Variable Name | Variable Label | Type | Codelist | / Controlled Terms | Core | SubClass ADVERSE EVENT Core | CDISC Notes |
|---|
AOCCFL | 1st Occurrence within Subject Flag | Char | Y | Perm | Perm | Character indicator for the first occurrence of any event/intervention/finding within the subject Example derivation: Sort the data in the required order and flag the first treatment product emergent record for each subject. |
AOCCPFL | 1st Occurrence of Preferred Term Flag | Char | Y | Perm | Perm | Character indicator for the first occurrence of the preferred term within the subject Example derivation: Sort the data in the required order and flag the first treatment product emergent record for each --DECOD for each subject. |
AOCCIFL | 1st Max Sev./Int. Occurrence Flag | Char | Y | Perm | Perm | Character indicator for the first occurrence of the event/intervention/finding with the maximum severity/intensity within the subject Example derivation: Sort the data in the required order and flag the first treatment product emergent record for maximum severity for each subject. |
AOCCPIFL | 1st Max Sev./Int. Occur Within PT Flag | Char | Y | Perm | Perm | Character indicator for the first occurrence of the maximum severity/intensity within the subject and preferred term Example derivation: Sort the data in the required order and flag the first treatment product emergent record for maximum severity within preferred term for each subject. |
AOCCzzFL | 1st Occurrence of ... | Char | Y | Perm | Perm | Additional flag variables as needed for analysis. Derivation rules for these flags need to be described in the metadata. |