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 |