol designed to evaluate intervention(s) aimed at identifying a disease or condition. (NCI) Diagnosis Study Production C49655 C66736 Trial Indication Type MITIGATION MITIGATION A type of study designed to identify actions necessary to eliminate or reduce the risk to human life or well-being as a result of a particular medication or treatment regimen. (NCI) Adverse Effect Mitigation Study Production C49657 C66736 Trial Indication Type PREVENTION PREVENTION A type of study designed to identify actions necessary to permanently eliminate or reduce the long-term risk to human life as a result of a particular medication or treatment regimen. Prevention Study Production C49656 C66736 Trial Indication Type TREATMENT TREATMENT A type of study protocol designed to evaluate intervention(s) for treatment of disease, syndrome or condition. Treatment Study Production C66737 C66737 Yes Trial Phase TPHASE TPHASE Trial Phase Clinical trials are broken into three or four phases: Phase I tests a new drug or treatment for safety in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people to measure whether the treatment actually benefits patients, and whether its benefits exceed its risks; and Phase IV takes place after the drug or treatment has been licensed and marketed. (NCI) CDISC SDTM Trial Phase Terminology Production C15600 C66737 Trial Phase Phase I Trial Phase I Trial Trial Phase 1; 1 The initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. NOTE: These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients included in Phase I studies varies with the drug, but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. [After FDA CDER Handbook, ICH E8] (CDISC glossary) Phase I Trial Production C15693 C66737 Trial Phase Phase I/II Trial Phase I/II Trial Trial Phase 1-2; 1-2 A class of clinical study that combines elements characteristic of traditional Phase I and Phase II trials. See also Phase I, Phase II. Phase I/II Trial Production C15601 C66737 Trial Phase Phase II Trial Phase II Trial Trial Phase 2; 2 Phase 2. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. NOTE: Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. [After FDA CDER Handbook, ICH E8] (CDISC glossary) Phase II Trial Production C15694 C66737 Trial Phase Phase II/III Trial Phase II/III Trial Trial Phase 2-3; 2-3 A class of clinical study that combines elements characteristic of traditional Phase II and Phase III trials. Phase II/III Trial Production C49686 C66737 Trial Phase Phase IIa Trial Phase IIa Trial Trial Phase 2A; 2A A clinical research protocol generally refered to as a pilot or feasibility trial that aims to prove the concept of the new intervention in question. (NCI) Phase IIa Trial Production C49688 C66737 Trial Phase Phase IIb Trial Phase IIb Trial Trial Phase 2B; 2B A clinical research protocol generally refered to as a well-controlled and pivotal trial that aims to prove the mechanism of action of the new intervention in question. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind. (NCI) Phase IIb Trial Production C15602 C66737 Trial Phase Phase III Trial Phase III Trial Trial Phase 3; 3 Phase 3. Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit–risk relationship of the drug and to provide an adequate basis for physician labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After FDA CDER Handbook, ICH E8] (CDISC glossary) Phase III Trial Production C49687 C66737 Trial Phase Phase IIIaTrial Phase IIIaTrial Trial Phase 3A; 3A A classification typically assigned retrospectively to a Phase III trial upon determination by regulatory authorities of a need for a Phase III B trial. Phase IIIa Trial Production C49689 C66737 Trial Phase Phase IIIb Trial Phase IIIb Trial Trial Phase 3B; 3B A subcategory of Phase III trials done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase IIIB trials are conducted. These trials may be required as a condition of regulatory authority approval. Phase IIIb Trial Production C15603 C66737 Trial Phase Phase IV Trial Phase IV Trial Trial Phase 4; 4 Phase 4. Postmarketing (Phase 4) studies to delineate additional information about the drug’s risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [After FDA CDER Handbook, ICH E8] (CDISC glossary) Phase IV Trial Production C47865 C66737 Trial Phase Phase V Trial Phase V Trial Trial Phase 5; 5 Postmarketing surveillance is sometimes referred to as Phase V. Phase V Trial Production C48660 C66737 Trial Phase NA NOT APPLICABLE NA Determination of a value is not relevant in the current context. (NCI) Not Applicable Production C66738 C66738 Yes Trial Summary Parameter Test Code TSPARMCD TSPARMCD Trial Summary Parameter Test Code Individual characteristics of a clinical trial, e.g. description of trial design, trial blinding schema, and primary objective of trial. (NCI) CDISC SDTM Trial Summary Parameter Terminology by Code Production C49703 C66738 Trial Summary Parameter Test Code ADDON ADDON Added on to Existing Treatments The addition of a therapeutic product to the existing regimen in a clinical trial, where both entities remain as discrete products. Test Product Added to Existing Treatment Production C49700 C66738 Trial Summary Parameter Test Code AEDICT AEDICT Adverse Event Dictionary A reference source that provides meanings of words related to adverse events. (NCI) Adverse Event Dictionary Production C49694 C66738 Trial Summary Parameter Test Code AGEMAX AGEMAX Planned Maximum Age of Subjects The anticipated maximum age of the subjects to be entered in a clinical trial. (NCI) Planned Maximum Age of Subjects Production C49693 C66738 Trial Summary Parameter Test Code AGEMIN AGEMIN Planned Minimum Age of Subjects The anticipated minimum age of the subjects to be entered in a clinical trial. (NCI) Planned Minimum Age of Subjects Production C20587 C66738 Trial Summary Parameter Test Code AGESPAN AGESPAN Age Span Subgroups of populations based on age. (NCI) Age Group Production C50400 C66738 Trial Summary Parameter Test Code AGEU AGEU Age Unit Those units of time that are routinely used to express the age of a person. (NCI) Age Unit Production C25488 C66738 Trial Summary Parameter Test Code DOSE DOSE Dose per Administration The amount of drug administered to a patient or test subject at one time or the total quantity administered. [AMA Manual of Style] (CDISC Glossary) Dose Production C49701 C66738 Trial Summary Parameter Test Code DRUGDICT DRUGDICT Drug Dictionary A reference source that provides meanings of words related to drugs. (NCI) Drug Dictionary Production C49697 C66738 Trial Summary Parameter Test Code LENGTH LENGTH Trial Length The anticipated length of a clinical trial measured as a unit of time. (NCI) Trial Length Production C49702 C66738 Trial Summary Parameter Test Code MHDICT MHDICT Medical History Dictionary A reference source that provides meanings of words related to medical history. (NCI) Medical History Dictionary Production C49692 C66738 Trial Summary Parameter Test Code PLANSUB PLANSUB Planned Number of Subjects The number of subjects entered in a clinical trial. (NCI) Planned Subject Number Production C25196 C66738 Trial Summary Parameter Test Code RANDOM RANDOM Trial is Randomized The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Unequal randomization is used to allocate subjects into groups at a differential rate; for example, three subjects may be assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See also balanced study. (CDISC glossary) Randomization Production C38114 C66738 Trial Summary Parameter Test Code ROUTE ROUTE Route of Administration The course by which a substance was administered in order to reach the site of action in the body. Route of Administration Production C49696 C66738 Trial Summary Parameter Test Code SEXPOP SEXPOP Sex of Participants The specific sex, either male, female, or mixed of the subject group being studied. (NCI) Sex of Study Group Production C49698 C66738 Trial Summary Parameter Test Code STOPRULE STOPRULE Study Stop Rules The rule, regulation and/or condition that determines the point in time when a clinical trial will be terminated. (NCI) Study Stop Rules Production C49658 C66738 Trial Summary Parameter Test Code TBLIND TBLIND Trial Blinding Schema The name of a code list that contains terms to define the type of blinding for the trial. (NCI) Trial Blinding Schema Production C49647 C66738 Trial Summary Parameter Test Code TCNTRL TCNTRL Control Type Comparator against which the study treatment is evaluated (e.g., concurrent (placebo, no treatment, dose-response, active), external (historical, published literature). Control Type Production C49650 C66738 Trial Summary Parameter Test Code TDIGRP TDIGRP Diagnosis Group A grouping of individuals on the basis of a shared procedure or disease, or lack thereof (e.g. healthy volunteers, type 2 diabetic subjects, subjects with renal cell cancer). Standardized naming systems are available that define the groups within which a subject should be placed. (NCI) Diagnosis Group Production C49652 C66738 Trial Summary Parameter Test Code TINDTP TINDTP Trial Indication Type The name of a code list that contains terms to define the type of trial, e.g. cure or prevention. (NCI) Trial Indication Type Production C49802 C66738 Trial Summary Parameter Test Code TITLE TITLE Trial Title The name of a clinical trial. (NCI) Trial Title Production C48281 C66738 Trial Summary Parameter Test Code TPHASE TPHASE Trial Phase Classification Clinical trials are broken into three or four phases: Phase I tests a new drug or treatment for safety in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people to measure whether the treatment actually benefits patients, and whether its benefits exceed its risks; and Phase IV takes place after the drug or treatment has been licensed and marketed. (NCI) Trial Phase Production C49660 C66738 Trial Summary Parameter Test Code TTYPE TTYPE Trial Type The type of clinical trial performed e.g. efficacy, safety. (NCI) Trial Type Production C67152 C67152 Yes Trial Summary Parameter Test Name TSPARM TSPARM Trial Summary Parameter Test Name Individual characteristics of a clinical trial, e.g. description of trial design, trial blinding schema, and primary objective of trial. (NCI) CDISC SDTM Trial Summary Parameter Terminology by Name Production C49703 C67152 Trial Summary Parameter Test Name Added on to Existing Treatments ADDON Added on to Existing Treatments The addition of a therapeutic product to the existing regimen in a clinical trial, where both entities remain as discrete products. Test Product Added to Existing Treatment Production C49700 C67152 Trial Summary Parameter Test Name Adverse Event Dictionary AEDICT Adverse Event Dictionary A reference source that provides meanings of words related to adverse events. (NCI) Adverse Event Dictionary Production C49694 C67152 Trial Summary Parameter Test Name Planned Maximum Age of Subjects AGEMAX Planned Maximum Age of Subjects The anticipated maximum age of the subjects to be entered in a clinical trial. (NCI) Planned Maximum Age of Subjects Production C49693 C67152 Trial Summary Parameter Test Name Planned Minimum Age of Subjects AGEMIN Planned Minimum Age of Subjects The anticipated minimum age of the subjects to be entered in a clinical trial. (NCI) Planned Minimum Age of Subjects Production C20587 C67152 Trial Summary Parameter Test Name Age Group AGESPAN Age Group Subgroups of populations based on age. (NCI) Age Group Production C50400 C67152 Trial Summary Parameter Test Name Age Unit AGEU Age Unit Those units of time that are routinely used to express the age of a person. (NCI) Age Unit Production C25488 C67152 Trial Summary Parameter Test Name Dose per Administration DOSE Dose per Administration The amount of drug administered to a patient or test subject at one time or the total quantity administered. [AMA Manual of Style] (CDISC Glossary) Dose Production C49701 C67152 Trial Summary Parameter Test Name Drug Dictionary DRUGDICT Drug Dictionary A reference source that provides meanings of words related to drugs. (NCI) Drug Dictionary Production C49697 C67152 Trial Summary Parameter Test Name Trial Length LENGTH Trial Length The anticipated length of a clinical trial measured as a unit of time. (NCI) Trial Length Production C49702 C67152 Trial Summary Parameter Test Name Medical History Dictionary MHDICT Medical History Dictionary A reference source that provides meanings of words related to medical history. (NCI) Medical History Dictionary Production C49692 C67152 Trial Summary Parameter Test Name Planned Number of Subjects PLANSUB Planned Number of Subjects The number of subjects entered in a clinical trial. (NCI) Planned Subject Number Production C25196 C67152 Trial Summary Parameter Test Name Trial is Randomized RANDOM Trial is Randomized The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Unequal randomization is used to allocate subjects into groups at a differential rate; for example, three subjects may be assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See also balanced study. (CDISC glossary) Randomization Production C38114 C67152 Trial Summary Parameter Test Name Route of Administration ROUTE Route of Administration The course by which a substance was administered in order to reach the site of action in the body. Route of Administration Production C49696 C67152 Trial Summary Parameter Test Name Sex of Participants SEXPOP Sex of Participants The specific sex, either male, female, or mixed of the subject group being studied. (NCI) Sex of Study Group Production C49698 C67152 Trial Summary Parameter Test Name Study Stop Rules STOPRULE Study Stop Rules The rule, regulation and/or condition that determines the point in time when a clinical trial will be terminated. (NCI) Study Stop Rules Production C49658 C67152 Trial Summary Parameter Test Name Trial Blinding Schema TBLIND Trial Blinding Schema The name of a code list that contains terms to define the type of blinding for the trial. (NCI) Trial Blinding Schema Production C49647 C67152 Trial Summary Parameter Test Name Control Type TCNTRL Control Type Comparator against which the study treatment is evaluated (e.g., concurrent (placebo, no treatment, dose-response, active), external (historical, published literature). Control Type Production C49650 C67152 Trial Summary Parameter Test Name Diagnosis Group TDIGRP Diagnosis Group A grouping of individuals on the basis of a shared procedure or disease, or lack thereof (e.g. healthy volunteers, type 2 diabetic subjects, subjects with renal cell cancer). Standardized naming systems are available that define the groups within which a subject should be placed. (NCI) Diagnosis Group Production C49652 C67152 Trial Summary Parameter Test Name Trial Indication Type TINDTP Trial Indication Type The name of a code list that contains terms to define the type of trial, e.g. cure or prevention. (NCI) Trial Indication Type Production C49802 C67152 Trial Summary Parameter Test Name Trial Title TITLE Trial Title The name of a clinical trial. (NCI) Trial Title Production C48281 C67152 Trial Summary Parameter Test Name Trial Phase Classification TPHASE Trial Phase Classification Clinical trials are broken into three or four phases: Phase I tests a new drug or treatment for safety in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people to measure whether the treatment actually benefits patients, and whether its benefits exceed its risks; and Phase IV takes place after the drug or treatment has been licensed and marketed. (NCI) Trial Phase Production C49660 C67152 Trial Summary Parameter Test Name Trial Type TTYPE Trial Type The type of clinical trial performed e.g. efficacy, safety. (NCI) Trial Type Production C66739 C66739 Yes Trial Type TTYPE TTYPE Trial Type The type of clinical trial performed e.g. efficacy, safety. (NCI) CDISC SDTM Trial Type Terminology Production C49664 C66739 Trial Type BIO-AVAILABILITY BIO-AVAILABILITY A study of the degree to which or rate at which a drug or other substance is absorbed or becomes available at the site of physiological activity after administration. (NCI) Bioavailability Study Production C49665 C66739 Trial Type BIO-EQUIVALENCE BIO-EQUIVALENCE A study most often used to compare the efficacy of different formulations to treat a given disease. It is the testing of an old versus a new formulation in healthy volunteers or subjects with the disease under study and usually in one dose. (NCI) Therapeutic Equivalency Study Production C49666 C66739 Trial Type EFFICACY EFFICACY A study of the relative therapeutic efficacy of treatment of a disease. Usually this is a Phase II or III study. (NCI) Efficacy Study Production C49662 C66739 Trial Type PHARMACODYNAMIC PHARMACODYNAMIC A study of the biochemical and physiological effect of a drug and the mechanism of drug action and the relationship between drug concentration and effect. (NCI) Pharmacodynamic Study Production C39493 C66739 Trial Type PHARMACOECONOMIC PHARMACOECONOMIC A study that assesses the value associated with a given drug in therapeutic and economic terms. This type of study is multidisciplinary in nature and takes into consideration the social and economic costs (resource utilization costs including direct, indirect, and intangible costs) of drug therapy in addition to its direct therapeutic benefits. Analyses relate the difference in therapeutic benefits to the difference in costs between treatment alternatives. (NCI) Pharmacoeconomic Study Production C49661 C66739 Trial Type PHARMACOGENOMIC PHARMACOGENOMIC A study of identification and analysis of genomic variations that affect the efficacy of a drug. Pharmacogenomic studies can potentially be predictive of an individual's drug-response or adverse reactions or susceptibility to iatrogenic disorders, and may also reveal new targets that can help in the design of new drugs. (NCI) Pharmacogenomic Study Production C49663 C66739 Trial Type PHARMACOKINETIC PHARMACOKINETIC A study of the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. (NCI) Pharmacokinetic Study Production C49667 C66739 Trial Type SAFETY SAFETY A study of the relative safety of treatment of a disease. Usually this is a Phase I or II trial. (NCI) Safety Study Production C66770 C66770 Yes Units for Vital Signs Results VSRESU VSRESU Units for Vital Signs Results The unit used to record and describe the result of a test investigating a vital sign. (NCI) CDISC SDTM Unit for Vital Sign Result Terminology Production C25613 C66770 Units for Vital Signs Results % % Percentage A fraction or ratio with 100 understood as the denominator. (NCI) Percentage Production C49673 C66770 Units for Vital Signs Results BEATS/MIN BEATS/MIN Beats per Minute The number of heartbeats measured per minute time. (NCI) Beats per Minute Production C49674 C66770 Units for Vital Signs Results BREATHS/MIN BREATHS/MIN Breaths per Minute The number of breaths (inhalation and exhalation) taken per minute time. (NCI) Breaths per Minute Production C42559 C66770 Units for Vital Signs Results C C Degree Celsius A unit of temperature of the temperature scale designed so that the freezing point of water is 0 degrees and the boiling point is 100 degrees at standard atmospheric pressure. The current official definition of the Celsius sets 0.01 C to be at the triple point of water and a degree to be 1/273.16 of the difference in temperature between the triple point of water and absolute zero. One degree Celsius represents the same temperature difference as one Kelvin. (NCI) Degree Celsius Production C49668 C66770 Units for Vital Signs Results cm cm Centimeter A basic unit of length in the former CGS version of metric system, equal to one hundredth of a meter or approximately 0.393 700 787 inch. (NCI) Centimeter Production C44277 C66770 Units for Vital Signs Results F F Degree Fahrenheit The Fahrenheit temperature scale is named after the German physicist Gabriel Fahrenheit (1686-1736), who proposed it in 1724. In this scale, the freezing point of water is 32 degrees Fahrenheit and the boiling point is 212 degrees, placing the boiling and melting points of water 180 degrees apart. In this scale a degree Fahrenheit is 5/9ths of a kelvin (or of a degree Celsius), and minus 40 degrees Fahrenheit is equal to minus 40 degrees Celsius. (NCI) Degree Fahrenheit Production C48155 C66770 Units for Vital Signs Results g g Gram A metric unit of mass equal to one one thousandth of a kilogram. (NCI) Gram Production C48500 C66770 Units for Vital Signs Results IN IN Inch A traditional unit of length equal to 2.54 centimeters. (NCI) Inch Production C28252 C66770 Units for Vital Signs Results kg kg Kilogram The basic SI unit of mass. It is defined as the mass of an international prototype in the form of a platinum-iridium cylinder kept at Sevres in France. It is the only basic unit still defined in terms of a material object, and also the only one with a prefix [kilo] already in place. A kilogram is equal to 1,000 grams and 2.204 622 6 pounds. (NCI) Kilogram Production C49671 C66770 Units for Vital Signs Results kg/m2 kg/m2 Kilogram Per Square Meter The SI derived unit of spread rate of a substance by mass, used also as a measure of area density. (NCI) Kilogram Per Square Meter Production C48531 C66770 Units for Vital Signs Results LB LB Pound A traditional unit of mass. By international agreement, one avoirdupois pound is equal to exactly 0.453 592 37 kilogram, 16 ounces, or 1.215 28 troy pounds. (NCI) Pound Production C42569 C66770 Units for Vital Signs Results m2 m2 Square Meter The SI unit of area measurement equal to a square whose sides are one meter long. Square meter is equal to 10,000 square centimeters; 0.01 ares; 1.196 square yards; 10.76 square feet; 1550 square inches. (NCI) Square Meter Production C49670 C66770 Units for Vital Signs Results mmHg mmHg Millimeter of Mercury A unit of pressure equal to 0.001316 atmosphere and equal to the pressure indicated by one millimeter rise of mercury in a barometer at the Earth's surface. (NCI) Millimeter of Mercury Production C42554 C66770 Units for Vital Signs Results ohm ohm ohm A unit of electrical resistance equal to the resistance between two points on a conductor when a potential difference of one volt between them produces a current of one ampere. Ohm is also used to measure impedance and reactance for complex resistance. A measurement in ohms is the reciprocal of a measurement in siemens. (NCI) Ohm Production C66741 C66741 Yes Vital Signs Test Code VSTESTCD VSTESTCD Vital Signs Test Code The name given to the test that analyzes a particular set of vital signs including temperature, respiratory rate, heart beat (pulse), and blood pressure. (NCI) CDISC SDTM Vital Sign Terminology by Code Production C16358 C66741 Vital Signs Test Code BMI BMI Body Mass Index A general indicator of the body fat an individual is carrying based upon the ratio of weight to height. (NCI) Body Mass Index Production C12472 C66741 Vital Signs Test Code BODYFAT BODYFAT Adipose Tissue A specialized form of connective tissue consisting primarily of adipocytes (fat cells), surrounded by a meshwork of collagen fibers. Adipose Tissue Production C25157 C66741 Vital Signs Test Code BSA BSA Body Surface Area A measure of the 2-dimensional extent of the body surface (i.e., the skin). Body surface area (BSA) can be calculated by mathematical formula or from a chart that relates height to weight. BSA is often an important factor in dosing. (NCI) Body Surface Area Production C25299 C66741 Vital Signs Test Code DIABP DIABP Diastolic Blood Pressure The blood pressure after the contraction of the heart while the chambers of the heart refill with blood. (NCI) Diastolic Blood Pressure Production C49680 C66741 Vital Signs Test Code FRMSIZE FRMSIZE Body Frame Size The categorization of a person's body frame into small, medium and large based on the measurement of wrist circumference or the breadth of the elbow. (NCI) Body Frame Size Production C25347 C66741 Vital Signs Test Code HEIGHT HEIGHT Height The vertical measurement or distance from the base to the top of an object; the vertical dimension of extension. (NCI) Height Production C49677 C66741 Vital Signs Test Code HR HR Heart Rate The number of heartbeats per unit of time, usually expressed as beats per minute. (NCI) Heart Rate Production C49679 C66741 Vital Signs Test Code MAP MAP Mean Arterial Pressure The mean pressure of the blood within the arterial circulation. The arterial pressure may be directly measured by insertion of an intra-arterial catheter connected to a transducer. The mean arterial pressure (MAP) can be calculated by subsequent analysis of the waveform. MAP can be approximated without an invasive procedure using the following formula: diastolic pressure plus 1/3 of the pulse pressure, where pulse pressure is systolic pressure - diastolic pressure. (NCI) Mean Arterial Pressure Production C49676 C66741 Vital Signs Test Code PULSE PULSE Pulse Rate The rate of the pulse as observed in an artery, expressed as beats per minute. It can be measured at several anatomical sites, including the wrist, neck, temple, groin, behind the knees, or on top of the foot. (NCI) Pulse Rate Production C49678 C66741 Vital Signs Test Code RESP RESP Respiratory Rate The rate of breathing (inhalation and exhalation) measured within in a unit time, usually expressed as breaths per minute. (NCI) Respiratory Rate Production C25298 C66741 Vital Signs Test Code SYSBP SYSBP Systolic Blood The blood pressure during the contraction of the left ventricle of the heart. Systolic Blood Pressure Production C25206 C66741 Vital Signs Test Code TEMP TEMP Temperature The property of a body or region of space that determines whether or not there will be a net flow of heat into it or out of it from a neighboring body or region and in which direction (if any) the heat will flow, perceptible by living organism as a somatic sensation of cold or heat. It is a measure of the average translational kinetic energy associated with the disordered microscopic motion of atoms and molecules. Temperature is measured in one of the three standard temperature scales: Celsius, Kelvin, and Fahrenheit. (NCI) Temperature Production C25208 C66741 Vital Signs Test Code WEIGHT WEIGHT Weight The vertical force exerted by a mass as a result of gravity. (NCI) Weight Production C67153 C67153 Yes Vital Signs Test Name VSTEST VSTEST Vital Signs Test Name The name given to the test that analyzes a particular set of vital signs including temperature, respiratory rate, heart beat (pulse), and blood pressure. (NCI) CDISC SDTM Vital Sign Terminology by Name Production C16358 C67153 Vital SignsTest Name Body Mass Index BMI Body Mass Index A general indicator of the body fat an individual is carrying based upon the ratio of weight to height. (NCI) Body Mass Index Production C12472 C67153 Vital SignsTest Name Adipose Tissue BODYFAT Adipose Tissue A specialized form of connective tissue consisting primarily of adipocytes (fat cells), surrounded by a meshwork of collagen fibers. Adipose Tissue Production C25157 C67153 Vital SignsTest Name Body Surface Area BSA Body Surface Area A measure of the 2-dimensional extent of the body surface (i.e., the skin). Body surface area (BSA) can be calculated by mathematical formula or from a chart that relates height to weight. BSA is often an important factor in dosing. (NCI) Body Surface Area Production C25299 C67153 Vital SignsTest Name Diastolic Blood Pressure DIABP Diastolic Blood Pressure The blood pressure after the contraction of the heart while the chambers of the heart refill with blood. (NCI) Diastolic Blood Pressure Production C49680 C67153 Vital SignsTest Name Body Frame Size FRMSIZE Body Frame Size The categorization of a person's body frame into small, medium and large based on the measurement of wrist circumference or the breadth of the elbow. (NCI) Body Frame Size Production C25347 C67153 Vital SignsTest Name Height HEIGHT Height The vertical measurement or distance from the base to the top of an object; the vertical dimension of extension. (NCI) Height Production C49677 C67153 Vital SignsTest Name Heart Rate HR Heart Rate The number of heartbeats per unit of time, usually expressed as beats per minute. (NCI) Heart Rate Production C49679 C67153 Vital SignsTest Name Mean Arterial Pressure MAP Mean Arterial Pressure The mean pressure of the blood within the arterial circulation. The arterial pressure may be directly measured by insertion of an intra-arterial catheter connected to a transducer. The mean arterial pressure (MAP) can be calculated by subsequent analysis of the waveform. MAP can be approximated without an invasive procedure using the following formula: diastolic pressure plus 1/3 of the pulse pressure, where pulse pressure is systolic pressure - diastolic pressure. (NCI) Mean Arterial Pressure Production C49676 C67153 Vital SignsTest Name Pulse Rate PULSE Pulse Rate The rate of the pulse as observed in an artery, expressed as beats per minute. It can be measured at several anatomical sites, including the wrist, neck, temple, groin, behind the knees, or on top of the foot. (NCI) Pulse Rate Production C49678 C67153 Vital SignsTest Name Respiratory Rate RESP Respiratory Rate The rate of breathing (inhalation and exhalation) measured within in a unit time, usually expressed as breaths per minute. (NCI) Respiratory Rate Production C25298 C67153 Vital SignsTest Name Systolic Blood Pressure SYSBP Systolic Blood Pressure The blood pressure during the contraction of the left ventricle of the heart. Systolic Blood Pressure Production C25206 C67153 Vital SignsTest Name Temperature TEMP Temperature The property of a body or region of space that determines whether or not there will be a net flow of heat into it or out of it from a neighboring body or region and in which direction (if any) the heat will flow, perceptible by living organism as a somatic sensation of cold or heat. It is a measure of the average translational kinetic energy associated with the disordered microscopic motion of atoms and molecules. Temperature is measured in one of the three standard temperature scales: Celsius, Kelvin, and Fahrenheit. (NCI) Temperature Production C25208 C67153 Vital SignsTest Name Weight WEIGHT Weight The vertical force exerted by a mass as a result of gravity. (NCI) Weight Production C66742 C66742 No No Yes Response NY NY No Yes Response A term that is used to indicate a question with permissible values of yes/no/unknown/not applicable. CDISC SDTM Yes No Unknown or Not Applicable Response Terminology Production C49487 C66742 No Yes Response N N No The non-affirmative response to a question. (NCI) No Production C48660 C66742 No Yes Response NA NOT APPLICABLE NA Determination of a value is not relevant in the current context. (NCI) Not Applicable Production C17998 C66742 No Yes Response U UNKNOWN U; Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown Production C49488 C66742 No Yes Response Y Y Yes The affirmative response to a question. (NCI) Yes Production C65047 C65047 Yes Laboratory Test Code LBTESTCD LBTESTCD Laboratory Test Code Terminology used for Laboratory Tests of the CDISC Standard Data Tabulation Model. CDISC SDTM Laboratory Test Terminology by Code Production C35266 C65047 Laboratory Test Code ANISO ANISO Anisocytosis A measurement of the inequality in the size of the red blood cells in a whole blood specimen. Anisocytosis Production C35267 C65047 Laboratory Test Code POIKILO POIKILO Poikilocytes A measurement of the odd-shaped erythrocytes in a whole blood specimen. Poikilocytosis Production C38037 C65047 Laboratory Test Code BILI BILI Bilirubin A measurement of the total bilirubin in a biological specimen. Total Bilirubin Production C38462 C65047 Laboratory Test Code APTT APTT Activated Partial Thromboplastin Time A measurement of the length of time that it takes for clotting to occur when reagents are added to a plasma specimen. The test is partial due to the absence of tissue factor (Factor III) from the reaction mixture. Partial Thromboplastin Time Production C41376 C65047 Laboratory Test Code GLUC GLUC Glucose A measurement of the glucose in a biological specimen. Plasma Glucose Measurement Production C45997 C65047 Laboratory Test Code PH PH pH A measure of the acidity or alkalinity of a fluid on a scale of 0 to 14. pH Production C51946 C65047 Laboratory Test Code RBC RBC Erythrocytes A count of the total erythrocytes per unit of a biological specimen. Erythrocyte Count Production C51947 C65047 Laboratory Test Code RETI RETI Reticulocytes A count of the reticulocytes per unit of a biological specimen. Reticulocyte Count Production C51948 C65047 Laboratory Test Code WBC WBC Leukocytes A count of the leukocytes per unit of a biological specimen. Leukocyte Count Production C51949 C65047 Laboratory Test Code LYM LYM Lymphocytes A count of the lymphocytes per unit of a biological specimen. Lymphocyte Count Production C51951 C65047 Laboratory Test Code PLAT PLAT Platelet A count of the platelets per unit of a biological specimen. Platelet Count Production C61019 C65047 Laboratory Test Code BUN BUN Blood Urea Nitrogen A measurement of the urea nitrogen in a blood specimen. Blood Urea Nitrogen Measurement Production C61032 C65047 Laboratory Test Code CHOL CHOL Cholesterol A measurement of the cholesterol in a biological specimen. Serum Total Cholesterol Measurement Production C61041 C65047 Laboratory Test Code HDL HDL HDL Cholesterol A measurement of the high density lipoprotein cholesterol in a biological specimen. Serum HDL Cholesterol Measurement Production C61042 C65047 Laboratory Test Code LDL LDL LDL Cholesterol A measurement of the low density lipoprotein cholesterol in a biological specimen. Serum LDL Cholesterol Measurement Production C62656 C65047 Laboratory Test Code PT PT Prothrombin Time A blood clotting measurement that evaluates the extrinsic pathway of coagulation and is expressed in units of time or percent activity. Prothrombin Time Production C63321 C65047 Laboratory Test Code NEUT NEUT Neutrophils A count of the neutrophils per unit of a biological specimen. Absolute Neutrophil Count Production C64431 C65047 Laboratory Test Code ALB ALB Albumin A measurement of the albumin protein in a biological specimen. Albumin Measurement Production C64432 C65047 Laboratory Test Code ALP ALP Alkaline Phosphatase A measurement of the alkaline phosphatase in a biological specimen. Alkaline Phosphatase Measurement Production C64433 C65047 Laboratory Test Code ALT ALT Alanine Aminotransferase A measurement of the alanine aminotransferase in a biological specimen. Alanine Aminotransferase Measurement Production C64434 C65047 Laboratory Test Code AMYLASE AMYLASE Amylase A measurement of the pancreatic enzyme amylase in a biological specimen. Amylase Measurement Production C64467 C65047 Laboratory Test Code AST AST Aspartate Aminotransferase A measurement of the aspartate aminotransferase in a biological specimen. Aspartate Aminotransferase Measurement Production C64469 C65047 Laboratory Test Code BACT BACT Bacteria A measurement of the bacteria in a biological specimen. Bacterial Count Production C64470 C65047 Laboratory Test Code BASO BASO Basophils A count of the basophils per unit of a biological specimen. Total Basophil Count Production C64471 C65047 Laboratory Test Code BASOLE BASOLE Basophils/Leukocytes A relative measure (ratio or percentage) of the basophils to leukocytes in a biological specimen. Basophil To Leukocyte Ratio Production C64481 C65047 Laboratory Test Code BILDIR BILDIR Direct Bilirubin A measurement of the conjugated or water-soluble bilirubin in a biological specimen. Direct Bilirubin Measurement Production C64483 C65047 Laboratory Test Code BILIND BILIND Indirect Bilirubin A measurement of the unconjugated or non-water-soluble bilirubin in a biological specimen. Indirect Bilirubin Measurement Production C64487 C65047 Laboratory Test Code BLASTLE BLASTLE Blasts/Leukocytes A relative measure (ratio or percentage) of the blasts to leukocytes in a biological specimen. Blast To Leukocyte Ratio Production C64488 C65047 Laboratory Test Code CA CA Calcium A measurement of the calcium in a biological specimen. Calcium Measurement Production C64489 C65047 Laboratory Test Code CK CK Creatine Kinase A measurement of the total creatine kinase in a biological specimen. Creatine Kinase Measurement Production C64490 C65047 Laboratory Test Code CKBB CKBB Creatine Kinase BB A measurement of the homozygous B-type creatine kinase in a biological specimen. Creatine Kinase BB Measurement Production C64491 C65047 Laboratory Test Code CKMB CKMB Creatine Kinase MB A measurement of the heterozygous MB-type creatine kinase in a biological specimen. Creatine Kinase MB Measurement Production C64494 C65047 Laboratory Test Code CKMM CKMM Creatine Kinase MM A measurement of the homozygous M-type creatine kinase in a biological specimen. Creatine Kinase MM Measurement Production C64495 C65047 Laboratory Test Code CL CL Chloride A measurement of the chloride in a biological specimen. Chloride Measurement Production C64545 C65047 Laboratory Test Code CO2 CO2 Carbon Dioxide A measurement of the carbon dioxide gas in a biological specimen. Carbon Dioxide Measurement Production C64546 C65047 Laboratory Test Code COLOR COLOR Color A measurement of the color of a biological specimen. Color Assessment Production C64547 C65047 Laboratory Test Code CREAT CREAT Creatinine A measurement of the creatinine in a biological specimen. Creatinine Measurement Production C64548 C65047 Laboratory Test Code CRP CRP C Reactive Protein A measurement of the C reactive protein in a biological specimen. C-Reactive Protein Measurement Production C64549 C65047 Laboratory Test Code ELLIPCY ELLIPCY Elliptocytes A count of the elliptocytes per unit of a biological specimen. Elliptocyte Count Production C64550 C65047 Laboratory Test Code EOS EOS Eosinophils A count of the eosinophils per unit of a biological specimen. Eosinophil Count Production C64604 C65047 Laboratory Test Code EOSLE EOSLE Eosinophils/Leukocytes A relative measure (ratio or percentage) of the eosinophils to leukocytes in a biological specimen. Eosinophil To Leukocyte Ratio Production C64605 C65047 Laboratory Test Code EPIC EPIC Epithelial Cells A measurement of the epithelial cells in a biological specimen. Epithelial Cell Count Production C64606 C65047 Laboratory Test Code FIBRINO FIBRINO Fibrinogen A measurement of the fibrinogen in a biological specimen. Fibrinogen Measurement Production C64796 C65047 Laboratory Test Code HCT HCT Hematocrit The percentage of a whole blood specimen that is composed of red blood cells (erythrocytes). Hematocrit Production C64797 C65047 Laboratory Test Code MCH MCH Ery. Mean Corpuscular Hemoglobin A quantitative measurement of the mean amount of hemoglobin per erythrocyte in a biological specimen. Erythrocyte Mean Corpuscular Hemoglobin Production C64798 C65047 Laboratory Test Code MCHC MCHC Ery. Mean Corpuscular HB Concentration A quantitative measurement of the mean amount of hemoglobin per erythrocytes in a specified volume of a biological specimen. Erythrocyte Mean Corpuscular Hemoglobin Concentration Production C64799 C65047 Laboratory Test Code MCV MCV Ery. Mean Corpuscular Volume A quantitative measurement of the mean volume of erythrocytes in a biological specimen. Erythrocyte Mean Corpuscular Volume Production C64800 C65047 Laboratory Test Code RDW RDW Erythrocytes Distribution Width A value derived from mean corpuscular volume and the standard deviation of the red blood cell volume in a whole blood specimen. Erythrocyte Distribution Width Measurement Production C64801 C65047 Laboratory Test Code TEARDCY TEARDCY Dacryocytes A count of dacryocytes in unit of a biological specimen. Dacryocyte Analysis Production C64802 C65047 Laboratory Test Code HYPO HYPO Hypochromia An observation which indicates that the hemoglobin concentration in a red blood cell specimen has fallen below a specified level. Hypochromia Production C64803 C65047 Laboratory Test Code POLYCHR POLYCHR Polychromasia A measurement of the blue-staining characteristic of newly generated erythrocytes. Polychromasia Production C64805 C65047 Laboratory Test Code INR INR Prothrombin Intl. Normalized Ratio A ratio that represents the prothrombin time for a plasma specimen, divided by the result for a control plasma specimen, further standardized for the International Sensitivity Index of the tissue factor (thromboplastin) used in the test. International Normalized Ratio of Prothrombin Time Production C64806 C65047 Laboratory Test Code VLDL VLDL VLDL Cholesterol A measurement of the very low density lipoprotein cholesterol in a biological specimen. Serum VLDL Cholesterol Measurement Production C64807 C65047 Laboratory Test Code LIPASE LIPASE Triacylglycerol Lipase A measurement of the pancreatic lipase in a biological specimen. Triacylglycerol Lipase Measurement Production C64809 C65047 Laboratory Test Code SODIUM SODIUM Sodium A measurement of the sodium in a biological specimen. Sodium Measurement Production C64810 C65047 Laboratory Test Code NITRITE NITRITE Nitrite A measurement of the nitrite in a urine specimen. Nitrite Measurement Production C64812 C65047 Laboratory Test Code TRIG TRIG Triglycerides A measurement of the triglycerides in a biological specimen. Triglyceride Measurement Production C64813 C65047 Laboratory Test Code TSH TSH Thyrotropin A measurement of the thyrotropin in a biological specimen. Thyrotropin Measurement Production C64814 C65047 Laboratory Test Code URATE URATE Urate A measurement of the urate in a biological specimen. Urate Measurement Production C64815 C65047 Laboratory Test Code UREA UREA Urea A measurement of the urea in a biological specimen. Urea Measurement Production C64816 C65047 Laboratory Test Code UROBIL UROBIL Urobilinogen A measurement of the urobilinogen in a biological specimen. Urobilinogen Measurement Production C64817 C65047 Laboratory Test Code VITB12 VITB12 Vitamin B12 A measurement of the Vitamin B12 in a serum specimen. Vitamin B12 Measurement Production C64818 C65047 Laboratory Test Code LYMAT LYMAT Lymphocytes Atypical A count of the atypical lymphocytes per unit of a biological specimen. Atypical Lymphocyte Count Production C64819 C65047 Laboratory Test Code LYMATLE LYMATLE Lymphocytes Atypical/Leukocytes A relative measure (ratio or percentage) of the atypical lymphocytes to leukocytes in a biological specimen. Atypical Lymphocyte To Leukocyte Ratio Production C64820 C65047 Laboratory Test Code LYMLE LYMLE Lymphocytes/Leukocytes A relative measure (ratio or percentage) of the lymphocytes to leukocytes in a biological specimen. Lymphocyte To Leukocyte Ratio Production C64821 C65047 Laboratory Test Code MACROCY MACROCY Macrocytes A count of the macrocytes per unit of a biological specimen. Macrocyte Count Production C64822 C65047 Laboratory Test Code MICROCY MICROCY Microcytes A count of the microcytes per unit of a biological specimen. Microcyte Count Production C64823 C65047 Laboratory Test Code MONO MONO Monocytes A count of the monocytes per unit of a biological specimen. Monocyte Count Production C64824 C65047 Laboratory Test Code MONOLE MONOLE Monocytes/Leukocytes A relative measure (ratio or percentage) of the monocytes to leukocytes in a biological specimen. Monocyte To Leukocyte Ratio Production C64825 C65047 Laboratory Test Code MYBLALE MYBLALE Myeloblasts/Leukocytes A relative measure (ratio or percentage) of the myeloblasts to leukocytes in a biological specimen. Myeloblast To Leukocyte Ratio Production C64826 C65047 Laboratory Test Code MYCYLE MYCYLE Myelocytes/Leukocytes A relative measure (ratio or percentage) of the myelocytes to leukocytes in a biological specimen. Myelocyte To Leukocyte Ratio Production C64827 C65047 Laboratory Test Code NEUTLE NEUTLE Neutrophils/Leukocytes The determination of the ratio of neutrophils compared to leukocytes in a blood sample. The measurement may be expressed as a ratio or percentage. Neutrophil To Leukocyte Ratio Production C64828 C65047 Laboratory Test Code RETIRBC RETIRBC Reticulocytes/Erythrocytes A relative measure (ratio or percentage) of reticulocytes to erythrocytes in a biological specimen. Reticulocyte To Erythrocyte Ratio Production C64829 C65047 Laboratory Test Code PRLYMLE PRLYMLE Prolymphocytes/Leukocytes A relative measure (ratio or percentage) of prolymphocytes to leukocytes in a biological specimen. Prolymphocyte To Leukocyte Ratio Production C64830 C65047 Laboratory Test Code NEUTB NEUTB Neutrophils Band Form A count of the banded neutrophils per unit of a biological specimen. Neutrophil Band Form Count Production C64831 C65047 Laboratory Test Code NEUTBLE NEUTBLE Neutrophils Band Form/Leukocytes A relative measure (ratio or percentage) of the banded neutrophils to leukocytes in a biological specimen. Neutrophil Band Form To Leukocyte Ratio Production C64832 C65047 Laboratory Test Code SPGRAV SPGRAV Specific Gravity A ratio of the density of a fluid to the density of water. Specific Gravity Production C64840 C65047 Laboratory Test Code MG MG Magnesium A measurement of the magnesium in a biological specimen. Magnesium Measurement Production C64847 C65047 Laboratory Test Code GGT GGT Gamma Glutamyl Transferase A measurement of the gamma glutamyl transpeptidase in a biological specimen. Gamma Glutamyl Transpeptidase Measurement Production C64848 C65047 Laboratory Test Code HGB HGB Hemoglobin A measurement of the hemoglobin in a biological specimen. Hemoglobin Measurement Production C64849 C65047 Laboratory Test Code HBA1C HBA1C Hemoglobin A1C A measurement of the glycosylated hemoglobin in a biological specimen. Glycosylated Hemoglobin Measurement Production C64850 C65047 Laboratory Test Code HBSAG HBSAG Hepatitis B Virus Surface Antigen A measurement of the surface antigen reaction of a biological specimen to the Hepatitis B virus. Hepatitis B Virus Surface Antigen Measurement Production C64851 C65047 Laboratory Test Code HCG HCG Choriogonadotropin Beta A measurement of the Choriogonadotropin Beta in a biological specimen. Choriogonadotropin Beta Measurement Production C64853 C65047 Laboratory Test Code K K Potassium A measurement of the potassium in a biological specimen. Potassium Measurement Production C64854 C65047 Laboratory Test Code KETONES KETONES Ketones A measurement of the ketones in a biological specimen. Ketone Measurement Production C64855 C65047 Laboratory Test Code LDH LDH Lactate Dehydrogenase A measurement of the lactate dehydrogenase in a biological specimen. Lactate Dehydrogenase Measurement Production C64856 C65047 Laboratory Test Code LEUKASE LEUKASE Leukocyte Esterase A measurement of the enzyme which indicates the presence of white blood cells in a biological specimen. Leukocyte Esterase Measurement Production C64857 C65047 Laboratory Test Code PHOS PHOS Phosphate A measurement of the phosphate in a biological specimen. Phosphate Measurement Production C64858 C65047 Laboratory Test Code PROT PROT Protein A measurement of a group of complex organic macromolecules composed of one or more alpha-L-amino acid chains in a biological specimen. Total Protein Measurement Production C67154 C67154 Yes Laboratory Test Name LBTEST LBTEST Laboratory Test Name Terminology used for Laboratory Tests of the CDISC Standard Data Tabulation Model. CDISC SDTM Laboratory Test Terminology by Name Production C35266 C67154 Laboratory Test Name Anisocytosis ANISO Anisocytosis A measurement of the inequality in the size of the red blood cells in a whole blood specimen. Anisocytosis Production C35267 C67154 Laboratory Test Name Poikilocytes POIKILO Poikilocytes A measurement of the odd-shaped erythrocytes in a whole blood specimen. Poikilocytosis Production C38037 C67154 Laboratory Test Name Bilirubin BILI Bilirubin A measurement of the total bilirubin in a biological specimen. Total Bilirubin Production C38462 C67154 Laboratory Test Name Activated Partial Thromboplastin Time APTT Activated Partial Thromboplastin Time A measurement of the length of time that it takes for clotting to occur when reagents are added to a plasma specimen. The test is partial due to the absence of tissue factor (Factor III) from the reaction mixture. Partial Thromboplastin Time Production C41376 C67154 Laboratory Test Name Glucose GLUC Glucose A measurement of the glucose in a biological specimen. Plasma Glucose Measurement Production C45997 C67154 Laboratory Test Name pH PH pH A measure of the acidity or alkalinity of a fluid on a scale of 0 to 14. pH Production C51946 C67154 Laboratory Test Name Erythrocytes RBC Erythrocytes A count of the total erythrocytes per unit of a biological specimen. Erythrocyte Count Production C51947 C67154 Laboratory Test Name Reticulocytes RETI Reticulocytes A count of the reticulocytes per unit of a biological specimen. Reticulocyte Count Production C51948 C67154 Laboratory Test Name Leukocytes WBC Leukocytes A count of the leukocytes per unit of a biological specimen. Leukocyte Count Production C51949 C67154 Laboratory Test Name Lymphocytes LYM Lymphocytes A count of the lymphocytes per unit of a biological specimen. Lymphocyte Count Production C51951 C67154 Laboratory Test Name Platelet PLAT Platelet A count of the platelets per unit of a biological specimen. Platelet Count Production C61019 C67154 Laboratory Test Name Blood Urea Nitrogen BUN Blood Urea Nitrogen A measurement of the urea nitrogen in a blood specimen. Blood Urea Nitrogen Measurement Production C61032 C67154 Laboratory Test Name Cholesterol CHOL Cholesterol A measurement of the cholesterol in a biological specimen. Serum Total Cholesterol Measurement Production C61041 C67154 Laboratory Test Name HDL Cholesterol HDL HDL Cholesterol A measurement of the high density lipoprotein cholesterol in a biological specimen. Serum HDL Cholesterol Measurement Production C61042 C67154 Laboratory Test Name LDL Cholesterol LDL LDL Cholesterol A measurement of the low density lipoprotein cholesterol in a biological specimen. Serum LDL Cholesterol Measurement Production C62656 C67154 Laboratory Test Name Prothrombin Time PT Prothrombin Time A blood clotting measurement that evaluates the extrinsic pathway of coagulation and is expressed in units of time or percent activity. Prothrombin Time Production C63321 C67154 Laboratory Test Name Neutrophils NEUT Neutrophils A count of the neutrophils per unit of a biological specimen. Absolute Neutrophil Count Production C64431 C67154 Laboratory Test Name Albumin ALB Albumin A measurement of the albumin protein in a biological specimen. Albumin Measurement Production C64432 C67154 Laboratory Test Name Alkaline Phosphatase ALP Alkaline Phosphatase A measurement of the alkaline phosphatase in a biological specimen. Alkaline Phosphatase Measurement Production C64433 C67154 Laboratory Test Name Alanine Aminotransferase ALT Alanine Aminotransferase A measurement of the alanine aminotransferase in a biological specimen. Alanine Aminotransferase Measurement Production C64434 C67154 Laboratory Test Name Amylase AMYLASE Amylase A measurement of the pancreatic enzyme amylase in a biological specimen. Amylase Measurement Production C64467 C67154 Laboratory Test Name Aspartate Aminotransferase AST Aspartate Aminotransferase A measurement of the aspartate aminotransferase in a biological specimen. Aspartate Aminotransferase Measurement Production C64469 C67154 Laboratory Test Name Bacteria BACT Bacteria A measurement of the bacteria in a biological specimen. Bacterial Count Production C64470 C67154 Laboratory Test Name Basophils BASO Basophils A count of the basophils per unit of a biological specimen. Total Basophil Count Production C64471 C67154 Laboratory Test Name Basophils/Leukocytes BASOLE Basophils/Leukocytes A relative measure (ratio or percentage) of the basophils to leukocytes in a biological specimen. Basophil To Leukocyte Ratio Production C64481 C67154 Laboratory Test Name Direct Bilirubin BILDIR Direct Bilirubin A measurement of the conjugated or water-soluble bilirubin in a biological specimen. Direct Bilirubin Measurement Production C64483 C67154 Laboratory Test Name Indirect Bilirubin BILIND Indirect Bilirubin A measurement of the unconjugated or non-water-soluble bilirubin in a biological specimen. Indirect Bilirubin Measurement Production C64487 C67154 Laboratory Test Name Blasts/Leukocytes BLASTLE Blasts/Leukocytes A relative measure (ratio or percentage) of the blasts to leukocytes in a biological specimen. Blast To Leukocyte Ratio Production C64488 C67154 Laboratory Test Name Calcium CA Calcium A measurement of the calcium in a biological specimen. Calcium Measurement Production C64489 C67154 Laboratory Test Name Creatine Kinase CK Creatine Kinase A measurement of the total creatine kinase in a biological specimen. Creatine Kinase Measurement Production C64490 C67154 Laboratory Test Name Creatine Kinase BB CKBB Creatine Kinase BB A measurement of the homozygous B-type creatine kinase in a biological specimen. Creatine Kinase BB Measurement Production C64491 C67154 Laboratory Test Name Creatine Kinase MB CKMB Creatine Kinase MB A measurement of the heterozygous MB-type creatine kinase in a biological specimen. Creatine Kinase MB Measurement Production C64494 C67154 Laboratory Test Name Creatine Kinase MM CKMM Creatine Kinase MM A measurement of the homozygous M-type creatine kinase in a biological specimen. Creatine Kinase MM Measurement Production C64495 C67154 Laboratory Test Name Chloride CL Chloride A measurement of the chloride in a biological specimen. Chloride Measurement Production C64545 C67154 Laboratory Test Name Carbon Dioxide CO2 Carbon Dioxide A measurement of the carbon dioxide gas in a biological specimen. Carbon Dioxide Measurement Production C64546 C67154 Laboratory Test Name Color COLOR Color A measurement of the color of a biological specimen. Color Assessment Production C64547 C67154 Laboratory Test Name Creatinine CREAT Creatinine A measurement of the creatinine in a biological specimen. Creatinine Measurement Production C64548 C67154 Laboratory Test Name C Reactive Protein CRP C Reactive Protein A measurement of the C reactive protein in a biological specimen. C-Reactive Protein Measurement Production C64549 C67154 Laboratory Test Name Elliptocytes ELLIPCY Elliptocytes A count of the elliptocytes per unit of a biological specimen. Elliptocyte Count Production C64550 C67154 Laboratory Test Name Eosinophils EOS Eosinophils A count of the eosinophils per unit of a biological specimen. Eosinophil Count Production C64604 C67154 Laboratory Test Name Eosinophils/Leukocytes EOSLE Eosinophils/Leukocytes A relative measure (ratio or percentage) of the eosinophils to leukocytes in a biological specimen. Eosinophil To Leukocyte Ratio Production C64605 C67154 Laboratory Test Name Epithelial Cells EPIC Epithelial Cells A measurement of the epithelial cells in a biological specimen. Epithelial Cell Count Production C64606 C67154 Laboratory Test Name Fibrinogen FIBRINO Fibrinogen A measurement of the fibrinogen in a biological specimen. Fibrinogen Measurement Production C64796 C67154 Laboratory Test Name Hematocrit HCT Hematocrit The percentage of a whole blood specimen that is composed of red blood cells (erythrocytes). Hematocrit Production C64797 C67154 Laboratory Test Name Ery. Mean Corpuscular Hemoglobin MCH Ery. Mean Corpuscular Hemoglobin A quantitative measurement of the mean amount of hemoglobin per erythrocyte in a biological specimen. Erythrocyte Mean Corpuscular Hemoglobin Production C64798 C67154 Laboratory Test Name Ery. Mean Corpuscular HB Concentration MCHC Ery. Mean Corpuscular HB Concentration A quantitative measurement of the mean amount of hemoglobin per erythrocytes in a specified volume of a biological specimen. Erythrocyte Mean Corpuscular Hemoglobin Concentration Production C64799 C67154 Laboratory Test Name Ery. Mean Corpuscular Volume MCV Ery. Mean Corpuscular Volume A quantitative measurement of the mean volume of erythrocytes in a biological specimen. Erythrocyte Mean Corpuscular Volume Production C64800 C67154 Laboratory Test Name Erythrocytes Distribution Width RDW Erythrocytes Distribution Width A value derived from mean corpuscular volume and the standard deviation of the red blood cell volume in a whole blood specimen. Erythrocyte Distribution Width Measurement Production C64801 C67154 Laboratory Test Name Dacryocytes TEARDCY Dacryocytes A count of dacryocytes in unit of a biological specimen. Dacryocyte Analysis Production C64802 C67154 Laboratory Test Name Hypochromia HYPO Hypochromia An observation which indicates that the hemoglobin concentration in a red blood cell specimen has fallen below a specified level. Hypochromia Production C64803 C67154 Laboratory Test Name Polychromasia POLYCHR Polychromasia A measurement of the blue-staining characteristic of newly generated erythrocytes. Polychromasia Production C64805 C67154 Laboratory Test Name Prothrombin Intl. Normalized Ratio INR Prothrombin Intl. Normalized Ratio A ratio that represents the prothrombin time for a plasma specimen, divided by the result for a control plasma specimen, further standardized for the International Sensitivity Index of the tissue factor (thromboplastin) used in the test. International Normalized Ratio of Prothrombin Time Production C64806 C67154 Laboratory Test Name VLDL Cholesterol VLDL VLDL Cholesterol A measurement of the very low density lipoprotein cholesterol in a biological specimen. Serum VLDL Cholesterol Measurement Production C64807 C67154 Laboratory Test Name Triacylglycerol Lipase LIPASE Triacylglycerol Lipase A measurement of the pancreatic lipase in a biological specimen. Triacylglycerol Lipase Measurement Production C64809 C67154 Laboratory Test Name Sodium SODIUM Sodium A measurement of the sodium in a biological specimen. Sodium Measurement Production C64810 C67154 Laboratory Test Name Nitrite NITRITE Nitrite A measurement of the nitrite in a urine specimen. Nitrite Measurement Production C64812 C67154 Laboratory Test Name Triglycerides TRIG Triglycerides A measurement of the triglycerides in a biological specimen. Triglyceride Measurement Production C64813 C67154 Laboratory Test Name Thyrotropin TSH Thyrotropin A measurement of the thyrotropin in a biological specimen. Thyrotropin Measurement Production C64814 C67154 Laboratory Test Name Urate URATE Urate A measurement of the urate in a biological specimen. Urate Measurement Production C64815 C67154 Laboratory Test Name Urea UREA Urea A measurement of the urea in a biological specimen. Urea Measurement Production C64816 C67154 Laboratory Test Name Urobilinogen UROBIL Urobilinogen A measurement of the urobilinogen in a biological specimen. Urobilinogen Measurement Production C64817 C67154 Laboratory Test Name Vitamin B12 VITB12 Vitamin B12 A measurement of the Vitamin B12 in a serum specimen. Vitamin B12 Measurement Production C64818 C67154 Laboratory Test Name Lymphocytes Atypical LYMAT Lymphocytes Atypical A count of the atypical lymphocytes per unit of a biological specimen. Atypical Lymphocyte Count Production C64819 C67154 Laboratory Test Name Lymphocytes Atypical/Leukocytes LYMATLE Lymphocytes Atypical/Leukocytes A relative measure (ratio or percentage) of the atypical lymphocytes to leukocytes in a biological specimen. Atypical Lymphocyte To Leukocyte Ratio Production C64820 C67154 Laboratory Test Name Lymphocytes/Leukocytes LYMLE Lymphocytes/Leukocytes A relative measure (ratio or percentage) of the lymphocytes to leukocytes in a biological specimen. Lymphocyte To Leukocyte Ratio Production C64821 C67154 Laboratory Test Name Macrocytes MACROCY Macrocytes A count of the macrocytes per unit of a biological specimen. Macrocyte Count Production C64822 C67154 Laboratory Test Name Microcytes MICROCY Microcytes A count of the microcytes per unit of a biological specimen. Microcyte Count Production C64823 C67154 Laboratory Test Name Monocytes MONO Monocytes A count of the monocytes per unit of a biological specimen. Monocyte Count Production C64824 C67154 Laboratory Test Name Monocytes/Leukocytes MONOLE Monocytes/Leukocytes A relative measure (ratio or percentage) of the monocytes to leukocytes in a biological specimen. Monocyte To Leukocyte Ratio Production C64825 C67154 Laboratory Test Name Myeloblasts/Leukocytes MYBLALE Myeloblasts/Leukocytes A relative measure (ratio or percentage) of the myeloblasts to leukocytes in a biological specimen. Myeloblast To Leukocyte Ratio Production C64826 C67154 Laboratory Test Name Myelocytes/Leukocytes MYCYLE Myelocytes/Leukocytes A relative measure (ratio or percentage) of the myelocytes to leukocytes in a biological specimen. Myelocyte To Leukocyte Ratio Production C64827 C67154 Laboratory Test Name Neutrophils/Leukocytes NEUTLE Neutrophils/Leukocytes The determination of the ratio of neutrophils compared to leukocytes in a blood sample. The measurement may be expressed as a ratio or percentage. Neutrophil To Leukocyte Ratio Production C64828 C67154 Laboratory Test Name Reticulocytes/Erythrocytes RETIRBC Reticulocytes/Erythrocytes A relative measure (ratio or percentage) of reticulocytes to erythrocytes in a biological specimen. Reticulocyte To Erythrocyte Ratio Production C64829 C67154 Laboratory Test Name Prolymphocytes/Leukocytes PRLYMLE Prolymphocytes/Leukocytes A relative measure (ratio or percentage) of prolymphocytes to leukocytes in a biological specimen. Prolymphocyte To Leukocyte Ratio Production C64830 C67154 Laboratory Test Name Neutrophils Band Form NEUTB Neutrophils Band Form A count of the banded neutrophils per unit of a biological specimen. Neutrophil Band Form Count Production C64831 C67154 Laboratory Test Name Neutrophils Band Form/Leukocytes NEUTBLE Neutrophils Band Form/Leukocytes A relative measure (ratio or percentage) of the banded neutrophils to leukocytes in a biological specimen. Neutrophil Band Form To Leukocyte Ratio Production C64832 C67154 Laboratory Test Name Specific Gravity SPGRAV Specific Gravity A ratio of the density of a fluid to the density of water. Specific Gravity Production C64840 C67154 Laboratory Test Name Magnesium MG Magnesium A measurement of the magnesium in a biological specimen. Magnesium Measurement Production C64847 C67154 Laboratory Test Name Gamma Glutamyl Transferase GGT Gamma Glutamyl Transferase A measurement of the gamma glutamyl transpeptidase in a biological specimen. Gamma Glutamyl Transpeptidase Measurement Production C64848 C67154 Laboratory Test Name Hemoglobin HGB Hemoglobin A measurement of the hemoglobin in a biological specimen. Hemoglobin Measurement Production C64849 C67154 Laboratory Test Name Hemoglobin A1C HBA1C Hemoglobin A1C A measurement of the glycosylated hemoglobin in a biological specimen. Glycosylated Hemoglobin Measurement Production C64850 C67154 Laboratory Test Name Hepatitis B Virus Surface Antigen HBSAG Hepatitis B Virus Surface Antigen A measurement of the surface antigen reaction of a biological specimen to the Hepatitis B virus. Hepatitis B Virus Surface Antigen Measurement Production C64851 C67154 Laboratory Test Name Choriogonadotropin Beta HCG Choriogonadotropin Beta A measurement of the Choriogonadotropin Beta in a biological specimen. Choriogonadotropin Beta Measurement Production C64853 C67154 Laboratory Test Name Potassium K Potassium A measurement of the potassium in a biological specimen. Potassium Measurement Production C64854 C67154 Laboratory Test Name Ketones KETONES Ketones A measurement of the ketones in a biological specimen. Ketone Measurement Production C64855 C67154 Laboratory Test Name Lactate Dehydrogenase LDH Lactate Dehydrogenase A measurement of the lactate dehydrogenase in a biological specimen. Lactate Dehydrogenase Measurement Production C64856 C67154 Laboratory Test Name Leukocyte Esterase LEUKASE Leukocyte Esterase A measurement of the enzyme which indicates the presence of white blood cells in a biological specimen. Leukocyte Esterase Measurement Production C64857 C67154 Laboratory Test Name Phosphate PHOS Phosphate A measurement of the phosphate in a biological specimen. Phosphate Measurement Production C64858 C67154 Laboratory Test Name Protein PROT Protein A measurement of a group of complex organic macromolecules composed of one or more alpha-L-amino acid chains in a biological specimen. Total Protein Measurement Production