Output Overview Descriptions | Clinical | AE Distribution

AE Distribution
Running this process with Nicardipine using Planned for Treatment Variable to Use generates the tabbed Results window for AE Distribution as shown below. Differences with other processes are noted throughout this output description. Output from the process is organized into tabs. Each tab contains one or more plots, data panels, data filters, or other elements that facilitate your analysis.
The Results window contains the following panes:
Tab Viewer
This pane provides you with a space to view individual tabs within the Results window. Use the tabs to access and view the output plots and associated data sets.
The following tabs are generated by this process:
Counts Graph or TreeMap Results (depending on version): 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 Treatment Variable to Use. 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:
Demographic Grouping: Panel enables analysis of various demographic groups by selected AE.
AE Stacking: Panel enables analysis of various AEs by selected demographic group.
Profile Subjects: Generates Patient Profiles for subjects experiencing selected events. See Profile Subjects for more detail.
Show Subjects: Subsets and opens ADSL (or DM, if unavailable) for subjects experiencing selected events. A Table of USUBJIDs is also presented.
Cluster Subjects: Clusters subjects experiencing selected events based on available covariates. See Cluster Subjects for more detail.
Create Subject Filter: Creates a data set of USUBJIDs for subjects experiencing selected events, which subsets all subsequently run processes to those selected individuals. The currently available filter data set can be applied by selecting Apply subject filter in any process dialog.
Related CM (AE Distribution only): For subjects experiencing selected events, launches Interventions Distribution to summarize the distribution of concomitant medications (CM).
Demographic Counts: For subjects experiencing selected events, generates a stacked Histogram to show subjects across study sites by Treatment Variable to Use. Not available for Events Distribution.
Related Labs: For subjects experiencing selected events, launches Findings Time Trends to summarize laboratory results (LB) across time. See Findings Time Trends for more detail. Not available for Events Distribution.
Related Vitals: For subjects experiencing selected events, launches Findings Time Trends to summarize vitals signs (VS) across time. See Findings Time Trends for more detail. Not available for Events Distribution.
Related ECG: For subjects experiencing selected events, launches Findings Time Trends to summarize ECG measurements (EG) across time. See Findings Time Trends for more detail. Not available for Events Distribution.
Related AE (Interventions Distribution only): For subjects taking selected medications, launches AE Distribution to summarize the distribution of adverse events (AE).
General
Click View Data to view the associated data table. Refer to View Data for more information.
Click Reopen Dialog to reopen the completed process dialog used to generate this output.
Click Create Report to generate a standardized pdf- or rtf-formatted report containing the plots and charts of selected tabs.
Click Add Notes to take notes, and store them in a central location. Refer to Add Notes for more information.
Click View Notes to read user-generated notes. Refer to View Notes for more information.
Click Close All to close all graphics windows and underlying data sets associated with the output.