| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
|---|---|---|---|---|---|
STUDYID | Study Identifier | text | |||
| USUBJID | Unique Subject Identifier | text | |||
| SITEID | Study Site Identifier | text | |||
TRT01P | Planned Treatment for Period 01 | text | |||
| TRT01A | Actual Treatment for Period 01 | text | |||
| ASTDT | Analysis Start Date | integer | |||
| AENDT | Analysis End Date | integer | |||
| ASTDY | Analysis Start Relative Day | integer | |||
| AENDY | Analysis End Relative Day | integer | |||
| AOCCFL | 1st Occurrence within Subject Flag | text | |||
| AOCCPFL | 1st Occurrence of Preferred Term Flag | text | |||
| AOCCSFL | 1st Occurrence of SOC Flag | text | |||
| COUNTRY | Country | text | |||
| AGE | Age | integer | |||
| SEX | Sex | text | |||
| RACE | Race | text | |||
| ETHNIC | Ethnicity | text | |||
| SAFFL | Safety Population Flag | text | |||
| COMPLFL | Completers Population Flag | text | |||
| RANDFL | Randomized Population Flag | text | |||
| TRTSDT | Date of First Exposure to Treatment | integer | |||
| TRTEDT | Date of Last Exposure to Treatment | integer | |||
| MHTERM | Reported Term for the Medical History | text | |||
| MHBODSYS | Body System or Organ Class | text | |||
| MHDECOD | Dictionary-Derived Term | text | |||
| MHSEQ | Sequence Number | integer | |||
| MHSPID | Sponsor-Defined Identifier | text |
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