| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
|---|
| Study Identifier |
CharDM.STUDYID, ADSL STUDYID, and/or STUDYID from another ADaM or SDTM dataset appropriate to the analysis.| MH.STUDYID |
| USUBJID | Unique Subject Identifier |
CharDM.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. | NumCreated from converting Convert 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.NumCreated from converting XX.--ENDTC | Convert MH.MHENDTC 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 < TRTSDTThis variable may instead be copied from --ENDY. |
| AOCCFL | 1st Occurrence within Subject Flag |
CharCharacter 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 |
CharCharacter 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. |
| AOCCSFL | 1st Occurrence of SOC Flag |
CharCharacter 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. |
| 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. | | text | Product A;Product B | Cond | ADSL.TRT01P |
TRTxxP | Planned Treatment for Period xx | Char | Cond | ADSL.TRTxxPTRTxxA | 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 | 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- | | text | Product A;Product B | Cond | ADSL.TRT01A |
| SAFFL | Safety Population Flag | text |
CharSDSL| ADSL.SAFFL |
| RANDFL | Randomized Population Flag | text |
Char| Y;N | Cond | ADSL.RANDFL |
| TRTSDT | Date of First Exposure to Treatment |
Num| integer |
| Perm | ADSL.TRTSDT |
| TRTEDT | Date of Last Exposure to Treatment |
Num| integer |
| Perm | ADSL.TRTEDT |
| MHTERM | Reported Term |
Char| text |
| Req | MH.MHTERM |
| MHDECOD | Dictionary-Derived Term | text |
| Cond | MH.MHDECOD |
| MHCAT | Category for Medical History | text |
| Perm | MH.MHCAT |
| MHBODSYS | Body System or Organ Class |
Char |
| MHSTDTC | Start Date/Time of Medical History Event | text |
| Perm | MH.MHSTDTC |
| MHENDTC | End Date/Time of Medical History Event | text |
| Perm | MH.MHENDTC |
MHDECOD | Dictionary-Derived Term | Char | Cond | MH.MHDECODNum