MedDRA coding is typically used for adverse events and medical history. Copy the needed MedDRA terms and codes from SDTM to the analysis dataset.

For the SubClass ADVERSE EVENT, it is required that all levels of terms for the primary path in the MedDRA hierarchy—System Organ Class (SOC), High Level Group Term (HLGT), High Level Term (HLT), Lowest Level Term (LLT), and Preferred Term (PT)—be included. For other OCCDS datasets, these variables are recommended (they are frequently useful in further analyses of events), but not required.

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

--TERM

Reported Term

Char


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 details.  Required for adverse event data.

--DECOD

Dictionary-Derived Term

Char

MedDRA

Cond

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

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

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

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

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

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

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

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

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.

--HLGTCD

High Level Group Term Code

Num

MedDRA

Perm

Copied from XX.--HLGTCD or the supplemental qualifier

Include the dictionary version in the metadata. Required for adverse event data.

--SOC

Primary System Organ Class

Char

MedDRA

Cond

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

Copied from XX.--SOCCD or the supplemental qualifier

Include the dictionary version in the metadata. Required for adverse event data.

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