This variable label differs depending on the SDTM domain. See SDTM v1.7 Section 2.2.2, The Events Observation Class, and SDTMIG v3.3 Section 6.2, Models for Events Domains, for details.
--DECOD
Dictionary-Derived Term
Char
MedDRA
Cond
Req
Copied from XX.--DECOD
This variable is typically one of the primary variables used in an analysis and would be brought in from the SDTM domain. Equivalent to the MedDRA PT. 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
Req
Copied from XX.--BODSYS
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
Req
Copied from XX.--BDSYCD or the supplemental qualifier
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
Req
Copied from XX.-- LLT or the supplemental qualifier
Include the dictionary version in the metadata.
Conditional on whether coded and used for analysis.
--LLTCD
Lowest Level Term Code
Num
MedDRA
Perm
Req
Copied from XX.--LLTCD or the supplemental qualifier
Include the dictionary version in the metadata.
--PTCD
Preferred Term Code
Num
MedDRA
Perm
Req
Copied from XX.--PTCD or the supplemental qualifier
Include the dictionary version in the metadata.
--HLT
High Level Term
Char
MedDRA
Cond
Req
Copied from XX.--HLT or the supplemental qualifier
Include the dictionary version in the metadata.
Conditional on whether used for analysis.
--HLTCD
High Level Term Code
Num
MedDRA
Perm
Req
Copied from XX.--HLTCD or the supplemental qualifier
Include the dictionary version in the metadata.
--HLGT
High Level Group Term
Char
MedDRA
Cond
Req
Copied from XX.--HLGT or the supplemental qualifier
Include the dictionary version in the metadata.
Conditional on whether used for analysis.
-‑HLGTCD
High Level Group Term Code
Num
MedDRA
Perm
Req
Copied from XX.--HLGTCD or the supplemental qualifier
Include the dictionary version in the metadata.
--SOC
Primary System Organ Class
Char
MedDRA
Cond
Req
Copied from XX.--SOC or the supplemental qualifier
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
Req
Copied from XX.--SOCCD or the supplemental qualifier