Reports | Treatment Emergent AE Summary

Treatment Emergent AE Summary
This report creates tabular and graphical overviews of treatment emergent adverse events for the safety population by actual treatment arm .
Report Results Description
Running Treatment Emergent AE Summary for Nicardipine using default settings generates the Report shown below.
The following sections are generated by this report:
Summary Chart : This section contains a Bar Chart summarizing the counts of various treatment emergent adverse events by treatment. Click the Open TEAE Summary.rtf link to open an rtf file (shown below) that summarizes the treatment emergent adverse events. Percentages of subjects experiencing an event by arm are also included in this summary.
This enables you to subset subjects based on demographic characteristics and study site. Refer to Data Filter for more information.
Action Buttons
Action buttons, provide you with an easy way to drill down into your data. The following action buttons are generated by this report:
Profile Subjects : Select subjects and click to generate the patient profiles for subjects experiencing selected events. See Profile Subjects for additional information.
Show Subjects : Select subjects and click to open the ADSL (or DM if ADSL is unavailable) of selected subjects for subjects experiencing selected events.
Cluster Subjects : Select subjects and click to cluster subjects experiencing selected events based on available covariates . See Cluster Subjects for additional information.
AE Narrative : Select subjects and click to open the AE Narrative generator.
Demographic Counts : Select subjects and click to create a data set of USUBJID s for subjects experiencing selected events, which subsets all subsequently run reports to those selected subjects.
Click to generate a standardized pdf - or rtf -formatted report containing the plots and charts of selected sections.
Click the Options arrow to reopen the completed report dialog used to generate this output.
Click the gray border to the left of the Options tab to open a dynamic report navigator that lists all of the reports in the review. Refer to Report Navigator for more information.
Note : For information about how treatment emergent adverse events (TEAEs) are defined in JMP Clinical, please refer to How does JMP Clinical determine whether an Event Is a Treatment Emergent Adverse Event? .
Report Options
Report Option Descriptions
Specific documentation for each of the options can be viewed by clicking on the following links:
General Options
Treatment or Comparison Variable to Use , Treatment or Comparison Variable
Include serious adverse events only , Ignore available treatment emergent flags , Include summary for subjects with severe TEAE
Subject Filter 1
Additional Filters
Additional Filter to Include Subjects 2 , Merge supplemental domain , Filter to Include Adverse Events , Select the population to include in the analysis , By Variables
Perform incidence analysis using the following SMQs:
Treatment Control Level
Stratification Variables
Multiple Testing Adjustment Options : Multiple Testing Method , Alpha , -l og 10 (p-Value) Cutoff
RTF , PDF , Number of decimals to display for event percentages in tables

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

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