| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
|---|---|---|---|---|---|
STUDYID | Study Identifier | Char | Req | DM.STUDYID, ADSL STUDYID, and/or STUDYID from another ADaM or SDTM dataset appropriate to the analysis. | |
| USUBJID | Unique Subject Identifier | Char | Req | DM.USUBJID, ADSL.USUBJID, and/or USUBJID from another ADaM or SDTM dataset appropriate to the analysis. | |
| 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 | Perm | 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. | |
| ASTDTM | Analysis Start Date/Time | Num | Cond | Created from converting AE.AESTDTC from character ISO8601 format to numeric time format, applying imputation rules as specified in the SAP or metadata. 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 | Created from converting XX.--ENDTC from character ISO8601 format to numeric time format, applying imputation rules as specified in the SAP or metadata. Conditional on whether end time is pertinent for study and is populated in SDTM. | |
| ASTDY | Analysis Start Relative Day | Num | Cond | Example 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. | |
| 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 | 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: If ADSL.TRTSDT≤ASTDT≤ADSL.TRTEDT + x days then TRTEMFL=’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. |
| AETRTEM | Treatment Emergent Flag | Char | (NY) | Perm | Treatment emergent flag from SDTM, if available. See the SDTMIG version 3.2 [3] for more information. Derivation: SUPPAE.QVAL where QNAM=’AETRTEM’. TRTEMFL may differ from AETRTEM due to different definitions, date imputation and other analysis rules. Including AETRTEM in addition to TRTEMFL will add traceability. |
| AOCCFL | 1st Occurrence within Subject Flag | Char | Y | Perm | Character 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. |
| AOCCPFL | 1st Occurrence of Preferred Term Flag | Char | Y | Perm | 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. |
| AOCCSFL | 1st Occurrence of SOC Flag | Char | Y | Perm | 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. |
| AESER | Serious Event | Char | (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 | 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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