| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
|---|---|---|---|---|---|
STUDYID | Study Identifier | text | |||
| USUBJID | Unique Subject Identifier | text | |||
| SITEID | Study Site Identifier | text | |||
| CMTRT | Reported Name of Drug, Med, or Therapy | text | |||
| CMDECOD | Standardized Medication Name | text | |||
| ASTDT | Analysis Start Date | integer | |||
| AENDT | Analysis End Date | integer | |||
| ASTDY | Analysis Start Relative Day | integer | |||
| AENDY | Analysis End Relative Day | integer | |||
| APERIOD | Period | integer | |||
| APERIODC | Period (C) | text | |||
| APHASE | Phase | text | |||
| ONTRTFL | On Treatment Record Flag | text | |||
| FUPFL | |||||
| PREFL | Pre-treatment Flag | text | |||
| 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 | |||
| CMATC | WHO-DD ATC Text | text | |||
| CMATC1 | WHO-DD ATC Level 1 | text | |||
| CMATC1CD | WHO-DD ATC Level 1 Code | text | |||
| CMATC2 | WHO-DD ATC Level 2 | text | |||
| CMATC2CD | WHO-DD ATC Level 2 Code | text | |||
| CMATC3 | WHO-DD ATC Level 3 | text | |||
| CMATC3CD | WHO-DD ATC Level 3 Code | text | |||
| CMATCCD | WHO-DD ATC Code | text | |||
| CMSTDTC | Start Date/Time of Medication | datetime | |||
| CMENDTC | End Date/Time of Medication | datetime | |||
| CMENRF | End Relative to Reference Period | text | |||
| CMPT | Preferred Term | text | |||
| CMSEQ | Sequence Number | integer |
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