| 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 |
|