Variable Name | Variable Label | Type | Codelist/ Controlled Terms | Core | SubClass ADVERSE EVENT Core | CDISC Notes |
|---|
--TERM | | CharReq |
| Req | Copied from XX.--TERM 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 for details. Required for adverse event data. |
--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. Required for adverse event data. |
--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. Required for adverse event data. |
--LLTCD | Lowest Level Term Code | Num | MedDRA | Perm | Req | Copied from XX.--LLTCD or the supplemental qualifier Include the dictionary version in the metadata. Required for adverse event data. |
--PTCD | Preferred Term Code | Num | MedDRA | Perm | Req | Copied from XX.--PTCD or the supplemental qualifier Include the dictionary version in the metadata. Required for adverse event data. |
--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. Required for adverse event data. |
--HLTCD | High Level Term Code | Num | MedDRA | Perm | Req | Copied from XX.--HLTCD or the supplemental qualifier Include the dictionary version in the metadata. Required for adverse event data. |
--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. Required for adverse event data. |
--‑HLGTCDHLGTCD | High Level Group Term Code | Num | MedDRA | Perm | Req | Copied from XX.--HLGTCD or the supplemental qualifier Include the dictionary version in the metadata. Required for adverse event data. |
| 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. Required for adverse event data. |
--SOCCD | Primary System Organ Class Code | Num | MedDRA | Perm | Req | Copied from XX.--SOCCD or the supplemental qualifier Include the dictionary version in the metadata. Required for adverse event data. |