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Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes |
| STUDYID | Study Identifier | text | CM.STUDYID | ||
| USUBJID | Unique Subject Identifier | text | CM.USUBJID | ||
| CMTRT | text | CM.CMTRT | |||
| CMDECOD | text | CM.CMDECOD | |||
| CMCLAS | text | CM.CMCLAS | |||
| ASTDT | Analysis Start Date | integer | numeric SAS date variable based on CMSTDTC with no imputation for partial dates | ||
| ASTDTF | |||||
| AENDT | Analysis End Date | integer | numeric SAS date variable based on CMENDTC with no imputation for partial dates | ||
| AENDTF | |||||
| ASTDY | Analysis Start Relative Day | integer | ASTDT-TRTSDT - add one if ASTDT is on or after TRTSDT | ||
| AENDY | Analysis End Relative Day | integer | AENDT-TRTSDT - add one if ASTDT is on or after TRTSDT | ||
| CMSTDTC | text | CM.CMSTDTC | |||
| CMENDTC | text | CM.CMENDTC | |||
| AOCCFL | 1st Occurrence within Subject Flag | text | Y | Perm | sort by USUBJID, CMCLAS, CMDECOD, CMSTDTC and then set to Y for the first record |
| AOCCPFL | 1st Occurrence of Preferred Term Flag | text | Y | Perm | sort by USUBJID, CMCLAS, CMDECOD, CMSTDTC and then set to Y for the first record within CMCLAS and CMDECOD |
| AOCC01FL | 1st Occurrence of CMCLAS | text | Y | Perm | sort by USUBJID, CMCLAS, CMDECOD, CMSTDTC and then set to Y for the first record within CMCLAS |
| PREFL | Pre-treatment Flag | text | Y | Cond | |
| ONTRTFL | On Treatment Record Flag | text | Y | Cond | |
| FUPFL | Follow-up Flag | text | Y | Cond | |
| TRTP | text | ADSL.TRT01P | |||
| CMDOSE | CM.CMDOSE | ||||
| CMDOSTXT | text | CM.CMDOSTXT | |||
| CMDOSU | text | CM.CMDOSU | |||
| SAFFL | text | ADSL.SAFFL | |||
| CMSEQ | integer | CM.CMSEQ |
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