Variable Name,Variable Label,Type,Codelist / Controlled Terms,Core,CDISC Notes
--TERM,Reported Term*,Char,,Req,"XX.--TERM
This would be copied from the SDTM domain XX."
--DECOD,Dictionary- Derived Term,Char,MedDRA,Cond,"XX.--DECOD
This would be copied from the SDTM domain XX. It is typically one of the primary variables used in an analysis and would be brought in from the SDTM domain. Equivalent to the Preferred Term (PT in MedDRA). As mentioned above, all other SDTM domain variables and supplemental qualifiers needed for analysis or traceability should also be included. Include the dictionary version in the metadata.
Conditional on whether coded and used for analysis. Required for Adverse Event data."
--BODSYS,Body System or Organ Class,Char,MedDRA,Cond,"XX.--BODSYS
This would be copied from the SDTM domain XX. It is typically one of the primary variables used in an analysis and would be brought in from the SDTM domain. As mentioned above, all other SDTM domain variables and supplemental qualifiers needed for analysis or traceability should also be included. Include the dictionary version in the metadata.
Conditional on whether coded and used for analysis. Required for Adverse Event data."
--BDSYCD,"Body System or Organ Class
Code",Num,MedDRA,Perm,"XX.--BDSYCD
This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary version in the metadata."
--LLT,Lowest Level Term,Char,MedDRA,Cond,"XX.-- LLT
This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary version in the metadata.
Conditional on whether coded and used for analysis."
--LLTCD,Lowest Level Term Code,Num,MedDRA,Perm,"XX.--LLTCD
This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary version in the metadata."
--PTCD,Preferred Term Code,Num,MedDRA,Perm,"XX.--PTCD
This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary version in the metadata."
--HLT,High Level Term,Char,MedDRA,Cond,"XX.--HLT
This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary version in the metadata.
Conditional on whether used for analysis."
--HLTCD,High Level Term Code,Num,MedDRA,Perm,"XX.--HLTCD
This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary version in the metadata."
--HLGT,High Level Group Term,Char,MedDRA,Cond,"XX.--HLGT
This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary version in the metadata.
Conditional on whether used for analysis."
--HLGTCD,"High Level
Group Term Code",Num,MedDRA,Perm,"XX.--HLGTCD
This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary version in the metadata."
--SOC,Primary System Organ Class,Char,MedDRA,Cond,"XX.--SOC
This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary version in the metadata.
Conditional on whether a secondary SOC was used for analysis."
--SOCCD,"Primary System
Organ Class Code",Num,MedDRA,Perm,"XX.--SOCCD
This would be copied from the SDTM domain XX or supplemental qualifier dataset. Include the dictionary version in the metadata."
