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Variable NameVariable LabelTypeCodelist/Controlled TermsCoreNotes

STUDYID

Study IdentifierChar
ReqDM.STUDYID, ADSL STUDYID, and/or STUDYID from another ADaM or SDTM dataset appropriate to the analysis.
USUBJIDUnique Subject IdentifierChar
ReqDM.USUBJID, ADSL.USUBJID, and/or USUBJID from another ADaM or SDTM dataset appropriate to the analysis.
SUBJIDSubject Identifier for the StudyChar
PermDM.SUBJID, ADSL.SUBJID, and/or SUBJID from another ADaM dataset appropriate to the analysis. SUBJID is required in ADSL, but permissible in other datasets.
SITEIDStudy Site IdentifierChar
PermDM.SITEID, ADSL.SITEID, and/or SITEID from another ADaM dataset appropriate to the analysis. SITEID is required in ADSL, but permissible in other datasets.
ASTDTAnalysis Start DateNum
Cond

Created from converting MH.MHSTDTC from character ISO8601 format to numeric date format, applying imputation rules as specified in the SAP or metadata.
Conditional on whether start date is pertinent for study and is populated in SDTM.

AENDTAnalysis End DateNum
CondCreated from converting XX.--ENDTC from character ISO8601 format to numeric date format, applying imputation rules as specified in the SAP or metadata.
Conditional on whether end date is pertinent for study and is populated in SDTM.
ASTDYAnalysis Start Relative DayNum
CondExample derivation:
ASTDT – ADSL.TRTSDT + 1 if ASTDT ≥ TRTSDT, else ASTDT – ADSL.TRTSDT if ASTDT< TRTSDT
This variable may instead be copied from --STDY.
Conditional on whether analysis start relative day is pertinent to the study.
AENDYAnalysis End Relative DayNum
CondExample derivation:
AENDT – ADSL.TRTSDT + 1 if AENDT ≥ TRTSDT, else AENDT – ADSL.TRTSDT if AENDT < TRTSDT
This variable may instead be copied from --ENDY.
AOCCFL1st Occurrence within Subject FlagCharYPermCharacter indicator for the first occurrence of any event/intervention/finding within the subject.
Example derivation: Sort the data in the required order and flag the first treatment emergent record for each subject.
AOCCPFL1st Occurrence of Preferred Term FlagCharYPermCharacter indicator for the first occurrence of the preferred term within the subject.
Example derivation: Sort the data in the required order and flag the first treatment emergent record for each MHDECOD for each subject.
AOCCSFL1st Occurrence of SOC FlagCharYPermCharacter indicator for the first occurrence of the system organ class within the subject.
Example derivation: Sort the data in the required order and flag the first treatment emergent record for each body system for each subject.
TRTPPlanned TreatmentChar
CondTRTP is a record-level identifier that represents the planned treatment attributed to a record for analysis purposes. TRTP indicates how treatment varies by record within a subject and enables analysis of crossover and other designs. Though there is no requirement that TRTP will correspond to the TRTxxP as defined by the record's value of APERIOD, if populated, TRTP must match at least one value of the character planned treatment variables in ADSL (e.g., TRTxxP, TRTSEQP, TRxxPGy).
As noted previously, at least one treatment variable is required even in non-randomized trials. This requirement is satisfied by any subject-level or record-level treatment variables (e.g., TRTxxP, TRTP, TRTA). Even if not used for analysis, any ADSL treatment variable may be included in the BDS dataset.
TRTxxPPlanned Treatment for Period xxChar
CondADSL.TRTxxP
TRTAActual TreatmentChar
CondTRTA is a record-level identifier that represents the actual treatment attributed to a record for analysis purposes. TRTA indicates how treatment varies by record within a subject and enables analysis of crossover and other multi-period designs. Though there is no requirement that TRTA will correspond to the TRTxxA as defined by the record's value of APERIOD, TRTA must match at least one value of the character actual treatment variables in ADSL (e.g., TRTxxA, TRTSEQA, TRxxAGy).
As noted previously, at least one treatment variable is required. This requirement is satisfied by any subject-
TRTxxAActual Treatment for Period xxChar
CondADSL.TRTxxA
COUNTRYCountryChar
PermADSL.COUNTRY
AGEAgeNum
PermADSL.AGE
SEXSexChar
PermADSL.SEX
RACERaceChar
PermADSL.RACE
ETHNICEthnicityChar
PermADSL.ETHNIC
SAFFLSafety Population FlagChar
CondSDSL.SAFFL
RANDFLRandomized Population FlagChar
CondADSL.RANDFL
TRTSDTDate of First Exposure to TreatmentNum
PermADSL.TRTSDT
TRTEDTDate of Last Exposure to TreatmentNum
PermADSL.TRTEDT
MHTERMReported Term
for the Medical
History
Char
ReqMH.MHTERM
MHBODSYSBody System or Organ ClassChar
CondMH.MHBODSYS
MHDECODDictionary-Derived TermChar
CondMH.MHDECOD
MHSEQSequence NumberNum
PermMH.MHSEQ
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