| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Notes |
|---|---|---|---|---|
| STUDYID | Study Identifier | text | DM.STUDYID | |
| USUBJID | Unique Subject Identifier | text | DM.USUBJID | |
| SAFFL | Safety Population Flag | text | Y; N | Y if ADSL.TR01SDT is not null, otherwise N |
| EFFFL | Efficacy Population Flag | text | Y; N | Y if ADSL.SAFFL=Y and at least one post-baseline assessment was done, otherwise N |
| TRT01P | Planned Treatment for Period 01 | text | TREAT A; TREAT B | Set to DM.ARM |
| TRT01A | Actual Treatment for Period 01 | text | TREAT A; TREAT B | Set to EX.EXTRT |
| TRTSDT | integer | Set to date part of DM.RFXSTDTC captured as a numeric variable | ||
| TRTEDT | integer | Set to date part of DM.RFXENDTC and capture as a numeric variable | ||
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