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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
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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 Termsa
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Core
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SubClass ADVERSE EVENT Core
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CDISC Notes
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DECDORGw
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PT in Original Dictionary w
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Char
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MedDRAw
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Perm
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Perm
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Original preferred term coding of XX.--TERM using MedDRA or other dictionary version
X.X.
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Original or Prior WHODrug Coding Variables
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BDSYORGw
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SOC in Original Dictionary w
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Char
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MedDRAw
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Perm
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Perm
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Original body system coding of XX.--TERM using MedDRA or other dictionary version
X.X.
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HLGTORGw
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HLGT in Original Dictionary w
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Char
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MedDRAw
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Perm
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Perm
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Original HLGT coding of XX.--TERM using MedDRA or other dictionary version X.X
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HLTORGw
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HLT in Original Dictionary w
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Char
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MedDRAw
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Perm
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Perm
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Original HLT coding of XX.--TERM using MedDRA or other dictionary version X.X.
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LLTORGw
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LLT in Original Dictionary w
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Char
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MedDRAw
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Perm
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Perm
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Original LLT coding of XX.--TERM using MedDRA or other dictionary version X.X.
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LLTNORGw
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LLT Code in Original Dictionary w
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Char
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MedDRAw
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Perm
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Perm
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Original LLT code of XX.--TERM using MedDRA or other dictionary version X.X.
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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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DECDORGw
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Standardized Med Name in Orig Dict w
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Char
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WHODRUGw
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Perm
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Perm
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Original standardized medication name of CM.CMTRT using WHO Drug
version X.X
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CLASORGw
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Medication Class in Orig Dictionary w
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Char
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WHODRUGw
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Perm
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Perm
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Original medication class of CM.CMTRT using WHO Drug version X.X
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CLCDORGw
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Medication Class Code in Orig Dict w
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Char
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WHODRUGw
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Perm
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Perm
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Original medication class code of CM.CMTRT using WHO Drug version X.X
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ATyCORGw
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ATC Level y Code in Orig Dictionary w
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Char
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WHODRUGw
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Perm
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Perm
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Original ATC Level y code of CM.CMTRT using WHO Drug version X.X
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ATyTORGw
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ATC Level y Text in Orig Dictionary w
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Char
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WHODRUGw
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Perm
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Perm
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