Interventions Incidence Screen

Report Results Description

Report Options

Report Option Descriptions

This report 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 reports.

Report Results Description

Running this report for Nicardipine using default settings generates the report shown below.

Refer to the AE Incidence Screen , keeping in mind the following important differences in contrast with the example:

•	output (including section names) reflects concomitant medication or substance , rather than adverse event , incidence

•	Group Level is allowed to equal Category (such as CMCAT or SUCAT , depending on the domain)

Report Options

Report Option Descriptions

Specific documentation for each of the options can be viewed by clicking on the following links:

General Options

Domain , Term Level , Treatment or Comparison Variable to Use , Treatment or Comparison Variable

Intervention Type , Ignore available treatment emergent flags

Subject Filter ¹

Additional Filters

Additional Filter to Include Subjects ² , Merge supplemental domain , Filter to Include Interventions , Select the population to include in the analysis , By Variables

Test

Treatment Control Level , Time Scale , Trial Time Windows , Stratification Variables

Multiple Testing Adjustment Options : Perform Double FDR Adjustment , Group Level , Multiple Testing Method , Alpha , -l og 10 (p-Value) Cutoff

Output

X-Axis for Volcano Plot , Color Theme

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1

Subject-specific filters must be created using the Create Subject Filter report prior to your analysis.

2

For more information about how to specify a filter using this option, see The SAS WHERE Expression .