Appendixes | Clinical | Standardized MedDRA Queries Incidence Screen

Standardized MedDRA Queries Incidence Screen
This process screens Standard MedDRA Query terms by performing a Cochran-Mantel-Haenszel exact test on all 2 x 2 tables constructed from event incidence and treatment arm . Output is a table of multiplicity-adjusted p-values , an accompanying volcano plot of relative risk and a SAS data set of indicator variables that can be used as input for other processes.
What do I need?
This process requires AE and either DM or ADSL . Required variables include USUBJID and AEDECOD . AELLT is desirable, but optional.
In addition, several text files defining MedDRA terms are required. These include: mq_content.asc (lists preferred and lower level terms associated with the queries), smq_list.asc ( list of SMQs ), pt.asc (lists preferred terms and codes), and llt.asc (lists lower-level terms and codes).
The output generated by this process is summarized in a tabbed report. Refer to the Standardized MedDRA Queries Incidence Screen output documentation for detailed descriptions and guides to interpreting your results.