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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 treatmentproduct-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
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Variable Name
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Variable Label
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Type
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Codelist
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Controlled Terms
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Core
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SubClass ADVERSE EVENT Core
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CDISC Notes
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MedDRA Occurrence Flag Variables
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AOCCFL
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1st Occurrence within Subject Flag
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Char
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Y
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Perm
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Perm
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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.
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AOCCPFL
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1st Occurrence of Preferred Term Flag
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Char
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Y
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Perm
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Perm
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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.
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AOCCIFL
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1st Max Sev./Int. Occurrence Flag
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Char
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Y
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Perm
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Perm
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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.
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AOCCPIFL
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1st Max Sev./Int. Occur Within PT Flag
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Char
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Y
...
Perm
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Perm
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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.
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AOCCzzFL
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1st Occurrence of ...
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Char
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Y
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Perm
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Perm
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Additional flag variables as needed for analysis. Derivation rules for these flags need to be described in the metadata.
MedDRA Occurrence Flag Variables
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Variable Name
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Variable Label
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Type
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Codelist
...
Controlled Terms
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Core
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SubClass ADVERSE EVENT Core
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CDISC Notes
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AOCCSFL
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1st Occurrence of SOC Flag
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Char
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Y
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Perm
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Perm
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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.
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AOCCSIFL
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1st Max Sev./Int. Occur Within SOC Flag
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Char
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Y
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Perm
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Perm
Character indicator for the first occurrence of the maximum severity/intensity within the subject and system organ class
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