| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
|---|---|---|---|---|---|
STUDYID | Study Identifier | text | |||
| USUBJID | Unique Subject Identifier | text | |||
| SITEID | Study Site Identifier | text | |||
| ASTDT | Analysis Start Date | integer | |||
| ASTDTM | Analysis Start Date/Time | integer | |||
| AENDT | Analysis End Date | integer | |||
| AENDTM | Analysis End Date/Time | integer | |||
| ASTDY | Analysis Start Relative Day | integer | |||
| AENDY | Analysis End Relative Day | integer | |||
| APERIOD | Period | integer | |||
| APERIODC | Period (C) | text | |||
| APHASE | Phase | text | |||
| TRTEMFL | Treatment Emergent Analysis Flag | text | |||
| AETRTEM | Treatment Emergent Flag | text | |||
| AOCCFL | 1st Occurrence within Subject Flag | text | |||
| AOCCPFL | 1st Occurrence of Preferred Term Flag | text | |||
| AOCCSFL | 1st Occurrence of SOC Flag | text | |||
| AESER | Serious Event | text | |||
| AEREL | Causality | text | |||
| RELGR1 | Pooled Causality Group 1 | text | |||
| RELGR1N | Pooled Causality Group 1 (N) | integer | |||
| AETOXGR | Standard Toxicity Grade | text | |||
| ATOXGR | Analysis Toxicity Grade | text | |||
| ATOXGRN | Analysis Toxicity Grade (N) | integer | |||
| TRTP | Planned Treatment | text | |||
| COUNTRY | Country | text | |||
| AGE | Age | integer | |||
| SEX | Sex | text | |||
| RACE | Race | text | |||
| ETHNIC | Ethnicity | text | |||
| SAFFL | Safety Population Flag | text | |||
| RANDFL | Randomized Population Flag | text | |||
| TRTSDT | Date of First Exposure to Treatment | integer | |||
| TRTEDT | Date of Last Exposure to Treatment | integer | |||
| AETERM | Reported Term for the Adverse Event | text | |||
| AEBODSYS | Body System or Organ Class | text | |||
| AEDECOD | Dictionary-Derived Term | text | |||
| AEOUT | Outcome of Adverse Event | text | |||
| AESEQ | Sequence Number | integer |
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