| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
|---|
| STUDYID | Study Identifier | Char |
| Req | DM.STUDYID |
| USUBJID | Unique Subject Identifier | Char |
| Req | DM.USUBJID |
| SUBJID | Subject Identifier for the Study | Char |
| Req | DM.SUBJID |
| SITEID | Study Site Identifier | Char |
| Req | DM.SITEID |
| AGE | Age | Num |
| Req | DM.AGE |
| AGEU | Age Units | Char | (AGEU) | Req | DM.AGEU |
| AGEGR1 | Pooled Age Group 1 | Char |
| Perm | Character description of a grouping or pooling of the subject's age for analysis purposes. |
| SEX | Sex | Char | (SEX) | Req | DM.SEX |
| RACE | Race | Char | (RACE) | Req | DM.RACE |
| ETHNIC | Ethnicity | Char |
| Perm | DM.ETHNIC |
| SAFFL | Safety Population Flag | Char | Y; N | Cond | Y if ADSL.TRTSDT is not null, otherwise N |
| RANDFL | Randomized Population Flag | Char | Y; N | Cond | Y if the subject was randomized, otherwise N |
| ARM | Description of Planned Arm | Char |
| Req | DM.ARM |
| ACTARM | Description of Actual Arm | Char |
| Perm | DM.ACTARM |
| TRT01P | Planned Product for Period 01 | Char |
| Req | DM.ARM |
| TRT01PN | Planned Product for Period 01 (N) | Num |
| Perm | Assigned based on the ARM value |
| TRT01A | Actual Product for Period 01 | Char |
| Cond | DM.ACTARM |
| TRT01AN | Actual Product for Period 01 (N) | Num |
| Perm | Assigned based on the ACTARM value |
| TRTSDT | Date of First Exposure to Product | Num |
| Cond | Numeric version of RFXSTDTC |
| TRTEDT | Date of Last Exposure to Product | Num |
| Cond | Numeric version of RFXENDTC |
| EOSSTT | End of Study Status | Char | (SBJTSTAT) | Perm | The subject's status as of the end of study or data cutoff. Examples: COMPLETED, DISCONTINUED, ONGOING. |
| EOSDT | End of Study Date | Num |
| Perm | Date subject ended the study - either date of completion or date of discontinuation or data cutoff date for interim analyses. |
| DCSREAS | Reason for Discontinuation from Study | Char |
| Perm | Reason for subject's discontinuation from study. The source would most likely be the SDTM DS dataset. Null for subjects who completed the study. |
| EOTSTT | End of Product Status | Char | (SBJTSTAT) | Perm | The subject's status as of the end of product or data cutoff. Examples: COMPLETED, DISCONTINUED, ONGOING. |
| DCTREAS | Reason for Discontinuation of Product | Char |
| Perm | If a subject discontinued product in the study, then this variable indicates the reason for discontinuation. This is for discontinuation of product in the overall study and not to be used for discontinuation reason within individual product periods. |
| RANDDT | Date of Randomization | Num |
| Cond | DS.DSSTDTC where DSDECOD=RANDOMIZED |