Table 3.2.9.1 Standardized MedDRA Query Variables (Copy)

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 standardized MedDRA queries 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)”

Analysis Dictionary-Derived Term y

Char

Perm

The terms used for the analysis when combining multiple customized query or multiple standardized MedDRA queries and the original MedDRA dictionary terms under 1 variable

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