ADAE Dataset Metadata
| Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
|---|---|---|---|---|---|---|---|
| ADAE | Adverse Events Analysis Dataset | OCCURRENCE DATA STRUCTURE | One record per subject per adverse event | Analysis | STUDYID, USUBJID, AEBODSYS, AEDECOD, AETERM | ADAE.xpt | ADAE.SAS/SAP |
ADAE Variable Metadata
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
|---|---|---|---|---|---|
STUDYID | Study Identifier | text | Req | AE.STUDYID | |
| USUBJID | Unique Subject Identifier | text | Req | AE.USUBJID | |
| AETERM | Reported Term for the Adverse Experience | 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 product 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 product 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 product 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 |
| TRTA | Actual Product | 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 |
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