Output Overview Descriptions | Clinical Reports | AE Distribution

AE Distribution
This report compares distributions of adverse events and demographic variables across treatment arm.
Note: Refer to Distribution Reports for a description of the general analysis performed by the JMP Clinical distribution reports.
Running AE Distribution with Nicardipine using Actual for Trial Time Windows generates the Report for AE Distribution as shown below. Differences with other processes are noted throughout this output description.
The report contains the following elements
View
Demographic Grouping: Panel enables analysis of various demographic groups by selected AE.
AE Stacking: Panel enables analysis of various AEs by selected demographic group.
Data Filter
This enables you to subset subjects based on demographic characteristics and other criteria. Refer to Data Filter for more information.
Results
The following results sections are generated by this process:
Counts Graph: Using a Bar Chart , this tab summarizes the distributions of terms based on xxDECOD or, if unavailable, xxTERM or xxTRT depending on CDISC domain type. Results are summarized by selected demographic grouping and can be displayed either as total counts or percentages.
Counts Table : If AEBODSYS is available, a Table summarizes the distribution of adverse events, body system or system organ class. Results are summarized by Trial Time Windows. For Interventions Distribution, xxCAT is used (if available) and the tab name reflects the appropriate label. For example, for CM, the tab is Category for Medication TreeMap.
Distributions (AE Distribution) : Presents Histograms of event characteristics such as Study Start Day, Causality, Outcome, Severity/Intensity, and Seriousness. Other Distribution processes present term, classification, and study day variables.
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.
Adverse Events Narrative Generation: Select subjects and click to open the AE Narrative dialog. From this dialog, you can customize options and generate a narrative.
Create Subject Filter: Select subjects and click to create a data set of USUBJIDs for subjects experiencing selected events, which subsets all subsequently run processes to those selected subjects. The currently available filter data set can be applied by selecting Apply Subject Filter in any process dialog.
Related CM (AE Distribution only): Select subjects and click to launch Interventions Distribution to summarize the distribution of concomitant medications (CM) for subjects experiencing selected events.
Demographic Counts: Select subjects and click to generate a stacked Histogram to show subjects experiencing selected events across study sites by Trial Time Windows. Not available for Events Distribution.
Related Labs: Select subjects and click to launch Findings Time Trends to summarize laboratory results (LB) across time. See Findings Time Trends for more detail. Not available for Events Distribution.
Related Vitals: Select subjects and click to launch Findings Time Trends to summarize vitals signs (VS) across time for subjects experiencing selected events,. See Findings Time Trends for more detail. Not available for Events Distribution.
Related ECG: Select subjects and click to launch Findings Time Trends to summarize ECG measurements (EG) across time for subjects experiencing selected events. See Findings Time Trends for more detail. Not available for Findings Time Trends.
Related AE (Interventions Distribution only): Select subjects taking selected medications and click to launch AE Distribution to summarize the distribution of adverse events (AE).
Uniques Occurrence Subject Counts: Select individual records and click consider the selected/filtered AE records only and take the FIRST OCCURRENCE for each subject per each adverse event.
General
Click to generate a standardized pdf- or rtf-formatted report containing the plots and charts of selected sections.
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.