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Metadataspec

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

SubClass ADVERSE EVENT Core

CDISC Notes

--CAT

Category

Char


Perm

Perm

Copied from XX.--CAT

This variable label differs depending on the SDTM domain. See SDTM v1.7 Section 2.2, The General Observation Classes, and SDTMIG v3.3 Section 6, Domain Models Based on the General Observation Classes, for details.

--SCAT

Subcategory

Char


Perm

Perm

Copied from XX.--SCAT

This variable label differs depending on the SDTM domain. See SDTM v1.7 Section 2.2, The General Observation Classes, and SDTMIG v3.3 Section 6, Domain Models Based on the General Observation Classes, for details.

ACATy

Analysis Category y

CharPerm


Perm

Category used in analysis. May be derived from --CAT and/or --SCAT. Examples include records of special interest like prohibited medications, concomitant medications taken during an infusion reaction, growth factors, antimicrobial medications, and other such categories not defined elsewhere or present in SDTM domains.

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