Appendixes | Clinical | Interventions Incidence Screen

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:
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.