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changes.mady.by.user Christine Connolly

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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 IdentifierCharReqDM.USUBJID, ADSL.USUBJID, and/or USUBJID from another ADaM or SDTM dataset appropriate to the analysis.SUBJIDSubject Identifier for the StudyCharPermDM.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 IdentifierCharPermDM.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 DateNumCond

Created from converting CM.CMSTDTC 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 DateNumCondCreated from converting CM.CMENDTC 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 DayNumCondExample 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 DayNumCondExample derivation:
AENDT – ADSL.TRTSDT + 1 if AENDT ≥ TRTSDT, else AENDT – ADSL.TRTSDT if AENDT < TRTSDT
This variable may instead be copied from --ENDY.APERIODPeriodNumCondAPERIOD is a record-level timing variable that represents the analysis period within the study associated with the record for analysis purposes. The value of APERIOD (if populated) must be one of the xx values found in the ADSL TRTxxP variable names. APERIOD is required if ASPER is present. APERIOD must be populated on all records where ASPER is populatedAPERIODCPeriod (C)CharPermText characterizing to which period the record belongs. One-to-one map to APERIOD.APHASEPhaseCharPermAPHASE is a categorization of timing within a study, for example a higher-level categorization of APERIOD or an analysis epoch. For example, APHASE could describe spans of time for SCREENING, ON TREATMENT, and FOLLOW-UP. APHASE may be used alone or in addition to APERIOD. APHASE is independent of TRTxxP within ADSL. APHASE may be populated for spans of time where a subject is not on treatment. The value of APHASE (if populated) must be one of the values found in the ADSL APHASEw variables.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 AEDECOD for each subject.AOCCzzFL1st Occurrence of ….CharYPermAdditional flag variables as needed for analysis. Derivation rules for these flags need to be described in the metadata.TRTPPlanned TreatmentCharCondTRTP 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 xxCharCondADSL.TRTxxPTRTAActual TreatmentCharCondTRTA 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 xxCharCondADSL.TRTxxACOUNTRYCountryCharPermADSL.COUNTRYAGEAgeNumPermADSL.AGESEXSexCharPermADSL.SEXRACERaceCharPermADSL.RACEETHNICEthnicityCharPermADSL.ETHNICSAFFLSafety Population FlagCharCondSDSL.SAFFLRANDFLRandomized Population FlagCharCondADSL.RANDFLTRTSDTDate of First Exposure to TreatmentNumPermADSL.TRTSDTTRTEDTDate of Last Exposure to TreatmentNumPermADSL.TRTEDTCMTRTReported Name of Drug, Med, or TherapyCharReqCM.CMTRTCMDECODStandardized Medication NameCharCondCM.CMDECODCMCLASMedication ClassCharReqCM.CMCLASATCyATC Level y TextCharPermCorresponds to the ATC Level Text for WHO Drug. Include the dictionary version in the variable metadata.
Conditional, based on analysis at multiple levels (y)CMCATCM.CMCATCMSCATCM.CMSCATACATyAnalysis Category yCharCategory used in analysis. May be derived from --CAT and/or --SCAT. Examples include records of special interest like prohibited medications, concomitant medications taken during an infusion reaction, growth factors, antimicrobial medications, and other such categories not defined elsewhere or present in SDTM domains.CMSEQSequence NumberNumPermCM.CMSEQCQzzNAMCustomized Query zz NameCharCondThe customized query (CQ) name or name of the AE of special interest category based on a grouping of terms. Would be blank for terms that are not in the CQ.
Conditional on whether CQ analysis is done.
Examples: “DERMATOLOGICAL EVENTS” “CARDIAC EVENTS”, “IARS (INFUSION ASSOCIATED REACTIONS)”
USUBJIDASTDTAENDTASTDYAENDYCMSTDTCCMENDTCAOCCFLAOCCPFLAOCC01FLTRTPSAFFLCMTRTCMDECODCMDOSECMDOSTXTCMDOSUCMCLASCMSEQ
ABC123ABC1230100101JAN200401JAN2004112004-01-012004-01-01




ASPIRIN
100
mg
1
ABC123ABC1230100102JAN200402JAN2004222004-01-022004-01-02




ASPIRIN
100
mg
2
ABC123ABC1230100103JAN200403JAN2004332004-01-032004-01-03




ASPIRIN
100
mg
3
ABC123ABC1230100107JAN200407JAN2004772004-01-072004-01-07




ASPIRIN
100
mg
4
ABC123ABC1230100107JAN200407JAN2004772004-01-072004-01-07




ASPIRIN
100
mg
5
ABC123ABC1230100109JAN200409JAN2004992004-01-092004-01-09




ASPIRIN
100
mg
6
ABC123ABC12301002



2004





DIOVAN
20
mg
1
ABC123ABC12301002



2004-01





ZOLOFT
50
mg
2
ABC123ABC1230100209JAN200410JUN20049102004-01-092004-06-10




ASTELIN

2 sprays in each nostril-137 mcgmcg
3
ABC123ABC1230100301JAN2004
1
2004-01-01





ASPIRIN
100
mg
1