| 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 CM.CMSTDTC from character ISO8601 format to numeric date format, applying imputation rules as specified in the SAP or metadata. | |
| AENDT | Analysis End Date | Num | Cond | Created 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. | |
| 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. | |
| 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. |
| AOCCzzFL | 1st Occurrence of …. | Char | Y | Perm | Additional flag variables as needed for analysis. Derivation rules for these flags need to be described in the metadata. |
| 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 | |
| CMTRT | Reported Name of Drug, Med, or Therapy | Char | Req | CM.CMTRT | |
| CMDECOD | Standardized Medication Name | Char | Cond | CM.CMDECOD | |
| CMCLAS | Medication Class | Char | Req | CM.CMCLAS | |
| ATCy | ATC Level y Text | Char | Perm | Corresponds to the ATC Level Text for WHO Drug. Include the dictionary version in the variable metadata. Conditional, based on analysis at multiple levels (y) | |
| CMCAT | CM.CMCAT | ||||
| CMSCAT | CM.CMSCAT | ||||
| ACATy | Analysis Category y | Char | Category 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. | ||
| CMSEQ | Sequence Number | Num | Perm | CM.CMSEQ | |
| 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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