Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Value NCI Preferred Term CDISC Definition CDISC Synonym(s) (where applicable) Pre-release/ Production C49499 C49499 No Action Taken with Study Treatment [ACN] The reason that changes were made to the therapy under study. (NCI) Action Taken with Study Treatment Production C49503 C49499 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) Production C49504 C49499 Action Taken with Study Treatment DOSE NOT CHANGED Dose Not Changed An indication that a medication schedule was maintained. (NCI) Production C49505 C49499 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) Production C49501 C49499 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 (NCI) Production C49502 C49499 Action Taken with Study Treatment DRUG WITHDRAWN Drug Withdrawn An indication that a medication schedule was modified through termination of a prescribed regimen of medication.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) Production C48660 C49499 Action Taken with Study Treatment NA Not Applicable Determination of a value is not relevant in the current context. (NCI) NOT APPLICABLE Production C17998 C49499 Action Taken with Study Treatment U Unknown Not known, not observed, not recorded, or refused. (NCI) UNKNOWN; Unknown Production C49489 C49489 No Adverse Event Outcome [OUT] A condition or event that is attributed to the adverse event and is the result or conclusion of the adverse event. (NCI) Outcome of Event Production C48275 C49489 Adverse Event Outcome 5 Death Related to Adverse Event The termination of life as a result of an adverse event. (NCI) Grade 5; FATAL Production C49494 C49489 Adverse Event Outcome NOT RECOVERED/NOT RESOLVED Not Recovered or Not Resolved One of the possible results of an adverse event outcome that indicates that the event has not improved or recuperated. (NCI) Production C49498 C49489 Adverse Event Outcome RECOVERED/RESOLVED Recovered or Resolved One of the possible results of an adverse event outcome that indicates that the event has improved or recuperated. (NCI) Production C49495 C49489 Adverse Event Outcome RECOVERED/RESOLVED WITH SEQUELAE Recovered or 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) Production C49496 C49489 Adverse Event Outcome RECOVERING/RESOLVING Recovering or Resolving One of the possible results of an adverse event outcome that indicates that the event is improving. (NCI) Production C17998 C49489 Adverse Event Outcome U Unknown Not known, not observed, not recorded, or refused. (NCI) UNKNOWN; Unknown Production C20587 C20587 Yes Age Group [AGESPAN] Subgroups of populations based on age. (NCI) Age Span Production C27954 C20587 Age Group ADOLESCENT (12-17 YEARS) Adolescent A juvenile between the onset of puberty and maturity; in the state of development between puberty and maturity. (NCI) Production C49685 C20587 Age Group ADULT (18-65) Adult 18-65 Years Old A person from 18 years to 65 years of age. (NCI) Production C49683 C20587 Age Group CHILDREN (2-11 YEARS) Children 2-11 Years Old A person from 2 years to 11 years of age. (NCI) Production C16268 C20587 Age Group ELDERLY (> 65) Elderly An age group comprised by people 65 years of age and older. (NCI) Production C49641 C20587 Age Group 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) Production C49643 C20587 Age Group INFANT AND TODDLER (28 DAYS - 23 MONTHS) Infant And Toddler A person from 28 days to 23 months of age. (NCI) Production C16731 C20587 Age Group NEWBORN (0-27 DAYS) Newborn An infant during the first month after birth. (NCI) Production C49642 C20587 Age Group PRETERM NEWBORN INFANTS Preterm Newborn Infant An infant born prior to completion of the normal gestation period. (NCI) Production C50400 C50400 No Age Unit [AGEU] Those units of time that are routinely used to express the age of a person. (NCI) Age Units Production C25301 C50400 Age Unit DAYS Day 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) Production C25529 C50400 Age Unit HOURS Hour A unit measure of time equal to 3,600 seconds or 60 minutes. It is approximately 1/24 of a median day. (NCI) Production C29846 C50400 Age Unit MONTHS Month 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) Production C29844 C50400 Age Unit WEEKS Week Any period of seven consecutive days. (NCI) Production C29848 C50400 Age Unit YEARS Year 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) Production C49480 C49480 No Category for Inclusion and or Exclusion [IECAT] A collection of criteria on which subjects are evaluated and that must be met by all study subjects. (NCI) Category for Inclusion/Exclusion Production C25370 C49480 Category for Inclusion and or 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) Production C25532 C49480 Category for Inclusion and or 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) Production C64388 C64388 No CDISC System Organ Class [SOC] Terms at the highest level of the CDISC system organ class terminology. System Organ Class Production C35814 C64388 CDISC System Organ Class BLOOD AND LYMPHATIC SYSTEM DISORDERS Hematopoietic and Lymphoid System Disorder 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) Production C3079 C64388 CDISC System Organ Class CARDIAC DISORDERS Heart Disorder Any deviation from the normal structure or function of the cardiac system that is manifested by a characteristic set of symptoms and signs. (NCI) Production C49399 C64388 CDISC System Organ Class CONGENITAL, FAMILIAL AND GENETIC DISORDERS Congenital, Familial and Genetic Disorder Class 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) Production C49400 C64388 CDISC System Organ Class EAR AND LABYRINTH DISORDERS Ear and Labyrinth Disorder Class 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) Production C3009 C64388 CDISC System Organ Class ENDOCRINE DISORDERS Endocrine Disorder Any deviation from the normal structure or function of the endocrine system that is manifested by a characteristic set of symptoms and signs. (NCI) Production C26767 C64388 CDISC System Organ Class EYE DISORDERS Eye Disorder Any deviation from the normal structure or function of the eye that is manifested by a characteristic set of symptoms and signs. (NCI) Production C2990 C64388 CDISC System Organ Class GASTROINTESTINAL DISORDERS Gastrointestinal Disorder Diseases of the digestive tract (oral cavity to anus) and associated organs (salivary glands, liver, pancreas). (NCI) Production C49401 C64388 CDISC System Organ Class GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS General Disorders and Administration Site Conditions Class 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) Production C3959 C64388 CDISC System Organ Class HEPATOBILIARY DISORDERS Liver and Biliary Tract Disorder 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) Production C3507 C64388 CDISC System Organ Class IMMUNE SYSTEM DISORDERS Immune System Disorder A disorder resulting from an abnormality in the immune system. -- 2003 (NCI) Production C26726 C64388 CDISC System Organ Class INFECTIONS AND INFESTATIONS Infectious Disorder 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) Production C49402 C64388 CDISC System Organ Class INJURY, POISONING AND PROCEDURAL COMPLICATIONS Injury, Poisoning and Procedural Complication Class A class of disorders that encompasses conditions resulting from an injury, poisoning or procedure. (NCI) Production C41198 C64388 CDISC System Organ Class INVESTIGATIONS Investigation 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) Production C49403 C64388 CDISC System Organ Class METABOLISM AND NUTRITION DISORDERS Metabolism and Nutrition Disorder Class A class of disorders that encompasses conditions occurring as a result of metabolic dysfunction or deviation from the normal nutritional requirements. (NCI) Production C27574 C64388 CDISC System Organ Class MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Connective and Soft Tissue Disorder 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) Production C3262 C64388 CDISC System Organ Class NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) Neoplasm 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) Production C26835 C64388 CDISC System Organ Class NERVOUS SYSTEM DISORDERS Nervous System Disorder Any deviation from the normal structure or function of the nervous system that is manifested by a characteristic set of symptoms and signs. (NCI) Production C49404 C64388 CDISC System Organ Class PREGNANCY, PUERPERIUM AND PERINATAL CONDITIONS Pregnancy, Puerperium and Perinatal Condition Class A class of conditions associated with pregnancy, puerperium and perinatal status. (NCI) Production C2893 C64388 CDISC System Organ Class PSYCHIATRIC DISORDERS Psychiatric Disorder 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) Production C3430 C64388 CDISC System Organ Class RENAL AND URINARY DISORDERS Urinary System Disorder Disorders of any part of the urologic system. (NCI) Production C49405 C64388 CDISC System Organ Class REPRODUCTIVE SYSTEM AND BREAST DISORDERS Reproductive System and Breast Disorder Class 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) Production C27669 C64388 CDISC System Organ Class RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Respiratory and Thoracic Disorder 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) Production C3371 C64388 CDISC System Organ Class SKIN AND SUBCUTANEOUS TISSUE DISORDERS Skin Disorder 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) Production C20188 C64388 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) Production C25218 C64388 CDISC System Organ Class SURGICAL AND MEDICAL PROCEDURES Procedure A particular course of action intended to achieve a result. (NCI) Production C35117 C64388 CDISC System Organ Class VASCULAR DISORDERS Vascular Disorder Any deviation from the normal structure or function of the vascular system that is manifested by a characteristic set of symptoms and signs. (NCI) Production C49704 C49704 No Common Terminology Criteria for Adverse Events [TOXGR] 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) Standard Toxicity Grade Production C41338 C49704 Common Terminology Criteria for Adverse Events 1 Mild Adverse Event 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. Grade 1; MILD Production C41339 C49704 Common Terminology Criteria for Adverse Events 2 Moderate Adverse Event 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. Grade 2; MODERATE Production C41340 C49704 Common Terminology Criteria for Adverse Events 3 Severe Adverse Event 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. Grade 3; SEVERE Production C41337 C49704 Common Terminology Criteria for Adverse Events 4 Life Threatening or Disabling Adverse Event 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. Grade 4; Production C48275 C49704 Common Terminology Criteria for Adverse Events 5 Death Related to Adverse Event The termination of life as a result of an adverse event. (NCI) Grade 5; FATAL Production C49647 C49647 Yes Control Type [TCNTRL] Comparator against which the study treatment is evaluated (e.g., concurrent (placebo, no treatment, dose-response, active), external (historical, published literature). Type of Control Production C49649 C49647 Control Type ACTIVE Active Control A type of control, which has a demonstrated effect, administered as a comparator, to subjects in a clinical trial. [From ICH E10]. Production C41132 C49647 Control Type NONE None No person or thing, nobody, not any. (NCI) Production C49648 C49647 Control Type PLACEBO Placebo Control 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) Production C25464 C25464 No 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) Country Production C17884 C25464 Country ABW Aruba Island in the Caribbean Sea, north of Venezuela. ARUBA Production C16267 C25464 Country AFG Afghanistan A country in Southern Asia, north and west of Pakistan, east of Iran. AFGHANISTAN Production C16292 C25464 Country AGO Angola A country in Southern Africa, bordering the South Atlantic Ocean, between Namibia and Democratic Republic of the Congo. ANGOLA Production C20133 C25464 Country AIA Anguilla An island in the Caribbean Sea, east of Puerto Rico. ANGUILLA Production C44481 C25464 Country 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 C25464 Country ALB Albania A country in Southeastern Europe, bordering the Adriatic Sea and Ionian Sea, between Greece and Serbia and Montenegro. ALBANIA Production C16289 C25464 Country AND Andorra A country in Southwestern Europe, between France and Spain. ANDORRA Production C16904 C25464 Country 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 C25464 Country 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 C25464 Country ARG Argentina A country in Southern South America, bordering the South Atlantic Ocean, between Chile and Uruguay. ARGENTINA Production C16306 C25464 Country ARM Armenia A country in Southwestern Asia, east of Turkey. ARMENIA Production C17739 C25464 Country ASM American Samoa A group of islands in the South Pacific Ocean, about half way between Hawaii and New Zealand. AMERICAN SAMOA Production C18007 C25464 Country ATA Antarctica The continent lying mostly south of the Antarctic Circle. ANTARCTICA Production C20105 C25464 Country 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 C25464 Country ATG Antigua and Barbuda Islands between the Caribbean Sea and the North Atlantic Ocean, east-southeast of Puerto Rico. ANTIGUA AND BARBUDA Production C16311 C25464 Country AUS Australia The continent between the Indian Ocean and the South Pacific Ocean. AUSTRALIA Production C16312 C25464 Country AUT Austria A country in Central Europe, north of Italy and Slovenia. AUSTRIA Production C16316 C25464 Country AZE Azerbaijan A country in Southwestern Asia, bordering the Caspian Sea, between Iran and Russia. AZERBAIJAN Production C16371 C25464 Country BDI Burundi A country in Central Africa, east of Democratic Republic of the Congo. BURUNDI Production C16329 C25464 Country BEL Belgium A country in Western Europe, bordering the North Sea, between France and the Netherlands. BELGIUM Production C16333 C25464 Country BEN Benin Republic A country in Western Africa, bordering the North Atlantic Ocean, between Nigeria and Togo. BENIN REPUBLIC Production C16369 C25464 Country BFA Burkina Faso A country in Western Africa, north of Ghana. BURKINA FASO Production C16323 C25464 Country BGD Bangladesh A country in Southern Asia, bordering the Bay of Bengal, between Burma and India. BANGLADESH Production C16368 C25464 Country BGR Bulgaria A country in Southeastern Europe, bordering the Black Sea, between Romania and Turkey. BULGARIA Production C16322 C25464 Country BHR Bahrain An archipelago in the Persian Gulf, east of Saudi Arabia. BAHRAIN Production C16321 C25464 Country BHS Bahamas A chain of islands in the North Atlantic Ocean, southeast of Florida. BAHAMAS Production C16361 C25464 Country BIH Bosnia-Herzegovina A country in Southeastern Europe, bordering the Adriatic Sea and Croatia. BOSNIA-HERZEGOVINA Production C16372 C25464 Country BLR Belarus A country in Eastern Europe, east of Poland. BELARUS Production C16331 C25464 Country BLZ Belize A country in Central America, bordering the Caribbean Sea, between Guatemala and Mexico. BELIZE Production C16334 C25464 Country BMU Bermuda No Definition BERMUDA Production C16359 C25464 Country BOL Bolivia A country in Central South America, southwest of Brazil. BOLIVIA Production C16364 C25464 Country BRA Brazil A country in Eastern South America, bordering the Atlantic Ocean. BRAZIL Production C16324 C25464 Country BRB Barbados An island between the Caribbean Sea and the North Atlantic Ocean, northeast of Venezuela. BARBADOS Production C16367 C25464 Country BRN Brunei Darussalam A country in Southeastern Asia, bordering the South China Sea and Malaysia. BRUNEI Production C16336 C25464 Country BTN Bhutan A country in Southern Asia, between China and India. BHUTAN Production C20104 C25464 Country BVT Bouvet Island An island in the South Atlantic Ocean, south-southwest of the Cape of Good Hope (South Africa). BOUVET ISLAND Production C16363 C25464 Country BWA Botswana A country in Southern Africa, north of South Africa. BOTSWANA Production C16409 C25464 Country CAF Central African Republic A country in Central Africa, north of Democratic Republic of the Congo. CENTRAL AFRICAN REPUBLIC Production C16380 C25464 Country 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 C25464 Country 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 C25464 Country CHE Switzerland A country in Central Europe, east of France, north of Italy. SWITZERLAND Production C16427 C25464 Country CHL Chile A country in Southern South America, bordering the South Atlantic Ocean and South Pacific Ocean, between Argentina and Peru. CHILE Production C16428 C25464 Country 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 C25464 Country CIV Cote d'Ivoire A country in Western Africa, bordering the North Atlantic Ocean, between Ghana and Liberia. COTE D'IVOIRE Production C16379 C25464 Country CMR Cameroon A country in Western Africa, bordering the Bight of Biafra, between Equatorial Guinea and Nigeria. CAMEROON Production C17266 C25464 Country COD Democratic Republic of the Congo A country in Central Africa, northeast of Angola. DEMOCRATIC REPUBLIC OF THE CONGO Production C16467 C25464 Country COG Congo A country in Western Africa, bordering the South Atlantic Ocean, between Angola and Gabon. CONGO Production C16469 C25464 Country 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 C25464 Country 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 C25464 Country 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 C25464 Country CPV Cape Verde A group of islands in the North Atlantic Ocean, west of Senegal. CAPE VERDE Production C16470 C25464 Country 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 C25464 Country CUB Cuba An island between the Caribbean Sea and the North Atlantic Ocean, 150 km south of Key West, Florida. CUBA Production C44482 C25464 Country CXR Christmas Island An Australian-administered island in the eastern Indian Ocean south of Java, Indonesia. CHRISTMAS ISLAND Production C16391 C25464 Country CYM Cayman Islands An island group in the Caribbean Sea, nearly one-half of the way from Cuba to Honduras. CAYMAN ISLANDS Production C16480 C25464 Country CYP Cyprus An island in the Mediterranean Sea, south of Turkey. CYPRUS Production C17668 C25464 Country CZE Czech Republic A country in Central Europe, southeast of Germany. CZECH REPUBLIC Production C16636 C25464 Country 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 C25464 Country DJI Djibouti A country in Eastern Africa, bordering the Gulf of Aden and the Red Sea, between Eritrea and Somalia. DJIBOUTI Production C16519 C25464 Country 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 C25464 Country 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 C25464 Country 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 C25464 Country DZA Algeria A country in Northern Africa, bordering the Mediterranean Sea, between Morocco and Tunisia. ALGERIA Production C16528 C25464 Country ECU Ecuador A country in Western South America, bordering the Pacific Ocean at the Equator, between Colombia and Peru. ECUADOR Production C16530 C25464 Country EGY Egypt A country in Northern Africa, bordering the Mediterranean Sea, between Libya and the Gaza Strip. EGYPT Production C16558 C25464 Country ERI Eritrea A country in Eastern Africa, bordering the Red Sea, between Djibouti and Sudan. ERITREA Production C20113 C25464 Country ESH Western Sahara A country in Northern Africa, bordering the North Atlantic Ocean, between Mauritania and Morocco. WESTERN SAHARA Production C17152 C25464 Country 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 C25464 Country EST Estonia A country in Eastern Europe, bordering the Baltic Sea and Gulf of Finland, between Latvia and Russia. ESTONIA Production C16563 C25464 Country ETH Ethiopia A country in Eastern Africa, west of Somalia. ETHIOPIA Production C16584 C25464 Country 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 C25464 Country FJI Fiji An island group in the South Pacific Ocean, about two-thirds of the way from Hawaii to New Zealand. FIJI Production C17954 C25464 Country FLK Falkland Islands Islands in the South Atlantic Ocean, east of southern Argentina. FALKLAND ISLANDS Production C16592 C25464 Country 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 C25464 Country 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 C25464 Country FSM Federated States of Micronesia An island group in the North Pacific Ocean, about three-quarters of the way from Hawaii to Indonesia. MICRONESIA, FEDERATED STATES OF Production C16596 C25464 Country 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 C25464 Country 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 C25464 Country GEO Georgia A country in Southwestern Asia, bordering the Black Sea, between Turkey and Russia. GEORGIA Production C64375 C25464 Country 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 C25464 Country GHA Ghana A country in Western Africa, bordering the Gulf of Guinea, between Cote d'Ivoire and Togo. GHANA Production C16638 C25464 Country GIB Gibraltar A dependency in Southwestern Europe, bordering the Strait of Gibraltar, on the southern coast of Spain. GIBRALTAR Production C16655 C25464 Country GIN Guinea A country in Western Africa, bordering the North Atlantic Ocean, between Guinea-Bissau and Sierra Leone. GUINEA Production C16651 C25464 Country GLP Guadeloupe Islands in the eastern Caribbean Sea, southeast of Puerto Rico. GUADELOUPE Production C16598 C25464 Country GMB Gambia A country in Western Africa, bordering the North Atlantic Ocean and Senegal. GAMBIA Production C16656 C25464 Country GNB Guinea-Bissau A country in Western Africa, bordering the North Atlantic Ocean, between Guinea and Senegal. GUINEA-BISSAU Production C16557 C25464 Country 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 C25464 Country GRC Greece A country in Southern Europe, bordering the Aegean Sea, Ionian Sea, and the Mediterranean Sea, between Albania and Turkey. GREECE Production C16647 C25464 Country GRD Grenada An island between the Caribbean Sea and Atlantic Ocean, north of Trinidad and Tobago. GRENADA Production C16646 C25464 Country GRL Greenland An island between the Arctic Ocean and the North Atlantic Ocean, northeast of Canada. GREENLAND Production C16654 C25464 Country 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 C25464 Country GUF French Guiana A country in Northern South America, bordering the North Atlantic Ocean, between Brazil and Suriname. FRENCH GUIANA Production C16652 C25464 Country GUM Guam Island in the North Pacific Ocean, about three-quarters of the way from Hawaii to the Philippines. GUAM Production C16657 C25464 Country GUY Guyana A country in Northern South America, bordering the North Atlantic Ocean, between Suriname and Venezuela. GUYANA Production C16695 C25464 Country HKG Hong Kong A special administrative region of China, bordering the South China Sea and China. HONG KONG Production C20106 C25464 Country 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 C25464 Country 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 C25464 Country HRV Croatia A country in Southeastern Europe, bordering the Adriatic Sea, between Bosnia and Herzegovina and Slovenia. CROATIA Production C16660 C25464 Country 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 C25464 Country HUN Hungary A country in Central Europe, northwest of Romania. HUNGARY Production C16728 C25464 Country IDN Indonesia A country in Southeastern Asia, comprising the archipelago between the Indian Ocean and the Pacific Ocean. INDONESIA Production C16727 C25464 Country IND India A country in Southern Asia, bordering the Arabian Sea and the Bay of Bengal, between Burma and Pakistan. INDIA Production C16365 C25464 Country 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 C25464 Country 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 C25464 Country 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 C25464 Country IRQ Iraq A country in the Middle East, bordering the Persian Gulf, between Iran and Kuwait. IRAQ Production C16704 C25464 Country ISL Iceland A country in Northern Europe, island between the Greenland Sea and the North Atlantic Ocean, northwest of the UK. ICELAND Production C16760 C25464 Country ISR Israel A country in the Middle East, bordering the Mediterranean Sea, between Egypt and Lebanon. ISRAEL Production C16761 C25464 Country ITA Italy A country in Southern Europe, occupying a peninsula extending into the central Mediterranean Sea, northeast of Tunisia. ITALY Production C16763 C25464 Country JAM Jamaica An island in the Caribbean Sea, south of Cuba. JAMAICA Production C16765 C25464 Country JOR Jordan A country in the Middle East, northwest of Saudi Arabia. JORDAN Production C16764 C25464 Country 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 C25464 Country 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 C25464 Country KAZ Kazakhstan A country in Central Asia, northwest of China. KAZAKHSTAN Production C16769 C25464 Country KEN Kenya A country in Eastern Africa, bordering the Indian Ocean, between Somalia and Tanzania. KENYA Production C16771 C25464 Country KGZ Kyrgyzstan A country in Central Asia, west of China. KYRGYZSTAN Production C16378 C25464 Country KHM Cambodia A country in Southeastern Asia, bordering the Gulf of Thailand, between Thailand, Vietnam, and Laos. CAMBODIA Production C16639 C25464 Country 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 C25464 Country 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 C25464 Country 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 C25464 Country KWT Kuwait A country in the Middle East, bordering the Persian Gulf, between Iraq and Saudi Arabia. KUWAIT Production C16780 C25464 Country LAO Lao People's Democratic Republic A country in Southeastern Asia, northeast of Thailand, west of Vietnam. LAO PEOPLE'S DEMOCRATIC REPUBLIC Production C16784 C25464 Country LBN Lebanon A country in the Middle East, bordering the Mediterranean Sea, between Israel and Syria. LEBANON Production C16791 C25464 Country LBR Liberia A country in Western Africa, bordering the North Atlantic Ocean, between Cote d'Ivoire and Sierra Leone. LIBERIA Production C16793 C25464 Country LBY Libyan Arab Jamahiriya A country in Northern Africa, bordering the Mediterranean Sea, between Egypt and Tunisia. LIBYAN ARAB JAMAHIRIYA Production C17113 C25464 Country 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 C25464 Country LIE Liechtenstein A country in Central Europe, between Austria and Switzerland. LIECHTENSTEIN Production C17163 C25464 Country LKA Sri Lanka A country in Southern Asia, occupying an island in the Indian Ocean, south of India. SRI LANKA Production C16787 C25464 Country LSO Lesotho A country in Southern Africa, an enclave of South Africa. LESOTHO Production C16799 C25464 Country LTU Lithuania A country in Eastern Europe, bordering the Baltic Sea, between Latvia and Russia. LITHUANIA Production C16803 C25464 Country LUX Luxembourg A country in Western Europe, between France, Belgium, and Germany. LUXEMBOURG Production C16783 C25464 Country LVA Latvia A country in Eastern Europe, bordering the Baltic Sea, between Estonia and Lithuania. LATVIA Production C16807 C25464 Country MAC Macao A country in Eastern Asia, bordering the South China Sea and China. MACAO Production C16878 C25464 Country MAR Morocco A country in Northern Africa, bordering the North Atlantic Ocean and the Mediterranean Sea, between Algeria and Western Sahara. MOROCCO Production C16874 C25464 Country 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 C25464 Country MDA Moldova A country in Eastern Europe, northeast of Romania. MOLDOVA, REPUBLIC OF Production C16808 C25464 Country MDG Madagascar A country in Southern Africa, occupying an island in the Indian Ocean, east of Mozambique. MADAGASCAR Production C16815 C25464 Country MDV Maldives A country in Southern Asia, occupying a group of atolls in the Indian Ocean, south-southwest of India. MALDIVES Production C16850 C25464 Country 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 C25464 Country 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 C25464 Country MKD Republic of Macedonia A country in Southeastern Europe, north of Greece. REPUBLIC OF MACEDONIA Production C16816 C25464 Country MLI Mali A country in Western Africa, southwest of Algeria. MALI Production C16817 C25464 Country MLT Malta A country in Southern Europe, occupying islands in the Mediterranean Sea, south of Sicily (Italy). MALTA Production C16370 C25464 Country MMR Myanmar A country in Southeastern Asia, bordering the Andaman Sea and the Bay of Bengal, between Bangladesh and Thailand. MYANMAR Production C64378 C25464 Country 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 C25464 Country MNG Mongolia A country in Northern Asia, between China and Russia. MONGOLIA Production C17882 C25464 Country 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 C25464 Country MOZ Mozambique A country in Southern Africa, bordering the Mozambique Channel, between South Africa and Tanzania. MOZAMBIQUE Production C16826 C25464 Country MRT Mauritania A country in Northern Africa, bordering the North Atlantic Ocean, between Senegal and Western Sahara. MAURITANIA Production C16876 C25464 Country MSR Montserrat A country in the Caribbean, occupying an island in the Caribbean Sea, southeast of Puerto Rico. MONTSERRAT Production C16823 C25464 Country MTQ Martinique An island in the Caribbean Sea, north of Trinidad and Tobago. MARTINIQUE Production C16827 C25464 Country MUS Mauritius A country in Southern Africa, occupying an island in the Indian Ocean, east of Madagascar. MAURITIUS Production C16813 C25464 Country MWI Malawi A country in Southern Africa, east of Zambia. MALAWI Production C16814 C25464 Country 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 C25464 Country 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 C25464 Country NAM Namibia A country in Southern Africa, bordering the South Atlantic Ocean, between Angola and South Africa. NAMIBIA Production C16913 C25464 Country NCL New Caledonia A country in the Pacific, comprised of islands in the South Pacific Ocean, east of Australia. NEW CALEDONIA Production C16916 C25464 Country NER Niger A country in Western Africa, southeast of Algeria. NIGER Production C16919 C25464 Country NFK Norfolk Island A country in the Pacific, occupying an island in the South Pacific Ocean, east of Australia. NORFOLK ISLAND Production C16917 C25464 Country NGA Nigeria A country in Western Africa, bordering the Gulf of Guinea, between Benin and Cameroon. NIGERIA Production C16915 C25464 Country 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 C25464 Country NIU Niue A country in the Pacific, occupying an island in the South Pacific Ocean, east of Tonga. NIUE Production C16903 C25464 Country NLD Netherlands A country in Western Europe, bordering the North Sea, between Belgium and Germany. NETHERLANDS Production C16920 C25464 Country NOR Norway A country in Northern Europe, bordering the North Sea and the North Atlantic Ocean, west of Sweden. NORWAY Production C16901 C25464 Country NPL Nepal A country in Southern Asia, between China and India. NEPAL Production C16896 C25464 Country NRU Nauru A country in Oceania, occupying an island in the South Pacific Ocean, south of the Marshall Islands. NAURU Production C16914 C25464 Country NZL New Zealand A country in the Pacific, comprised of islands in the South Pacific Ocean, southeast of Australia. NEW ZEALAND Production C16933 C25464 Country 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 C25464 Country 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 C25464 Country 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 C25464 Country PCN Pitcairn Island A country in the Pacific, comprised of islands in the South Pacific Ocean, about midway between Peru and New Zealand. PITCAIRN Production C16972 C25464 Country PER Peru A country in Western South America, bordering the South Pacific Ocean, between Chile and Ecuador. PERU Production C16978 C25464 Country 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 C25464 Country PLW Palau A country in the Pacific, comprising a group of islands in the North Pacific Ocean, southeast of the Philippines. PALAU Production C16952 C25464 Country 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 C25464 Country POL Poland A country in Central Europe, east of Germany. POLAND Production C17043 C25464 Country PRI Puerto Rico An island between the Caribbean Sea and the North Atlantic Ocean, east of the Dominican Republic. PUERTO RICO Production C16773 C25464 Country 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 C25464 Country PRT Portugal A country in Southwestern Europe, bordering the North Atlantic Ocean, west of Spain. PORTUGAL Production C16953 C25464 Country PRY Paraguay A country in Central South America, northeast of Argentina. PARAGUAY Production C20110 C25464 Country PSE Palestinian Territory, Occupied A collective name for the West Bank and the Gaza Strip, two territories in Palestine. PALESTINIAN TERRITORY, OCCUPIED Production C16594 C25464 Country 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 C25464 Country QAT Qatar A country in the Middle East, occupying a peninsula bordering the Persian Gulf and Saudi Arabia. QATAR Production C17095 C25464 Country REU Reunion An Southern Africa, occupying an island in the Indian Ocean, east of Madagascar. REUNION Production C17108 C25464 Country ROU Romania A country in Southeastern Europe, bordering the Black Sea, between Bulgaria and Ukraine. ROMANIA Production C17111 C25464 Country RUS Russia 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. RUSSIAN FEDERATION Production C17112 C25464 Country RWA Rwanda A country in Central Africa, east of Democratic Republic of the Congo. RWANDA Production C17117 C25464 Country SAU Saudi Arabia A country in the Middle East, bordering the Persian Gulf and the Red Sea, north of Yemen. SAUDI ARABIA Production C64377 C25464 Country 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 C25464 Country SDN Sudan A country in Northern Africa, bordering the Red Sea, between Egypt and Eritrea. SUDAN Production C17121 C25464 Country SEN Senegal A country in Western Africa, bordering the North Atlantic Ocean, between Guinea-Bissau and Mauritania. SENEGAL Production C17134 C25464 Country SGP Singapore A country in Southeastern Asia, comprised of islands between Malaysia and Indonesia. SINGAPORE Production C20111 C25464 Country 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 C25464 Country SHN Saint Helena Islands in the South Atlantic Ocean, about midway between South America and Africa. SAINT HELENA Production C17178 C25464 Country 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 C25464 Country SLB Solomon Islands A group of islands in the South Pacific Ocean, east of Papua New Guinea. SOLOMON ISLANDS Production C17130 C25464 Country SLE Sierra Leone A country in Western Africa, bordering the North Atlantic Ocean, between Guinea and Liberia. SIERRA LEONE Production C16532 C25464 Country SLV El Salvador A country in Central America, bordering the North Pacific Ocean, between Guatemala and Honduras. EL SALVADOR Production C17115 C25464 Country SMR San Marino A country in Southern Europe, an enclave in central Italy. SAN MARINO Production C17149 C25464 Country SOM Somalia A country in Eastern Africa, bordering the Gulf of Aden and the Indian Ocean, east of Ethiopia. SOMALIA Production C17165 C25464 Country 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 C25464 Country 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 C25464 Country SUR Suriname A country in Northern South America, bordering the North Atlantic Ocean, between French Guiana and Guyana. SURINAME Production C17669 C25464 Country SVK Slovakia A country in Central Europe, south of Poland. SLOVAKIA Production C17138 C25464 Country SVN Slovenia A country in Central Europe, bordering the Adriatic Sea, between Austria and Croatia. SLOVENIA Production C17180 C25464 Country SWE Sweden A country in Northern Europe, bordering the Baltic Sea, Gulf of Bothnia, Kattegat, and Skagerrak, between Finland and Norway. SWEDEN Production C17179 C25464 Country SWZ Swaziland A country in Southern Africa, between Mozambique and South Africa. SWAZILAND Production C17129 C25464 Country SYC Seychelles A country in Eastern Africa, comprised of a group of islands in the Indian Ocean, northeast of Madagascar. SEYCHELLES Production C17182 C25464 Country SYR Syria A country in the Middle East, bordering the Mediterranean Sea, between Lebanon and Turkey. SYRIAN ARAB REPUBLIC Production C17224 C25464 Country TCA Turks and Caicos Islands Two island groups in the North Atlantic Ocean, southeast of The Bahamas. TURKS AND CAICOS ISLANDS Production C16412 C25464 Country TCD Chad A country in Central Africa, south of Libya. CHAD Production C17202 C25464 Country TGO Togo A country in Western Africa, bordering the Bight of Benin, between Benin and Ghana. TOGO Production C17192 C25464 Country THA Thailand A country in Southeastern Asia, bordering the Andaman Sea and the Gulf of Thailand, southeast of Burma. THAILAND Production C17183 C25464 Country TJK Tajikistan A country in Central Asia, west of China. TAJIKISTAN Production C17704 C25464 Country 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 C25464 Country TKM Turkmenistan A country in Central Asia, bordering the Caspian Sea, between Iran and Kazakhstan. TURKMENISTAN Production C17200 C25464 Country 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 C25464 Country TON Tonga An archipelago in the South Pacific Ocean, about two-thirds of the way from Hawaii to New Zealand. TONGA Production C17217 C25464 Country TTO Trinidad and Tobago Islands between the Caribbean Sea and the North Atlantic Ocean, northeast of Venezuela. TRINIDAD AND TOBAGO Production C17221 C25464 Country TUN Tunisia A country in Northern Africa, bordering the Mediterranean Sea, between Algeria and Libya. TUNISIA Production C17222 C25464 Country 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 C25464 Country 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 C25464 Country 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 C25464 Country TZA Tanzania A country in Eastern Africa, bordering the Indian Ocean, between Kenya and Mozambique. TANZANIA, UNITED REPUBLIC OF Production C17228 C25464 Country UGA Uganda A country in Eastern Africa, west of Kenya. UGANDA Production C17229 C25464 Country UKR Ukraine A country in Eastern Europe, bordering the Black Sea, between Poland and Russia. UKRAINE Production C20112 C25464 Country 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 C25464 Country URY Uruguay A country in Southern South America, bordering the South Atlantic Ocean, between Argentina and Brazil. URUGUAY Production C17234 C25464 Country 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 C25464 Country UZB Uzbekistan A country in Central Asia, north of Afghanistan. UZBEKISTAN Production C17249 C25464 Country VAT Holy See An enclave of Rome (Italy). VATICAN CITY STATE Production C17114 C25464 Country 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 C25464 Country VEN Venezuela A country in Northern South America, bordering the Caribbean Sea and the North Atlantic Ocean, between Colombia and Guyana. VENEZUELA Production C17653 C25464 Country VGB British Virgin Islands Islands between the Caribbean Sea and the North Atlantic Ocean, east of Puerto Rico. VIRGIN ISLANDS,BRITISH Production C17255 C25464 Country VIR United States Virgin Islands Islands between the Caribbean Sea and the North Atlantic Ocean, east of Puerto Rico. VIRGIN ISLANDS, U.S. Production C17252 C25464 Country 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 C25464 Country VUT Vanuatu A group of islands in the South Pacific Ocean, about three-quarters of the way from Hawaii to Australia. VANUATU Production C17259 C25464 Country WLF Wallis and Futuna Islands Islands in the South Pacific Ocean, about two-thirds of the way from Hawaii to New Zealand. WALLIS AND FUTUNA Production C17740 C25464 Country 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 C25464 Country 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 C25464 Country ZAF South Africa A country in Southern Africa, at the southern tip of the continent of Africa. SOUTH AFRICA Production C17267 C25464 Country ZMB Zambia A country in Southern Africa, east of Angola. ZAMBIA Production C17268 C25464 Country ZWE Zimbabwe A country in Southern Africa, between South Africa and Zambia. ZIMBABWE Production C49650 C49650 Yes Diagnosis Group [TDIGRP] 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 C49651 C49650 Diagnosis Group HEALTHY SUBJECTS Healthy Subject An individual who is or becomes a participant in a research study and has no significant health-related issues. (NCI) Production C50399 C50399 Yes Dictionary Name [DICTNAM] A name given to a reference source that lists words and gives their meaning. (NCI) Name of Dictionary Production C49471 C50399 Dictionary Name COSTART Thesaurus of Adverse Reaction Term Coding Symbols 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) Coding Symbols for a Thesaurus of Adverse Reaction Terms Production C49474 C50399 Dictionary Name 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 C50399 Dictionary Name 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 C50399 Dictionary Name MedDRA MedDRA 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) Medical Dictionary for Regulatory Activities Production C53489 C50399 Dictionary Name 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 C50399 Dictionary Name WHOART World Health Organization Adverse Reaction Terminology 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 Terms Production C49475 C50399 Dictionary Name 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 C49484 C49484 No Not Done [ND] Indicates a task, process or examination that has either not been initiated or completed. (NCI) Not Done; ND Production C49484 C49484 Not Done NOT DONE Not Done Indicates a task, process or examination that has either not been initiated or completed. (NCI) Not Done; ND Production C16564 C16564 C16960 Yes Patient Ethnic Group [ETHNIC] 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) Ethnicity Production C16960 C16564 C16960 Yes Patient Ethnic Group [Patient] A person who receives medical attention, care, or treatment, or who is registered with medical professional or institution with the purpose to receive medical care when necessary. (NCI) Production C17459 C16564 C16960 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) Production C41222 C16564 C16960 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) Production C43234 C16564 C16960 Patient Ethnic Group Not reported Not Stated Not provided or available Production C17998 C16564 C16960 Patient Ethnic Group U Unknown Not known, not observed, not recorded, or refused. (NCI) UNKNOWN; Unknown Production C42636 C42636 Yes Pharmaceutical Dosage Form [FRM] 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. Dose Form Production C42887 C42636 Pharmaceutical Dosage Form AEROSOL Aerosol Dosage Form 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) Production C42888 C42636 Pharmaceutical Dosage Form AEROSOL, FOAM Aerosol Foam Dosage Form 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) Production C42960 C42636 Pharmaceutical Dosage Form AEROSOL, METERED Metered Aerosol Dosage Form A pressurized dosage form consisting of metered dose valves which allow for the delivery of a uniform quantity of spray upon each activation. (NCI) Production C42971 C42636 Pharmaceutical Dosage Form AEROSOL, POWDER Powder Aerosol Dosage Form 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) Production C42889 C42636 Pharmaceutical Dosage Form AEROSOL, SPRAY Aerosol Spray Dosage Form 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) Production C42892 C42636 Pharmaceutical Dosage Form BAR, CHEWABLE Chewable Bar Dosage Form A solid dosage form usually in the form of a rectangle that is meant to be chewed. (NCI) Production C42890 C42636 Pharmaceutical Dosage Form BEAD Bead Dosage Form A solid dosage form in the shape of a small ball. (NCI) Production C43451 C42636 Pharmaceutical Dosage Form BEAD, IMPLANT, EXTENDED RELEASE Extended Release Bead Implant Dosage Form 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) Production C42891 C42636 Pharmaceutical Dosage Form BLOCK Block Dosage Form Solid dosage form, usually in the shape of a square or rectangle. (NCI) Production C25158 C42636 Pharmaceutical Dosage Form CAPSULE Capsule Dosage Form 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) Production C42895 C42636 Pharmaceutical Dosage Form CAPSULE, COATED Coated Capsule Dosage Form 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) Production C42896 C42636 Pharmaceutical Dosage Form CAPSULE, COATED PELLETS Coated Pellets in Capsule Dosage Form 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) Production C42917 C42636 Pharmaceutical Dosage Form CAPSULE, COATED, EXTENDED RELEASE Extended Release Coated Capsule Dosage Form 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) Production C42902 C42636 Pharmaceutical Dosage Form CAPSULE, DELAYED RELEASE Delayed Release Capsule Dosage Form 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) Production C42904 C42636 Pharmaceutical Dosage Form CAPSULE, DELAYED RELEASE PELLETS Delayed Release Pellets in Capsule Dosage Form 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) Production C42916 C42636 Pharmaceutical Dosage Form CAPSULE, EXTENDED RELEASE Extended Release Capsule Dosage Form 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) Production C42928 C42636 Pharmaceutical Dosage Form CAPSULE, FILM COATED, EXTENDED RELEASE Extended Release Film Coated Capsule Dosage Form 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) Production C42936 C42636 Pharmaceutical Dosage Form CAPSULE, GELATIN COATED Gelatin Coated Capsule Dosage Form 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) Production C42954 C42636 Pharmaceutical Dosage Form CAPSULE, LIQUID FILLED Liquid Filled Capsule Dosage Form 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) Production C45414 C42636 Pharmaceutical Dosage Form CEMENT Cement Dosage Form A substance that serves to produce solid union between two surfaces. (NCI) Production C42678 C42636 Pharmaceutical Dosage Form CIGARETTE Cigarette Dosage Form 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) Production C60884 C42636 Pharmaceutical Dosage Form CLOTH Cloth Dosage Form ALT_DEFINITION: A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing. (FDA) Production C60891 C42636 Pharmaceutical Dosage Form CONCENTRATE Concentrate Dosage Form A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration. (NCI) Production C42900 C42636 Pharmaceutical Dosage Form CONE Cone Dosage Form 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) Production C42919 C42636 Pharmaceutical Dosage Form CORE, EXTENDED RELEASE Extended Release Core Dosage Form An ocular system placed in the eye from which the drug diffuses through a membrane at a constant rate over a specified period. (NCI) Production C28944 C42636 Pharmaceutical Dosage Form CREAM Cream Dosage Form A semisolid emulsion of either the oil-in-water or the water-in-oil type, ordinarily intended for topical use. (NCI) Production C60897 C42636 Pharmaceutical Dosage Form CREAM, AUGMENTED Augmented Cream Dosage Form 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) Production C42901 C42636 Pharmaceutical Dosage Form CRYSTAL Crystal Dosage Form 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. Production C45415 C42636 Pharmaceutical Dosage Form CULTURE Culture Dosage Form The propagation of microorganisms or of living tissue cells in special media conducive to their growth. (NCI) Production C47890 C42636 Pharmaceutical Dosage Form DIAPHRAGM Diaphragm Dosage Form A device usually dome-shaped, worn during copulation over the cervical mouth for prevention of conception or infection. (NCI) Production C43525 C42636 Pharmaceutical Dosage Form DISC Disc Dosage Form A circular plate-like organ or structure. (FDA) Production C42679 C42636 Pharmaceutical Dosage Form DOUCHE Douche Dosage Form 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) Production C42763 C42636 Pharmaceutical Dosage Form DRESSING Dressing Dosage Form The application of various materials for protecting a wound.(FDA) Production C17423 C42636 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) Production C42912 C42636 Pharmaceutical Dosage Form ELIXIR Elixir Dosage Form A clear, pleasantly flavored, sweetened hydroalcoholic liquid containing dissolved medicinal agents; it is intended for oral use. (NCI) Production C42913 C42636 Pharmaceutical Dosage Form EMULSION Emulsion Dosage Form 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) Production C42915 C42636 Pharmaceutical Dosage Form ENEMA Enema Dosage Form A rectal preparation for therapeutic, diagnostic, or nutritive purposes. (NCI) Production C42929 C42636 Pharmaceutical Dosage Form EXTRACT Extract Dosage Form 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) Production C60926 C42636 Pharmaceutical Dosage Form FIBER, EXTENDED RELEASE Extended Release Fiber Dosage Form 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) Production C42932 C42636 Pharmaceutical Dosage Form FILM Film Dosage Form A thin layer or coating. (NCI) Production C42920 C42636 Pharmaceutical Dosage Form FILM, EXTENDED RELEASE Extended Release Film Dosage Form 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) Production C42984 C42636 Pharmaceutical Dosage Form FILM, SOLUBLE Soluble Film Dosage Form A thin layer or coating which is susceptible to being dissolved when in contact with a liquid. (NCI) Production C60927 C42636 Pharmaceutical Dosage Form FOR SOLUTION Dosage Form For Solution A product, usually a solid, intended for solution prior to administration. (FDA) Production C60928 C42636 Pharmaceutical Dosage Form FOR SUSPENSION Dosage Form For Suspension A product, usually a solid, intended for suspension prior to administration. (FDA) Production C60929 C42636 Pharmaceutical Dosage Form FOR SUSPENSION, EXTENDED RELEASE Extended Release Dosage Form For Suspension 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) Production C42933 C42636 Pharmaceutical Dosage Form GAS Gas Dosage Form Any elastic aeriform fluid in which the molecules are separated from one another and have free paths. (NCI) Production C42934 C42636 Pharmaceutical Dosage Form GEL Gel Dosage Form 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) Production C42906 C42636 Pharmaceutical Dosage Form GEL, DENTIFRICE Dentifrice Gel Dosage Form 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) Production C60930 C42636 Pharmaceutical Dosage Form GEL, METERED Metered Gel Dosage Form A gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity of gel upon each activation. (FDA) Production C48193 C42636 Pharmaceutical Dosage Form GENERATOR Generator Dosage Form 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) Production C42937 C42636 Pharmaceutical Dosage Form GLOBULE Globule Dosage Form 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) Production C45416 C42636 Pharmaceutical Dosage Form GRAFT Graft Dosage Form A slip of skin or of other tissue for implantation. (NCI) Production C42938 C42636 Pharmaceutical Dosage Form GRANULE Granule Dosage Form A small particle or grain. (NCI) Production C42903 C42636 Pharmaceutical Dosage Form GRANULE, DELAYED RELEASE Delayed Release Granule Dosage Form 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) Production C42909 C42636 Pharmaceutical Dosage Form GRANULE, EFFERVESCENT Effervescent Granule Dosage Form 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) Production C42939 C42636 Pharmaceutical Dosage Form GRANULE, FOR SOLUTION Granule For Solution Dosage Form 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) Production C42940 C42636 Pharmaceutical Dosage Form GRANULE, FOR SUSPENSION Granule For Suspension Dosage Form 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) Production C42921 C42636 Pharmaceutical Dosage Form GRANULE, FOR SUSPENSION, EXTENDED RELEASE Extended Release Granule For Suspension Dosage Form 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) Production C42941 C42636 Pharmaceutical Dosage Form GUM Gum Dosage Form A mucilaginous excretion from various plants. (NCI) Production C42894 C42636 Pharmaceutical Dosage Form GUM, CHEWING Chewing Gum Dosage Form A sweetened and flavored insoluble plastic material of various shapes which when chewed, releases a drug substance into the oral cavity. (NCI) Production C42978 C42636 Pharmaceutical Dosage Form GUM, RESIN Resin Gum Dosage Form Natural mixture of gum and resin, usually obtained as exudations from plants. (NCI) Production C42942 C42636 Pharmaceutical Dosage Form IMPLANT Implant Dosage Form 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) Production C42944 C42636 Pharmaceutical Dosage Form INHALANT Inhalant Dosage Form 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) Production C60931 C42636 Pharmaceutical Dosage Form INJECTABLE, LIPOSOMAL Liposomal Injection Dosage Form 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) Production C42946 C42636 Pharmaceutical Dosage Form INJECTION Injectable Dosage Form A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP. (NCI) Production C42914 C42636 Pharmaceutical Dosage Form INJECTION, EMULSION Emulsion for Injection Dosage Form An emulsion consisting of a sterile, pyrogen-free preparation intended to be administered parenterally.(FDA) Production C42950 C42636 Pharmaceutical Dosage Form INJECTION, LIPID COMPLEX Injectable Lipid Complex Dosage Form [definition pending](FDA) Production C42974 C42636 Pharmaceutical Dosage Form INJECTION, POWDER, FOR SOLUTION Powder For Injectable Solution Dosage Form A sterile preparation intended for reconstitution to form a solution for parenteral use. (NCI) Production C42976 C42636 Pharmaceutical Dosage Form INJECTION, POWDER, FOR SUSPENSION Powder For Injectable Suspension Dosage Form A sterile preparation intended for reconstitution to form a suspension for parenteral use. (NCI) Production C42977 C42636 Pharmaceutical Dosage Form INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE Powder For Injectable Extended Release Suspension Dosage Form 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) Production C42959 C42636 Pharmaceutical Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR LIPOSOMAL SUSPENSION Lyophilized Powder For Injectable Liposomal Suspension Dosage Form 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) Production C42957 C42636 Pharmaceutical Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION Lyophilized Powder For Injectable Solution Dosage Form 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) Production C42958 C42636 Pharmaceutical Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION Lyophilized Powder For Injectable Suspension Dosage Form 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) Production C42956 C42636 Pharmaceutical Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION, EXTENDED RELEASE Lyophilized Powder For Extended Release Injectable Suspension Dosage Form 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) Production C42945 C42636 Pharmaceutical Dosage Form INJECTION, SOLUTION Injectable Solution Dosage Form 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) Production C42899 C42636 Pharmaceutical Dosage Form INJECTION, SOLUTION, CONCENTRATE Concentrate for Injectable Solution Dosage Form 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) Production C42995 C42636 Pharmaceutical Dosage Form INJECTION, SUSPENSION Injectable Suspension Dosage Form 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) Production C42926 C42636 Pharmaceutical Dosage Form INJECTION, SUSPENSION, EXTENDED RELEASE Injectable Extended Release Suspension Dosage Form 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) Production C42951 C42636 Pharmaceutical Dosage Form INJECTION, SUSPENSION, LIPOSOMAL Injectable Liposomal Suspension Dosage Form 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) Production C42988 C42636 Pharmaceutical Dosage Form INJECTION, SUSPENSION, SONICATED Injectable Sonicated Suspension Dosage Form 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) Production C60933 C42636 Pharmaceutical Dosage Form INSERT Insert Dosage Form 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) Production C42922 C42636 Pharmaceutical Dosage Form INSERT, EXTENDED RELEASE Extended Release Insert Dosage Form 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) Production C47915 C42636 Pharmaceutical Dosage Form INTRAUTERINE DEVICE Intrauterine Device Dosage Form A device inserted and left in the uterus to prevent effective conception. (NCI) Production C42947 C42636 Pharmaceutical Dosage Form IRRIGANT Irrigant Dosage Form A sterile solution intended to bathe or flush open wounds or body cavities; they're used topically, never parenterally. (NCI) Production C42948 C42636 Pharmaceutical Dosage Form JELLY Jelly Dosage Form 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) Production C47916 C42636 Pharmaceutical Dosage Form KIT Kit Dosage Form A packaged collection of related material. (NCI) Production C45413 C42636 Pharmaceutical Dosage Form LINER, DENTAL Dental Liner Dosage Form A material applied to the inside of the dental cavity, for protection or insulation of the surface.(FDA) Production C42949 C42636 Pharmaceutical Dosage Form LINIMENT Liniment Dosage Form A solution or mixture of various substances in oil, alcoholic solutions of soap, or emulsions intended for external application. (NCI) Production C42952 C42636 Pharmaceutical Dosage Form LIPSTICK Lipstick Dosage Form A waxy solid, usually colored cosmetic, in stick form for the lips. (NCI) Production C42953 C42636 Pharmaceutical Dosage Form LIQUID Liquid Dosage Form 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) Production C60934 C42636 Pharmaceutical Dosage Form LIQUID, EXTENDED RELEASE Extended Release Liquid Dosage Form 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) Production C29167 C42636 Pharmaceutical Dosage Form LOTION Lotion Dosage Form 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) Production C60957 C42636 Pharmaceutical Dosage Form LOTION. AUGMENTED Augmented Lotion Dosage Form 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) Production C60958 C42636 Pharmaceutical Dosage Form LOTION/SHAMPOO Lotion Shampoo Dosage Form 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) Production C42955 C42636 Pharmaceutical Dosage Form LOZENGE Lozenge Dosage Form 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) Production C29269 C42636 Pharmaceutical Dosage Form MOUTHWASH Mouthwash Dosage Form An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect. (NCI) Production C48624 C42636 Pharmaceutical Dosage Form NOT APPLICABLE Dosage Form Not Applicable The use of a dosage form term is not relevant or appropriate. (NCI) Production C42965 C42636 Pharmaceutical Dosage Form OIL Oil Dosage Form 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) Production C42966 C42636 Pharmaceutical Dosage Form OINTMENT Ointment Dosage Form 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) Production C60984 C42636 Pharmaceutical Dosage Form OINTMENT, AUGMENTED Augmented Ointment Dosage Form 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) Production C47887 C42636 Pharmaceutical Dosage Form PACKING Packing Dosage Form 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) Production C42967 C42636 Pharmaceutical Dosage Form PASTE Paste Dosage Form 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) Production C42907 C42636 Pharmaceutical Dosage Form PASTE, DENTIFRICE Dentifrice Paste Dosage Form A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents. (NCI) Production C60985 C42636 Pharmaceutical Dosage Form PASTILLE Pastille Dosage Form An aromatic preparation, often with a pleasing flavor, usually intended to dissolve in the mouth. (FDA) Production C42968 C42636 Pharmaceutical Dosage Form PATCH Patch Dosage Form 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) Production C42923 C42636 Pharmaceutical Dosage Form PATCH, EXTENDED RELEASE Extended Release Patch Dosage Form 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) Production C42911 C42636 Pharmaceutical Dosage Form PATCH, EXTENDED RELEASE, ELECTRICALLY CONTROLLED Electrically Controlled Extended Release Patch Dosage Form 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) Production C42969 C42636 Pharmaceutical Dosage Form PELLET Pellet Dosage Form 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) Production C42943 C42636 Pharmaceutical Dosage Form PELLET, IMPLANTABLE Implantable Pellet Dosage Form 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) Production C42918 C42636 Pharmaceutical Dosage Form PELLETS, COATED, EXTENDED RELEASE Extended Release Coated Pellets Dosage Form 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) Production C25394 C42636 Pharmaceutical Dosage Form PILL Pill Dosage Form A dose of medicine in the form of a small pellet. (NCI) Production C42970 C42636 Pharmaceutical Dosage Form PLASTER Plaster Dosage Form 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) Production C47913 C42636 Pharmaceutical Dosage Form POULTICE Poultice Dosage Form A soft, moist mass of meal, herbs, seed, etc., usually applied hot in cloth that consists of gruel-like consistency. (NCI) Production C42972 C42636 Pharmaceutical Dosage Form POWDER Powder Dosage Form An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. (NCI) Production C42908 C42636 Pharmaceutical Dosage Form POWDER, DENTIFRICE Dentifrice Powder Dosage Form A powder formulation intended to clean and/or polish the teeth, and which may contain certain additional agents. (NCI) Production C42973 C42636 Pharmaceutical Dosage Form POWDER, FOR SOLUTION Powder for Solution Dosage Form An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution. (NCI) Production C42975 C42636 Pharmaceutical Dosage Form POWDER, FOR SUSPENSION Powder for Suspension Dosage Form 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) Production C42961 C42636 Pharmaceutical Dosage Form POWDER, METERED Metered Powder Dosage Form A powder dosage form that is situated inside a container that has a mechanism to deliver a specified quantity. (NCI) Production C60988 C42636 Pharmaceutical Dosage Form RING Ring Dosage Form 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) Production C42979 C42636 Pharmaceutical Dosage Form RINSE Rinse Dosage Form A liquid used to cleanse by flushing. (NCI) Production C42980 C42636 Pharmaceutical Dosage Form SALVE Salve Dosage Form A thick ointment or cerate (a fat or wax based preparation with a consistency between an ointment and a plaster). (NCI) Production C42981 C42636 Pharmaceutical Dosage Form SHAMPOO Shampoo Dosage Form A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents. (NCI) Production C42982 C42636 Pharmaceutical Dosage Form SHAMPOO, SUSPENSION Shampoo Suspension Dosage Form 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) Production C42983 C42636 Pharmaceutical Dosage Form SOAP Soap Dosage Form 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) Production C42986 C42636 Pharmaceutical Dosage Form SOLUTION Solution Dosage Form 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) Production C42898 C42636 Pharmaceutical Dosage Form SOLUTION, CONCENTRATE Concentrate for Solution Dosage Form 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) Production C42987 C42636 Pharmaceutical Dosage Form SOLUTION, FOR SLUSH Solution For Slush Dosage Form 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) Production C60994 C42636 Pharmaceutical Dosage Form SOLUTION, GEL FORMING / DROPS Gel Forming Drops Solution Dosage Form A solution, which after usually being administered in a drop-wise fashion, forms a gel. (FDA) Production C42935 C42636 Pharmaceutical Dosage Form SOLUTION, GEL FORMING, EXTENDED RELEASE Extended Release Gel Forming Solution Dosage Form A solution that forms a gel when it comes in contact with ocular fluid, and which allows at least a reduction in dosing frequency Production C60992 C42636 Pharmaceutical Dosage Form SOLUTION/ DROPS Drops Solution Dosage Form A solution which is usually administered in a drop-wise fashion. (FDA) Production C47912 C42636 Pharmaceutical Dosage Form SPONGE Sponge Dosage Form 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) Production C42989 C42636 Pharmaceutical Dosage Form SPRAY Spray Dosage Form A liquid minutely divided as by a jet of air or steam. (NCI) Production C42962 C42636 Pharmaceutical Dosage Form SPRAY, METERED Metered Spray Dosage Form A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation. (NCI) Production C42990 C42636 Pharmaceutical Dosage Form SPRAY, SUSPENSION Spray Suspension Dosage Form 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) Production C42991 C42636 Pharmaceutical Dosage Form STICK Stick Dosage Form A dosage form prepared in a relatively long and slender often cylindrical form. (NCI) Production C47914 C42636 Pharmaceutical Dosage Form STRIP Strip Dosage Form A long narrow piece of material. Production C42993 C42636 Pharmaceutical Dosage Form SUPPOSITORY Suppository Dosage Form 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) Production C42924 C42636 Pharmaceutical Dosage Form SUPPOSITORY, EXTENDED RELEASE Extended Release Suppository Dosage Form A drug delivery system in the form of a suppository that allows at least a reduction in dosing frequency. (NCI) Production C42994 C42636 Pharmaceutical Dosage Form SUSPENSION Suspension Dosage Form 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) Production C42925 C42636 Pharmaceutical Dosage Form SUSPENSION, EXTENDED RELEASE Extended Release Suspension Dosage Form 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) Production C60995 C42636 Pharmaceutical Dosage Form SUSPENSION/DROPS Drops Suspension Dosage Form A suspension which is usually administered in a dropwise fashion. (FDA) Production C47889 C42636 Pharmaceutical Dosage Form SUTURE Suture Dosage Form A strand or fiber used to hold wound edges in apposition during healing. (NCI) Production C47898 C42636 Pharmaceutical Dosage Form SWAB Swab Dosage Form 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) Production C42996 C42636 Pharmaceutical Dosage Form SYRUP Syrup Dosage Form 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) Production C42998 C42636 Pharmaceutical Dosage Form TABLET Tablet Dosage Form A solid dosage form containing medicinal substances with or without suitable diluents. (NCI) Production C42893 C42636 Pharmaceutical Dosage Form TABLET, CHEWABLE Chewable Tablet Dosage Form 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) Production C42897 C42636 Pharmaceutical Dosage Form TABLET, COATED Coated Tablet Dosage Form A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating. (NCI) Production C60997 C42636 Pharmaceutical Dosage Form TABLET, COATED PARTICLES Tablet Coated Particles Dosage Form A solid dosage form containing a conglomerate of medicinal particles that have each been covered with a coating. (FDA) Production C42905 C42636 Pharmaceutical Dosage Form TABLET, DELAYED RELEASE Delayed Release Tablet Dosage Form 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) Production C42997 C42636 Pharmaceutical Dosage Form TABLET, DELAYED RELEASE PARTICLES Delayed Release Particles Tablet Dosage Form 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) Production C42910 C42636 Pharmaceutical Dosage Form TABLET, EFFERVESCENT Effervescent Tablet Dosage Form 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) Production C42927 C42636 Pharmaceutical Dosage Form TABLET, EXTENDED RELEASE Extended Release Tablet Dosage Form 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) Production C42931 C42636 Pharmaceutical Dosage Form TABLET, FILM COATED Film Coated Tablet Dosage Form 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) Production C42930 C42636 Pharmaceutical Dosage Form TABLET, FILM COATED, EXTENDED RELEASE Film Coated Extended Release Tablet Dosage Form 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) Production C61004 C42636 Pharmaceutical Dosage Form TABLET, FOR SOLUTION Tablet For Solution Dosage Form A tablet that forms a solution when placed in a liquid. (FDA) Production C61005 C42636 Pharmaceutical Dosage Form TABLET, FOR SUSPENSION Tablet For Suspension Dosage Form A tablet that forms a suspension when placed in a liquid (formerly referred to as a Dispersible Tablet). TABLET, DISPERSIBLE Production C42964 C42636 Pharmaceutical Dosage Form TABLET, MULTILAYER Multilayered Tablet Dosage Form 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) Production C42963 C42636 Pharmaceutical Dosage Form TABLET, MULTILAYER, EXTENDED RELEASE Multilayered Extended Release Tablet Dosage Form 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) Production C42999 C42636 Pharmaceutical Dosage Form TABLET, ORALLY DISINTEGRATING Orally Disintegrating Tablet Dosage Form A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue. (NCI) Production C61006 C42636 Pharmaceutical Dosage Form TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE Tablet Orally Disintegrating Delayed Release Dosage Form 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) Production C42985 C42636 Pharmaceutical Dosage Form TABLET, SOLUBLE Soluble Tablet Dosage Form A solid dosage form that contains medicinal substances with or without suitable diluents and possesses the ability to dissolve in fluids. (NCI) Production C42992 C42636 Pharmaceutical Dosage Form TABLET, SUGAR COATED Sugar Coated Tablet Dosage Form 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) Production C47892 C42636 Pharmaceutical Dosage Form TAMPON Tampon Dosage Form 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) Production C47897 C42636 Pharmaceutical Dosage Form TAPE Tape Dosage Form A narrow woven fabric, or a narrow extruded synthetic (such as plastic), usually with an adhesive on one or both sides. (NCI) Production C43000 C42636 Pharmaceutical Dosage Form TINCTURE Tincture Dosage Form An alcoholic or hydroalcoholic solution prepared from vegetable materials or from chemical substances. (NCI) Production C43001 C42636 Pharmaceutical Dosage Form TROCHE Troche Dosage Form 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) Production C43002 C42636 Pharmaceutical Dosage Form UNASSIGNED Unassigned Dosage Form A dosage form has yet to be assigned. (NCI) Production C43003 C42636 Pharmaceutical Dosage Form WAFER Wafer Dosage Form A thin slice of material containing a medicinal agent. (NCI) Production C49627 C49627 Yes Reason for Non-Completion [NCOMPLT] The reason that a subject was discontinued from a clinical trial. Completion/Reason for Non-Completion Production C41331 C49627 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) Production C25250 C49627 Reason for Non-Completion COMPLETED Complete To possess every necessary or normal part or component or step; having come or been brought to a conclusion. (NCI) Production C28554 C49627 Reason for Non-Completion DEATH Death The absence of life or state of being dead. (NCI) Production C48226 C49627 Reason for Non-Completion LACK OF EFFICACY Lack of Efficacy The lack of expected or desired effect related to a therapy. (NCI) Production C48227 C49627 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) Production C49631 C49627 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) Production C17649 C49627 Reason for Non-Completion OTHER Other Different than the one(s) previously specified or mentioned. (NCI) Other Production C48250 C49627 Reason for Non-Completion PHYSICIAN DECISION Physician Decision A position, opinion or judgment reached after consideration by a physician with reference to subject. (NCI) Production C25742 C49627 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) Production C35571 C49627 Reason for Non-Completion PROGRESSIVE DISEASE Progressive Disease A disease process that is increasing in scope or severity. (NCI) Production C48251 C49627 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) Production C25746 C49627 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) Production C49628 C49627 Reason for Non-Completion SCREEN FAILURE Trial Screen Failure The potential subject who does not meet one or more criteria required for participation in a trial. Production C49632 C49627 Reason for Non-Completion STUDY TERMINATED BY SPONSOR Study Terminated By Sponsor An indication that a clinical study was stopped by its sponsor. (NCI) Production C49633 C49627 Reason for Non-Completion TECHNICAL PROBLEMS Technical Problem A problem with some technical aspect of a clinical study, usually related to an instrument. (NCI) Production C49634 C49627 Reason for Non-Completion WITHDRAWAL BY SUBJECT Withdrawal by Subject An indication that a study participant has removed itself from the study. (NCI) Production C49638 C49638 No Relation to Reference Period [STENRF] The name of a code list that contains terms that reference timepoints within and without a defined time period. Relation to Reference Period Production C38008 C49638 Relation to Reference Period AFTER Status Post The time period following a point or another period of time. (NCI) Production C25629 C49638 Relation to Reference Period BEFORE Prior Earlier in time or order. (NCI) Production C25490 C49638 Relation to Reference Period DURING During At some point in a given period of time. (NCI) Production C49640 C49638 Relation to Reference Period DURING/AFTER During Or After Within a certain period of time or after a certain point or period in time. (NCI) Production C17998 C49638 Relation to Reference Period U Unknown Not known, not observed, not recorded, or refused. (NCI) UNKNOWN; Unknown Production C38114 C38114 Yes Route of Administration [ROUTE] The course by which a substance was administered in order to reach the site of action in the body. Route of Administration Production C38192 C38114 Route of Administration AURICULAR (OTIC) Auricular Route of Administration Administration to or by way of the ear.(FDA) Production C38193 C38114 Route of Administration BUCCAL Buccal Route of Administration Administration directed toward the cheek, generally from within the mouth.(FDA) Production C38194 C38114 Route of Administration CONJUNCTIVAL Conjunctival Route of Administration Administration to the conjunctiva, the delicate membrane that lines the eyelids and covers the exposed surface of the eyeball.(FDA) Production C38675 C38114 Route of Administration CUTANEOUS Cutaneous Route of Administration Administration to the skin.(FDA) Production C38197 C38114 Route of Administration DENTAL Dental Route of Administration Administration to a tooth or teeth.(FDA) Production C38633 C38114 Route of Administration ELECTRO-OSMOSIS Electro-osmosis Route of Administration Administration of through the diffusion of substance through a membrane in an electric field.(FDA) Production C38205 C38114 Route of Administration ENDOCERVICAL Endocervical Route of Administration Administration within the canal of the cervix uteri. Synonymous with the term intracervical.(FDA) Production C38206 C38114 Route of Administration ENDOSINUSIAL Endosinusial Route of Administration Administration within the nasal sinuses of the head.(FDA) Production C38208 C38114 Route of Administration ENDOTRACHEAL Endotracheal Route of Administration Administration directly into the trachea. Synonymous with the term intratracheal.(FDA) Production C38209 C38114 Route of Administration ENTERAL Enteral Route of Administration Administration directly into the intestines.(FDA) Production C38210 C38114 Route of Administration EPIDURAL Epidural Route of Administration Administration upon or over the dura mater.(FDA) Production C38211 C38114 Route of Administration EXTRA-AMNIOTIC Extraamniotic Route of Administration Administration to the outside of the membrane enveloping the fetus.(FDA) Production C38212 C38114 Route of Administration EXTRACORPOREAL Extracorporeal Circulation Route of Administration Administration outside of the body.(FDA) Production C38200 C38114 Route of Administration HEMODIALYSIS Administration Via Hemodialysis Administration through hemodialysate fluid.(FDA) Production C38215 C38114 Route of Administration INFILTRATION Infiltration Route of Administration Administration that results in substances passing into tissue spaces or into cells.(FDA) Production C38219 C38114 Route of Administration INTERSTITIAL Interstitial Route of Administration Administration to or in the interstices of a tissue.(FDA) Production C38220 C38114 Route of Administration INTRA-ABDOMINAL Intraabdominal Route of Administration Administration within the abdomen.(FDA) Production C38221 C38114 Route of Administration INTRA-AMNIOTIC Intraamniotic Route of Administration Administration within the amnion.(FDA) Production C38222 C38114 Route of Administration INTRA-ARTERIAL Intraarterial Route of Administration Administration within an artery or arteries.(FDA) Production C38223 C38114 Route of Administration INTRA-ARTICULAR Intraarticular Route of Administration Administration within a joint.(FDA) Production C38224 C38114 Route of Administration INTRABILIARY Intrabiliary Route of Administration Administration within the bile, bile ducts or gallbladder.(FDA) Production C38225 C38114 Route of Administration INTRABRONCHIAL Intrabronchial Route of Administration Administration within a bronchus.(FDA) Production C38226 C38114 Route of Administration INTRABURSAL Intrabursal Route of Administration Administration within a bursa.(FDA) Production C38227 C38114 Route of Administration INTRACARDIAC Intracardiac Route of Administration Administration within the heart.(FDA) Production C38228 C38114 Route of Administration INTRACARTILAGINOUS Intracartilaginous Route of Administration Administration within a cartilage; endochondral.(FDA) Production C38229 C38114 Route of Administration INTRACAUDAL Intracaudal Route of Administration Administration within the cauda equina.(FDA) Production C38230 C38114 Route of Administration INTRACAVERNOUS Intracavernous Route of Administration Administration within a pathologic cavity, such as occurs in the lung in tuberculosis.(FDA) Production C38231 C38114 Route of Administration INTRACAVITARY Intracavitary Route of Administration 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) Production C38232 C38114 Route of Administration INTRACEREBRAL Intracerebral Route of Administration Administration within the cerebrum.(FDA) Production C38233 C38114 Route of Administration INTRACISTERNAL Intracisternal Route of Administration Administration within the cisterna magna cerebellomedularis.(FDA) Production C38234 C38114 Route of Administration INTRACORNEAL Intracorneal Route of Administration Administration within the cornea (the transparent structure forming the anterior part of the fibrous tunic of the eye).(FDA) Production C38217 C38114 Route of Administration INTRACORONAL, DENTAL Intracoronal Dental Route of Administration 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) Production C38218 C38114 Route of Administration INTRACORONARY Intracoronary Route of Administration Administration within the coronary arteries.(FDA) Production C38235 C38114 Route of Administration INTRACORPORUS CAVERNOSUM Intracorporus Cavernosum Route of Administration Administration within the dilatable spaces of the corporus cavernosa of the penis.(FDA) Production C38238 C38114 Route of Administration INTRADERMAL Intradermal Route of Administration Administration within the dermis.(FDA) Production C38239 C38114 Route of Administration INTRADISCAL Intradiscal Route of Administration Administration within a disc.(FDA) Production C38240 C38114 Route of Administration INTRADUCTAL Intraductal Route of Administration Administration within the duct of a gland.(FDA) Production C38241 C38114 Route of Administration INTRADUODENAL Intraduodenal Route of Administration Administration within the duodenum.(FDA) Production C38242 C38114 Route of Administration INTRADURAL Intradural Route of Administration Administration within or beneath the dura.(FDA) Production C38243 C38114 Route of Administration INTRAEPIDERMAL Intraepidermal Route of Administration Administration within the epidermis.(FDA) Production C38245 C38114 Route of Administration INTRAESOPHAGEAL Intraesophageal Route of Administration Administration within the esophagus.(FDA) Production C38246 C38114 Route of Administration INTRAGASTRIC Intragastric Route of Administration Administration within the stomach.(FDA) Production C38247 C38114 Route of Administration INTRAGINGIVAL Intragingival Route of Administration Administration within the gingivae.(FDA) Production C38249 C38114 Route of Administration INTRAILEAL Intraileal Route of Administration Administration within the distal portion of the small intestine, from the jejunum to the cecum.(FDA) Production C38250 C38114 Route of Administration INTRALESIONAL Intralesional Route of Administration Administration within or introduced directly into a localized lesion.(FDA) Production C38251 C38114 Route of Administration INTRALUMINAL Intraluminal Route of Administration Administration within the lumen of a tube.(FDA) Production C38252 C38114 Route of Administration INTRALYMPHATIC Intralymphatic Route of Administration Administration within the lymph.(FDA) Production C38253 C38114 Route of Administration INTRAMEDULLARY Intramedullary Route of Administration Administration within the marrow cavity of a bone.(FDA) Production C38254 C38114 Route of Administration INTRAMENINGEAL Intrameningeal Route of Administration Administration within the meninges (the three membranes that envelope the brain and spinal cord).(FDA) Production C28161 C38114 Route of Administration INTRAMUSCULAR Intramuscular Route of Administration Administration within a muscle. (FDA) Production C38255 C38114 Route of Administration INTRAOCULAR Intraocular Route of Administration Administration within the eye.(FDA) Production C38256 C38114 Route of Administration INTRAOVARIAN Intraovarian Route of Administration Administration within the ovary.(FDA) Production C38257 C38114 Route of Administration INTRAPERICARDIAL Intrapericardial Route of Administration Administration within the pericardium.(FDA) Production C38258 C38114 Route of Administration INTRAPERITONEAL Intraperitoneal Route of Administration Administration within the peritoneal cavity.(FDA) Production C38259 C38114 Route of Administration INTRAPLEURAL Intrapleural Route of Administration Administration within the pleura.(FDA) Production C38260 C38114 Route of Administration INTRAPROSTATIC Intraprostatic Route of Administration Administration within the prostate gland.(FDA) Production C38261 C38114 Route of Administration INTRAPULMONARY Intrapulmonary Route of Administration Administration within the lungs or its bronchi.(FDA) Production C38262 C38114 Route of Administration INTRASINAL Intrasinal Route of Administration Administration within the nasal or periorbital sinuses.(FDA) Production C38263 C38114 Route of Administration INTRASPINAL Intraspinal Route of Administration Administration within the vertebral column.(FDA) Production C38264 C38114 Route of Administration INTRASYNOVIAL Intrasynovial Route of Administration Administration within the synovial cavity of a joint.(FDA) Production C38265 C38114 Route of Administration INTRATENDINOUS Intratendinous Route of Administration Administration within a tendon.(FDA) Production C38266 C38114 Route of Administration INTRATESTICULAR Intratesticular Route of Administration Administration within the testicle.(FDA) Production C38267 C38114 Route of Administration INTRATHECAL Intrathecal Route of Administration Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.(FDA) Production C38207 C38114 Route of Administration INTRATHORACIC Endothoracic Route of Administration Administration within the thorax (internal to the ribs); synonymous with the term endothoracic.(FDA) Production C38268 C38114 Route of Administration INTRATUBULAR Intratubular Route of Administration Administration within the tubules of an organ.(FDA) Production C38269 C38114 Route of Administration INTRATUMOR Intratumoral Route of Administration Administration within a tumor.(FDA) Intratumor Route of Administration Production C38270 C38114 Route of Administration INTRATYMPANIC Intratympanic Route of Administration Administration within the auris media.(FDA) Production C38272 C38114 Route of Administration INTRAUTERINE Intrauterine Route of Administration Administration within the uterus.(FDA) Production C38273 C38114 Route of Administration INTRAVASCULAR Intravascular Route of Administration Administration within a vessel or vessels.(FDA) Production C38276 C38114 Route of Administration INTRAVENOUS Intravenous Route of Administration Administration within or into a vein or veins.(FDA) Production C38274 C38114 Route of Administration INTRAVENOUS BOLUS Intravenous Bolus Administration within or into a vein or veins all at once.(FDA) Production C38279 C38114 Route of Administration INTRAVENOUS DRIP Intravenous Drip Administration within or into a vein or veins over a sustained period of time.(FDA) Production C38277 C38114 Route of Administration INTRAVENTRICULAR Intraventricular Route of Administration Administration within a ventricle.(FDA) Production C38278 C38114 Route of Administration INTRAVESICAL Intravesical Route of Administration Administration within the bladder.(FDA) Production C38280 C38114 Route of Administration INTRAVITREAL Intravitreal Route of Administration Administration within the vitreous body of the eye.(FDA) Production C38203 C38114 Route of Administration IONTOPHORESIS Iontophoresis Route of Administration Administration by means of an electric current where ions of soluble salts migrate into the tissues of the body.(FDA) Production C38281 C38114 Route of Administration IRRIGATION Irrigation-Route of Administration Administration to bathe or flush open wounds or body cavities.(FDA) Production C38282 C38114 Route of Administration LARYNGEAL Laryngeal Route of Administration Administration directly upon the larynx.(FDA) Production C38284 C38114 Route of Administration NASAL Nasal Route of Administration Administration to the nose; administered by way of the nose.(FDA) Production C38285 C38114 Route of Administration NASOGASTRIC Nasogastric Route of Administration Administration through the nose and into the stomach, usually by means of a tube.(FDA) Production C48623 C38114 Route of Administration NOT APPLICABLE Route of Administration Not Applicable Routes of administration are not applicable.(FDA) Production C38286 C38114 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) Production C38287 C38114 Route of Administration OPHTHALMIC Ophthalmic Route of Administration Administration to the external eye.(FDA) Production C38288 C38114 Route of Administration ORAL Oral Route of Administration Administration to or by way of the mouth.(FDA) Production C38289 C38114 Route of Administration OROPHARYNGEAL Oropharyngeal Route of Administration Administration directly to the mouth and pharynx.(FDA) Production C38290 C38114 Route of Administration OTHER Other Route of Administration Administration is different from others on this list.(FDA) Production C38291 C38114 Route of Administration PARENTERAL Parenteral Route of Administration Administration by injection, infusion, or implantation.(FDA) Production C38676 C38114 Route of Administration PERCUTANEOUS Percutaneous Route of Administration Administration through the skin.(FDA) Production C38292 C38114 Route of Administration PERIARTICULAR Periarticular Route of Administration Administration around a joint.(FDA) Production C38677 C38114 Route of Administration PERIDURAL Peridural Route of Administration Administration to the outside of the dura mater of the spinal cord.(FDA) Production C38293 C38114 Route of Administration PERINEURAL Perineural Route of Administration Administration surrounding a nerve or nerves.(FDA) Production C38294 C38114 Route of Administration PERIODONTAL Periodontal Route of Administration Administration around a tooth.(FDA) Production C38295 C38114 Route of Administration RECTAL Rectal Route of Administration Administration to the rectum.(FDA) Production C38216 C38114 Route of Administration RESPIRATORY (INHALATION) Inhalation Route of Administration Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.(FDA) Production C38296 C38114 Route of Administration RETROBULBAR Retrobulbar Route of Administration Administration behind the pons or behind the eyeball.(FDA) Production C38198 C38114 Route of Administration SOFT TISSUE Soft Tissue Route Of Administration Administration into any soft tissue.(FDA) Production C38297 C38114 Route of Administration SUBARACHNOID Subarachnoid Route of Administration Administration beneath the arachnoid.(FDA) Production C38298 C38114 Route of Administration SUBCONJUNCTIVAL Subconjunctival Route of Administration Administration beneath the conjunctiva.(FDA) Production C38299 C38114 Route of Administration SUBCUTANEOUS Subcutaneous Route of Administration Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.(FDA) Production C38300 C38114 Route of Administration SUBLINGUAL Sublingual Route of Administration Administration beneath the tongue.(FDA) Production C38301 C38114 Route of Administration SUBMUCOSAL Submucosal Route of Administration Administration beneath the mucous membrane.(FDA) Production C38304 C38114 Route of Administration TOPICAL Topical Route of Administration Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.(FDA) Production C38305 C38114 Route of Administration TRANSDERMAL Transdermal Route of Administration Administration through the dermal layer of the skin to the systemic circulation by diffusion.(FDA) Production C38283 C38114 Route of Administration TRANSMUCOSAL Mucosal Route of Administration Administration across the mucosa.(FDA) Production C38307 C38114 Route of Administration TRANSPLACENTAL Transplacental Route of Administration Administration through or across the placenta.(FDA) Production C38308 C38114 Route of Administration TRANSTRACHEAL Transtracheal Route of Administration Administration through the wall of the trachea.(FDA) Production C38309 C38114 Route of Administration TRANSTYMPANIC Transtympanic Route of Administration Administration across or through the tympanic cavity.(FDA) Production C38310 C38114 Route of Administration UNASSIGNED Unassigned Route of Administration Route of administration has not yet been assigned.(FDA) Production C38311 C38114 Route of Administration UNKNOWN Unknown Route of Administration Route of administration is unknown.(FDA) Production C38312 C38114 Route of Administration URETERAL Ureteral Route of Administration Administration into the ureter.(FDA) Production C38271 C38114 Route of Administration URETHRAL Intraurethral Route of Administration Administration into the urethra.(FDA) Production C38313 C38114 Route of Administration VAGINAL Vaginal Route of Administration Administration into the vagina.(FDA) Production C49705 C49705 No Severity/Intensity Scale for Adverse Events [AESEV] 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) Severity/Intensity of an Adverse Event Production C41338 C49705 Severity/Intensity Scale for Adverse Events 1 Mild Adverse Event 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. Grade 1; MILD Production C41339 C49705 Severity/Intensity Scale for Adverse Events 2 Moderate Adverse Event 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. Grade 2; MODERATE Production C41340 C49705 Severity/Intensity Scale for Adverse Events 3 Severe Adverse Event 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. Grade 3; SEVERE Production C28421 C28421 No 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) Sex Production C16576 C28421 Sex 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 C28421 Sex 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 C28421 Sex U Unknown Not known, not observed, not recorded, or refused. (NCI) UNKNOWN; Unknown Production C45908 C28421 Sex UN Intersex 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) Undifferentiated Production C49696 C49696 No Sex of Study Group [SEXPOP] The specific sex, either male, female, or mixed of the subject group being studied. (NCI) Sex of Participants Production C49636 C49696 Sex of Study Group BOTH Both One and the other; relating to or being two in conjunction. (NCI) Production C16576 C49696 Sex of Study Group 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 C49696 Sex of Study Group 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 C25681 C25681 Yes Size [SIZE] Size The physical magnitude of something. (NCI) Size Production C49508 C25681 Size LARGE Large Of considerable or relatively great size, extent, or capacity. (NCI) Production C49507 C25681 Size MEDIUM Medium Mid-way between small and large in number, quantity, magnitude or extent. (NCI) Production C25376 C25681 Size SMALL Small Limited in number, quantity, magnitude or extent. (NCI) Production C49558 C49558 Yes Submission Domain Abbreviation [DOMAIN] 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) Domain Abbreviation Production C49563 C49558 Submission Domain Abbreviation AD Analysis Dataset Domain Datasets used for statistical analysis and reporting by the sponsor. These are submitted in addition to the data tabulation datasets. Analysis Dataset Production C49562 C49558 Submission Domain Abbreviation AE Adverse Event Domain Adverse events may be captured either as free text or a pre-specified list of terms. Adverse Events Production C49565 C49558 Submission Domain Abbreviation AU Autopsy Domain Additional data about deaths, specific to findings from autopsies. Autopsy Production C49566 C49558 Submission Domain Abbreviation BM Bone Mineral Density Data Domain Findings resulting from evaluations of bone mineral density. Bone Mineral Density (BMD) Data Production C49567 C49558 Submission Domain Abbreviation BR Biopsy Domain Findings resulting from biopsies. Biopsy Production C49568 C49558 Submission Domain Abbreviation CM Concomitant Medication Domain 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 Meds Production C49569 C49558 Submission Domain Abbreviation CO Comment Domain 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. Comments Production C49578 C49558 Submission Domain Abbreviation DA Drug Accountability Domain Data regarding the accountability of study drug, such as information on the receipt, dispensing, return, and packaging. Drug Accountability Production C49570 C49558 Submission Domain Abbreviation DC Disease Characteristics Domain Data related to the characteristics of a specific disease state under study for a subject. Disease Characteristics Production C49572 C49558 Submission Domain Abbreviation DM Demographics Domain 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 Production C49576 C49558 Submission Domain Abbreviation DS Disposition Domain A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to disposition. (NCI) Disposition Production C49585 C49558 Submission Domain Abbreviation DV Protocol Deviations Domain 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 Production C49625 C49558 Submission Domain Abbreviation EE Electroencephalogram Domain Findings resulting from electroencephalogram (EEG) tests. Electroencephalogram Production C49626 C49558 Submission Domain Abbreviation EG Electrocardiogram Domain 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 Production C49587 C49558 Submission Domain Abbreviation EX Exposure Domain 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 Production C49588 C49558 Submission Domain Abbreviation FH Family History Domain A subject domain utilized for the submission of information encompassing and representing data, vocabulary or records related to family history. (NCI) Family History Production C49589 C49558 Submission Domain Abbreviation HU Healthcare Resource Utilization Domain Healthcare resource utilization data such as subject visits to physicians, hospitalizations, and nursing home stays. Healthcare Resource Utilization Production C61536 C49558 Submission Domain Abbreviation IE Inclusion Exclusion Domain 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 Production C49592 C49558 Submission Domain Abbreviation LB Laboratory Data Domain 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 Production C49602 C49558 Submission Domain Abbreviation MB Microbiology Specimen Domain Microbiology specimen findings, including gram stain results, and organisms found. Microbiology Production C49603 C49558 Submission Domain Abbreviation MH Medical History Domain 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 Production C49604 C49558 Submission Domain Abbreviation ML Meal Data Domain 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 Production C61531 C49558 Submission Domain Abbreviation MS Microbiology Susceptibility Domain This includes microbiology susceptibility test results, plus results of any other organism-related tests. Microbiology Susceptibility Production C49605 C49558 Submission Domain Abbreviation OM Organ Measurement Domain Findings from organ measurement evaluations. Organ Measurements Production C49606 C49558 Submission Domain Abbreviation PC Pharmacokinetic Concentration Domain Concentrations of drugs/metabolites in fluids or tissues as a function of time. Pharmacokinetic Concentration Production C49608 C49558 Submission Domain Abbreviation PE Physical Exam Domain 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 Production C61529 C49558 Submission Domain Abbreviation PG Pharmacogenomics Domain Pharmacogenomics findings that initially focus on genotype and gene expression data. Pharmacogenomics Production C49607 C49558 Submission Domain Abbreviation PP Pharmacokinetic Parameters Domain Pharmacokinetic parameters derived from pharmacokinetic concentration-time (PC) data. Pharmacokinetic Parameters Production C49609 C49558 Submission Domain Abbreviation QS Questionnaire Domain 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). Questionnaires Production C49610 C49558 Submission Domain Abbreviation SC Subject Characteristics Domain 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 Production C49616 C49558 Submission Domain Abbreviation SE Subject Element Domain 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 Production C49611 C49558 Submission Domain Abbreviation SG Surgery Domain Surgical information. Surgery Production C49612 C49558 Submission Domain Abbreviation SK Skin Test Domain Findings from diagnostic skin tests. Skin Test Production C49613 C49558 Submission Domain Abbreviation SL Sleep Polysomnography Domain Findings from diagnostic sleep tests (polysomnography). Sleep Polysomnography Data Production C49614 C49558 Submission Domain Abbreviation ST Stress Exercise Test Data Domain Findings from exercise stress tests. Stress (Exercise) Test Data Production C49615 C49558 Submission Domain Abbreviation SU Substance Use Domain 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 Production C49617 C49558 Submission Domain Abbreviation SV Subject Visits Domain The subject visits table describes the actual start and end data/time for each visit of each individual subject. Subject Visits Production C49618 C49558 Submission Domain Abbreviation TA Trial Arms Domain The trial arms table describes each planned arm in the trial. An arm is described as an ordered sequence of elements. Trial Arms Production C49619 C49558 Submission Domain Abbreviation TE Trial Elements Domain 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 Production C49620 C49558 Submission Domain Abbreviation TI Trial Inclusion and Exclusion Criteria Domain 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/Exclusion Criteria Production C53483 C49558 Submission Domain Abbreviation TS Trial Summary Domain The trial summary information domain is not subject oriented. It contains one record for each trial summary characteristic. Trial Summary Production C49621 C49558 Submission Domain Abbreviation TV Trial Visits Domain The trial visits table describes the planned order and number of visits in the study within each arm. Trial Visits Production C49622 C49558 Submission Domain Abbreviation VS Vital Signs Domain Measurements including but not limited to blood pressure, temperature, respiration, body surface area, BMI, height and weight. Vital Signs Production C49658 C49658 Yes Trial Blinding Schema [TBLIND] The name of a code list that contains terms to define the type of blinding for the trial. (NCI) Trial Blinding Schema Production C15228 C49658 Trial Blinding Schema DOUBLE BLIND Double Blind Study 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) Production C49659 C49658 Trial Blinding Schema OPEN LABEL Open Label Study A trial in which subjects and investigators know which product each subject is receiving; opposite of a blinded or double-blind study. (CDISC glossary) Production C28233 C49658 Trial Blinding Schema SINGLE BLIND Single Blind Study 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) Production C49652 C49652 Yes Trial Indication Type [TINDTP] 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 C49654 C49652 Trial Indication Type CURE Cure Study A type of study protocol designed to evaluate intervention(s) aimed to cure a disease or condition. (NCI) Production C49653 C49652 Trial Indication Type DIAGNOSIS Diagnosis Study A type of study protocol designed to evaluate intervention(s) aimed at identifying a disease or condition. (NCI) Production C49655 C49652 Trial Indication Type MITIGATION Adverse Effect Mitigation Study 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) Production C49657 C49652 Trial Indication Type PREVENTION Prevention Study 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. Production C49656 C49652 Trial Indication Type TREATMENT Treatment Study A type of study protocol designed to evaluate intervention(s) for treatment of disease, syndrome or condition. Production C48281 C48281 Yes Trial Phase [TPHASE] 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 C15600 C48281 Trial Phase 1 Phase I Trial 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) Trial Phase 1 Production C15693 C48281 Trial Phase 1-2 Phase I/II Trial A class of clinical study that combines elements characteristic of traditional Phase I and Phase II trials. See also Phase I, Phase II. Trial Phase 1-2 Production C15601 C48281 Trial Phase 2 Phase II Trial 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) Trial Phase 2 Production C15694 C48281 Trial Phase 2-3 Phase II/III Trial A class of clinical study that combines elements characteristic of traditional Phase II and Phase III trials. Trial Phase 2-3 Production C49686 C48281 Trial Phase 2A Phase II A Trial 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) Trial Phase 2A Production C49688 C48281 Trial Phase 2B Phase II B Trial 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) Trial Phase 2B Production C15602 C48281 Trial Phase 3 Phase III Trial 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) Trial Phase 3 Production C49687 C48281 Trial Phase 3A Phase IIIA Trial A classification typically assigned retrospectively to a Phase III trial upon determination by regulatory authorities of a need for a Phase III B trial. Trial Phase 3A Production C49689 C48281 Trial Phase 3B Phase III B Trial 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. Trial Phase 3B Production C15603 C48281 Trial Phase 4 Phase IV Trial 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) Trial Phase 4 Production C47865 C48281 Trial Phase 5 Phase V Trial Postmarketing surveillance is sometimes referred to as Phase V. Trial Phase 5 Production C48660 C48281 Trial Phase NA Not Applicable Determination of a value is not relevant in the current context. (NCI) NOT APPLICABLE Production C49691 C49691 Yes Trial Summary Parameter [TSPARM] Individual characteristics of a clinical trial, e.g. description of trial design, trial blinding schema, and primary objective of trial. (NCI) Trial Summary Parameter Production C49703 C49691 Trial Summary Parameter ADDON Test Product Added to Existing Treatment The addition of a therapeutic product to the existing regimen in a clinical trial, where both entities remain as discrete products. Added on to Existing Treatments Production C49700 C49691 Trial Summary Parameter AEDICT Adverse Event Dictionary A reference source that provides meanings of words related to adverse events. (NCI) Adverse Event Dictionary Production C49694 C49691 Trial Summary Parameter 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 C49691 Trial Summary Parameter 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 C49691 Trial Summary Parameter AGESPAN Age Group Subgroups of populations based on age. (NCI) Age Span Production C50400 C49691 Trial Summary Parameter AGEU Age Unit Those units of time that are routinely used to express the age of a person. (NCI) Age Units Production C25488 C49691 Trial Summary Parameter DOSE Dose 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 per Administration Production C49701 C49691 Trial Summary Parameter DRUGDICT Drug Dictionary A reference source that provides meanings of words related to drugs. (NCI) Drug Dictionary Production C49697 C49691 Trial Summary Parameter LENGTH Trial Length The anticipated length of a clinical trial measured as a unit of time. (NCI) Length of Trial Production C49702 C49691 Trial Summary Parameter MHDICT Medical History Dictionary A reference source that provides meanings of words related to medical history. (NCI) Medical History Dictionary Production C49692 C49691 Trial Summary Parameter PLANSUB Planned Subject Number The number of subjects entered in a clinical trial. (NCI) Planned Number of Subjects Production C25196 C49691 Trial Summary Parameter RANDOM Randomization 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) Trial is Randomized Production C38114 C49691 Trial Summary Parameter 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 C49691 Trial Summary Parameter SEXPOP Sex of Study Group The specific sex, either male, female, or mixed of the subject group being studied. (NCI) Sex of Participants Production C49698 C49691 Trial Summary Parameter STOPRULE Study Stop Rules The rule, regulation and/or condition that determines the point in time when a clinical trial will be terminated. (NCI) Stopping Rules for the Study Production C49658 C49691 Trial Summary Parameter 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 C49691 Trial Summary Parameter TCNTRL Control Type Comparator against which the study treatment is evaluated (e.g., concurrent (placebo, no treatment, dose-response, active), external (historical, published literature). Type of Control Production C49650 C49691 Trial Summary Parameter 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 C49691 Trial Summary Parameter 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 C49691 Trial Summary Parameter TITLE Trial Title The name of a clinical trial. (NCI) Trial Title Production C48281 C49691 Trial Summary Parameter 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) Trial Phase Production C49660 C49691 Trial Summary Parameter TTYPE Trial Type The type of clinical trial performed e.g. efficacy, safety. (NCI) Type of Trial Production C49660 C49660 Yes Trial Type [TTYPE] The type of clinical trial performed e.g. efficacy, safety. (NCI) Type of Trial Production C49664 C49660 Trial Type BIO-AVAILABILITY Bioavailability Study 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) Production C49665 C49660 Trial Type BIO-EQUIVALENCE Therapeutic Equivalency Study 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) Production C49666 C49660 Trial Type EFFICACY Efficacy Study A study of the relative therapeutic efficacy of treatment of a disease. Usually this is a Phase II or III study. (NCI) Production C49662 C49660 Trial Type PHARMACODYNAMIC Pharmacodynamic Study 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) Production C39493 C49660 Trial Type PHARMACOECONOMIC Pharmacoeconomic Study 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) Production C49661 C49660 Trial Type PHARMACOGENOMIC Pharmacogenomic Study 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) Production C49663 C49660 Trial Type PHARMACOKINETIC Pharmacokinetic Study A study of the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. (NCI) Production C49667 C49660 Trial Type SAFETY Safety Study A study of the relative safety of treatment of a disease. Usually this is a Phase I or II trial. (NCI) Production C49675 C49675 Yes Units for Vital Signs Results [VSRESU] The unit used to record and describe the result of a test investigating a vital sign. (NCI) Units for Vital Signs Results Production C25613 C49675 Units for Vital Signs Results % Percentage A fraction or ratio with 100 understood as the denominator. (NCI) Percentage Production C49673 C49675 Units for Vital Signs Results BEATS/MIN Beats per Minute The number of heartbeats measured per minute time. (NCI) Beats per Minute Production C49674 C49675 Units for Vital Signs Results BREATHS/MIN Breaths per Minute The number of breaths (inhalation and exhalation) taken per minute time. (NCI) Breaths per Minute Production C42559 C49675 Units for Vital Signs Results 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 C49675 Units for Vital Signs Results 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 C49675 Units for Vital Signs Results 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 C49675 Units for Vital Signs Results g Gram A metric unit of mass equal to one one thousandth of a kilogram. (NCI) Gram Production C48500 C49675 Units for Vital Signs Results IN Inch A traditional unit of length equal to 2.54 centimeters. (NCI) Inch Production C28252 C49675 Units for Vital Signs Results 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 C49675 Units for Vital Signs Results 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 C49675 Units for Vital Signs Results 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 C49675 Units for Vital Signs Results 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 C49675 Units for Vital Signs Results 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 C49675 Units for Vital Signs Results 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) Production C49672 C49672 Yes Vital Signs [VSTEST] 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) Vital Signs Test Name Production C16358 C49672 Vital Signs 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 C49672 Vital Signs BODYFAT Adipose Tissue A specialized form of connective tissue consisting primarily of adipocytes (fat cells), surrounded by a meshwork of collagen fibers. Body Fat Production C25157 C49672 Vital Signs 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 C49672 Vital Signs 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 C49672 Vital Signs 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) Frame Size Production C25347 C49672 Vital Signs 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 C49672 Vital Signs HR Heart Rate The number of heartbeats per unit of time, usually expressed as beats per minute. (NCI) Heart Rate Production C49679 C49672 Vital Signs 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 C49672 Vital Signs 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 C49672 Vital Signs 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 C49672 Vital Signs SYSBP Systolic Blood Pressure The blood pressure during the contraction of the left ventricle of the heart. Systolic Blood Pressure Production C25206 C49672 Vital Signs 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 C49672 Vital Signs WEIGHT Weight The vertical force exerted by a mass as a result of gravity. (NCI) Weight Production C49486 C49486 No Yes, No, Unknown, or Not Applicable Response [NY] A term that is used to indicate a question with permissible values of yes/no/unknown/not applicable. No Yes Response Production C49487 C49486 Yes, No, Unknown, or Not Applicable Response N No The non-affirmative response to a question. (NCI) No Production C48660 C49486 Yes, No, Unknown, or Not Applicable Response NA Not Applicable Determination of a value is not relevant in the current context. (NCI) NOT APPLICABLE Production C17998 C49486 Yes, No, Unknown, or Not Applicable Response U Unknown Not known, not observed, not recorded, or refused. (NCI) UNKNOWN; Unknown Production C49488 C49486 Yes, No, Unknown, or Not Applicable Response Y Yes The affirmative response to a question. (NCI) Yes Production C65047 C65047 Yes CDISC SDTM Laboratory Test Terminology [LABTEST] Terminology used for Laboratory Tests of the CDISC Standard Data Tabulation Model. Pre-release C35266 C65047 CDISC SDTM Laboratory Test Terminology ANISO Anisocytosis A measurement of the inequality in the size of the red blood cells in a whole blood specimen. Anisocytosis Pre-release C35267 C65047 CDISC SDTM Laboratory Test Terminology POIKILO Poikilocytosis A measurement of the odd-shaped erythrocytes in a whole blood specimen. Poikilocytosis Pre-release C38037 C65047 CDISC SDTM Laboratory Test Terminology BILI Total Bilirubin A measurement of the total bilirubin in a biological specimen. Bilirubin Pre-release C38462 C65047 CDISC SDTM Laboratory Test Terminology APTT 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. Activated Partial Thromboplastin Time Pre-release C41376 C65047 CDISC SDTM Laboratory Test Terminology GLUC Plasma Glucose Measurement A measurement of the glucose in a biological specimen. Glucose Pre-release C45997 C65047 CDISC SDTM Laboratory Test Terminology PH pH A measure of the acidity or alkalinity of a fluid on a scale of 0 to 14. pH Pre-release C51946 C65047 CDISC SDTM Laboratory Test Terminology RBC Erythrocyte Count A count of the total erythrocytes per unit of a biological specimen. Erythrocytes Pre-release C51947 C65047 CDISC SDTM Laboratory Test Terminology RETI Reticulocyte Count A count of the reticulocytes per unit of a biological specimen. Reticulocytes Pre-release C51948 C65047 CDISC SDTM Laboratory Test Terminology WBC Leukocyte Count A count of the leukocytes per unit of a biological specimen. Leukocytes Pre-release C51949 C65047 CDISC SDTM Laboratory Test Terminology LYM Lymphocyte Count A count of the lymphocytes per unit of a biological specimen. Lymphocytes Pre-release C51951 C65047 CDISC SDTM Laboratory Test Terminology PLAT Platelet Count A count of the platelets per unit of a biological specimen. Platelet Pre-release C61019 C65047 CDISC SDTM Laboratory Test Terminology BUN Blood Urea Nitrogen Measurement A measurement of the urea nitrogen in a blood specimen. Blood Urea Nitrogen Pre-release C61032 C65047 CDISC SDTM Laboratory Test Terminology CHOL Serum Total Cholesterol Measurement A measurement of the cholesterol in a biological specimen. Cholesterol Pre-release C61041 C65047 CDISC SDTM Laboratory Test Terminology HDL Serum HDL Cholesterol Measurement A measurement of the high density lipoprotein cholesterol in a biological specimen. HDL Cholesterol Pre-release C61042 C65047 CDISC SDTM Laboratory Test Terminology LDL Serum LDL Cholesterol Measurement A measurement of the low density lipoprotein cholesterol in a biological specimen. LDL Cholesterol Pre-release C62656 C65047 CDISC SDTM Laboratory Test Terminology 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 Pre-release C63321 C65047 CDISC SDTM Laboratory Test Terminology NEUT Absolute Neutrophil Count A count of the neutrophils per unit of a biological specimen. Neutrophils Pre-release C64431 C65047 CDISC SDTM Laboratory Test Terminology ALB Albumin Measurement A measurement of the albumin protein in a biological specimen. Albumin Pre-release C64432 C65047 CDISC SDTM Laboratory Test Terminology ALP Alkaline Phosphatase Measurement A measurement of the alkaline phosphatase in a biological specimen. Alkaline Phosphatase Pre-release C64433 C65047 CDISC SDTM Laboratory Test Terminology ALT Alanine Aminotransferase Measurement A measurement of the alanine aminotransferase in a biological specimen. Alanine Aminotransferase Pre-release C64434 C65047 CDISC SDTM Laboratory Test Terminology AMYLASE Amylase Measurement A measurement of the pancreatic enzyme amylase in a biological specimen. Amylase Pre-release C64467 C65047 CDISC SDTM Laboratory Test Terminology AST Aspartate Aminotransferase Measurement A measurement of the aspartate aminotransferase in a biological specimen. Aspartate Aminotransferase Pre-release C64469 C65047 CDISC SDTM Laboratory Test Terminology BACT Bacterial Count A measurement of the bacteria in a biological specimen. Bacteria Pre-release C64470 C65047 CDISC SDTM Laboratory Test Terminology BASO Total Basophil Count A count of the basophils per unit of a biological specimen. Basophils Pre-release C64471 C65047 CDISC SDTM Laboratory Test Terminology BASOLE Basophil To Leukocyte Ratio A relative measure (ratio or percentage) of the basophils to leukocytes in a biological specimen. Basophils/Leukocytes Pre-release C64481 C65047 CDISC SDTM Laboratory Test Terminology BILDIR Direct Bilirubin Measurement A measurement of the conjugated or water-soluble bilirubin in a biological specimen. Direct Bilirubin Pre-release C64483 C65047 CDISC SDTM Laboratory Test Terminology BILIND Indirect Bilirubin Measurement A measurement of the unconjugated or non-water-soluble bilirubin in a biological specimen. Indirect Bilirubin Pre-release C64487 C65047 CDISC SDTM Laboratory Test Terminology BLASTLE Blast To Leukocyte Ratio A relative measure (ratio or percentage) of the blasts to leukocytes in a biological specimen. Blasts/Leukocytes Pre-release C64488 C65047 CDISC SDTM Laboratory Test Terminology CA Calcium Measurement A measurement of the calcium in a biological specimen. Calcium Pre-release C64489 C65047 CDISC SDTM Laboratory Test Terminology CK Creatine Kinase Measurement A measurement of the total creatine kinase in a biological specimen. Creatine Kinase Pre-release C64490 C65047 CDISC SDTM Laboratory Test Terminology CKBB Creatine Kinase BB Measurement A measurement of the homozygous B-type creatine kinase in a biological specimen. Creatine Kinase BB Pre-release C64491 C65047 CDISC SDTM Laboratory Test Terminology CKMB Creatine Kinase MB Measurement A measurement of the heterozygous MB-type creatine kinase in a biological specimen. Creatine Kinase MB Pre-release C64494 C65047 CDISC SDTM Laboratory Test Terminology CKMM Creatine Kinase MM Measurement A measurement of the homozygous M-type creatine kinase in a biological specimen. Creatine Kinase MM Pre-release C64495 C65047 CDISC SDTM Laboratory Test Terminology CL Chloride Measurement A measurement of the chloride in a biological specimen. Chloride Pre-release C64545 C65047 CDISC SDTM Laboratory Test Terminology CO2 Carbon Dioxide Measurement A measurement of the carbon dioxide gas in a biological specimen. Carbon Dioxide Pre-release C64546 C65047 CDISC SDTM Laboratory Test Terminology COLOR Color Assessment A measurement of the color of a biological specimen. Color Pre-release C64547 C65047 CDISC SDTM Laboratory Test Terminology CREAT Creatinine Measurement A measurement of the creatinine in a biological specimen. Creatinine Pre-release C64548 C65047 CDISC SDTM Laboratory Test Terminology CRP C-Reactive Protein Measurement A measurement of the C reactive protein in a biological specimen. C Reactive Protein Pre-release C64549 C65047 CDISC SDTM Laboratory Test Terminology ELLIPCY Elliptocyte Count A count of the elliptocytes per unit of a biological specimen. Elliptocytes Pre-release C64550 C65047 CDISC SDTM Laboratory Test Terminology EOS Eosinophil Count A count of the eosinophils per unit of a biological specimen. Eosinophils Pre-release C64604 C65047 CDISC SDTM Laboratory Test Terminology EOSLE Eosinophil To Leukocyte Ratio A relative measure (ratio or percentage) of the eosinophils to leukocytes in a biological specimen. Eosinophils/Leukocytes Pre-release C64605 C65047 CDISC SDTM Laboratory Test Terminology EPIC Epithelial Cell Count A measurement of the epithelial cells in a biological specimen. Epithelial Cells Pre-release C64606 C65047 CDISC SDTM Laboratory Test Terminology FIBRINO Fibrinogen Measurement A measurement of the fibrinogen in a biological specimen. Fibrinogen Pre-release C64796 C65047 CDISC SDTM Laboratory Test Terminology HCT Hematocrit The percentage of a whole blood specimen that is composed of red blood cells (erythrocytes). Hematocrit Pre-release C64797 C65047 CDISC SDTM Laboratory Test Terminology MCH Erythrocyte Mean Corpuscular Hemoglobin A quantitative measurement of the mean amount of hemoglobin per erythrocyte in a biological specimen. Ery. Mean Corpuscular Hemoglobin Pre-release C64798 C65047 CDISC SDTM Laboratory Test Terminology MCHC Erythrocyte Mean Corpuscular Hemoglobin Concentration A quantitative measurement of the mean amount of hemoglobin per erythrocytes in a specified volume of a biological specimen. Ery. Mean Corpuscular HB Concentration Pre-release C64799 C65047 CDISC SDTM Laboratory Test Terminology MCV Erythrocyte Mean Corpuscular Volume A quantitative measurement of the mean volume of erythrocytes in a biological specimen. Ery. Mean Corpuscular Volume Pre-release C64800 C65047 CDISC SDTM Laboratory Test Terminology RDW Erythrocyte Distribution Width Measurement A value derived from mean corpuscular volume and the standard deviation of the red blood cell volume in a whole blood specimen. Erythrocytes Distribution Width Pre-release C64801 C65047 CDISC SDTM Laboratory Test Terminology TEARDCY Dacryocyte Analysis A count of dacryocytes in unit of a biological specimen. Dacryocytes Pre-release C64802 C65047 CDISC SDTM Laboratory Test Terminology HYPO Hypochromia An observation which indicates that the hemoglobin concentration in a red blood cell specimen has fallen below a specified level. Hypochromia Pre-release C64803 C65047 CDISC SDTM Laboratory Test Terminology POLYCHR Polychromasia A measurement of the blue-staining characteristic of newly generated erythrocytes. Polychromasia Pre-release C64805 C65047 CDISC SDTM Laboratory Test Terminology INR International Normalized Ratio of Prothrombin Time 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. Prothrombin Intl. Normalized Ratio Pre-release C64806 C65047 CDISC SDTM Laboratory Test Terminology VLDL Serum VLDL Cholesterol Measurement A measurement of the very low density lipoprotein cholesterol in a biological specimen. VLDL Cholesterol Pre-release C64807 C65047 CDISC SDTM Laboratory Test Terminology LIPASE Triacylglycerol Lipase Measurement A measurement of the pancreatic lipase in a biological specimen. Triacylglycerol Lipase Pre-release C64809 C65047 CDISC SDTM Laboratory Test Terminology NA Sodium Measurement A measurement of the sodium in a biological specimen. Sodium Pre-release C64810 C65047 CDISC SDTM Laboratory Test Terminology NITRITE Nitrite Measurement A measurement of the nitrite in a urine specimen. Nitrite Pre-release C64812 C65047 CDISC SDTM Laboratory Test Terminology TRIG Triglyceride Measurement A measurement of the triglycerides in a biological specimen. Triglycerides Pre-release C64813 C65047 CDISC SDTM Laboratory Test Terminology TSH Thyrotropin Measurement A measurement of the thyrotropin in a biological specimen. Thyrotropin Pre-release C64814 C65047 CDISC SDTM Laboratory Test Terminology URATE Urate Measurement A measurement of the urate in a biological specimen. Urate Pre-release C64815 C65047 CDISC SDTM Laboratory Test Terminology UREA Urea Measurement A measurement of the urea in a biological specimen. Urea Pre-release C64816 C65047 CDISC SDTM Laboratory Test Terminology UROBIL Urobilinogen Measurement A measurement of the urobilinogen in a biological specimen. Urobilinogen Pre-release C64817 C65047 CDISC SDTM Laboratory Test Terminology VITB12 Vitamin B12 Measurement A measurement of the Vitamin B12 in a serum specimen. Vitamin B12 Pre-release C64818 C65047 CDISC SDTM Laboratory Test Terminology LYMAT Atypical Lymphocyte Count A count of the atypical lymphocytes per unit of a biological specimen. Lymphocytes Atypical Pre-release C64819 C65047 CDISC SDTM Laboratory Test Terminology LYMATLE Atypical Lymphocyte To Leukocyte Ratio A relative measure (ratio or percentage) of the atypical lymphocytes to leukocytes in a biological specimen. Lymphocytes Atypical/Leukocytes Pre-release C64820 C65047 CDISC SDTM Laboratory Test Terminology LYMLE Lymphocyte To Leukocyte Ratio A relative measure (ratio or percentage) of the lymphocytes to leukocytes in a biological specimen. Lymphocytes/Leukocytes Pre-release C64821 C65047 CDISC SDTM Laboratory Test Terminology MACROCY Macrocyte Count A count of the macrocytes per unit of a biological specimen. Macrocytes Pre-release C64822 C65047 CDISC SDTM Laboratory Test Terminology MICROCY Microcyte Count A count of the microcytes per unit of a biological specimen. Microcytes Pre-release C64823 C65047 CDISC SDTM Laboratory Test Terminology MONO Monocyte Count A count of the monocytes per unit of a biological specimen. Monocytes Pre-release C64824 C65047 CDISC SDTM Laboratory Test Terminology MONOLE Monocyte To Leukocyte Ratio A relative measure (ratio or percentage) of the monocytes to leukocytes in a biological specimen. Monocytes/Leukocytes Pre-release C64825 C65047 CDISC SDTM Laboratory Test Terminology MYBLALE Myeloblast To Leukocyte Ratio A relative measure (ratio or percentage) of the myeloblasts to leukocytes in a biological specimen. Myeloblasts/Leukocytes Pre-release C64826 C65047 CDISC SDTM Laboratory Test Terminology MYCYLE Myelocyte To Leukocyte Ratio A relative measure (ratio or percentage) of the myelocytes to leukocytes in a biological specimen. Myelocytes/Leukocytes Pre-release C64827 C65047 CDISC SDTM Laboratory Test Terminology NEUTLE Neutrophil To Leukocyte Ratio The determination of the ratio of neutrophils compared to leukocytes in a blood sample. The measurement may be expressed as a ratio or percentage. Neutrophils/Leukocytes Pre-release C64828 C65047 CDISC SDTM Laboratory Test Terminology RETIRBC Reticulocyte To Erythrocyte Ratio A relative measure (ratio or percentage) of reticulocytes to erythrocytes in a biological specimen. Reticulocytes/Erythrocytes Pre-release C64829 C65047 CDISC SDTM Laboratory Test Terminology PRLYMLE Prolymphocyte To Leukocyte Ratio A relative measure (ratio or percentage) of prolymphocytes to leukocytes in a biological specimen. Prolymphocytes/Leukocytes Pre-release C64830 C65047 CDISC SDTM Laboratory Test Terminology NEUTB Neutrophil Band Form Count A count of the banded neutrophils per unit of a biological specimen. Neutrophils Band Form Pre-release C64831 C65047 CDISC SDTM Laboratory Test Terminology NEUTBLE Neutrophil Band Form To Leukocyte Ratio A relative measure (ratio or percentage) of the banded neutrophils to leukocytes in a biological specimen. Neutrophils Band Form/Leukocytes Pre-release C64832 C65047 CDISC SDTM Laboratory Test Terminology SPGRAV Specific Gravity A ratio of the density of a fluid to the density of water. Specific Gravity Pre-release C64840 C65047 CDISC SDTM Laboratory Test Terminology MG Magnesium Measurement A measurement of the magnesium in a biological specimen. Magnesium Pre-release C64847 C65047 CDISC SDTM Laboratory Test Terminology GGT Gamma Glutamyl Transpeptidase Measurement A measurement of the gamma glutamyl transpeptidase in a biological specimen. Gamma Glutamyl Transferase Pre-release C64848 C65047 CDISC SDTM Laboratory Test Terminology HGB Hemoglobin Measurement A measurement of the hemoglobin in a biological specimen. Hemoglobin Pre-release C64849 C65047 CDISC SDTM Laboratory Test Terminology HBA1C Glycosylated Hemoglobin Measurement A measurement of the glycosylated hemoglobin in a biological specimen. Hemoglobin A1C Pre-release C64850 C65047 CDISC SDTM Laboratory Test Terminology HBSAG Hepatitis B Virus Surface Antigen Measurement A measurement of the surface antigen reaction of a biological specimen to the Hepatitis B virus. Hepatitis B Virus Surface Antigen Pre-release C64851 C65047 CDISC SDTM Laboratory Test Terminology HCG Choriogonadotropin Beta Measurement A measurement of the Choriogonadotropin Beta in a biological specimen. Choriogonadotropin Beta Pre-release C64853 C65047 CDISC SDTM Laboratory Test Terminology K Potassium Measurement A measurement of the potassium in a biological specimen. Potassium Pre-release C64854 C65047 CDISC SDTM Laboratory Test Terminology KETONES Ketone Measurement A measurement of the ketones in a biological specimen. Ketones Pre-release C64855 C65047 CDISC SDTM Laboratory Test Terminology LDH Lactate Dehydrogenase Measurement A measurement of the lactate dehydrogenase in a biological specimen. Lactate Dehydrogenase Pre-release C64856 C65047 CDISC SDTM Laboratory Test Terminology LEUKASE Leukocyte Esterase Measurement A measurement of the enzyme which indicates the presence of white blood cells in a biological specimen. Leukocyte Esterase Pre-release C64857 C65047 CDISC SDTM Laboratory Test Terminology PHOS Phosphate Measurement A measurement of the phosphate in a biological specimen. Phosphate Pre-release C64858 C65047 CDISC SDTM Laboratory Test Terminology PROT Total Protein Measurement A measurement of a group of complex organic macromolecules composed of one or more alpha-L-amino acid chains in a biological specimen. Protein Pre-release