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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 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 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 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 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.