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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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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 product 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 product 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 product 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

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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 product 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.

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Include Page
OCCDS MedDRA Occurrence Flag Variables
OCCDS 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

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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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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 product- 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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Pagenav