CDISC CDASH Controlled Terminology

CDISC CDASH Controlled Terminology, 2022-06-24
Legend:
CodeList
CodeListItem
NCI attributes
C78418Concomitant Medication Dose Form
C78417Concomitant Medication Dose Units
C78419Concomitant Medication Dosing Frequency per Interval
C78420Concomitant Medication Route of Administration
C78422ECG Original Units
C128690Ethnicity As Collected
C78426Exposure Dose Form
C78745Exposure Dosing Frequency per Interval
C78425Exposure Route of Administration
C181165Mode of Delivery
C128689Race As Collected
C177909Serious Adverse Event Report Category
C181164Study Agent Dechallenge Reaction Response
C181163Study Agent Rechallenge Reaction Response
C83004Substance Use Never/Current/Former Classification
C78428Total Volume Administration Unit
C78427Unit for the Duration of Treatment Interruption
C78421Unit of Drug Dispensed or Returned
C78429Unit of Measure for Flow Rate
C78423Units for Exposure
C78430Units for Planned Exposure
C78431Vital Signs Position of Subject

Codelist Definitions

OIDName
(CDISC Submission Value)
DataType
Extensible
NCI CodeCDISC SynonymCDISC DefinitionPreferred Term
CDISC Submission Value [ODM:CodedValue]
CL.C78418.CMDOSFRMConcomitant Medication Dose Form
(CMDOSFRM)
text
Extensible: Yes
C78418Concomitant Medication Dose FormA terminology subset of the CDISC SDTM Pharmaceutical Dosage Form codelist created for CDASH Concomitant Medication Dose Form codelist. (NCI)CDISC CDASH Concomitant Medication Dose Form Terminology
AEROSOLC42887aerA 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
CAPSULEC25158capA 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
CREAMC28944A semisolid emulsion of either the oil-in-water or the water-in-oil type, ordinarily intended for topical use. (NCI)Cream Dosage Form
GASC42933Any elastic aeriform fluid in which the molecules are separated from one another and have free paths. (NCI)Gas Dosage Form
GELC42934A 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
OINTMENTC42966ointA 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
PATCHC42968A 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
POWDERC42972An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. (NCI)Powder Dosage Form
SPRAYC42989A liquid minutely divided as by a jet of air or steam. (NCI)Spray Dosage Form
SUPPOSITORYC42993suppA 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
SUSPENSIONC42994Ready to Use Suspension;suspA 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.Suspension Dosage Form
TABLETC42998tabA solid dosage form containing medicinal substances with or without suitable diluents. (NCI)Tablet Dosage Form
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CL.C78417.CMDOSUConcomitant Medication Dose Units
(CMDOSU)
text
Extensible: Yes
C78417Concomitant Medication Dose UnitsA terminology subset of the CDISC SDTM Unit codelist created for CDASH Concomitant Medication Dose Units codelist. (NCI)CDISC CDASH Concomitant Medication Dose Units Terminology
CAPSULEC48480cap;Capsule Dosing UnitA dosing measurement based on the capsule unit.(NCI)Capsule Dosing Unit
gC48155GramA 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
IUC48579IE;International UnitThe 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
mgC28253MilligramA unit of mass equal to one thousandth (1E-3) of a gram.Milligram
mLC28254cm3;MilliliterA unit of volume equal to one thousandth (1E-3) of a liter.Milliliter
PUFFC65060Puff Dosing UnitA 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
TABLETC48542tab;Tablet Dosing UnitA dosing measurement based on the tablet unit.(NCI)Tablet Dosing Unit
ugC48152mcg;MicrogramA unit of mass equal to one millionth (1E-6) of a gram.Microgram
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CL.C78419.CMDOSFRQConcomitant Medication Dosing Frequency per Interval
(CMDOSFRQ)
text
Extensible: Yes
C78419Concomitant Medication Dosing Frequency per IntervalA terminology subset of the CDISC SDTM Frequency codelist created for CDASH Concomitant Medication Dosing Frequency per Interval codelist. (NCI)CDISC CDASH Concomitant Medication Dosing Frequency per Interval Terminology
BIDC64496BD;Twice per dayTwo times per day, at unspecified times. (NCI)Twice Daily
PRNC64499As neededAs needed. (NCI)As Needed
QDC25473/day;Daily;Per DayA rate of occurrences within a period of time equal to one day.Daily
QIDC645304 times per dayFour times per day. (NCI)Four Times Daily
QMC64498Every Month;Per MonthEvery month. (NCI)Monthly
QODC64525Every other day;Every Second Day;Every Two Days;Q2DEvery other day. (NCI)Every Other Day
TIDC645273 times per dayThree times per day. (NCI)Three Times Daily
UNKNOWNC17998U;UNK;UnknownNot known, not observed, not recorded, or refused. (NCI)Unknown
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CL.C78420.CMROUTEConcomitant Medication Route of Administration
(CMROUTE)
text
Extensible: Yes
C78420Concomitant Medication Route of AdministrationA terminology subset of the CDISC SDTM Route codelist created for CDASH Concomitant Medication Route of Administration codelist. (NCI)CDISC CDASH Concomitant Medication Route of Administration Terminology
INTRALESIONALC38250Administration within or introduced directly into a localized lesion. (FDA)Intralesional Route of Administration
INTRAMUSCULARC28161Administration within a muscle. (FDA)Intramuscular Route of Administration
INTRAOCULARC38255Administration within the eye. (FDA)Intraocular Route of Administration
INTRAPERITONEALC38258Administration within the peritoneal cavity. (FDA)Intraperitoneal Route of Administration
NASALC38284Intranasal Route of AdministrationAdministration to the nose; administered by way of the nose. (FDA)Nasal Route of Administration
ORALC38288Intraoral Route of Administration;POAdministration to or by way of the mouth. (FDA)Oral Route of Administration
RECTALC38295Administration to the rectum. (FDA)Rectal Route of Administration
RESPIRATORY (INHALATION)C38216Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect. (FDA)Inhalation Route of Administration
SUBCUTANEOUSC38299SC;Subdermal Route of AdministrationAdministration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL. (FDA)Subcutaneous Route of Administration
TOPICALC38304TOPAdministration 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
TRANSDERMALC38305Administration through the dermal layer of the skin to the systemic circulation by diffusion. (FDA)Transdermal Route of Administration
VAGINALC38313Administration into the vagina. (FDA)Vaginal Route of Administration
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CL.C78422.EGORRESUECG Original Units
(EGORRESU)
text
Extensible: Yes
C78422ECG Original UnitsA terminology subset of the CDISC SDTM Unit codelist created for CDASH ECG Original Units codelist. (NCI)CDISC CDASH ECG Original Units Terminology
beats/minC49673Beats per Minute;bpm;BPMThe number of heartbeats measured per minute time. (NCI)Beats per Minute
msC41140Millisecond;ms;msecA unit of time, which is equal to one thousandth of a second.(NCI)Millisecond
sC42535sec;SecondThe 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
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CL.C128690.ETHNICCEthnicity As Collected
(ETHNICC)
text
Extensible: Yes
C128690Ethnicity As CollectedA terminology codelist relevant to the ethnicity of an individual as collected on the case report form.CDISC SDTM Collected Ethnicity Terminology
ACHANGC158197ACA Chinese person from the Achang ethnic group.Achang Chinese
ASHKENAZI JEWC17950A person of Ashkenazi Jewish descent.Ashkenazi Jew
BAIC158171BAA Chinese person from the Bai ethnic group.Bai Chinese
BLANGC158193BLA Chinese person from the Blang ethnic group.Blang Chinese
BONANC158203BNA Chinese person from the Bonan ethnic group.Bonan Chinese
BUYEIC158169BYA Chinese person from the Buyei ethnic group.Buyei Chinese
CENTRAL AMERICANC67118A person of Central American descent.Central American
CHOSENC158172CSA Chinese person from the Chosen ethnic group.Chosen Chinese
CUBAN AMERICANC67115A person of Cuban and American descent.Cuban or Cuban American
CUBANC107608A person of Cuban descent.Cuban
DAIC158176DAA Chinese person from the Dai (including several different Tai-speaking groups historically referred to as Bai-yi) ethnic group.Dai Chinese
DAURC158191DUA Chinese person from the Daur ethnic group.Daur Chinese
DEANGC158202DEA Chinese person from the Deang ethnic group.Deang Chinese
DERUNGC158209DRA Chinese person from the Derung ethnic group.Derung Chinese
DONGC158168DOA Chinese person from the Dong ethnic group.Dong Chinese
DONGXIANGC158179DXA Chinese person from the Dongxiang ethnic group.Dongxiang Chinese
EWENKIC158199EWA Chinese person from the Ewenki ethnic group.Ewenki Chinese
GAOSHANC158211GSA Chinese person from the Gaoshan ethnic group.Gaoshan Chinese
GELAOC158180GLA Chinese person from the Gelao ethnic group.Gelao Chinese
GINC158200GIA Chinese person from the Gin ethnic group.Gin Chinese
HANC158158HAA Chinese person from the Han ethnic group (including Chuanqing).Han Chinese
HANIC158173HNA Chinese person from the Hani (including Sangkong) ethnic group.Hani Chinese
HEZHENC158210HZA Chinese person from the Hezhen ethnic group.Hezhen Chinese
HISPANIC OR LATINOC17459A person of Mexican, Puerto Rican, Cuban, Central or South American or other Spanish culture or origin, regardless of race. (NCI)Hispanic or Latino
HUIC158160HUA Chinese person from the Hui (including Utsuls of Hainan, descended from Cham refugees) ethnic group.Hui Chinese
JINGPOC158190JPA Chinese person from the Jingpo ethnic group.Jingpo Chinese
JINOC158201JNA Chinese person from the Jino ethnic group.Jino Chinese
KAZAKC158175KZA Chinese person from the Kazak ethnic group.Kazak Chinese
KIRGIZC158189KGA Chinese person from the Kirgiz ethnic group.Kirgiz Chinese
LAHUC158181LHA Chinese person from the Lahu ethnic group.Lahu Chinese
LATIN AMERICANC126531A person of Latin American descent.Latin American
LHOBAC158212LBA Chinese person from the Lhoba ethnic group.Lhoba Chinese
LIC158174LIA Chinese person from the Li ethnic group.Li Chinese
LISUC158178LSA Chinese person from the Lisu ethnic group.Lisu Chinese
MANC158161MAA Chinese person from the Man ethnic group.Man Chinese
MAONANC158194MNA Chinese person from the Maonan (including the Then) ethnic group.Maonan Chinese
MEXICAN AMERICANC67114A person of Mexican and American descent.Mexican American
MEXICANC67113A person of Mexican descent.Mexican
MIAOC158163MHA Chinese person from the Miao (Including Hmong) ethnic group.Miao Chinese
MONBAC158207MBA Chinese person from the Monba ethnic group.Monba Chinese
MONGOLC158167MGA Chinese person from the Mongol ethnic group.Mongol Chinese
MULAOC158187MLA Chinese person from the Mulao (including the Qago) ethnic group.Mulao Chinese
NAXIC158184NXA Chinese person from the Naxi (including Mosuo) ethnic group.Naxi Chinese
NOT HISPANIC OR LATINOC41222A 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 REPORTEDC43234Not reportedNot provided or available.Not Reported
NUC158198NUA Chinese person from the Nu ethnic group.Nu Chinese
OROQENC158208ORA Chinese person from the Oroqen ethnic group.Oroqen Chinese
PUERTO RICANC67112A person of Puerto Rican descent.Puerto Rican
PUMIC158196PMA Chinese person from the Pumi ethnic group.Pumi Chinese
QIANGC158185QIA Chinese person from the Qiang ethnic group.Qiang Chinese
RUSSC158204RSA Chinese person from the Russ ethnic group.Russ Chinese
SALARC158192SLA Chinese person from the Salar ethnic group.Salar Chinese
SEPHARDIC JEWC103283A person of Sephardic Jewish descent.Sephardic Jew
SHEC158177SHA Chinese person from the She ethnic group.She Chinese
SOUTH AMERICANC126532A person of South American descent.South American
SPANISHC67120A person from Spain or of Spanish descent.Spanish
SUIC158183SUA Chinese person from the Sui ethnic group.Sui Chinese
TAJIKC158195TAA Chinese person from the Tajik ethnic group.Tajik Chinese
TATARC158213TTA Chinese person from the Tatar ethnic group.Tatar Chinese
TUC158186TUA Chinese person from the Tu ethnic group.Tu Chinese
TUJIAC158165TJA Chinese person from the Tujia ethnic group.Tujia Chinese
UNKNOWNC17998U;UNK;UnknownNot known, not observed, not recorded, or refused. (NCI)Unknown
UYGURC158162UGA Chinese person from the Uygur ethnic group.Uygur Chinese
UZBEKC158206UZA Chinese person from the Uzbek ethnic group.Uzbek Chinese
VAC158182VAA Chinese person from the Va ethnic group.Va Chinese
XIBEC158188XBA Chinese person from the Xibe ethnic group.Xibe Chinese
YAOC158170YAA Chinese person from the Yao ethnic group.Yao Chinese
YIC158164YIA Chinese person from the Yi ethnic group.Yi Chinese
YUGURC158205YGA Chinese person from the Yugur ethnic group.Yugur Chinese
ZANGC158166ZAA Chinese person from the Zang (including Amdowa, Khampa and some Pumi speakers) ethnic group.Zang Chinese
ZHUANGC158159ZHA Chinese person from the Zhuang ethnic group.Zhuang Chinese
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CL.C78426.EXDOSFRMExposure Dose Form
(EXDOSFRM)
text
Extensible: Yes
C78426Exposure Dose FormA terminology subset of the CDISC SDTM Pharmaceutical Dosage Form codelist created for CDASH Exposure Dose Form codelist. (NCI)CDISC CDASH Exposure Dose Form Terminology
AEROSOLC42887aerA 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
CAPSULEC25158capA 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
CREAMC28944A semisolid emulsion of either the oil-in-water or the water-in-oil type, ordinarily intended for topical use. (NCI)Cream Dosage Form
GASC42933Any elastic aeriform fluid in which the molecules are separated from one another and have free paths. (NCI)Gas Dosage Form
GELC42934A 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
OINTMENTC42966ointA 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
PATCHC42968A 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
POWDERC42972An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. (NCI)Powder Dosage Form
SPRAYC42989A liquid minutely divided as by a jet of air or steam. (NCI)Spray Dosage Form
SUPPOSITORYC42993suppA 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
SUSPENSIONC42994Ready to Use Suspension;suspA 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.Suspension Dosage Form
TABLETC42998tabA solid dosage form containing medicinal substances with or without suitable diluents. (NCI)Tablet Dosage Form
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CL.C78745.EXDOSFRQExposure Dosing Frequency per Interval
(EXDOSFRQ)
text
Extensible: Yes
C78745Exposure Dosing Frequency per IntervalA terminology subset of the CDISC SDTM Frequency codelist created for CDASH Exposure Dosing Frequency per Interval codelist. (NCI)CDISC CDASH Exposure Dosing Frequency per Interval Terminology
BIDC64496BD;Twice per dayTwo times per day, at unspecified times. (NCI)Twice Daily
PRNC64499As neededAs needed. (NCI)As Needed
QDC25473/day;Daily;Per DayA rate of occurrences within a period of time equal to one day.Daily
QIDC645304 times per dayFour times per day. (NCI)Four Times Daily
QMC64498Every Month;Per MonthEvery month. (NCI)Monthly
QODC64525Every other day;Every Second Day;Every Two Days;Q2DEvery other day. (NCI)Every Other Day
TIDC645273 times per dayThree times per day. (NCI)Three Times Daily
UNKNOWNC17998U;UNK;UnknownNot known, not observed, not recorded, or refused. (NCI)Unknown
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CL.C78425.EXROUTEExposure Route of Administration
(EXROUTE)
text
Extensible: Yes
C78425Exposure Route of AdministrationA terminology subset of the CDISC SDTM Route codelist created for CDASH Exposure Route of Administration codelist. (NCI)CDISC CDASH Exposure Route of Administration Terminology
INTRALESIONALC38250Administration within or introduced directly into a localized lesion. (FDA)Intralesional Route of Administration
INTRAMUSCULARC28161Administration within a muscle. (FDA)Intramuscular Route of Administration
INTRAOCULARC38255Administration within the eye. (FDA)Intraocular Route of Administration
INTRAPERITONEALC38258Administration within the peritoneal cavity. (FDA)Intraperitoneal Route of Administration
NASALC38284Intranasal Route of AdministrationAdministration to the nose; administered by way of the nose. (FDA)Nasal Route of Administration
ORALC38288Intraoral Route of Administration;POAdministration to or by way of the mouth. (FDA)Oral Route of Administration
RECTALC38295Administration to the rectum. (FDA)Rectal Route of Administration
RESPIRATORY (INHALATION)C38216Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect. (FDA)Inhalation Route of Administration
SUBCUTANEOUSC38299SC;Subdermal Route of AdministrationAdministration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL. (FDA)Subcutaneous Route of Administration
TOPICALC38304TOPAdministration 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
TRANSDERMALC38305Administration through the dermal layer of the skin to the systemic circulation by diffusion. (FDA)Transdermal Route of Administration
VAGINALC38313Administration into the vagina. (FDA)Vaginal Route of Administration
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CL.C181165.MODDLVMode of Delivery
(MODDLV)
text
Extensible: Yes
C181165Mode of DeliveryA terminology codelist relevant to the mode of delivery of a fetus or neonate.CDISC SDTM Mode of Delivery Terminology
BREECH EXTRACTIONC114136The delivery of a breech-presenting fetus, which is manually pulled through the birth canal.Breech Extraction
CESAREAN SECTIONC46088Surgical delivery of one or more intrauterine fetuses though an abdominal incision.Cesarean Section
DELIVERY BY DESTRUCTIVE OPERATIONC114143Extraction of a fetus through the cervix using destructive surgical techniques.Delivery by Destructive Operation
VAGINAL ASSISTED DELIVERYC81301Operative Vaginal DeliveryBirth of the fetus through the vagina with the application of vacuum or forceps or any other instrument.Vaginal Assisted Delivery
VAGINAL BIRTH AFTER CESAREAN DELIVERYC81302A vaginal birth in a woman with one or more previous cesarean births. (reVITALize)Vaginal Birth after Cesarean Delivery
VAGINAL DELIVERYC81303Birth of the fetus through the vagina.Vaginal Delivery
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CL.C128689.RACECRace As Collected
(RACEC)
text
Extensible: Yes
C128689Race As CollectedA terminology codelist relevant to the race of an individual as collected on the case report form.CDISC SDTM Collected Race Terminology
ABORIGINAL AUSTRALIANC154875The native people of Australia.Aboriginal Australian
AFRICAN AMERICANC128937A person having origins in the original peoples of sub-Saharan Africa and the United States.African American
AFRICAN CARIBBEANC41226A person having origins in the original peoples of sub-Saharan Africa and the Caribbean.African Caribbean
AFRICANC42331A person having origins in any of the original peoples of sub-Saharan Africa.African
ALASKA NATIVEC18237The native people of Alaska.Alaska Native
AMERICAN INDIAN OR ALASKA NATIVEC41259A 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
AMERICAN INDIANC43877The native people of North America.American Indian
ARABC43876A person having origins in any of the original peoples of the Arabian peninsula and surrounding territories in the Middle East and northern Africa.Arab
ASIAN AMERICANC16310A person having origins in the original peoples of Asia and the United States.Asian American
ASIAN INDIANC41262A person having origins in any of the original peoples of the Indian subcontinent.Asian Indian
ASIANC41260A 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
BAHAMIANC67271A person having origins in any of the original peoples of the Bahamas.Bahamian
BANGLADESHIC43671A person having origins in any of the original peoples of Bangladesh.Bangladeshi
BARBADIANC43823A person having origins in any of the original peoples of Barbados.Barbadian
BHUTANESEC43673A person having origins in any of the original peoples of Bhutan.Bhutanese
BLACK CENTRAL AMERICANC128991A person having origins in the original peoples of sub-Saharan Africa and Central America.Black Central American
BLACK OR AFRICAN AMERICANC16352A 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
BLACK SOUTH AMERICANC128992A person having origins in the original peoples of sub-Saharan Africa and South America.Black South American
BLACKC128938A person having origins in the original peoples of sub-Saharan Africa or the Caribbean.Black
BOTSWANANC43830A person having origins in any of the original peoples of Botswana.Botswanan
BURMESEC43674A person having origins in any of the original peoples of Myanmar (formerly Burma).Burmese
CAMBODIANC43399A person having origins in any of the original peoples of Cambodia (formerly Kampuchea).Cambodian
CARIBBEAN INDIANC77810The native people of the Caribbean.Caribbean Indian
CENTRAL AMERICAN INDIANC44950The native people of Central America.Central American Indian
CENTRAL ASIANC126534A person having origins in any of the original peoples of Central Asia.Central Asian
CHAMORROC43403The native people of the Mariana Islands, including the United States territories of Guam and the Commonwealth of the Northern Mariana Islands in Micronesia.Chamorran
CHINESEC43391A person having origins in any of the original peoples of China.Chinese
DOMINICA ISLANDERC43824A person having origins in any of the original peoples of Dominica.Dominica Islander
DOMINICANC67117A person having origins in any of the original peoples of the Dominican Republic.Dominican
EAST ASIANC161419A person having origins in any of the original peoples of East Asia.East Asian
EASTERN EUROPEANC77819A person having origins in any of the original peoples of Eastern Europe.Eastern European
ETHIOPIANC43831A person having origins in any of the original peoples of Ethiopia.Ethiopian
EUROPEANC43851A person having origins in any of the original peoples of Europe.European
FILIPINOC43393A person having origins in any of the original peoples of the Philippines.Filipino
GREENLAND INUITC44265The native people of Greenland.Greenland Eskimo
GUAMANIAN OR CHAMORROC43837A 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
GUAMANIANC43404A person having origins in any of the original peoples of Guam.Guamanian
HAITIANC43825A person having origins in any of the original peoples of Haiti.Haitian
HMONGC43398The native people originating in China around the Yellow River or Hoang Ho.Hmong
INDONESIANC43715A person having origins in any of the original peoples of Indonesia.Indonesian
INUPIAT INUITC44268The native people inhabiting the territory spanning the Norton Sound on the Bering Sea to the Canadian border.Inupiat Eskimo
IWO JIMANC43718A person having origins in any of the original peoples of Iwo Jima.Iwo Jiman
JAMAICANC43826A person having origins in any of the original peoples of Jamaica.Jamaican
JAPANESEC43392A person having origins in any of the original peoples of Japan.Japanese
KHOISANC154874The native people of the Western Cape in southern Africa.Khoisan
KOREANC43395A person having origins in any of the original peoples of North and South Korea.Korean
LAOTIANC43397A person having origins in any of the original peoples of Laos.Laotian
LATIN AMERICANC126531A person of Latin American descent.Latin American
LIBERIANC43832A person having origins in any of the original peoples of Liberia.Liberian
MALAGASYC43722A person having origins in any of the original peoples of Madagascar.Malagasy
MALAYSIANC43716A person having origins in any of the original peoples of Malaysia.Malaysian
MALDIVIANC43719A person having origins in any of the original peoples of the Maldives.Maldivian
MAORIC158274The native people of New Zealand.Maori
MEDITERRANEANC77811A person having origins in any of the original peoples of the countries surrounding the Mediterranean sea.Mediterranean
MELANESIANC43409A person having origins in any of the original peoples of Melanesia.Melanesian
MICRONESIANC43402A person having origins in any of the original peoples of Micronesia.Micronesian
MIDDLE EASTERNC77820A person having origins in any of the original peoples of the Middle East.Middle Eastern
MONGOLIANC43864A person having origins in any of the original peoples of Mongolia.Mongolian
NAMIBIANC43833A person having origins in any of the original peoples of Namibia.Namibian
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERC41219Denotes 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
NATIVE HAWAIIANC43394A person having origins in any of the original peoples of Hawaii. (NCI)Native Hawaiian
NEPALESEC43720A person having origins in any of the original peoples of Nepal.Nepalese
NIGERIANC43834A person having origins in any of the original peoples of Nigeria.Nigerian
NORTH AFRICANC77813A person having origins in any of the original peoples of North Africa.North Coast of Africa
NORTHERN EUROPEANC77814A person having origins in any of the original peoples of Northern Europe.Northern European
NOT REPORTEDC43234Not reportedNot provided or available.Not Reported
OKINAWANC43717A person having origins in any of the original peoples of Okinawa.Okinawan
OTHER PACIFIC ISLANDERC107602A person having origins in the original peoples of the Pacific Islands, but not Guam, Hawaii, the Mariana Islands or Samoa. (NCI)Other Pacific Islander
PAKISTANIC43427A person having origins in any of the original peoples of Pakistan.Pakistani
POLYNESIANC43405A person having origins in any of the original peoples of Polynesia.Polynesian
RUSSIANC43860A person having origins in any of the original peoples of Russia.Russian
SAMOANC43407A person having origins in any of the original peoples of Samoa. (NCI)Samoan
SIBERIAN ESKIMOC44269The 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
SINGAPOREANC43721A person having origins in any of the original peoples of Singapore.Singaporean
SOUTH AMERICAN INDIANC44953The native people of South America.South American Indian
SOUTH ASIANC41263A person having origins in any of the original peoples of the South Asia.South Asian
SOUTHEAST ASIANC126533A person having origins in any of the original peoples of Southeast Asia.Southeast Asian
SOUTHERN AFRICAN COLOUREDC156583A person of mixed race, whose ancestry is from one or more of the naturalized racial groups of Southern Africa (typically Western European, South Asian, or Southeastern Asian) and one or more of the indigenous Southern African peoples.Southern African Coloured
SRI LANKANC43672A person having origins in any of the original peoples of Sri Lanka.Sri Lankan
TAIWANESEC43675A person having origins in any of the original peoples of Taiwan.Taiwanese
THAIC43400A person having origins in any of the original peoples of Thailand.Thai
TOBAGOANC43827A person having origins in any of the original peoples of Tobago.Tobagoan
TRINIDADIANC43828A person having origins in any of the original peoples of Trinidad.Trinidadian
UNKNOWNC17998U;UNK;UnknownNot known, not observed, not recorded, or refused. (NCI)Unknown
VIETNAMESEC43396A person having origins in any of the original peoples of Viet Nam.Vietnamese
WEST ASIANC153343A person having origins in any of the original peoples of Western Asia.Western Asian
WEST INDIANC43829A person having origins in any of the original peoples of the West Indies.West Indian
WESTERN EUROPEANC77817A person having origins in any of the original peoples of Western Europe.Western European
WHITE CARIBBEANC77816A person having origins in the original peoples of Europe, the Middle East, or North Africa, and the Caribbean.White Caribbean
WHITE CENTRAL AMERICANC128993A person having origins in the original peoples of Europe, the Middle East, or North Africa, and Central America.White Central American
WHITE SOUTH AMERICANC128994A person having origins in the original peoples of Europe, the Middle East, or North Africa, and South America.White South American
WHITEC41261Denotes a person with European, Middle Eastern, or North African ancestral origin who identifies, or is identified, as White. (FDA)White
YUPIK ESKIMOC44270The native people inhabiting western, southwestern, and southcentral Alaska and the Russian Far East.Yupik Eskimo
ZAIREANC43835A person having origins in any of the original peoples of Zaire.Zairean
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CL.C177909.SAERCATSerious Adverse Event Report Category
(SAERCAT)
text
Extensible: No
C177909Serious Adverse Event Report CategoryTerminology relevant to the classification of a serious adverse event report.CDISC CDASH Serious Adverse Event Report Category Response Terminology
AMENDMENTC41200AmendedAction(s) undertaken to modify by means of correction, addition, subtraction, or replacement.Amendment
NULLIFICATIONC178052NullifiedAction(s) undertaken to void, negate, or invalidate.Nullification
ORIGINALC25604Preceding all others in time or being as first made or performed.Original
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CL.C181164.SADCRRStudy Agent Dechallenge Reaction Response
(SADCRR)
text
Extensible: Yes
C181164Study Agent Dechallenge Reaction ResponseA terminology codelist relevant to the resultant reaction due to withdrawing, interrupting, or otherwise altering administration of study treatment.CDISC CDASH Study Agent Dechallenge Reaction Response Terminology
NEGATIVE DECHALLENGEC181222Continued presence of an adverse event after decrease or change in dose, or withdrawal of the product/drug.Negative Dechallenge Response
NOT APPLICABLE DECHALLENGEC181224The outcome of decreasing the dose or discontinuation of the product/drug is not relevant in the current context.Not Applicable Dechallenge Response
POSITIVE DECHALLENGEC181223Partial or complete abatement of an adverse event after decrease or change in dose, or withdrawal of the product/drug.Positive Dechallenge Response
UNKNOWN DECHALLENGEC181225No information regarding the outcome of decreasing the dose or discontinuation of the product/drug.Unknown Dechallenge Response
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CL.C181163.SARCRRStudy Agent Rechallenge Reaction Response
(SARCRR)
text
Extensible: Yes
C181163Study Agent Rechallenge Reaction ResponseA terminology codelist relevant to the resultant reaction due to restarting or otherwise returning administration of study treatment to previous level, after a dechallenge event.CDISC CDASH Study Agent Rechallenge Reaction Response Terminology
NEGATIVE RECHALLENGEC181226Failure 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
NOT APPLICABLE RECHALLENGEC181228The outcome of reintroduction of product/drug is not relevant in the current context.Not Applicable Rechallenge Response
POSITIVE RECHALLENGEC181227Recurrence of similar or new signs and symptoms upon reintroduction of the product/drug.Positive Rechallenge Response
UKNOWN RECHALLENGEC181229No information regarding the outcome of reintroduction of product/drug.Unknown Rechallenge Response
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CL.C83004.SUNCFSubstance Use Never/Current/Former Classification
(SUNCF)
text
Extensible: Yes
C83004Substance Use Never/Current/Former ClassificationA terminology subset of the CDISC SDTM Never/Current/Former Classification codelist created for CDASH Substance Use Never/Current/Former Classification codelist. (NCI)CDISC CDASH Substance Use Never/Current/Former Classification Terminology
CURRENTC25471Occurring in or belonging to the present time. (NCI)Current
FORMERC25627PreviousOccurring prior to something else. (NCI)Previous
NEVERC70543Not ever; at no time in the past.Never
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CL.C78428.EXVOLTUTotal Volume Administration Unit
(EXVOLTU)
text
Extensible: Yes
C78428Total Volume Administration UnitA terminology subset of the CDISC SDTM Unit codelist created for CDASH Total Volume Administration Unit codelist. (NCI)CDISC CDASH Total Volume Administration Unit Terminology
mgC28253MilligramA unit of mass equal to one thousandth (1E-3) of a gram.Milligram
mLC28254cm3;MilliliterA unit of volume equal to one thousandth (1E-3) of a liter.Milliliter
ugC48152mcg;MicrogramA unit of mass equal to one millionth (1E-6) of a gram.Microgram
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CL.C78427.EXINTPUUnit for the Duration of Treatment Interruption
(EXINTPU)
text
Extensible: Yes
C78427Unit for the Duration of Treatment InterruptionA terminology subset of the CDISC SDTM Unit codelist created for CDASH Unit for Duration of Treatment Interruption codelist. (NCI)CDISC CDASH Unit for Duration of Treatment Interruption Terminology
HOURSC25529h;Hours;hrA unit of measurement of time equal to 60 minutes.Hour
minC48154MinuteA unit of measurement of time equal to 60 seconds.Minute
sC42535sec;SecondThe 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
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CL.C78421.DAORRESUUnit of Drug Dispensed or Returned
(DAORRESU)
text
Extensible: Yes
C78421Unit of Drug Dispensed or ReturnedA terminology subset of the CDISC SDTM Unit codelist created for CDASH Unit of Drug Dispensed or Returned codelist. (NCI)CDISC CDASH Unit of Drug Dispensed or Returned Terminology
BAGC48474Bag Dosing UnitA dosing measurement based on the bag unit.(NCI)Bag Dosing Unit
BOTTLEC48477Bottle Dosing UnitA dosing measurement based on the bottle unit.(NCI)Bottle Dosing Unit
BOXC48478Box Dosing UnitA dosing measurement based on the box unit.(NCI)Box Dosing Unit
CAPSULEC48480cap;Capsule Dosing UnitA dosing measurement based on the capsule unit.(NCI)Capsule Dosing Unit
CONTAINERC48484Container Dosing UnitA dosing measurement based on the container unit.(NCI)Container Dosing Unit
DISKC48490Disk Dosing UnitA dosing measurement based on the disk unit.(NCI)Disk Dosing Unit
PACKAGEC48520Pack Dosing Unit;Package Dosing UnitA dosing measurement based on the package unit.(NCI)Package Dosing Unit
PACKETC48521Packet Dosing UnitA dosing measurement based on the packet unit.(NCI)Packet Dosing Unit
PATCHC48524Patch Dosing UnitA dosing measurement based on the patch unit.(NCI)Patch Dosing Unit
TABLETC48542tab;Tablet Dosing UnitA dosing measurement based on the tablet unit.(NCI)Tablet Dosing Unit
TUBEC48549Tube Dosing UnitA dosing measurement based on the tube unit.(NCI)Tube Dosing Unit
VIALC48551Vial Dosing UnitA dosing measurement based on the vial unit.(NCI)Vial Dosing Unit
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CL.C78429.EXFLRTUUnit of Measure for Flow Rate
(EXFLRTU)
text
Extensible: Yes
C78429Unit of Measure for Flow RateA terminology subset of the CDISC SDTM Unit codelist created for CDASH Unit of Measure for Flow Rate codelist. (NCI)CDISC CDASH Unit of Measure for Flow Rate Terminology
mL/minC64777A unit of flow rate equal to one milliliter per minute.Milliliter per Minute
mmol/dayC67420mmol/24hA unit of substance flow rate equal to one millimole per day.Millimole per 24 Hours
ug/dayC71205mcg/dayA unit of mass flow rate equal to one microgram per day.Microgram per Day
ug/minC71211mcg/minA unit of mass flow rate equal to one microgram per minute.Microgram per Minute
umol/dayC67406mcmol/dayA unit of substance flow rate equal to one micromole per day.Micromole per 24 Hours
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CL.C78423.EXDOSUUnits for Exposure
(EXDOSU)
text
Extensible: Yes
C78423Units for ExposureA terminology subset of the CDISC SDTM Unit codelist created for CDASH Units for Exposure codelist. (NCI)CDISC CDASH Units for Exposure Terminology
CAPSULEC48480cap;Capsule Dosing UnitA dosing measurement based on the capsule unit.(NCI)Capsule Dosing Unit
gC48155GramA 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
mgC28253MilligramA unit of mass equal to one thousandth (1E-3) of a gram.Milligram
mLC28254cm3;MilliliterA unit of volume equal to one thousandth (1E-3) of a liter.Milliliter
PUFFC65060Puff Dosing UnitA 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
TABLETC48542tab;Tablet Dosing UnitA dosing measurement based on the tablet unit.(NCI)Tablet Dosing Unit
ugC48152mcg;MicrogramA unit of mass equal to one millionth (1E-6) of a gram.Microgram
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CL.C78430.EXPDOSEUUnits for Planned Exposure
(EXPDOSEU)
text
Extensible: Yes
C78430Units for Planned ExposureA terminology subset of the CDISC SDTM Unit codelist created for CDASH Units for Planned Exposure codelist. (NCI)CDISC CDASH Units for Planned Exposure Terminology
CAPSULEC48480cap;Capsule Dosing UnitA dosing measurement based on the capsule unit.(NCI)Capsule Dosing Unit
gC48155GramA 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
mgC28253MilligramA unit of mass equal to one thousandth (1E-3) of a gram.Milligram
mLC28254cm3;MilliliterA unit of volume equal to one thousandth (1E-3) of a liter.Milliliter
PUFFC65060Puff Dosing UnitA 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
TABLETC48542tab;Tablet Dosing UnitA dosing measurement based on the tablet unit.(NCI)Tablet Dosing Unit
ugC48152mcg;MicrogramA unit of mass equal to one millionth (1E-6) of a gram.Microgram
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CL.C78431.VSPOSVital Signs Position of Subject
(VSPOS)
text
Extensible: Yes
C78431Vital Signs Position of SubjectA terminology subset of the CDISC SDTM Position codelist created for CDASH Vital Signs Position of Subject codelist. (NCI)CDISC CDASH Vital Signs Position of Subject Terminology
SITTINGC62122SittingThe state or act of one who sits; the posture of one who occupies a seat. (NCI)Sitting
STANDINGC62166Orthostatic;StandingThe act of assuming or maintaining an erect upright position. (NCI)Standing
SUPINEC62167SupineA posterior recumbent body position whereby the person lies on its back and faces upward. (NCI)Supine Position
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