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 emergent record for each subject.
AOCCPFL
1st Occurrence of Preferred Term Flag
Char
Y
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 emergent record for each --DECOD for each subject.
AOCCIFL
1st Max Sev./Int. Occurrence Flag
Char
Y
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 emergent record for maximum severity for each subject.
AOCCPIFL
1st Max Sev./Int. Occur Within PT Flag
Char
Y
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 emergent record for maximum severity within preferred term for each subject.
AOCCzzFL
1st Occurrence of ...
Char
Y
Perm
Additional flag variables as needed for analysis. Derivation rules for these flags need to be described in the metadata.