| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
|---|
| Study Identifier | text |
| Req | AE.STUDYID |
| USUBJID | Unique Subject Identifier | text |
| Req | AE.USUBJID |
| AETERM | Reported Term for the Adverse Event | text |
| Req | AE.AETERM |
| AEMODIFY | Modified Reported Term | text |
| Perm | AE.MODIFY |
| AEBODSYS | Body System or Organ Class | text |
| Req | AE.AEBODSYS |
| AEDECOD | Dictionary-Derived Term | text |
| Req | AE.AEDECOD |
| ASTDT | Analysis Start Date | integer |
| Cond | Created from converting AE.AESTDTC from character ISO8601 format to numeric date format |
| AENDT | Analysis End Date | integer |
| Cond | Created from converting AE.AEENDTC from character ISO8601 format to numeric date format |
| ASTDY | Analysis Start Relative Day | integer |
| Cond | ASTDT – ADSL.TRTSDT + 1 if ASTDT ≥ TRTSDT, else ASTDT – ADSL.TRTSDT if ASTDT< TRTSDT |
| AENDY | Analysis End Relative Day | integer |
| Cond | AENDT – ADSL.TRTSDT + 1 if AENDT ≥ TRTSDT, else AENDT – ADSL.TRTSDT if AENDT < TRTSDT |
| PREFL | Pre-product Flag | text | Y | Cond | If ASTDT < ADSL.TRTSDT then PREFL=’Y’ |
| TRTEMFL | Productt Emergent Analysis Flag | text | Y | Cond | If ADSL.TRTSDT≤ASTDT then TRTEMFL=’Y’ |
| FUPFL | Follow-up Flag | text | Y | Cond | If ASTDT > ADSL.TRTEDT then FUPFL=’Y’
|
| AETRTEM | Product Emergent Flag | text | (NY) | Perm | SUPPAE.QVAL where QNAM=’AETRTEM’. |
| AOCCFL | 1st Occurrence within Subject Flag | text | Y | Perm | Sort the data in the required order and flag the first treatment emergent record for each subject. |
| AOCCPFL | 1st Occurrence of Preferred Term Flag | text | Y | Perm | Sort the data in the required order and flag the first treatment emergent record for each AEDECOD for each subject. |
| AOCCSFL | 1st Occurrence of SOC Flag | text | Y | Perm | Sort the data in the required order and flag the first treatment emergent record for each body system for each subject. |
| AESER | Serious Event | text | (NY) | Req | AE.AESER |
| AEREL | Causality | text |
| Perm | AE.AEREL |
| AERLDEV | Relationship of Event to Device | text | * | Perm | AE.AERLDEV |
| RELGR1 | Pooled Causality Group y | text |
| Perm | set to RELATED if AE.AEREL in (DEFINITELY,PROBABLY,POSSIBLY), set to NOT RELATED if AEREL in (PROBABLY NOT, DEFINITELY NOT) |
| AEACN | Action Taken with Study Product | text | (ACN) | Perm | AE.AEACN |
| AEACNDEV | Action Taken with Device | text |
| Perm | AE.AEACNDEV |
|---|
| AEOUT | Outcome of Adverse Event | text | (OUT) | Perm | AE.AEOUT |
|---|
| TRTP | Planned Product | text | Cond | ADSL.TRT01P | TRTA | Actual Treatment | text |
| Cond | ADSL.TRT01A |
| SAFFL | Safety Population Flag | text |
| Cond | ADSL.SAFFL |
| TRTSDT | Date of First Exposure to Product | integer |
| Perm | ADSL.TRTSDT |
| TRTEDT | Date of Last Exposure to Product | integer |
| Perm | ADSL.TRTEDT |
| AEOUT | Outcome of Adverse Event | text |
| Perm | AE.AEOUT |
| AESEQ | Sequence Number | integer |
| Perm | AE.AESEQ |
| AESTDTC | Start Date/Time of
Adverse Event | text |
| Perm | AE.AESTDTC |
| AEENDTC | End Date/Time of
Adverse Event | text |
| Perm | AE.AEENDTC |
| AESTDY | Study Day of Start of
Adverse Event | text |
| Perm | AE.AESTDY |
| AEENDY | Study Day of End of
Adverse Event | text |
| Perm | AE.AEENDY |
| AEENRF | End Relative to
Reference Period | text |
| Perm | AE.AEENRF |