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Standardized MedDRA Queries are becoming increasingly common in clinical trial 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 table below 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.
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Variable Name | Variable Label | Type | Codelist | Controlled Terms | Core | SubClass ADVERSE EVENT Core | CDISC Notes |
SMQzzNAM | SMQ zz Name | Char | Cond | 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 | Perm | The standardized MedDRA queries number code | ||
SMQzzSC | SMQ zz Scope | Char | BROAD, NARROW | Cond | 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 | Perm | Will be null for terms that do not meet the criteria | |
CQzzNAM | Customized Query zz Name | Char | Cond | 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 | 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. |
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