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Occurrence flags can be used to prepare data for analysis. They are typically created by sorting the data in the required order and then flagging the first product-emergent record. The use of the word “first” in this section does not necessarily mean chronological, although that is an option. The more common occurrence flags and a structure for additional flags are shown below

OCCDS Occurrence Flag Variables

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.


MedDRA Occurrence Flag Variables

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 product- 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 product- emergent record for maximum severity within body system for each subject.

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