Processes | 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.