Processes | 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).
Output/Results
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.