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ReqDM.USUBJID, ADSL.USUBJID, and/or from another ADaM or SDTM dataset appropriate to the analysis.PermCreated from converting AE.AESTDTC from character ISO8601 format to numeric time format, applying imputation rules as specified in the SAP or metadata.Created from converting XX.--ENDTC from character ISO8601 format to numeric time format, applying imputation rules as specified in the SAP or metadata.Example derivation:
ASTDT – ADSL.TRTSDT + 1 if ASTDT ≥ TRTSDT, else ASTDT – ADSL.TRTSDT if ASTDT< TRTSDT
This variable may instead be copied from --STDY.Treatment emergent flag as defined for analysis. Variable TRTEMFL is to be used for any analysis of treatment-emergent AEs. This variable is conditional on whether the concept of treatment emergent is a key feature of the AE analyses.
Example derivation:=’Y’
The number x is defined by the producer and often incorporates the known half-life of the drug. It should be consistent with variable APHASE (described above) if APHASE is also used.Treatment emergent flag from SDTM, if available. See the SDTMIG version 3.2 [3] for more information.
Derivation:
SUPPAE.QVAL where QNAM=’AETRTEM’. due to different definitions, date imputation and other analysis rules. Including AETRTEM in addition to TRTEMFL will add traceability.Character indicator for the first occurrence of any event/intervention/finding within the subject.Character 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.Character 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.Char

Variable Name	Variable Label	Type	Codelist/Controlled Terms	Core	Notes
STUDYID	Study Identifier	Char		DM.STUDYID, ADSL STUDYID, and/or STUDYID from another ADaM or SDTM dataset appropriate to the analysis.	USUBJID	Unique Subject Identifier	Char	Req	USUBJID	SUBJID	Subject Identifier for the Study	Char	Perm	DM.SUBJID, ADSL.SUBJID, and/or SUBJID from another ADaM dataset appropriate to the analysis. SUBJID is required in ADSL, but permissible in other datasets.	SITEID	Study Site Identifier	Char		DM.SITEID, ADSL.SITEID, and/or SITEID from another ADaM dataset appropriate to the analysis. SITEID is required in ADSL, but permissible in other datasets.	ASTDT	Analysis Start Date	Num	Cond	Created from converting AE.AESTDTC 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.	ASTDTM	Analysis Start Date/Time	Num	Cond	Conditional on whether start time is pertinent for study and is populated in SDTM.	AENDT	Analysis End Date	Num	Cond	Created 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.	AENDTM	Analysis End Date/Time	Num	Cond	Conditional on whether end time is pertinent for study and is populated in SDTM.	ASTDY	Analysis Start Relative Day	Num	Cond	Conditional on whether analysis start relative day is pertinent to the study.	AENDY	Analysis End Relative Day	Num	Cond	Example derivation: AENDT – ADSL.TRTSDT + 1 if AENDT ≥ TRTSDT, else AENDT – ADSL.TRTSDT if AENDT < TRTSDT This variable may instead be copied from --ENDY.	APERIOD	Period	Num	Cond	APERIOD 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 populated	APERIODC	Period (C)	Char	Perm	Text characterizing to which period the record belongs. One-to-one map to APERIOD.	APHASE	Phase	Char	Perm	APHASE 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.	TRTEMFL	Treatment Emergent Analysis Flag	Char	Y	Cond	If ADSL.TRTSDT≤ASTDT≤ADSL.TRTEDT + x days then	TRTEMFL	AETRTEM	Treatment Emergent Flag	Char	(NY)	Perm	TRTEMFL may differ from	AETRTEM		AOCCFL	1st Occurrence within Subject Flag	Char	Y	Perm	Example derivation: Sort the data in the required order and flag the first treatment emergent record for each subject.	AOCCPFL	1st Occurrence of Preferred Term Flag	Char	Y	Perm	AOCCSFL	1st Occurrence of SOC Flag	Char	Y	Perm	AESER	Serious Event	(NY)	Req	AE.AESER	AEREL	Causality	Char	Perm	AE.AEREL	RELGRy	Pooled Causality Group y	Char	Perm	Pooled grouping of causality of study drug for analysis (e.g. related, Not related).	RELGRyN	Pooled Causality Group y (N)	Num	Perm	Code of RELGRy to numeric Low relation should correspond to low value	AETOXGR	Standard Toxicity Grade	Char	Perm	AE.AETOXGR	ATOXGR	Analysis Toxicity Grade	Char	Perm	Toxicity grade for analysis. May be based on AETOXGR or an imputed or assigned value. May change case of text, such as from all uppercase in AETOXGR to mixed case in ATOXGR.	ATOXGRN	Analysis Toxicity Grade (N)	Num	Perm	Code ATOXGR to numeric Low toxicity should correspond to low value
AEACN	Action Taken with Study Treatment	Char	(ACN)	Perm	AE.AEACN
TRTP	Planned Treatment	Char	Cond	TRTP 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.	TRTxxP	Planned Treatment for Period xx	Char	Cond	ADSL.TRTxxP	TRTA	Actual Treatment	Char	Cond
AEREL	RELGR1	AETOXGR	AEACN	TRTA	SAFFL	TRTSDT	TRTEDT	AETERM	AEBODSYS	AEDECOD	AEOUT
		Num		Perm
		Num		Perm
		Char		Req
		Char		Req
		Char		Req
		Char		Perm
		Num		Perm													AESEQ
		Char		Cond													SMQzzNAM
		Char		Cond													SMQzzSC
		Char		Cond													CQzzNAM
TRTA 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-	TRTxxA	Actual Treatment for Period xx	Char	Cond	ADSL.TRTxxA	COUNTRY	Country	Char	Perm	ADSL.COUNTRY	AGE	Age	Num	Perm	ADSL.AGE	SEX	Sex	Char	Perm	ADSL.SEX	RACE	Race	Char	Perm	ADSL.RACE	ETHNIC	Ethnicity	Char	Perm	ADSL.ETHNIC	SAFFL	Safety Population Flag	Char	Cond	SDSL.SAFFL	RANDFL	Randomized Population Flag	Char	Cond	ADSL.RANDFL	TRTSDT	Date of First Exposure to Treatment	Num	Perm	ADSL.TRTSDT	TRTEDT	Date of Last Exposure to Treatment	Num	Perm	ADSL.TRTEDT	AETERM	Reported Term for the Adverse Event	Char	Req	AE.AETERM	AEBODSYS	Body System or Organ Class	Char	Req	AE.AEBODSYS	AEDECOD	Dictionary-Derived Term	Char	Req	AE.AEDECOD	AEOUT	Outcome of Adverse Event	Char	Perm	AE.AEOUT	AESEQ	Sequence Number	Num	Perm	AE.AESEQ	SMQzzNAM	SMQ zz Name	Char	Cond	The standardized MedDRA queries name. Would be blank for terms that are not in the SMQ. Therefore this variable could be blank for all records if no terms within the study were included in the SMQ. Conditional on whether SMQ analysis is done.
SMQzzSC	SMQ zz Scope	Char	BROAD; NARROW	Cond	The search strategy for SMQs can be narrow or broad. The preferred terms that are narrow in scope have high specificity for identifying events of interest while the broad terms have high sensitivity. By definition, all narrow terms are also considered within the broad scope. Therefore, to summarize all broad terms, terms with either narrow OR broad would be considered. Will be null for terms that do not meet the criteria. Conditional on whether SMQ analysis is done.
CQzzNAM	Customized Query zz Name	Char	Cond	The 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)”

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