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Variable Name

Variable Label

Type

Codelist

Controlled Terms

Core

SubClass ADVERSE EVENT Core

CDISC Notes

AOCCSFL

1st Occurrence of SOC Flag

Char

Y


Perm

Perm

Character indicator for the first occurrence of the system organ class within the subject

Example derivation: Sort the data in the required order and flag the first treatment-emergent record for each body system for each subject.

AOCCSIFL

1st Max Sev./Int. Occur Within SOC Flag

Char

Y


Perm

Perm

Character indicator for the first occurrence of the maximum severity/intensity within the subject and system organ class

Example derivation: Sort the data in the required order and flag the first treatment-emergent record for maximum severity within body system for each subject.

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