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.
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: Panel enables analysis of various demographic groups by selected AE.
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: Panel enables analysis of various AEs by selected demographic group.
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This enables you to subset subjects based on demographic characteristics and other criteria. Refer to Data Filter for more information.
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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.
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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.
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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.
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Profile Subjects: Select subjects and click
 to generate the patient profiles for subjects experiencing selected events. See Profile Subjects for additional information. |
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Show Subjects: Select subjects and click
 to open the ADSL (or DM if ADSL is unavailable) of selected subjects for subjects experiencing selected events. |
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Cluster Subjects: Select subjects and click
 to cluster subjects experiencing selected events based on available covariates. See Cluster Subjects for additional information. |
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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. |
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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. |
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(AE Distribution only): Select subjects and click
 to launch Interventions Distribution to summarize the distribution of concomitant medications (CM) for subjects experiencing selected events. |
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: 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. |
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: 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. |
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: 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. |
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: 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. |
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(Interventions Distribution only): Select subjects taking selected medications and click
 to launch AE Distribution to summarize the distribution of adverse events (AE). |
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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. |
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Click
 to view the associated data tables. Refer to View Data for more information. |
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Click
 to generate a standardized pdf- or rtf-formatted report containing the plots and charts of selected sections. |
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Click
 to take notes, and store them in a central location. Refer to Add Notes for more information. |
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Click
 to read user-generated notes. Refer to View Notes for more information. |
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Click the arrow to reopen the completed process dialog used to generate this output.
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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.