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Keeping original coding variables is not common, but there are a couple of instances where it might be helpful:

• When a study is mapped to one version of a mapping dictionary for an interim analysis and another for final analysis
• When studies using different versions of a mapping dictionary are pooled together for an integrated analysis

Because the dictionary-coded values may change with each version, counts for study tables can differ between versions for the same study. Therefore, keeping the original variables provides traceability to original (or prior) analysis(es).

The variables described below provide traceability to original (or prior) analysis(es). The suffix “w” represents an integer (1-9) corresponding to a previous version. Include the dictionary name and version as part of the metadata for each variable.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 NameVariable LabelTypeCodelist/ Controlled TermsCoreCDISC Notes
DECDORGwPT in Original Dictionary wCharMedDRAwPermOriginal preferred term coding of XX.--TERM using MedDRA or other dictionary version X.X
BDSYORGwSOC in Original Dictionary wCharMedDRAwPermOriginal body system coding of XX.--TERM using MedDRA or other dictionary version X.X
HLGTORGwHLGT in Original Dictionary wCharMedDRAwPermOriginal HLGT coding of XX.--TERM using MedDRA or other dictionary version X.X
HLTORGwHLT in Original Dictionary wCharMedDRAwPermOriginal HLT coding of XX.--TERM using MedDRA or other dictionary version X.X
LLTORGwLLT in Original Dictionary wCharMedDRAwPermOriginal LLT coding of XX.--TERM using MedDRA or other dictionary version X.X
LLTNORGwLLT Code in Original Dictionary wCharMedDRAwPermOriginal LLT code of XX.--TERM using MedDRA or other dictionary version X.X

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 NameVariable LabelTypeCodelist/ Controlled TermsCoreCDISC Notes
DECDORGwStandardized Med Name in Orig Dict wCharWHODRUGwPermOriginal standardized medication name of CM.CMTRT using WHO Drug version X.X
CLASORGwMedication Class in Orig Dictionary wCharWHODRUGwPermOriginal medication class of CM.CMTRT using WHO Drug version X.X
CLCDORGwMedication Class Code in Orig Dict wCharWHODRUGwPermOriginal medication class code of CM.CMTRT using WHO Drug version X.X
ATyCORGwATC Level y Code in Orig Dictionary wCharWHODRUGwPermOriginal ATC Level y code of CM.CMTRT using WHO Drug version X.X
ATyTORGwATC Level y Text in Orig Dictionary wCharWHODRUGwPermOriginal ATC Level y text of CM.CMTRT using WHO Drug version X.X

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

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