CDISC CDASH Controlled Terminology CDISC CDASH Controlled Terminology, 2026-03-27 CDISC CDASH Controlled Terminology A terminology subset of the CDISC SDTM Pharmaceutical Dosage Form codelist created for CDASH Concomitant Medication Dose Form codelist. (NCI) aer 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). Aerosol Dosage Form cap A solid pharmaceutical dosage form that contains medicinal agent within either a hard or soft soluble container or shell, usually used for the oral administration of medicine. The shells are made of a suitable form of gelatin or other substance. (NCI) Capsule Dosage Form A semisolid emulsion of either the oil-in-water or the water-in-oil type, ordinarily intended for topical use. (NCI) Cream Dosage Form Any elastic aeriform fluid in which the molecules are separated from one another and have free paths. (NCI) Gas 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. Gel Dosage Form oint A suspension or emulsion, semisolid (1) dosage form, usually containing less than 20 percent water and volatiles (2) and greater than 50 percent 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. Ointment 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. Patch Dosage Form An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. (NCI) Powder Dosage Form A liquid minutely divided as by a jet of air or steam. (NCI) Spray Dosage Form supp 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. Suppository Dosage Form Ready to Use Suspension susp A dosage form that contains solid particles dispersed in a liquid vehicle. Suspension Dosage Form tab A solid dosage form containing medicinal substances with or without suitable diluents. (NCI) Tablet Dosage Form CMDOSFRM Concomitant Medication Dose Form CDISC CDASH Concomitant Medication Dose Form Terminology A terminology subset of the CDISC SDTM Unit codelist created for CDASH Concomitant Medication Dose Units codelist. (NCI) cap Capsule Dosing Unit A dosing measurement based on the capsule unit.(NCI) Capsule Dosing Unit Gram A unit of mass equal to one thousandth (1E-3) of a kilogram, the kilogram being the base unit of mass in the International System of Units (SI). Gram IE International Unit The unitage assigned by the WHO (World Health Organization) to International Biological Standards - substances, classed as biological according to the criteria provided by WHO Expert Committee on Biological Standardization, to enable the results of biological and immunological assay procedures to be expressed in the same way throughout the world. The definition of an international unit is generally arbitrary and technical, and has to be officially approved by the International Conference for Unification of Formulae.(NCI) International Unit Milligram A unit of mass equal to one thousandth (1E-3) of a gram. Milligram cc cm3 Cubic Centimeter Milliliter A unit of volume equal to one thousandth (1E-3) of a liter. Milliliter Puff Dosing Unit A means of delivering a defined dose of a therapeutic aerolized solution into either the upper or lower respiratory tract. Metered-dose inhalers or spray pumps are devices that provide a puff dose for delivery into either the oral or the nasal cavity.(NCI) Puff Dosing Unit tab Tablet Dosing Unit A dosing measurement based on the tablet unit.(NCI) Tablet Dosing Unit mcg Microgram A unit of mass equal to one millionth (1E-6) of a gram. Microgram CMDOSU Concomitant Medication Dose Units CDISC CDASH Concomitant Medication Dose Units Terminology A terminology subset of the CDISC SDTM Frequency codelist created for CDASH Concomitant Medication Dosing Frequency per Interval codelist. (NCI) BD Twice per day Two times per day, at unspecified times. (NCI) Twice Daily As needed As needed. (NCI) As Needed /day Daily Per Day A rate of occurrences within a period of time equal to one day. Daily 4 times per day Four times per day. (NCI) Four Times Daily Every Month Per Month Every month. (NCI) Monthly Every other day Every Second Day Every Two Days Q2D Every other day. (NCI) Every Other Day 3 times per day Three times per day. (NCI) Three Times Daily U UNK Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown CMDOSFRQ Concomitant Medication Dosing Frequency per Interval CDISC CDASH Concomitant Medication Dosing Frequency per Interval Terminology A terminology subset of the CDISC SDTM Route codelist created for CDASH Concomitant Medication Route of Administration codelist. (NCI) Administration within or introduced directly into a localized lesion. (FDA) Intralesional Route of Administration Administration within a muscle. (FDA) Intramuscular Route of Administration Administration within the eye. (FDA) Intraocular Route of Administration Administration within the peritoneal cavity. (FDA) Intraperitoneal Route of Administration Intranasal Route of Administration Administration to the nose; administered by way of the nose. (FDA) Nasal Route of Administration Intraoral Route of Administration PO Administration to or by way of the mouth. (FDA) Oral Route of Administration Administration to the rectum. (FDA) Rectal Route of Administration Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect. (FDA) Inhalation Route of Administration SC Subdermal Route of Administration Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL. (FDA) Subcutaneous Route of Administration TOP Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL. (FDA) Topical Route of Administration Administration through the dermal layer of the skin to the systemic circulation by diffusion. (FDA) Transdermal Route of Administration Administration into the vagina. (FDA) Vaginal Route of Administration CMROUTE Concomitant Medication Route of Administration CDISC CDASH Concomitant Medication Route of Administration Terminology A terminology subset of the CDISC SDTM Unit codelist created for CDASH ECG Original Units codelist. (NCI) Beats per Minute BPM bpm The number of heartbeats measured per minute time. (NCI) Beats per Minute Millisecond ms msec A unit of time, which is equal to one thousandth of a second.(NCI) Millisecond sec Second The base unit of time in the International System of Units (SI) equal to the duration of 9,192,631,770 periods of the specified light radiation corresponding to the transition between the two hyperfine levels of the cesium 133 atom in its ground state at 0 K. Second EGORRESU ECG Original Units CDISC CDASH ECG Original Units Terminology A terminology codelist relevant to the ethnicity of an individual as collected on the case report form. AC A Chinese person from the Achang ethnic group. Achang Chinese Black Latino A person of African and Latino descent. Afro-Latino A person of Ashkenazi Jewish descent. Ashkenazi Jew BA A Chinese person from the Bai ethnic group. Bai Chinese BL A Chinese person from the Blang ethnic group. Blang Chinese BN A Chinese person from the Bonan ethnic group. Bonan Chinese BY A Chinese person from the Buyei ethnic group. Buyei Chinese A person of Central American descent. Central American CS A Chinese person from the Chosen ethnic group. Chosen Chinese A person of Cuban and American descent. Cuban or Cuban American A person of Cuban descent. Cuban DA A Chinese person from the Dai (including several different Tai-speaking groups historically referred to as Bai-yi) ethnic group. Dai Chinese DU A Chinese person from the Daur ethnic group. Daur Chinese DE A Chinese person from the Deang ethnic group. Deang Chinese DR A Chinese person from the Derung ethnic group. Derung Chinese DO A Chinese person from the Dong ethnic group. Dong Chinese DX A Chinese person from the Dongxiang ethnic group. Dongxiang Chinese EW A Chinese person from the Ewenki ethnic group. Ewenki Chinese GS A Chinese person from the Gaoshan ethnic group. Gaoshan Chinese GL A Chinese person from the Gelao ethnic group. Gelao Chinese GI A Chinese person from the Gin ethnic group. Gin Chinese HA A Chinese person from the Han ethnic group (including Chuanqing). Han Chinese HN A Chinese person from the Hani (including Sangkong) ethnic group. Hani Chinese HZ A Chinese person from the Hezhen ethnic group. Hezhen Chinese A person of Mexican, Puerto Rican, Cuban, Central or South American or other Spanish culture or origin, regardless of race. (NCI) Hispanic or Latino Any of the peoples in the Americas and Spain who speak Spanish or are descended from Spanish-speaking communities. Hispanic HU A Chinese person from the Hui (including Utsuls of Hainan, descended from Cham refugees) ethnic group. Hui Chinese JP A Chinese person from the Jingpo ethnic group. Jingpo Chinese JN A Chinese person from the Jino ethnic group. Jino Chinese KZ A Chinese person from the Kazak ethnic group. Kazak Chinese KG A Chinese person from the Kirgiz ethnic group. Kirgiz Chinese A person from the Kurdish ethnic group. Kurdish LH A Chinese person from the Lahu ethnic group. Lahu Chinese A person of Latin American descent. Latin American Latina LatinX A person with origins from anywhere in Latin America (Mexico, South and Central America) and/or the Caribbean. Latino Latin Caribbean A person of Latino and Caribbean descent. Latino-Caribbean LB A Chinese person from the Lhoba ethnic group. Lhoba Chinese LI A Chinese person from the Li ethnic group. Li Chinese LS A Chinese person from the Lisu ethnic group. Lisu Chinese MA A Chinese person from the Man ethnic group. Man Chinese MN A Chinese person from the Maonan (including the Then) ethnic group. Maonan Chinese A person of Mexican and American descent. Mexican American A person of Mexican descent. Mexican MH A Chinese person from the Miao (Including Hmong) ethnic group. Miao Chinese MB A Chinese person from the Monba ethnic group. Monba Chinese MG A Chinese person from the Mongol ethnic group. Mongol Chinese ML A Chinese person from the Mulao (including the Qago) ethnic group. Mulao Chinese NX A Chinese person from the Naxi (including Mosuo) ethnic group. Naxi Chinese A person not of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. An arbitrary ethnic classification. (NCI) Not Hispanic or Latino Not reported Not provided or available. Not Reported NU A Chinese person from the Nu ethnic group. Nu Chinese OR A Chinese person from the Oroqen ethnic group. Oroqen Chinese A person of Puerto Rican descent. Puerto Rican PM A Chinese person from the Pumi ethnic group. Pumi Chinese QI A Chinese person from the Qiang ethnic group. Qiang Chinese RS A Chinese person from the Russ ethnic group. Russ Chinese SL A Chinese person from the Salar ethnic group. Salar Chinese A person of Sephardic Jewish descent. Sephardic Jew SH A Chinese person from the She ethnic group. She Chinese A person of South American descent. South American Spaniard A person from Spain or of Spanish descent. Spanish SU A Chinese person from the Sui ethnic group. Sui Chinese TA A Chinese person from the Tajik ethnic group. Tajik Chinese TT A Chinese person from the Tatar ethnic group. Tatar Chinese TU A Chinese person from the Tu ethnic group. Tu Chinese TJ A Chinese person from the Tujia ethnic group. Tujia Chinese U UNK Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown UG A Chinese person from the Uygur ethnic group. Uygur Chinese UZ A Chinese person from the Uzbek ethnic group. Uzbek Chinese VA A Chinese person from the Va ethnic group. Va Chinese XB A Chinese person from the Xibe ethnic group. Xibe Chinese YA A Chinese person from the Yao ethnic group. Yao Chinese YI A Chinese person from the Yi ethnic group. Yi Chinese YG A Chinese person from the Yugur ethnic group. Yugur Chinese ZA A Chinese person from the Zang (including Amdowa, Khampa and some Pumi speakers) ethnic group. Zang Chinese ZH A Chinese person from the Zhuang ethnic group. Zhuang Chinese ETHNICC Ethnicity As Collected CDISC SDTM Collected Ethnicity Terminology A terminology subset of the CDISC SDTM Pharmaceutical Dosage Form codelist created for CDASH Exposure Dose Form codelist. (NCI) aer 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). Aerosol Dosage Form cap A solid pharmaceutical dosage form that contains medicinal agent within either a hard or soft soluble container or shell, usually used for the oral administration of medicine. The shells are made of a suitable form of gelatin or other substance. (NCI) Capsule Dosage Form A semisolid emulsion of either the oil-in-water or the water-in-oil type, ordinarily intended for topical use. (NCI) Cream Dosage Form Any elastic aeriform fluid in which the molecules are separated from one another and have free paths. (NCI) Gas 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. Gel Dosage Form oint A suspension or emulsion, semisolid (1) dosage form, usually containing less than 20 percent water and volatiles (2) and greater than 50 percent 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. Ointment 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. Patch Dosage Form An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. (NCI) Powder Dosage Form A liquid minutely divided as by a jet of air or steam. (NCI) Spray Dosage Form supp 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. Suppository Dosage Form Ready to Use Suspension susp A dosage form that contains solid particles dispersed in a liquid vehicle. Suspension Dosage Form tab A solid dosage form containing medicinal substances with or without suitable diluents. (NCI) Tablet Dosage Form EXDOSFRM Exposure Dose Form CDISC CDASH Exposure Dose Form Terminology A terminology subset of the CDISC SDTM Frequency codelist created for CDASH Exposure Dosing Frequency per Interval codelist. (NCI) BD Twice per day Two times per day, at unspecified times. (NCI) Twice Daily As needed As needed. (NCI) As Needed /day Daily Per Day A rate of occurrences within a period of time equal to one day. Daily 4 times per day Four times per day. (NCI) Four Times Daily Every Month Per Month Every month. (NCI) Monthly Every other day Every Second Day Every Two Days Q2D Every other day. (NCI) Every Other Day 3 times per day Three times per day. (NCI) Three Times Daily U UNK Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown EXDOSFRQ Exposure Dosing Frequency per Interval CDISC CDASH Exposure Dosing Frequency per Interval Terminology A terminology subset of the CDISC SDTM Route codelist created for CDASH Exposure Route of Administration codelist. (NCI) Administration within or introduced directly into a localized lesion. (FDA) Intralesional Route of Administration Administration within a muscle. (FDA) Intramuscular Route of Administration Administration within the eye. (FDA) Intraocular Route of Administration Administration within the peritoneal cavity. (FDA) Intraperitoneal Route of Administration Intranasal Route of Administration Administration to the nose; administered by way of the nose. (FDA) Nasal Route of Administration Intraoral Route of Administration PO Administration to or by way of the mouth. (FDA) Oral Route of Administration Administration to the rectum. (FDA) Rectal Route of Administration Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect. (FDA) Inhalation Route of Administration SC Subdermal Route of Administration Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL. (FDA) Subcutaneous Route of Administration TOP Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL. (FDA) Topical Route of Administration Administration through the dermal layer of the skin to the systemic circulation by diffusion. (FDA) Transdermal Route of Administration Administration into the vagina. (FDA) Vaginal Route of Administration EXROUTE Exposure Route of Administration CDISC CDASH Exposure Route of Administration Terminology A terminology codelist relevant to the mode of delivery of a fetus or neonate. The delivery of a breech-presenting fetus, which is manually pulled through the birth canal. Breech Extraction C-Section Cesarean Delivery Surgical delivery of one or more intrauterine fetuses though an abdominal incision. Cesarean Section Extraction of a fetus through the cervix using destructive surgical techniques. Delivery by Destructive Operation Operative Vaginal Delivery Birth of the fetus through the vagina with the application of vacuum or forceps or any other instrument. Vaginal Assisted Delivery A vaginal birth in a woman with one or more previous cesarean births. (reVITALize) Vaginal Birth after Cesarean Delivery Birth of the fetus through the vagina. Vaginal Delivery MODDLV Mode of Delivery CDISC SDTM Mode of Delivery Terminology A terminology codelist relevant to the race of an individual as collected on the case report form. The native people of Australia. Aboriginal Australian Afghanistani A person having origins in any of the original peoples of Afghanistan. Afghanistani Afro-American A person having origins in the original peoples of sub-Saharan Africa and the United States. African American Afro-Caribbean A person having origins in the original peoples of sub-Saharan Africa and the Caribbean. African Caribbean A person having origins in any of the original peoples of Africa. African The native people of Alaska. Alaska Native A person having origins in any of the original peoples of North and South America (including Central America), and who maintains tribal affiliation or community attachment. (FDA) American Indian or Alaska Native The native people of North America. American Indian A person having origins in any of the original peoples of the Arabian peninsula and surrounding territories in the Middle East and northern Africa. Arab A person having origins in any of the original peoples of Aruba. Aruban A person having origins in the original peoples of Asia and the United States. Asian American A person having origins in any of the original peoples of the Indian subcontinent. Asian Indian A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. (FDA) Asian A person having origins in any of the original peoples of the Bahamas. Bahamian A person having origins in any of the original peoples of Bangladesh. Bangladeshi A person having origins in any of the original peoples of Barbados. Barbadian A person having origins in any of the original peoples of Belize. Belizean A person having origins in any of the original peoples of Bermuda. Bermudan A person having origins in any of the original peoples of Bhutan. Bhutanese A person having origins in the original peoples of sub-Saharan Africa and Central America. Black Central American A person having origins in any of the black racial groups of Africa. Terms such as "Haitian" or "Negro" can be used in addition to "Black or African American." (FDA) Black or African American A person whose ancestry is from one or more of the indigenous African peoples of South Africa. Black South African A person having origins in the original peoples of sub-Saharan Africa and South America. Black South American A person having origins in the original peoples of sub-Saharan Africa or the Caribbean. Black A person having origins in any of the original peoples of Botswana. Botswanan A person having origins in any of the original peoples of Brazil. Brazilian A person having origins in any of the original peoples of Myanmar (formerly Burma). Burmese Cape Verdean A person having origins in any of the original peoples of Cabo Verde (Cape Verde). Cabo Verdean A person having origins in any of the original peoples of Cambodia (formerly Kampuchea). Cambodian The native people of Canada. Canadian Indian The native people of the Caribbean. Caribbean Indian A person having origins in any of the original peoples of the Caribbean. Caribbean Race A person having origins in any of the original peoples of the Cayman Islands. Cayman Islander The native people of Central America. Central American Indian A person having origins in any of the original peoples of Central Asia. Central Asian The native people of the Mariana Islands, including the United States territories of Guam and the Commonwealth of the Northern Mariana Islands in Micronesia. Chamorran A person having origins in any of the original peoples of China. Chinese The native peoples of the Chuuk State in the Federated States of Micronesia. Chuukese Columbian A person having origins in any of the original peoples of Columbia. Colombian A person having origins in any of the original peoples of Comoros. Comorian A person having origins in any of the original peoples of the Democratic Republic of the Congo . Congolese A person having origins in any of the original peoples of Dominica. Dominica Islander A person having origins in any of the original peoples of the Dominican Republic. Dominican A person having origins in any of the original peoples of East Asia. East Asian A person having origins in any of the original peoples of Eastern Europe. Eastern European A person having origins in any of the original peoples of Egypt. Egyptian A person having origins in any of the original peoples of England. English A person having origins in any of the original peoples of Ethiopia. Ethiopian A person having origins in any of the original peoples of Europe. European Fiji Islander A person having origins in any of the original peoples of Fiji. Fiji Islander A person having origins in any of the original peoples of the Philippines. Filipino A person having origins in any of the original peoples of France. French A person having origins in any of the original peoples of Germany. German A person having origins in any of the original peoples of Ghana. Ghanian The native people of Greenland. Greenland Eskimo A person having origins in the original peoples of the United States territories of Guam and the Commonwealth of the Northern Mariana Islands in Micronesia. Guamanian or Chamorro A person having origins in any of the original peoples of Guam. Guamanian A person having origins in any of the original peoples of Guatemala. Guatemalan A person having origins in any of the original peoples of Guyana. Guyanese A person having origins in any of the original peoples of Haiti. Haitian A person of Mexican, Puerto Rican, Cuban, Central or South American or other Spanish culture or origin, regardless of race. (NCI) Hispanic or Latino The native people originating in China around the Yellow River or Hoang Ho. Hmong A person having origins in any of the original peoples of Honduras. Honduran A person having origins in any of the original peoples of Indonesia. Indonesian The native people inhabiting the territory spanning the Norton Sound on the Bering Sea to the Canadian border. Inupiat Eskimo A person having origins in any of the original peoples of Iran. Iranian A person having origins in any of the original peoples of Iraq. Iraqi A person having origins in any of the original peoples of Ireland. Irish A person having origins in any of the original peoples of Israel. Israeli A person having origins in any of the original peoples of Italy. Italian A person having origins in any of the original peoples of Iwo Jima. Iwo Jiman A person having origins in any of the original peoples of Jamaica. Jamaican A person having origins in any of the original peoples of Japan. Japanese The native people of the Western Cape in southern Africa. Khoisan A person having origins in any of the original peoples of North and South Korea. Korean A person having origins in any of the original peoples of Laos. Laotian The native people of Latin America (Mexico, South and Central America). Latin American Indian A person of Latin American descent. Latin American A person having origins in any of the original peoples of Lebanon. Lebanese A person having origins in any of the original peoples of Liberia. Liberian A person having origins in any of the original peoples of Madagascar. Malagasy A person having origins in any of the original peoples of Malaysia. Malaysian A person having origins in any of the original peoples of the Maldives. Maldivian The native people of New Zealand. Maori A person having origins in any of the original peoples of the Marshall Islands. Marshallese A person having origins in any of the original peoples of Mauritania. Mauritanian A person having origins in any of the original peoples of the countries surrounding the Mediterranean sea. Mediterranean A person having origins in any of the original peoples of Melanesia. Melanesian A person having origins in any of the original peoples of Micronesia. Micronesian Individuals with origins in any of the original peoples of the Middle East or North Africa. Middle Eastern or North African A person having origins in any of the original peoples of the Middle East. Middle Eastern A person having origins in any of the original peoples of Mongolia. Mongolian A person having origins in any of the original peoples of Morocco. Moroccan A person having origins in any of the original peoples of Namibia. Namibian Denotes a person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands. The term covers particularly people who identify themselves as part-Hawaiian, Native Hawaiian, Guamanian or Chamorro, Carolinian, Samoan, Chuu. (FDA) Native Hawaiian or Other Pacific Islander A person having origins in any of the original peoples of Hawaii. (NCI) Native Hawaiian A person having origins in any of the original peoples of Nepal. Nepalese A person having origins in any of the original peoples of Nigeria. Nigerian A person having origins in any of the original peoples of North Africa. North Coast of Africa A person having origins in any of the original peoples of Northern Europe. Northern European A person having origins in any of the original peoples of Norway. Norwegian Not reported Not provided or available. Not Reported A person having origins in any of the original peoples of Okinawa. Okinawan A person having origins in the original peoples of the Pacific Islands, but not Guam, Hawaii, the Mariana Islands or Samoa. (NCI) Other Pacific Islander Other Different than the one(s) previously specified or mentioned. (NCI) Other A person having origins in any of the original peoples of Pakistan. Pakistani A person having origins in any of the original peoples of Palau. Palauan A person having origins in any of the original peoples of Poland. Polish A person having origins in any of the original peoples of Polynesia. Polynesian A person having origins in any of the original peoples of Russia. Russian Salvadorian A person having origins in any of the original peoples of El Salvador. Salvadoran A person having origins in any of the original peoples of Samoa. (NCI) Samoan A person having origins in any of the original peoples of Scotland. Scottish The native Yupik people inhabiting the coast of the Chukchi Peninsula in the far northeast of the Russian Federation and on St. Lawrence Island in Alaska. Siberian Eskimo A person having origins in any of the original peoples of Singapore. Singaporean Somalian A person having origins in any of the original peoples of Somalia. Somali The native people of South America. South American Indian A person having origins in any of the original peoples of the South Asia. South Asian A person having origins in any of the original peoples of Southeast Asia. Southeast Asian A person whose ancestry is from one or more of the indigenous Southern African peoples and one or more of the naturalized racial groups of Southern Africa (typically Western European, South Asian, or Southeastern Asian). Southern African Coloured A person having origins in any of the original peoples of Sri Lanka. Sri Lankan A person having origins in any of the original peoples of sub-Saharan Africa. Sub-Saharan African A person having origins in any of the original peoples of Suriname. Surinamese A person having origins in any of the original peoples of Sweden. Swedish A person having origins in any of the original peoples of Syria. Syrian A person having origins in any of the original peoples of Tahiti. Tahitian A person having origins in any of the original peoples of Taiwan. Taiwanese A person having origins in any of the original peoples of Thailand. Thai A person having origins in any of the original peoples of Tobago. Tobagoan A person having origins in any of the original peoples of Tonga. Tongan A person having origins in any of the original peoples of Trinidad. Trinidadian U UNK Unknown Not known, not observed, not recorded, or refused. (NCI) Unknown A person having origins in any of the original peoples of Viet Nam. Vietnamese A person having origins in any of the original peoples of Western Asia. Western Asian A person having origins in any of the original peoples of the West Indies. West Indian A person having origins in any of the original peoples of Western Europe. Western European A person having origins in the original peoples of Europe, the Middle East, or North Africa, and the Caribbean. White Caribbean A person having origins in the original peoples of Europe, the Middle East, or North Africa, and Central America. White Central American A person having origins in the original peoples of Europe, the Middle East, or North Africa, and South America. White South American Denotes a person with European, Middle Eastern, or North African ancestral origin who identifies, or is identified, as White. (FDA) White A person having origins in any of the original peoples of Yemen. Yemeni The native people inhabiting western, southwestern, and southcentral Alaska and the Russian Far East. Yupik Eskimo A person having origins in any of the original peoples of Zaire. Zairean RACEC Race As Collected CDISC SDTM Collected Race Terminology Terminology relevant to the classification of a serious adverse event report. Amended Action(s) undertaken to modify by means of correction, addition, subtraction, or replacement. Amendment Nullified Action(s) undertaken to void, negate, or invalidate. Nullification Preceding all others in time or being as first made or performed. Original SAERCAT Serious Adverse Event Report Category CDISC CDASH Serious Adverse Event Report Category Response Terminology A terminology codelist relevant to the resultant reaction due to withdrawing, interrupting, or otherwise altering administration of study treatment. Continued presence of an adverse event after decrease or change in dose, or withdrawal of the product/drug. Negative Dechallenge Response The outcome of decreasing the dose or discontinuation of the product/drug is not relevant in the current context. Not Applicable Dechallenge Response Partial or complete abatement of an adverse event after decrease or change in dose, or withdrawal of the product/drug. Positive Dechallenge Response No information regarding the outcome of decreasing the dose or discontinuation of the product/drug. Unknown Dechallenge Response SADCRR Study Agent Dechallenge Reaction Response CDISC CDASH Study Agent Dechallenge Reaction Response Terminology A terminology codelist relevant to the resultant reaction due to restarting or otherwise returning administration of study treatment to previous level, after a dechallenge event. Failure of the product/drug, when reintroduced, to produce signs or symptoms similar to those observed when the product/drug was previously used. Negative Rechallenge Response The outcome of reintroduction of product/drug is not relevant in the current context. Not Applicable Rechallenge Response Recurrence of similar or new signs and symptoms upon reintroduction of the product/drug. Positive Rechallenge Response No information regarding the outcome of reintroduction of product/drug. Unknown Rechallenge Response SARCRR Study Agent Rechallenge Reaction Response CDISC CDASH Study Agent Rechallenge Reaction Response Terminology A terminology subset of the CDISC SDTM Never/Current/Former Classification codelist created for CDASH Substance Use Never/Current/Former Classification codelist. (NCI) Occurring in or belonging to the present time. (NCI) Current Previous Occurring prior to something else. (NCI) Previous Not ever; at no time in the past. Never SUNCF Substance Use Never/Current/Former Classification CDISC CDASH Substance Use Never/Current/Former Classification Terminology A terminology subset of the CDISC SDTM Unit codelist created for CDASH Total Volume Administration Unit codelist. (NCI) Milligram A unit of mass equal to one thousandth (1E-3) of a gram. Milligram cc cm3 Cubic Centimeter Milliliter A unit of volume equal to one thousandth (1E-3) of a liter. Milliliter mcg Microgram A unit of mass equal to one millionth (1E-6) of a gram. Microgram EXVOLTU Total Volume Administration Unit CDISC CDASH Total Volume Administration Unit Terminology A terminology subset of the CDISC SDTM Unit codelist created for CDASH Unit for Duration of Treatment Interruption codelist. (NCI) h Hours hr A unit of measurement of time equal to 60 minutes. Hour Minute A unit of measurement of time equal to 60 seconds. Minute sec Second The base unit of time in the International System of Units (SI) equal to the duration of 9,192,631,770 periods of the specified light radiation corresponding to the transition between the two hyperfine levels of the cesium 133 atom in its ground state at 0 K. Second EXINTPU Unit for the Duration of Treatment Interruption CDISC CDASH Unit for Duration of Treatment Interruption Terminology A terminology subset of the CDISC SDTM Unit codelist created for CDASH Unit of Drug Dispensed or Returned codelist. (NCI) Bag Dosing Unit A dosing measurement based on the bag unit.(NCI) Bag Dosing Unit Bottle Dosing Unit A dosing measurement based on the bottle unit.(NCI) Bottle Dosing Unit Box Dosing Unit A dosing measurement based on the box unit.(NCI) Box Dosing Unit cap Capsule Dosing Unit A dosing measurement based on the capsule unit.(NCI) Capsule Dosing Unit Container Dosing Unit A dosing measurement based on the container unit.(NCI) Container Dosing Unit Disk Dosing Unit A dosing measurement based on the disk unit.(NCI) Disk Dosing Unit Pack Dosing Unit Package Dosing Unit A dosing measurement based on the package unit.(NCI) Package Dosing Unit Packet Dosing Unit A dosing measurement based on the packet unit.(NCI) Packet Dosing Unit Patch Dosing Unit A dosing measurement based on the patch unit.(NCI) Patch Dosing Unit tab Tablet Dosing Unit A dosing measurement based on the tablet unit.(NCI) Tablet Dosing Unit Tube Dosing Unit A dosing measurement based on the tube unit.(NCI) Tube Dosing Unit Vial Dosing Unit A dosing measurement based on the vial unit.(NCI) Vial Dosing Unit DAORRESU Unit of Drug Dispensed or Returned CDISC CDASH Unit of Drug Dispensed or Returned Terminology A terminology subset of the CDISC SDTM Unit codelist created for CDASH Unit of Measure for Flow Rate codelist. (NCI) A unit of flow rate equal to one milliliter per minute. Milliliter per Minute mmol/24h A unit of substance flow rate equal to one millimole per day. Millimole per 24 Hours mcg/day A unit of mass flow rate equal to one microgram per day. Microgram per Day mcg/min A unit of mass flow rate equal to one microgram per minute. Microgram per Minute mcmol/day A unit of substance flow rate equal to one micromole per day. Micromole per 24 Hours EXFLRTU Unit of Measure for Flow Rate CDISC CDASH Unit of Measure for Flow Rate Terminology A terminology subset of the CDISC SDTM Unit codelist created for CDASH Units for Exposure codelist. (NCI) cap Capsule Dosing Unit A dosing measurement based on the capsule unit.(NCI) Capsule Dosing Unit Gram A unit of mass equal to one thousandth (1E-3) of a kilogram, the kilogram being the base unit of mass in the International System of Units (SI). Gram Milligram A unit of mass equal to one thousandth (1E-3) of a gram. Milligram cc cm3 Cubic Centimeter Milliliter A unit of volume equal to one thousandth (1E-3) of a liter. Milliliter Puff Dosing Unit A means of delivering a defined dose of a therapeutic aerolized solution into either the upper or lower respiratory tract. Metered-dose inhalers or spray pumps are devices that provide a puff dose for delivery into either the oral or the nasal cavity.(NCI) Puff Dosing Unit tab Tablet Dosing Unit A dosing measurement based on the tablet unit.(NCI) Tablet Dosing Unit mcg Microgram A unit of mass equal to one millionth (1E-6) of a gram. Microgram EXDOSU Units for Exposure CDISC CDASH Units for Exposure Terminology A terminology subset of the CDISC SDTM Unit codelist created for CDASH Units for Planned Exposure codelist. (NCI) cap Capsule Dosing Unit A dosing measurement based on the capsule unit.(NCI) Capsule Dosing Unit Gram A unit of mass equal to one thousandth (1E-3) of a kilogram, the kilogram being the base unit of mass in the International System of Units (SI). Gram Milligram A unit of mass equal to one thousandth (1E-3) of a gram. Milligram cc cm3 Cubic Centimeter Milliliter A unit of volume equal to one thousandth (1E-3) of a liter. Milliliter Puff Dosing Unit A means of delivering a defined dose of a therapeutic aerolized solution into either the upper or lower respiratory tract. Metered-dose inhalers or spray pumps are devices that provide a puff dose for delivery into either the oral or the nasal cavity.(NCI) Puff Dosing Unit tab Tablet Dosing Unit A dosing measurement based on the tablet unit.(NCI) Tablet Dosing Unit mcg Microgram A unit of mass equal to one millionth (1E-6) of a gram. Microgram EXPDOSEU Units for Planned Exposure CDISC CDASH Units for Planned Exposure Terminology A terminology subset of the CDISC SDTM Position codelist created for CDASH Vital Signs Position of Subject codelist. (NCI) Sitting The state or act of one who sits; the posture of one who occupies a seat. (NCI) Sitting Orthostatic Standing The act of assuming or maintaining an erect upright position. (NCI) Standing Supine A posterior recumbent body position whereby the person lies on its back and faces upward. (NCI) Supine Position VSPOS Vital Signs Position of Subject CDISC CDASH Vital Signs Position of Subject Terminology