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These variable names at this time are recommendations only. Additional prior or original variables needed for traceability may be added following the same conventions. There is an ADaM subteam working on integration, and this group may create different naming conventions for that type of analysis.


Original or Prior MedDRA Coding Variables

Variable Name

Variable Label

Type

Codelist

Controlled Termsa

Core

SubClass ADVERSE EVENT Core

CDISC Notes

DECDORGw

PT in Original Dictionary w

Char


MedDRAw

Perm

Perm

Original preferred term coding of XX.--TERM using MedDRA or other dictionary version

X.X.

BDSYORGw

SOC in Original Dictionary w

Char


MedDRAw

Perm

Perm

Original body system coding of XX.--TERM using MedDRA or other dictionary version

X.X.

HLGTORGw

HLGT in Original Dictionary w

Char


MedDRAw

Perm

Perm

Original HLGT coding of XX.--TERM using MedDRA or other dictionary version X.X

HLTORGw

HLT in Original Dictionary w

Char


MedDRAw

Perm

Perm

Original HLT coding of XX.--TERM using MedDRA or other dictionary version X.X.

LLTORGw

LLT in Original Dictionary w

Char


MedDRAw

Perm

Perm

Original LLT coding of XX.--TERM using MedDRA or other dictionary version X.X.

LLTNORGw

LLT Code in Original Dictionary w

Char


MedDRAw

Perm

Perm

Original LLT code of XX.--TERM using MedDRA or other dictionary version X.X.


Original or Prior WHO Drug Coding Variables

Variable Name

Variable Label

Type

Codelist

Controlled Terms

Core

SubClass ADVERSE EVENT Core

CDISC Notes

DECDORGw

Standardized Med Name in Orig Dict w

Char


WHODRUGw

Perm

Perm

Original standardized medication name of CM.CMTRT using WHO Drug

version X.X

CLASORGw

Medication Class in Orig Dictionary w

Char


WHODRUGw

Perm

Perm

Original medication class of CM.CMTRT using WHO Drug version X.X

CLCDORGw

Medication Class Code in Orig Dict w

Char


WHODRUGw

Perm

Perm

Original medication class code of CM.CMTRT using WHO Drug version X.X

ATyCORGw

ATC Level y Code in Orig Dictionary w

Char


WHODRUGw

Perm

Perm

Original ATC Level y code of CM.CMTRT using WHO Drug version X.X

ATyTORGw

ATC Level y Text in Orig Dictionary w

Char


WHODRUGw

Perm

Perm

Original ATC Level y text of CM.CMTRT using WHO Drug version X.X