dataset,variable,label,type,core
ADSL,STUDYID,Study Identifier,Char,Req
ADSL,USUBJID,Unique Subject Identifier,Char,Req
ADSL,SUBJID,Subject Identifier,Char,Req
ADSL,SITEID,Study Site Identifier,Char,Req
ADSL,AGE,Age,Num,Req
ADSL,AGEU,Age Units,Char,Req
ADSL,AGEGR1,Pooled Age Group 1,Char,Cond
ADSL,AGEGR1N,Pooled Age Group 1 (N),Num,Cond
ADSL,SEX,Sex,Char,Req
ADSL,RACE,Race,Char,Req
ADSL,ETHNIC,Ethnicity,Char,Cond
ADSL,COUNTRY,Country,Char,Cond
ADSL,ARM,Description of Planned Arm,Char,Req
ADSL,ARMCD,Planned Arm Code,Char,Req
ADSL,ACTARM,Description of Actual Arm,Char,Req
ADSL,ACTARMCD,Actual Arm Code,Char,Req
ADSL,TRT01P,Planned Treatment for Period 01,Char,Req
ADSL,TRT01PN,Planned Treatment for Period 01 (N),Num,Req
ADSL,TRT01A,Actual Treatment for Period 01,Char,Req
ADSL,TRT01AN,Actual Treatment for Period 01 (N),Num,Req
ADSL,TRTSDT,Date of First Exposure to Treatment,Num,Req
ADSL,TRTEDT,Date of Last Exposure to Treatment,Num,Req
ADSL,RFSTDTC,Subject Reference Start Date/Time,Char,Req
ADSL,RFENDTC,Subject Reference End Date/Time,Char,Req
ADSL,SAFFL,Safety Population Flag,Char,Req
ADSL,ITTFL,Intent-To-Treat Population Flag,Char,Req
ADSL,EFFFL,Efficacy Population Flag,Char,Cond
ADSL,COMP8FL,Completers of Week 8 Population Flag,Char,Cond
ADSL,COMP16FL,Completers of Week 16 Population Flag,Char,Cond
ADSL,COMP24FL,Completers of Week 24 Population Flag,Char,Cond
ADSL,RANDFL,Randomized Population Flag,Char,Cond
ADSL,RANDDT,Date of Randomization,Num,Cond
ADSL,DTHDT,Date of Death,Num,Cond
ADSL,DTHFL,Subject Death Flag,Char,Cond
ADSL,DTHDTC,Date/Time of Death,Char,Cond
ADAE,STUDYID,Study Identifier,Char,Req
ADAE,USUBJID,Unique Subject Identifier,Char,Req
ADAE,TRTA,Actual Treatment,Char,Req
ADAE,TRTAN,Actual Treatment (N),Num,Req
ADAE,AGE,Age,Num,Req
ADAE,AGEGR1,Pooled Age Group 1,Char,Cond
ADAE,SEX,Sex,Char,Req
ADAE,RACE,Race,Char,Req
ADAE,SAFFL,Safety Population Flag,Char,Req
ADAE,AEBODSYS,Body System or Organ Class,Char,Req
ADAE,AEDECOD,Dictionary-Derived Term,Char,Req
ADAE,AETERM,Reported Term,Char,Req
ADAE,AESEV,Severity/Intensity,Char,Cond
ADAE,AESER,Serious Event,Char,Req
ADAE,AEREL,Causality,Char,Cond
ADAE,AEACN,Action Taken,Char,Cond
ADAE,AEOUT,Outcome,Char,Cond
ADAE,ASTDT,Analysis Start Date,Num,Req
ADAE,AENDT,Analysis End Date,Num,Cond
ADAE,ASTDTF,Analysis Start Date Imputation Flag,Char,Cond
ADAE,AENDTF,Analysis End Date Imputation Flag,Char,Cond
ADAE,AESTDTC,Start Date/Time,Char,Cond
ADAE,AEENDTC,End Date/Time,Char,Cond
ADAE,TRTEMFL,Treatment Emergent Analysis Flag,Char,Req
ADAE,AOCCFL,1st Occurrence within Subject Flag,Char,Cond
ADAE,AOCCSFL,1st Occurrence of SOC within Subject,Char,Cond
ADAE,AOCCPFL,1st Occurrence of PT within Subject,Char,Cond
ADAE,CQ01NAM,Customized Query 01 Name,Char,Cond
ADAE,AOESSION,Occurrence with Subject Sequence,Num,Cond
ADLB,STUDYID,Study Identifier,Char,Req
ADLB,USUBJID,Unique Subject Identifier,Char,Req
ADLB,TRTA,Actual Treatment,Char,Req
ADLB,TRTAN,Actual Treatment (N),Num,Req
ADLB,PARAMCD,Parameter Code,Char,Req
ADLB,PARAM,Parameter,Char,Req
ADLB,PARAMN,Parameter (N),Num,Cond
ADLB,PARCAT1,Parameter Category 1,Char,Cond
ADLB,AVAL,Analysis Value,Num,Req
ADLB,AVALC,Analysis Value (C),Char,Cond
ADLB,BASE,Baseline Value,Num,Req
ADLB,BASEC,Baseline Value (C),Char,Cond
ADLB,CHG,Change from Baseline,Num,Cond
ADLB,PCHG,Percent Change from Baseline,Num,Cond
ADLB,ABLFL,Baseline Record Flag,Char,Req
ADLB,ANRLO,Analysis Normal Range Lower Limit,Num,Cond
ADLB,ANRHI,Analysis Normal Range Upper Limit,Num,Cond
ADLB,A1LO,Analysis Range 1 Lower Limit,Num,Cond
ADLB,A1HI,Analysis Range 1 Upper Limit,Num,Cond
ADLB,ANRIND,Analysis Reference Range Indicator,Char,Cond
ADLB,AVISIT,Analysis Visit,Char,Req
ADLB,AVISITN,Analysis Visit (N),Num,Req
ADLB,ADT,Analysis Date,Num,Req
ADLB,ADY,Analysis Relative Day,Num,Cond
ADLB,ATPT,Analysis Timepoint,Char,Cond
ADLB,ATPTN,Analysis Timepoint (N),Num,Cond
ADLB,DTYPE,Derivation Type,Char,Cond
ADLB,SAFFL,Safety Population Flag,Char,Req
ADLB,ONTRTFL,On Treatment Record Flag,Char,Cond
ADLB,LBSEQ,Sequence Number,Num,Cond
ADLB,LBTESTCD,Lab Test Code,Char,Cond
ADTTE,STUDYID,Study Identifier,Char,Req
ADTTE,USUBJID,Unique Subject Identifier,Char,Req
ADTTE,PARAMCD,Parameter Code,Char,Req
ADTTE,PARAM,Parameter,Char,Req
ADTTE,PARAMN,Parameter (N),Num,Cond
ADTTE,AVAL,Analysis Value,Num,Req
ADTTE,CNSR,Censor,Num,Req
ADTTE,EVNTDESC,Event Description,Char,Cond
ADTTE,CNSDTDSC,Censor Date Description,Char,Cond
ADTTE,STARTDT,Time-to-Event Origin Date,Num,Req
ADTTE,ADT,Analysis Date,Num,Req
ADTTE,SRCDOM,Source Domain,Char,Cond
ADTTE,SRCVAR,Source Variable,Char,Cond
ADTTE,SRCSEQ,Source Sequence Number,Num,Cond
ADTTE,TRTA,Actual Treatment,Char,Cond
ADTTE,TRTAN,Actual Treatment (N),Num,Cond
ADTTE,AGE,Age,Num,Cond
ADTTE,AGEGR1,Pooled Age Group 1,Char,Cond
ADTTE,SEX,Sex,Char,Cond
ADTTE,RACE,Race,Char,Cond
ADTTE,SAFFL,Safety Population Flag,Char,Cond
ADTTE,ITTFL,Intent-To-Treat Population Flag,Char,Cond
ADEFF,STUDYID,Study Identifier,Char,Req
ADEFF,USUBJID,Unique Subject Identifier,Char,Req
ADEFF,PARAMCD,Parameter Code,Char,Req
ADEFF,PARAM,Parameter,Char,Req
ADEFF,PARAMN,Parameter (N),Num,Cond
ADEFF,AVAL,Analysis Value,Num,Req
ADEFF,AVALC,Analysis Value (C),Char,Cond
ADEFF,BASE,Baseline Value,Num,Cond
ADEFF,CHG,Change from Baseline,Num,Cond
ADEFF,PCHG,Percent Change from Baseline,Num,Cond
ADEFF,ABLFL,Baseline Record Flag,Char,Req
ADEFF,AVISIT,Analysis Visit,Char,Req
ADEFF,AVISITN,Analysis Visit (N),Num,Req
ADEFF,ADT,Analysis Date,Num,Req
ADEFF,ADY,Analysis Relative Day,Num,Cond
ADEFF,TRTA,Actual Treatment,Char,Req
ADEFF,TRTAN,Actual Treatment (N),Num,Req
ADEFF,SAFFL,Safety Population Flag,Char,Cond
ADEFF,ITTFL,Intent-To-Treat Population Flag,Char,Cond
ADEFF,EFFFL,Efficacy Population Flag,Char,Cond
ADEFF,DTYPE,Derivation Type,Char,Cond
ADEFF,ANL01FL,Analysis Flag 01,Char,Cond
ADCM,STUDYID,Study Identifier,Char,Req
ADCM,USUBJID,Unique Subject Identifier,Char,Req
ADCM,TRTA,Actual Treatment,Char,Req
ADCM,TRTAN,Actual Treatment (N),Num,Req
ADCM,CMTRT,Reported Name of Drug,Char,Req
ADCM,CMDECOD,Standardized Medication Name,Char,Cond
ADCM,CMCAT,Category for Medication,Char,Cond
ADCM,CMINDC,Indication,Char,Cond
ADCM,CMCLAS,Medication Class,Char,Cond
ADCM,CMCLASCD,Medication Class Code,Char,Cond
ADCM,ASTDT,Analysis Start Date,Num,Req
ADCM,AENDT,Analysis End Date,Num,Cond
ADCM,ASTDTF,Analysis Start Date Imputation Flag,Char,Cond
ADCM,AENDTF,Analysis End Date Imputation Flag,Char,Cond
ADCM,ASTDY,Analysis Start Relative Day,Num,Cond
ADCM,AENDY,Analysis End Relative Day,Num,Cond
ADCM,ADURN,Analysis Duration (N),Num,Cond
ADCM,ADURU,Analysis Duration Units,Char,Cond
ADCM,SAFFL,Safety Population Flag,Char,Req
ADCM,ONTRTFL,On Treatment Record Flag,Char,Cond
ADCM,CMSEQ,Sequence Number,Num,Cond
ADCM,AGE,Age,Num,Cond
ADCM,SEX,Sex,Char,Cond
ADCM,RACE,Race,Char,Cond
ADVS,STUDYID,Study Identifier,Char,Req
ADVS,USUBJID,Unique Subject Identifier,Char,Req
ADVS,TRTA,Actual Treatment,Char,Req
ADVS,TRTAN,Actual Treatment (N),Num,Req
ADVS,PARAMCD,Parameter Code,Char,Req
ADVS,PARAM,Parameter,Char,Req
ADVS,PARAMN,Parameter (N),Num,Cond
ADVS,PARCAT1,Parameter Category 1,Char,Cond
ADVS,AVAL,Analysis Value,Num,Req
ADVS,AVALC,Analysis Value (C),Char,Cond
ADVS,BASE,Baseline Value,Num,Cond
ADVS,CHG,Change from Baseline,Num,Cond
ADVS,PCHG,Percent Change from Baseline,Num,Cond
ADVS,ABLFL,Baseline Record Flag,Char,Req
ADVS,ANRLO,Analysis Normal Range Lower Limit,Num,Cond
ADVS,ANRHI,Analysis Normal Range Upper Limit,Num,Cond
ADVS,ANRIND,Analysis Reference Range Indicator,Char,Cond
ADVS,AVISIT,Analysis Visit,Char,Req
ADVS,AVISITN,Analysis Visit (N),Num,Req
ADVS,ADT,Analysis Date,Num,Req
ADVS,ADY,Analysis Relative Day,Num,Cond
ADVS,ATPT,Analysis Timepoint,Char,Cond
ADVS,ATPTN,Analysis Timepoint (N),Num,Cond
ADVS,DTYPE,Derivation Type,Char,Cond
ADVS,SAFFL,Safety Population Flag,Char,Req
ADVS,ONTRTFL,On Treatment Record Flag,Char,Cond
ADVS,ANL01FL,Analysis Flag 01,Char,Cond
ADVS,VSSEQ,Sequence Number,Num,Cond
ADVS,VSTESTCD,Vital Signs Test Code,Char,Cond
ADEG,STUDYID,Study Identifier,Char,Req
ADEG,USUBJID,Unique Subject Identifier,Char,Req
ADEG,TRTA,Actual Treatment,Char,Req
ADEG,TRTAN,Actual Treatment (N),Num,Req
ADEG,PARAMCD,Parameter Code,Char,Req
ADEG,PARAM,Parameter,Char,Req
ADEG,PARAMN,Parameter (N),Num,Cond
ADEG,PARCAT1,Parameter Category 1,Char,Cond
ADEG,AVAL,Analysis Value,Num,Req
ADEG,AVALC,Analysis Value (C),Char,Cond
ADEG,BASE,Baseline Value,Num,Cond
ADEG,CHG,Change from Baseline,Num,Cond
ADEG,PCHG,Percent Change from Baseline,Num,Cond
ADEG,ABLFL,Baseline Record Flag,Char,Req
ADEG,ANRLO,Analysis Normal Range Lower Limit,Num,Cond
ADEG,ANRHI,Analysis Normal Range Upper Limit,Num,Cond
ADEG,ANRIND,Analysis Reference Range Indicator,Char,Cond
ADEG,AVISIT,Analysis Visit,Char,Req
ADEG,AVISITN,Analysis Visit (N),Num,Req
ADEG,ADT,Analysis Date,Num,Req
ADEG,ADY,Analysis Relative Day,Num,Cond
ADEG,ATPT,Analysis Timepoint,Char,Cond
ADEG,ATPTN,Analysis Timepoint (N),Num,Cond
ADEG,DTYPE,Derivation Type,Char,Cond
ADEG,SAFFL,Safety Population Flag,Char,Req
ADEG,ONTRTFL,On Treatment Record Flag,Char,Cond
ADEG,EGSEQ,Sequence Number,Num,Cond
ADEG,EGTESTCD,ECG Test Code,Char,Cond
ADMH,STUDYID,Study Identifier,Char,Req
ADMH,USUBJID,Unique Subject Identifier,Char,Req
ADMH,TRTA,Actual Treatment,Char,Req
ADMH,TRTAN,Actual Treatment (N),Num,Req
ADMH,MHTERM,Reported Term for Medical History,Char,Req
ADMH,MHDECOD,Dictionary-Derived Term,Char,Cond
ADMH,MHBODSYS,Body System or Organ Class,Char,Cond
ADMH,MHCAT,Category,Char,Cond
ADMH,MHSCAT,Subcategory,Char,Cond
ADMH,ASTDT,Analysis Start Date,Num,Cond
ADMH,AENDT,Analysis End Date,Num,Cond
ADMH,ASTDTF,Analysis Start Date Imputation Flag,Char,Cond
ADMH,AENDTF,Analysis End Date Imputation Flag,Char,Cond
ADMH,AREL,Analysis Relatedness to Treatment,Char,Cond
ADMH,SAFFL,Safety Population Flag,Char,Req
ADMH,MHSEQ,Sequence Number,Num,Cond
ADMH,AGE,Age,Num,Cond
ADMH,SEX,Sex,Char,Cond
ADMH,RACE,Race,Char,Cond
ADEX,STUDYID,Study Identifier,Char,Req
ADEX,USUBJID,Unique Subject Identifier,Char,Req
ADEX,TRTA,Actual Treatment,Char,Req
ADEX,TRTAN,Actual Treatment (N),Num,Req
ADEX,PARAMCD,Parameter Code,Char,Req
ADEX,PARAM,Parameter,Char,Req
ADEX,PARAMN,Parameter (N),Num,Cond
ADEX,PARCAT1,Parameter Category 1,Char,Cond
ADEX,AVAL,Analysis Value,Num,Req
ADEX,AVALC,Analysis Value (C),Char,Cond
ADEX,ASTDT,Analysis Start Date,Num,Cond
ADEX,AENDT,Analysis End Date,Num,Cond
ADEX,ASTDY,Analysis Start Relative Day,Num,Cond
ADEX,AENDY,Analysis End Relative Day,Num,Cond
ADEX,ADURN,Analysis Duration (N),Num,Cond
ADEX,ADURU,Analysis Duration Units,Char,Cond
ADEX,ABLFL,Baseline Record Flag,Char,Cond
ADEX,AVISIT,Analysis Visit,Char,Cond
ADEX,AVISITN,Analysis Visit (N),Num,Cond
ADEX,ADT,Analysis Date,Num,Cond
ADEX,SAFFL,Safety Population Flag,Char,Req
ADEX,EXSEQ,Sequence Number,Num,Cond
ADEX,EXDOSE,Dose per Administration,Num,Cond
ADEX,EXDOSU,Dose Units,Char,Cond
ADPC,STUDYID,Study Identifier,Char,Req
ADPC,USUBJID,Unique Subject Identifier,Char,Req
ADPC,TRTA,Actual Treatment,Char,Req
ADPC,TRTAN,Actual Treatment (N),Num,Req
ADPC,PARAMCD,Parameter Code,Char,Req
ADPC,PARAM,Parameter,Char,Req
ADPC,PARAMN,Parameter (N),Num,Cond
ADPC,PARCAT1,Parameter Category 1,Char,Cond
ADPC,AVAL,Analysis Value,Num,Req
ADPC,AVALC,Analysis Value (C),Char,Cond
ADPC,AVALU,Analysis Value Unit,Char,Cond
ADPC,ABLFL,Baseline Record Flag,Char,Cond
ADPC,AVISIT,Analysis Visit,Char,Cond
ADPC,AVISITN,Analysis Visit (N),Num,Cond
ADPC,ADT,Analysis Date,Num,Cond
ADPC,ATM,Analysis Time,Char,Cond
ADPC,ADTM,Analysis Datetime,Num,Cond
ADPC,ATPT,Analysis Timepoint,Char,Cond
ADPC,ATPTN,Analysis Timepoint (N),Num,Cond
ADPC,ARRLT,Actual Relative Time from Ref Dose,Num,Cond
ADPC,NRRLT,Nominal Relative Time from Ref Dose,Num,Cond
ADPC,PCTPT,Planned Time Point,Char,Cond
ADPC,PCTPTNUM,Planned Time Point (N),Num,Cond
ADPC,PCSPEC,Specimen Material Type,Char,Cond
ADPC,SAFFL,Safety Population Flag,Char,Req
ADPC,PKFL,PK Concentration Flag,Char,Cond
ADPC,PPFL,PK Parameter Flag,Char,Cond
ADPC,DTYPE,Derivation Type,Char,Cond
ADPC,AFRLT,Actual Relative Time from First Dose,Num,Cond
ADPC,NFRLT,Nominal Relative Time from First Dose,Num,Cond
ADPP,STUDYID,Study Identifier,Char,Req
ADPP,USUBJID,Unique Subject Identifier,Char,Req
ADPP,TRTA,Actual Treatment,Char,Req
ADPP,TRTAN,Actual Treatment (N),Num,Req
ADPP,PARAMCD,Parameter Code,Char,Req
ADPP,PARAM,Parameter,Char,Req
ADPP,PARAMN,Parameter (N),Num,Cond
ADPP,PARCAT1,Parameter Category 1,Char,Cond
ADPP,AVAL,Analysis Value,Num,Req
ADPP,AVALC,Analysis Value (C),Char,Cond
ADPP,AVALU,Analysis Value Unit,Char,Cond
ADPP,ABLFL,Baseline Record Flag,Char,Cond
ADPP,AVISIT,Analysis Visit,Char,Cond
ADPP,AVISITN,Analysis Visit (N),Num,Cond
ADPP,ADT,Analysis Date,Num,Cond
ADPP,SAFFL,Safety Population Flag,Char,Req
ADPP,PKFL,PK Concentration Flag,Char,Cond
ADPP,PPFL,PK Parameter Flag,Char,Cond
ADPP,PPSPEC,Specimen Material Type,Char,Cond
ADPP,PPCAT,Parameter Category,Char,Cond
ADPP,PPRFDTC,Reference Dose Date/Time,Char,Cond
ADPP,DTYPE,Derivation Type,Char,Cond
ADRS,STUDYID,Study Identifier,Char,Req
ADRS,USUBJID,Unique Subject Identifier,Char,Req
ADRS,TRTA,Actual Treatment,Char,Req
ADRS,TRTAN,Actual Treatment (N),Num,Req
ADRS,PARAMCD,Parameter Code,Char,Req
ADRS,PARAM,Parameter,Char,Req
ADRS,PARAMN,Parameter (N),Num,Cond
ADRS,PARCAT1,Parameter Category 1,Char,Cond
ADRS,AVAL,Analysis Value,Num,Req
ADRS,AVALC,Analysis Value (C),Char,Cond
ADRS,ABLFL,Baseline Record Flag,Char,Cond
ADRS,BASE,Baseline Value,Num,Cond
ADRS,BASEC,Baseline Value (C),Char,Cond
ADRS,CHG,Change from Baseline,Num,Cond
ADRS,PCHG,Percent Change from Baseline,Num,Cond
ADRS,AVISIT,Analysis Visit,Char,Cond
ADRS,AVISITN,Analysis Visit (N),Num,Cond
ADRS,ADT,Analysis Date,Num,Cond
ADRS,ADTF,Analysis Date Imputation Flag,Char,Cond
ADRS,AENDT,Analysis End Date,Num,Cond
ADRS,AENDTF,Analysis End Date Imputation Flag,Char,Cond
ADRS,DTYPE,Derivation Type,Char,Cond
ADRS,ANL01FL,Analysis Record Flag 01,Char,Cond
ADRS,CRIT1,Analysis Criterion 1,Char,Cond
ADRS,CRIT1FL,Criterion 1 Evaluation Result Flag,Char,Cond
ADRS,SAFFL,Safety Population Flag,Char,Req
ADRS,ITTFL,Intent-to-Treat Population Flag,Char,Req
ADRS,EFFFL,Efficacy Population Flag,Char,Cond
ADRS,RSSEQ,Sequence Number,Num,Cond
ADTR,STUDYID,Study Identifier,Char,Req
ADTR,USUBJID,Unique Subject Identifier,Char,Req
ADTR,TRTA,Actual Treatment,Char,Req
ADTR,TRTAN,Actual Treatment (N),Num,Req
ADTR,PARAMCD,Parameter Code,Char,Req
ADTR,PARAM,Parameter,Char,Req
ADTR,PARAMN,Parameter (N),Num,Cond
ADTR,PARCAT1,Parameter Category 1,Char,Cond
ADTR,AVAL,Analysis Value,Num,Req
ADTR,AVALC,Analysis Value (C),Char,Cond
ADTR,ABLFL,Baseline Record Flag,Char,Cond
ADTR,BASE,Baseline Value,Num,Cond
ADTR,CHG,Change from Baseline,Num,Cond
ADTR,PCHG,Percent Change from Baseline,Num,Cond
ADTR,AVISIT,Analysis Visit,Char,Cond
ADTR,AVISITN,Analysis Visit (N),Num,Cond
ADTR,ADT,Analysis Date,Num,Cond
ADTR,ADTF,Analysis Date Imputation Flag,Char,Cond
ADTR,DTYPE,Derivation Type,Char,Cond
ADTR,ANL01FL,Analysis Record Flag 01,Char,Cond
ADTR,SAFFL,Safety Population Flag,Char,Req
ADTR,ITTFL,Intent-to-Treat Population Flag,Char,Req
ADTR,EFFFL,Efficacy Population Flag,Char,Cond
ADTR,TRGRPID,Tumor Group ID,Char,Cond
ADTR,TRLNKID,Tumor Link ID,Char,Cond
ADTR,TRSEQ,Sequence Number,Num,Cond
