CDASH Terminology

CDISC CDASH Controlled Terminology, 2022-09-30 Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/cancerlibrary/terminologyresources/cdisc NCI Code CDISC Submission Value C78418 CMDOSFRM C78419 CMDOSFRQ C78417 CMDOSU C78420 CMROUTE C78421 DAORRESU C78422 EGORRESU C128690 ETHNICC C78426 EXDOSFRM C78745 EXDOSFRQ C78423 EXDOSU C78429 EXFLRTU C78427 EXINTPU C78430 EXPDOSEU C78425 EXROUTE C78428 EXVOLTU C181165 MODDLV C128689 RACEC C181164 SADCRR C177909 SAERCAT C181163 SARCRR C83004 SUNCF C78431 VSPOS Codelist Name Concomitant Medication Dose Form CDISC Definition A terminology subset of the CDISC SDTM Pharmaceutical Dosage Form codelist created for CDASH Concomitant Medication Dose Form codelist. (NCI) A terminology subset of the CDISC SDTM Frequency codelist created Concomitant Medication for CDASH Concomitant Medication Dosing Frequency per Interval Dosing Frequency per codelist. (NCI) Interval Concomitant Medication A terminology subset of the CDISC SDTM Unit codelist created for Dose Units CDASH Concomitant Medication Dose Units codelist. (NCI) Concomitant Medication A terminology subset of the CDISC SDTM Route codelist created for Route of Administration CDASH Concomitant Medication Route of Administration codelist. (NCI) Unit of Drug Dispensed or A terminology subset of the CDISC SDTM Unit codelist created for Returned CDASH Unit of Drug Dispensed or Returned codelist. (NCI) ECG Original Units A terminology subset of the CDISC SDTM Unit codelist created for CDASH ECG Original Units codelist. (NCI) Ethnicity As Collected A terminology codelist relevant to the ethnicity of an individual as collected on the case report form. Exposure Dose Form A terminology subset of the CDISC SDTM Pharmaceutical Dosage Form codelist created for CDASH Exposure Dose Form codelist. (NCI) Exposure Dosing Frequency A terminology subset of the CDISC SDTM Frequency codelist created per Interval for CDASH Exposure Dosing Frequency per Interval codelist. (NCI) Units for Exposure A terminology subset of the CDISC SDTM Unit codelist created for CDASH Units for Exposure codelist. (NCI) Unit of Measure for Flow A terminology subset of the CDISC SDTM Unit codelist created for Rate CDASH Unit of Measure for Flow Rate codelist. (NCI) Unit for the Duration of A terminology subset of the CDISC SDTM Unit codelist created for Treatment Interruption CDASH Unit for Duration of Treatment Interruption codelist. (NCI) Units for Planned Exposure A terminology subset of the CDISC SDTM Unit codelist created for CDASH Units for Planned Exposure codelist. (NCI) Exposure Route of A terminology subset of the CDISC SDTM Route codelist created for Administration CDASH Exposure Route of Administration codelist. (NCI) Total Volume Administration A terminology subset of the CDISC SDTM Unit codelist created for Unit CDASH Total Volume Administration Unit codelist. (NCI) Mode of Delivery A terminology codelist relevant to the mode of delivery of a fetus or neonate. Race As Collected A terminology codelist relevant to the race of an individual as collected on the case report form. Study Agent Dechallenge A terminology codelist relevant to the resultant reaction due to Reaction Response withdrawing, interrupting, or otherwise altering administration of study treatment. Serious Adverse Event Terminology relevant to the classification of a serious adverse event Report Category report. Study Agent Rechallenge A terminology codelist relevant to the resultant reaction due to Reaction Response restarting or otherwise returning administration of study treatment to previous level, after a dechallenge event. A terminology subset of the CDISC SDTM Never/Current/Former Substance Use Classification codelist created for CDASH Substance Use Never/Current/Former Never/Current/Former Classification codelist. (NCI) Classification Vital Signs Position of A terminology subset of the CDISC SDTM Position codelist created for Subject CDASH Vital Signs Position of Subject codelist. (NCI) Page 1 of 29 Codelist Extensible Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes CMDOSFRM (Concomitant Medication Dose Form) NCI Code: C78418, Codelist extensible: Yes C78418 NCI Code C42887 CMDOSFRM CDISC Submission Value AEROSOL aer C25158 CAPSULE cap C28944 CREAM C42933 GAS C42934 GEL C42966 OINTMENT C42968 PATCH C42972 POWDER C42989 SPRAY C42993 SUPPOSITORY supp C42994 SUSPENSION Ready to Use Suspension;susp C42998 TABLET tab CDISC Synonym oint CDISC Definition 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). 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) A semisolid emulsion of either the oil-in-water or the water-in-oil type, ordinarily intended for topical use. (NCI) Any elastic aeriform fluid in which the molecules are separated from one another and have free paths. (NCI) 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. 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. 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. An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. (NCI) A liquid minutely divided as by a jet of air or steam. (NCI) 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. 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. A solid dosage form containing medicinal substances with or without suitable diluents. (NCI) Page 2 of 29 NCI Preferred Term Aerosol Dosage Form Capsule Dosage Form Cream Dosage Form Gas Dosage Form Gel Dosage Form Ointment Dosage Form Patch Dosage Form Powder Dosage Form Spray Dosage Form Suppository Dosage Form Suspension Dosage Form Tablet Dosage Form CMDOSFRQ (Concomitant Medication Dosing Frequency per Interval) NCI Code: C78419, Codelist extensible: Yes C78419 NCI Code C64496 CMDOSFRQ CDISC Submission Value BID C64499 C25473 PRN QD C64530 QID C64498 C64525 C64527 QM QOD TID C17998 UNKNOWN CDISC Synonym CDISC Definition Two times per day, at unspecified times. (NCI) As needed As needed. (NCI) /day;Daily;Per Day A rate of occurrences within a period of time equal to one day. 4 times per day Four times per day. (NCI) Every Month;Per Month Every month. (NCI) Every other day;Every Second Day;Every Two Days;Q2D Every other day. (NCI) 3 times per day Three times per day. (NCI) U;UNK;Unknown Not known, not observed, not recorded, or refused. (NCI) BD;Twice per day Page 3 of 29 NCI Preferred Term Twice Daily As Needed Daily Four Times Daily Monthly Every Other Day Three Times Daily Unknown CMDOSU (Concomitant Medication Dose Units) NCI Code: C78417, Codelist extensible: Yes C78417 NCI Code C48480 CMDOSU CDISC Submission Value CAPSULE CDISC Synonym cap;Capsule Dosing Unit C48155 g Gram C48579 IU IE;International Unit C28253 mg Milligram C28254 mL cm3;Milliliter C65060 PUFF Puff Dosing Unit C48542 TABLET tab;Tablet Dosing Unit C48152 ug mcg;Microgram CDISC Definition A dosing measurement based on the capsule unit.(NCI) 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). 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) A unit of mass equal to one thousandth (1E-3) of a gram. A unit of volume equal to one thousandth (1E-3) of a liter. 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) A dosing measurement based on the tablet unit.(NCI) A unit of mass equal to one millionth (1E-6) of a gram. Page 4 of 29 NCI Preferred Term Capsule Dosing Unit Gram International Unit Milligram Milliliter Puff Dosing Unit Tablet Dosing Unit Microgram CMROUTE (Concomitant Medication Route of Administration) NCI Code: C78420, Codelist extensible: Yes C78420 NCI Code C38250 CMROUTE CDISC Submission Value INTRALESIONAL C28161 C38255 C38258 INTRAMUSCULAR INTRAOCULAR INTRAPERITONEAL C38284 NASAL C38288 ORAL C38295 C38216 RECTAL RESPIRATORY (INHALATION) C38299 SUBCUTANEOUS C38304 TOPICAL C38305 TRANSDERMAL C38313 VAGINAL CDISC Synonym CDISC Definition Administration within or introduced directly into a localized lesion. (FDA) Administration within a muscle. (FDA) Administration within the eye. (FDA) Administration within the peritoneal cavity. (FDA) Intranasal Route of Administration Administration to the nose; administered by way of the nose. (FDA) Intraoral Route of Administration;PO Administration to or by way of the mouth. (FDA) Administration to the rectum. (FDA) Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect. (FDA) SC;Subdermal Route of Administration Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL. (FDA) 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) Administration through the dermal layer of the skin to the systemic circulation by diffusion. (FDA) Administration into the vagina. (FDA) Page 5 of 29 NCI Preferred Term Intralesional Route of Administration Intramuscular Route of Administration Intraocular Route of Administration Intraperitoneal Route of Administration Nasal Route of Administration Oral Route of Administration Rectal Route of Administration Inhalation Route of Administration Subcutaneous Route of Administration Topical Route of Administration Transdermal Route of Administration Vaginal Route of Administration DAORRESU (Unit of Drug Dispensed or Returned) NCI Code: C78421, Codelist extensible: Yes C78421 NCI Code C48474 DAORRESU CDISC Submission Value BAG C48477 BOTTLE C48478 BOX C48480 CAPSULE C48484 CONTAINER C48490 DISK C48520 PACKAGE C48521 PACKET C48524 PATCH C48542 TABLET C48549 TUBE C48551 VIAL CDISC Synonym Bag Dosing Unit CDISC Definition A dosing measurement based on the bag unit.(NCI) Bottle Dosing Unit A dosing measurement based on the bottle unit.(NCI) Box Dosing Unit A dosing measurement based on the box unit.(NCI) cap;Capsule Dosing Unit A dosing measurement based on the capsule unit.(NCI) Container Dosing Unit A dosing measurement based on the container unit.(NCI) Disk Dosing Unit A dosing measurement based on the disk unit.(NCI) Pack Dosing Unit;Package Dosing Unit A dosing measurement based on the package unit.(NCI) Packet Dosing Unit A dosing measurement based on the packet unit.(NCI) Patch Dosing Unit A dosing measurement based on the patch unit.(NCI) tab;Tablet Dosing Unit A dosing measurement based on the tablet unit.(NCI) Tube Dosing Unit A dosing measurement based on the tube unit.(NCI) Vial Dosing Unit A dosing measurement based on the vial unit.(NCI) Page 6 of 29 NCI Preferred Term Bag Dosing Unit Bottle Dosing Unit Box Dosing Unit Capsule Dosing Unit Container Dosing Unit Disk Dosing Unit Package Dosing Unit Packet Dosing Unit Patch Dosing Unit Tablet Dosing Unit Tube Dosing Unit Vial Dosing Unit EGORRESU (ECG Original Units) NCI Code: C78422, Codelist extensible: Yes C78422 NCI Code C49673 EGORRESU CDISC Submission Value beats/min CDISC Synonym Beats per Minute;BPM;bpm C41140 ms Millisecond;ms;msec C42535 s sec;Second CDISC Definition NCI Preferred Term The number of heartbeats measured per minute Beats per Minute time. (NCI) A unit of time, which is equal to one thousandth Millisecond of a second.(NCI) The base unit of time in the International Second 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. Page 7 of 29 ETHNICC (Ethnicity As Collected) NCI Code: C128690, Codelist extensible: Yes C128690 NCI Code C158197 ETHNICC CDISC Submission Value ACHANG C17950 C158171 C158193 C158203 C158169 C67118 C158172 ASHKENAZI JEW BAI BLANG BONAN BUYEI CENTRAL AMERICAN CHOSEN C67115 C107608 C158176 CUBAN AMERICAN CUBAN DAI DA C158191 C158202 C158209 DAUR DEANG DERUNG DU DE DR C158168 C158179 DONG DONGXIANG DO DX C158199 EWENKI EW C158211 GAOSHAN GS C158180 C158200 C158158 GELAO GIN HAN GL GI HA C158173 HANI HN C158210 HEZHEN HZ C17459 HISPANIC OR LATINO C158160 HUI HU C158190 C158201 C158175 C158189 C158181 C126531 C158212 C158174 C158178 C158161 C158194 JINGPO JINO KAZAK KIRGIZ LAHU LATIN AMERICAN LHOBA LI LISU MAN MAONAN JP JN KZ KG LH C67114 C67113 C158163 MEXICAN AMERICAN MEXICAN MIAO MH C158207 MONBA MB C158167 MONGOL MG C158187 MULAO ML C158184 NAXI NX C41222 NOT HISPANIC OR LATINO C43234 C158198 C158208 NOT REPORTED NU OROQEN C67112 C158196 C158185 C158204 C158192 C103283 C158177 PUERTO RICAN PUMI QIANG RUSS SALAR SEPHARDIC JEW SHE CDISC Synonym AC BA BL BN BY CS LB LI LS MA MN Not reported NU OR PM QI RS SL SH CDISC Definition A Chinese person from the Achang ethnic group. A person of Ashkenazi Jewish descent. A Chinese person from the Bai ethnic group. A Chinese person from the Blang ethnic group. A Chinese person from the Bonan ethnic group. A Chinese person from the Buyei ethnic group. A person of Central American descent. A Chinese person from the Chosen ethnic group. A person of Cuban and American descent. A person of Cuban descent. A Chinese person from the Dai (including several different Tai-speaking groups historically referred to as Bai-yi) ethnic group. A Chinese person from the Daur ethnic group. A Chinese person from the Deang ethnic group. A Chinese person from the Derung ethnic group. A Chinese person from the Dong ethnic group. A Chinese person from the Dongxiang ethnic group. A Chinese person from the Ewenki ethnic group. A Chinese person from the Gaoshan ethnic group. A Chinese person from the Gelao ethnic group. A Chinese person from the Gin ethnic group. A Chinese person from the Han ethnic group (including Chuanqing). A Chinese person from the Hani (including Sangkong) ethnic group. A Chinese person from the Hezhen ethnic group. A person of Mexican, Puerto Rican, Cuban, Central or South American or other Spanish culture or origin, regardless of race. (NCI) A Chinese person from the Hui (including Utsuls of Hainan, descended from Cham refugees) ethnic group. A Chinese person from the Jingpo ethnic group. A Chinese person from the Jino ethnic group. A Chinese person from the Kazak ethnic group. A Chinese person from the Kirgiz ethnic group. A Chinese person from the Lahu ethnic group. A person of Latin American descent. A Chinese person from the Lhoba ethnic group. A Chinese person from the Li ethnic group. A Chinese person from the Lisu ethnic group. A Chinese person from the Man ethnic group. A Chinese person from the Maonan (including the Then) ethnic group. A person of Mexican and American descent. A person of Mexican descent. A Chinese person from the Miao (Including Hmong) ethnic group. A Chinese person from the Monba ethnic group. A Chinese person from the Mongol ethnic group. A Chinese person from the Mulao (including the Qago) ethnic group. A Chinese person from the Naxi (including Mosuo) ethnic group. 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 provided or available. A Chinese person from the Nu ethnic group. A Chinese person from the Oroqen ethnic group. A person of Puerto Rican descent. A Chinese person from the Pumi ethnic group. A Chinese person from the Qiang ethnic group. A Chinese person from the Russ ethnic group. A Chinese person from the Salar ethnic group. A person of Sephardic Jewish descent. A Chinese person from the She ethnic group. Page 8 of 29 NCI Preferred Term Achang Chinese Ashkenazi Jew Bai Chinese Blang Chinese Bonan Chinese Buyei Chinese Central American Chosen Chinese Cuban or Cuban American Cuban Dai Chinese Daur Chinese Deang Chinese Derung Chinese Dong Chinese Dongxiang Chinese Ewenki Chinese Gaoshan Chinese Gelao Chinese Gin Chinese Han Chinese Hani Chinese Hezhen Chinese Hispanic or Latino Hui Chinese Jingpo Chinese Jino Chinese Kazak Chinese Kirgiz Chinese Lahu Chinese Latin American Lhoba Chinese Li Chinese Lisu Chinese Man Chinese Maonan Chinese Mexican American Mexican Miao Chinese Monba Chinese Mongol Chinese Mulao Chinese Naxi Chinese Not Hispanic or Latino Not Reported Nu Chinese Oroqen Chinese Puerto Rican Pumi Chinese Qiang Chinese Russ Chinese Salar Chinese Sephardic Jew She Chinese C128690 NCI Code C126532 C67120 C158183 C158195 C158213 C158186 C158165 C17998 ETHNICC CDISC Submission Value SOUTH AMERICAN SPANISH SUI TAJIK TATAR TU TUJIA UNKNOWN SU TA TT TU TJ U;UNK;Unknown C158162 C158206 C158182 C158188 C158170 C158164 C158205 C158166 UYGUR UZBEK VA XIBE YAO YI YUGUR ZANG UG UZ VA XB YA YI YG ZA C158159 ZHUANG ZH CDISC Synonym CDISC Definition A person of South American descent. A person from Spain or of Spanish descent. A Chinese person from the Sui ethnic group. A Chinese person from the Tajik ethnic group. A Chinese person from the Tatar ethnic group. A Chinese person from the Tu ethnic group. A Chinese person from the Tujia ethnic group. Not known, not observed, not recorded, or refused. (NCI) A Chinese person from the Uygur ethnic group. A Chinese person from the Uzbek ethnic group. A Chinese person from the Va ethnic group. A Chinese person from the Xibe ethnic group. A Chinese person from the Yao ethnic group. A Chinese person from the Yi ethnic group. A Chinese person from the Yugur ethnic group. A Chinese person from the Zang (including Amdowa, Khampa and some Pumi speakers) ethnic group. A Chinese person from the Zhuang ethnic group. Page 9 of 29 NCI Preferred Term South American Spanish Sui Chinese Tajik Chinese Tatar Chinese Tu Chinese Tujia Chinese Unknown Uygur Chinese Uzbek Chinese Va Chinese Xibe Chinese Yao Chinese Yi Chinese Yugur Chinese Zang Chinese Zhuang Chinese EXDOSFRM (Exposure Dose Form) NCI Code: C78426, Codelist extensible: Yes C78426 NCI Code C42887 EXDOSFRM CDISC Submission Value AEROSOL aer C25158 CAPSULE cap C28944 CREAM C42933 GAS C42934 GEL C42966 OINTMENT C42968 PATCH C42972 POWDER C42989 SPRAY C42993 SUPPOSITORY supp C42994 SUSPENSION Ready to Use Suspension;susp C42998 TABLET tab CDISC Synonym oint CDISC Definition 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). 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) A semisolid emulsion of either the oil-in-water or the water-in-oil type, ordinarily intended for topical use. (NCI) Any elastic aeriform fluid in which the molecules are separated from one another and have free paths. (NCI) 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. 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. 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. An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. (NCI) A liquid minutely divided as by a jet of air or steam. (NCI) 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. 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. A solid dosage form containing medicinal substances with or without suitable diluents. (NCI) Page 10 of 29 NCI Preferred Term Aerosol Dosage Form Capsule Dosage Form Cream Dosage Form Gas Dosage Form Gel Dosage Form Ointment Dosage Form Patch Dosage Form Powder Dosage Form Spray Dosage Form Suppository Dosage Form Suspension Dosage Form Tablet Dosage Form EXDOSFRQ (Exposure Dosing Frequency per Interval) NCI Code: C78745, Codelist extensible: Yes C78745 NCI Code C64496 EXDOSFRQ CDISC Submission Value BID C64499 C25473 PRN QD C64530 QID C64498 C64525 C64527 QM QOD TID C17998 UNKNOWN CDISC Synonym CDISC Definition Two times per day, at unspecified times. (NCI) As needed As needed. (NCI) /day;Daily;Per Day A rate of occurrences within a period of time equal to one day. 4 times per day Four times per day. (NCI) Every Month;Per Month Every month. (NCI) Every other day;Every Second Day;Every Two Days;Q2D Every other day. (NCI) 3 times per day Three times per day. (NCI) U;UNK;Unknown Not known, not observed, not recorded, or refused. (NCI) BD;Twice per day Page 11 of 29 NCI Preferred Term Twice Daily As Needed Daily Four Times Daily Monthly Every Other Day Three Times Daily Unknown EXDOSU (Units for Exposure) NCI Code: C78423, Codelist extensible: Yes C78423 NCI Code C48480 EXDOSU CDISC Submission Value CAPSULE CDISC Synonym cap;Capsule Dosing Unit C48155 g Gram C28253 mg Milligram C28254 mL cm3;Milliliter C65060 PUFF Puff Dosing Unit C48542 TABLET tab;Tablet Dosing Unit C48152 ug mcg;Microgram CDISC Definition A dosing measurement based on the capsule unit.(NCI) 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). A unit of mass equal to one thousandth (1E-3) of a gram. A unit of volume equal to one thousandth (1E-3) of a liter. 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) A dosing measurement based on the tablet unit.(NCI) A unit of mass equal to one millionth (1E-6) of a gram. Page 12 of 29 NCI Preferred Term Capsule Dosing Unit Gram Milligram Milliliter Puff Dosing Unit Tablet Dosing Unit Microgram EXFLRTU (Unit of Measure for Flow Rate) NCI Code: C78429, Codelist extensible: Yes C78429 NCI Code C64777 EXFLRTU CDISC Submission Value mL/min C67420 mmol/day mmol/24h C71205 ug/day mcg/day C71211 ug/min mcg/min C67406 umol/day mcmol/day CDISC Synonym CDISC Definition A unit of flow rate equal to one milliliter per minute. A unit of substance flow rate equal to one millimole per day. A unit of mass flow rate equal to one microgram per day. A unit of mass flow rate equal to one microgram per minute. A unit of substance flow rate equal to one micromole per day. Page 13 of 29 NCI Preferred Term Milliliter per Minute Millimole per 24 Hours Microgram per Day Microgram per Minute Micromole per 24 Hours EXINTPU (Unit for the Duration of Treatment Interruption) NCI Code: C78427, Codelist extensible: Yes C78427 NCI Code C25529 EXINTPU CDISC Submission Value HOURS CDISC Synonym h;Hours;hr C48154 min Minute C42535 s sec;Second CDISC Definition A unit of measurement of time equal to 60 minutes. A unit of measurement of time equal to 60 seconds. 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. Page 14 of 29 NCI Preferred Term Hour Minute Second EXPDOSEU (Units for Planned Exposure) NCI Code: C78430, Codelist extensible: Yes C78430 NCI Code C48480 EXPDOSEU CDISC Submission Value CAPSULE CDISC Synonym cap;Capsule Dosing Unit C48155 g Gram C28253 mg Milligram C28254 mL cm3;Milliliter C65060 PUFF Puff Dosing Unit C48542 TABLET tab;Tablet Dosing Unit C48152 ug mcg;Microgram CDISC Definition A dosing measurement based on the capsule unit.(NCI) 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). A unit of mass equal to one thousandth (1E-3) of a gram. A unit of volume equal to one thousandth (1E-3) of a liter. 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) A dosing measurement based on the tablet unit.(NCI) A unit of mass equal to one millionth (1E-6) of a gram. Page 15 of 29 NCI Preferred Term Capsule Dosing Unit Gram Milligram Milliliter Puff Dosing Unit Tablet Dosing Unit Microgram EXROUTE (Exposure Route of Administration) NCI Code: C78425, Codelist extensible: Yes C78425 NCI Code C38250 EXROUTE CDISC Submission Value INTRALESIONAL C28161 C38255 C38258 INTRAMUSCULAR INTRAOCULAR INTRAPERITONEAL C38284 NASAL C38288 ORAL C38295 C38216 RECTAL RESPIRATORY (INHALATION) C38299 SUBCUTANEOUS C38304 TOPICAL C38305 TRANSDERMAL C38313 VAGINAL CDISC Synonym CDISC Definition Administration within or introduced directly into a localized lesion. (FDA) Administration within a muscle. (FDA) Administration within the eye. (FDA) Administration within the peritoneal cavity. (FDA) Intranasal Route of Administration Administration to the nose; administered by way of the nose. (FDA) Intraoral Route of Administration;PO Administration to or by way of the mouth. (FDA) Administration to the rectum. (FDA) Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect. (FDA) SC;Subdermal Route of Administration Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL. (FDA) 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) Administration through the dermal layer of the skin to the systemic circulation by diffusion. (FDA) Administration into the vagina. (FDA) Page 16 of 29 NCI Preferred Term Intralesional Route of Administration Intramuscular Route of Administration Intraocular Route of Administration Intraperitoneal Route of Administration Nasal Route of Administration Oral Route of Administration Rectal Route of Administration Inhalation Route of Administration Subcutaneous Route of Administration Topical Route of Administration Transdermal Route of Administration Vaginal Route of Administration EXVOLTU (Total Volume Administration Unit) NCI Code: C78428, Codelist extensible: Yes C78428 NCI Code C28253 EXVOLTU CDISC Submission Value mg CDISC Synonym Milligram C28254 mL cm3;Milliliter C48152 ug mcg;Microgram CDISC Definition NCI Preferred Term A unit of mass equal to one thousandth (1E-3) Milligram of a gram. A unit of volume equal to one thousandth (1E-3) Milliliter of a liter. A unit of mass equal to one millionth (1E-6) of a Microgram gram. Page 17 of 29 MODDLV (Mode of Delivery) NCI Code: C181165, Codelist extensible: Yes C181165 NCI Code C114136 MODDLV CDISC Submission Value BREECH EXTRACTION C46088 CESAREAN SECTION C114143 DELIVERY BY DESTRUCTIVE OPERATION C81301 VAGINAL ASSISTED DELIVERY C81302 VAGINAL BIRTH AFTER CESAREAN DELIVERY C81303 VAGINAL DELIVERY CDISC Synonym Operative Vaginal Delivery Page 18 of 29 CDISC Definition The delivery of a breechpresenting fetus, which is manually pulled through the birth canal. Surgical delivery of one or more intrauterine fetuses though an abdominal incision. Extraction of a fetus through the cervix using destructive surgical techniques. Birth of the fetus through the vagina with the application of vacuum or forceps or any other instrument. A vaginal birth in a woman with one or more previous cesarean births. (reVITALize) Birth of the fetus through the vagina. NCI Preferred Term Breech Extraction Cesarean Section Delivery by Destructive Operation Vaginal Assisted Delivery Vaginal Birth after Cesarean Delivery Vaginal Delivery RACEC (Race As Collected) NCI Code: C128689, Codelist extensible: Yes C128689 NCI Code C154875 RACEC CDISC Submission Value ABORIGINAL AUSTRALIAN C128937 AFRICAN AMERICAN C41226 AFRICAN CARIBBEAN C42331 AFRICAN C18237 ALASKA NATIVE C41259 AMERICAN INDIAN OR ALASKA NATIVE C43877 AMERICAN INDIAN C43876 ARAB C16310 ASIAN AMERICAN C41262 ASIAN INDIAN C41260 ASIAN C67271 BAHAMIAN C43671 BANGLADESHI C43823 BARBADIAN C43673 BHUTANESE C128991 BLACK CENTRAL AMERICAN CDISC Synonym Page 19 of 29 CDISC Definition The native people of Australia. A person having origins in the original peoples of sub-Saharan Africa and the United States. A person having origins in the original peoples of sub-Saharan Africa and the Caribbean. A person having origins in any of the original peoples of sub-Saharan Africa. The native people of Alaska. 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) The native people of North America. A person having origins in any of the original peoples of the Arabian peninsula and surrounding territories in the Middle East and northern Africa. A person having origins in the original peoples of Asia and the United States. A person having origins in any of the original peoples of the Indian subcontinent. 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) A person having origins in any of the original peoples of the Bahamas. A person having origins in any of the original peoples of Bangladesh. A person having origins in any of the original peoples of Barbados. A person having origins in any of the original peoples of Bhutan. A person having origins in the original peoples of sub-Saharan Africa and Central NCI Preferred Term Aboriginal Australian African American African Caribbean African Alaska Native American Indian or Alaska Native American Indian Arab Asian American Asian Indian Asian Bahamian Bangladeshi Barbadian Bhutanese Black Central American C128689 NCI Code RACEC CDISC Submission Value C16352 BLACK OR AFRICAN AMERICAN C128992 BLACK SOUTH AMERICAN C128938 BLACK C43830 BOTSWANAN C43674 BURMESE C43399 CAMBODIAN C77810 CARIBBEAN INDIAN C44950 CENTRAL AMERICAN INDIAN C126534 CENTRAL ASIAN C43403 CHAMORRO C43391 CHINESE C43824 DOMINICA ISLANDER C67117 DOMINICAN C161419 EAST ASIAN C77819 EASTERN EUROPEAN C43853 ENGLISH C43831 ETHIOPIAN C43851 EUROPEAN C43393 FILIPINO CDISC Synonym Page 20 of 29 CDISC Definition America. 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) A person having origins in the original peoples of sub-Saharan Africa and South America. A person having origins in the original peoples of sub-Saharan Africa or the Caribbean. A person having origins in any of the original peoples of Botswana. A person having origins in any of the original peoples of Myanmar (formerly Burma). A person having origins in any of the original peoples of Cambodia (formerly Kampuchea). The native people of the Caribbean. The native people of Central America. A person having origins in any of the original peoples of Central Asia. The native people of the Mariana Islands, including the United States territories of Guam and the Commonwealth of the Northern Mariana Islands in Micronesia. A person having origins in any of the original peoples of China. A person having origins in any of the original peoples of Dominica. A person having origins in any of the original peoples of the Dominican Republic. A person having origins in any of the original peoples of East Asia. A person having origins in any of the original peoples of Eastern Europe. A person having origins in any of the original peoples of England. A person having origins in any of the original peoples of Ethiopia. A person having origins in any of the original peoples of Europe. A person having origins in any of the original peoples of the Philippines. NCI Preferred Term Black or African American Black South American Black Botswanan Burmese Cambodian Caribbean Indian Central American Indian Central Asian Chamorran Chinese Dominica Islander Dominican East Asian Eastern European English Ethiopian European Filipino C128689 NCI Code C44265 RACEC CDISC Submission Value GREENLAND INUIT C43837 GUAMANIAN OR CHAMORRO C43404 GUAMANIAN C43825 HAITIAN C43398 HMONG C43715 INDONESIAN C44268 INUPIAT INUIT C43856 IRISH C43718 IWO JIMAN C43826 JAMAICAN C43392 JAPANESE C154874 KHOISAN C43395 KOREAN C43397 LAOTIAN C126531 LATIN AMERICAN C43832 LIBERIAN C43722 MALAGASY C43716 MALAYSIAN C43719 MALDIVIAN C158274 MAORI C77811 MEDITERRANEAN CDISC Synonym Page 21 of 29 CDISC Definition The native people of Greenland. 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. A person having origins in any of the original peoples of Guam. A person having origins in any of the original peoples of Haiti. The native people originating in China around the Yellow River or Hoang Ho. A person having origins in any of the original peoples of Indonesia. The native people inhabiting the territory spanning the Norton Sound on the Bering Sea to the Canadian border. A person having origins in any of the original peoples of Ireland. A person having origins in any of the original peoples of Iwo Jima. A person having origins in any of the original peoples of Jamaica. A person having origins in any of the original peoples of Japan. The native people of the Western Cape in southern Africa. A person having origins in any of the original peoples of North and South Korea. A person having origins in any of the original peoples of Laos. A person of Latin American descent. A person having origins in any of the original peoples of Liberia. A person having origins in any of the original peoples of Madagascar. A person having origins in any of the original peoples of Malaysia. A person having origins in any of the original peoples of the Maldives. The native people of New Zealand. A person having origins in any of the original peoples of the countries surrounding the NCI Preferred Term Greenland Eskimo Guamanian or Chamorro Guamanian Haitian Hmong Indonesian Inupiat Eskimo Irish Iwo Jiman Jamaican Japanese Khoisan Korean Laotian Latin American Liberian Malagasy Malaysian Maldivian Maori Mediterranean C128689 NCI Code RACEC CDISC Submission Value CDISC Synonym C43409 MELANESIAN C43402 MICRONESIAN C77820 MIDDLE EASTERN C43864 MONGOLIAN C43833 NAMIBIAN C41219 NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER C43394 NATIVE HAWAIIAN C43720 NEPALESE C43834 NIGERIAN C77813 NORTH AFRICAN C77814 NORTHERN EUROPEAN C43234 NOT REPORTED C43717 OKINAWAN C107602 OTHER PACIFIC ISLANDER C17649 OTHER C43427 PAKISTANI C43405 POLYNESIAN C43860 RUSSIAN C43407 SAMOAN Not reported Other Page 22 of 29 CDISC Definition Mediterranean sea. A person having origins in any of the original peoples of Melanesia. A person having origins in any of the original peoples of Micronesia. A person having origins in any of the original peoples of the Middle East. A person having origins in any of the original peoples of Mongolia. A person having origins in any of the original peoples of Namibia. 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 partHawaiian, Native Hawaiian, Guamanian or Chamorro, Carolinian, Samoan, Chuu. (FDA) A person having origins in any of the original peoples of Hawaii. (NCI) A person having origins in any of the original peoples of Nepal. A person having origins in any of the original peoples of Nigeria. A person having origins in any of the original peoples of North Africa. A person having origins in any of the original peoples of Northern Europe. Not provided or available. A person having origins in any of the original peoples of Okinawa. A person having origins in the original peoples of the Pacific Islands, but not Guam, Hawaii, the Mariana Islands or Samoa. (NCI) Different than the one(s) previously specified or mentioned. (NCI) A person having origins in any of the original peoples of Pakistan. A person having origins in any of the original peoples of Polynesia. A person having origins in any of the original peoples of Russia. A person having origins in any of the NCI Preferred Term Melanesian Micronesian Middle Eastern Mongolian Namibian Native Hawaiian or Other Pacific Islander Native Hawaiian Nepalese Nigerian North Coast of Africa Northern European Not Reported Okinawan Other Pacific Islander Other Pakistani Polynesian Russian Samoan C128689 NCI Code RACEC CDISC Submission Value C44269 SIBERIAN ESKIMO C43721 SINGAPOREAN C44953 SOUTH AMERICAN INDIAN C41263 SOUTH ASIAN C126533 SOUTHEAST ASIAN C156583 SOUTHERN AFRICAN COLOURED C43672 SRI LANKAN C43675 TAIWANESE C43400 THAI C43827 TOBAGOAN C43828 TRINIDADIAN C17998 UNKNOWN C43396 VIETNAMESE C153343 WEST ASIAN C43829 WEST INDIAN C77817 WESTERN EUROPEAN C77816 WHITE CARIBBEAN C128993 WHITE CENTRAL AMERICAN CDISC Synonym U;UNK;Unknown Page 23 of 29 CDISC Definition original peoples of Samoa. (NCI) 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. A person having origins in any of the original peoples of Singapore. The native people of South America. A person having origins in any of the original peoples of the South Asia. A person having origins in any of the original peoples of Southeast Asia. A 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. A person having origins in any of the original peoples of Sri Lanka. A person having origins in any of the original peoples of Taiwan. A person having origins in any of the original peoples of Thailand. A person having origins in any of the original peoples of Tobago. A person having origins in any of the original peoples of Trinidad. Not known, not observed, not recorded, or refused. (NCI) A person having origins in any of the original peoples of Viet Nam. A person having origins in any of the original peoples of Western Asia. A person having origins in any of the original peoples of the West Indies. A person having origins in any of the original peoples of Western Europe. A person having origins in the original peoples of Europe, the Middle East, or North Africa, and the Caribbean. A person having origins in the original peoples of NCI Preferred Term Siberian Eskimo Singaporean South American Indian South Asian Southeast Asian Southern African Coloured Sri Lankan Taiwanese Thai Tobagoan Trinidadian Unknown Vietnamese Western Asian West Indian Western European White Caribbean White Central American C128689 NCI Code RACEC CDISC Submission Value C128994 WHITE SOUTH AMERICAN C41261 WHITE C44270 YUPIK ESKIMO C43835 ZAIREAN CDISC Synonym Page 24 of 29 CDISC Definition Europe, the Middle East, or North Africa, and Central America. A person having origins in the original peoples of Europe, the Middle East, or North Africa, and South America. Denotes a person with European, Middle Eastern, or North African ancestral origin who identifies, or is identified, as White. (FDA) The native people inhabiting western, southwestern, and southcentral Alaska and the Russian Far East. A person having origins in any of the original peoples of Zaire. NCI Preferred Term White South American White Yupik Eskimo Zairean SADCRR (Study Agent Dechallenge Reaction Response) NCI Code: C181164, Codelist extensible: Yes C181164 NCI Code C181222 SADCRR CDISC Submission Value NEGATIVE DECHALLENGE C181224 NOT APPLICABLE DECHALLENGE C181223 POSITIVE DECHALLENGE C181225 UNKNOWN DECHALLENGE CDISC Synonym CDISC Definition Continued presence of an adverse event after decrease or change in dose, or withdrawal of the product/drug. The outcome of decreasing the dose or discontinuation of the product/drug is not relevant in the current context. Partial or complete abatement of an adverse event after decrease or change in dose, or withdrawal of the product/drug. No information regarding the outcome of decreasing the dose or discontinuation of the product/drug. Page 25 of 29 NCI Preferred Term Negative Dechallenge Response Not Applicable Dechallenge Response Positive Dechallenge Response Unknown Dechallenge Response SAERCAT (Serious Adverse Event Report Category) NCI Code: C177909, Codelist extensible: No C177909 NCI Code C41200 SAERCAT CDISC Submission Value AMENDMENT CDISC Synonym Amended C178052 NULLIFICATION Nullified C25604 ORIGINAL CDISC Definition Action(s) undertaken to modify by means of correction, addition, subtraction, or replacement. Action(s) undertaken to void, negate, or invalidate. Preceding all others in time or being as first made or performed. Page 26 of 29 NCI Preferred Term Amendment Nullification Original SARCRR (Study Agent Rechallenge Reaction Response) NCI Code: C181163, Codelist extensible: Yes C181163 NCI Code C181226 SARCRR CDISC Submission Value NEGATIVE RECHALLENGE C181228 NOT APPLICABLE RECHALLENGE C181227 POSITIVE RECHALLENGE C181229 UKNOWN RECHALLENGE CDISC Synonym CDISC Definition Failure of the product/drug, when reintroduced, to produce signs or symptoms similar to those observed when the product/drug was previously used. The outcome of reintroduction of product/drug is not relevant in the current context. Recurrence of similar or new signs and symptoms upon reintroduction of the product/drug. No information regarding the outcome of reintroduction of product/drug. Page 27 of 29 NCI Preferred Term Negative Rechallenge Response Not Applicable Rechallenge Response Positive Rechallenge Response Unknown Rechallenge Response SUNCF (Substance Use Never/Current/Former Classification) NCI Code: C83004, Codelist extensible: Yes C83004 NCI Code C25471 SUNCF CDISC Submission Value CURRENT C25627 C70543 FORMER NEVER CDISC Synonym Previous CDISC Definition Occurring in or belonging to the present time. (NCI) Occurring prior to something else. (NCI) Not ever; at no time in the past. Page 28 of 29 NCI Preferred Term Current Previous Never VSPOS (Vital Signs Position of Subject) NCI Code: C78431, Codelist extensible: Yes C78431 NCI Code C62122 VSPOS CDISC Submission Value SITTING Sitting C62166 STANDING Orthostatic;Standing C62167 SUPINE Supine CDISC Synonym CDISC Definition The state or act of one who sits; the posture of one who occupies a seat. (NCI) The act of assuming or maintaining an erect upright position. (NCI) A posterior recumbent body position whereby the person lies on its back and faces upward. (NCI) Page 29 of 29 NCI Preferred Term Sitting Standing Supine Position