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Metadataspec
Not UsedNot UsedNot Used

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

SubClass ADVERSE EVENT Core

CDISC Notes

CMTRT

Reported Name of Drug, Med, or Therapy

Char


Req

Not Used

CM.CMTRT

CMDECOD

Standardized Medication Name

Char

WHO Drug

Cond

Not Used

CM.CMDECOD

This is typically one of the primary variables used in CM analysis and would be copied from the SDTM CM domain. Include the dictionary version in the variable metadata.

Conditional on whether coded and used for analysis.

CMCLAS

Medication Class

Char


Perm

Not Used

CM.CMCLAS

Include the dictionary version in the metadata.

CMCLASCD

Medication Class Code

Char


Perm

CM.CMCLASCD

Include the dictionary version in the metadata.

ATCy

ATC Level y Text

Char

WHO Drug

Cond

Corresponds to the ATC Level Text for WHO Drug. Include the dictionary version in the variable metadata.

Conditional, based on analysis at multiple levels (y)

ATCyCD

ATC Level y Code

Char

WHO Drug

Cond

Corresponds to the ATC Level Code for WHO Drug. Include the dictionary version in the variable metadata.

Conditional, based on analysis at multiple levels (y)