Standardized MedDRA queries (SMQs) are becoming increasingly common in clinical study safety evaluations, particularly when known or suspected safety issues are associated with experimental compounds. In addition, customized queries (CQs) are often used to modify an SMQ or identify records of special interest. The following table lists variables used to identify SMQs and CQs, where zz is replaced with a zero-padded 2-digit integer (01-99) for each SMQ or CQ of interest. This ordering can be based on importance or some other producer-defined criteria. It is recommended that ordering be consistent across studies within a development program, but it is recognized that there may be situations where this is not possible or practical.

Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

SMQzzNAM

SMQ zz Name

Char


Cond

The Standardized MedDRA query name. Would be blank for terms that are not in the SMQ. Therefore this variable could be blank for all records if no terms within the study were included in the SMQ.

Conditional on whether SMQ analysis is done

SMQzzCD

SMQ zz Code

Num


Perm

The SMQ number code

SMQzzSC

SMQ zz Scope

Char

BROAD, NARROW

Cond

The search strategy for SMQs can be narrow or broad. The preferred terms that are narrow in scope have high specificity for identifying events of interest, whereas the broad terms have high sensitivity. By definition, all narrow terms are also considered within the broad scope. Therefore, to summarize all broad terms, terms with either narrow or broad would be considered. Will be null for terms that do not meet the criteria.

Conditional on whether SMQ analysis is done

SMQzzSCN

SMQ zz Scope (N)

Num

1, 2

Perm

Will be null for terms that do not meet the criteria

CQzzNAM

Customized Query zz Name

Char


Cond

The CQ name or name of the adverse event of special interest category based on a grouping of terms. Would be blank for terms that are not in the CQ.

Conditional on whether CQ analysis is done

Examples: “DERMATOLOGICAL EVENTS” “CARDIAC EVENTS”, “IARS (INFUSION ASSOCIATED REACTIONS)”

ADECODy

Analysis Dictionary-Derived Term y

Char


Perm

The terms used for the analysis when combining multiple CQs or multiple SMQs and the original MedDRA terms under 1 variable

Although designed for MedDRA queries, this variable could be used for other OCCDS analysis needs.

« Descriptive Variables

Original or Prior Coding Variables »

  • No labels