Interventions Incidence Screen

This process screens all interventions by performing a Cochran-Mantel-Haenszel exact test on all 2 x 2 tables constructed from event (concomitant medications or substance use) 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 several demographic- and medication-related variables. These include:

•

USUBJID ,

•	a treatment variable ( the actual treatment received by each subject ( TRT01A )),

•	the planned treatment (intent-to-treat) for each subject ( TRT01P ), or the description of the planned treatment arm ( ARM ), and

•	either CMDECOD , CMSTDTC , and CMENDTC (for CM ), or SUDECOD , SUSTDTC , and SUENDTC (for SU ).

Variables can be taken either from the subject level analysis data set ( ADSL ) included in the Analysis Data Model ( ADaM ) folder or from the DM , CM, or SU domains in SDTM . Refer to Localization-Specific Value Specification for more information about these data sets.

Output/Results

The output generated by this process is summarized in a tabbed report. Refer to the Interventions Incidence Screen output documentation for detailed descriptions and guides to interpreting your results.