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

CDISC Notes

AOCCFL

1st Occurrence within Subject Flag

Char

Y

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

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

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

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

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

CDISC Notes

AOCCSFL

1st Occurrence of SOC Flag

Char

Y

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

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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