Treatment Emergent AE Summary

This report creates tabular and graphical overviews of treatment emergent adverse events for the safety population by actual treatment arm .

Running Treatment Emergent AE Summary for Nicardipine using default settings generates the Report shown below.

The Results window contains the following panes:

The following sections are generated by this process:

•

Summary Chart : This tab 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.

•	Data Filter

This enables you to subset subjects based on demographic characteristics and study site. Refer to Data Filter for more information.

Drill Down Buttons

Drill down buttons provide you with an easy way to drill down into your data. The following drill down buttons are generated by this process:

•	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.

•	Create Subject Filter : Select subjects and click to create a data set of USUBJID s for subjects experiencing selected events, which subsets all subsequently run processes to those selected subjects.

General

•	Click to view the associated data tables. Refer to View Data for more information.

•	Click to generate a standardized pdf - or rtf -formatted report containing the plots and charts of selected sections.

•	Click to take notes, and store them in a central location. Refer to Add Notes for more information.

•	Click to read user-generated notes. Refer to View Notes for more information.

•	Click the Options arrow to reopen the completed process dialog used to generate this output.

Note : For information about how treatment emergent adverse events (TEAEs) are defined in JMP Clinical, please refer to Determining If an Event Is a Treatment Emergent Adverse Event .