Adverse Events Distribution

This report enables you to compare distributions of adverse events across treatment arms for subgroups defined by demographics such as age, sex and race. It reports each subject only once per adverse event regardless of how many incidents of the event occur.

Note: Refer to Distribution Reports for a description of the general analysis performed by all JMP Clinical distribution reports.

Report Results Description

Running Adverse Events Distribution with Nicardipine using Actual for Treatment or Comparison Variable to Use generates the Report for Adverse Events Distribution as shown below. Differences with other reports are noted throughout this output description.

The report contains the following elements:

Bar Chart

Using a Bar Chart or Tree Map, this section 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.

In the example shown here, Dictionary-Derived Term counts by treatment are displayed.

Tabulate

The Tabulate section contains one Table detailing the counts (and Percentages) for each treatment group, for each dictionary-derived term within each body system or organ class. The counts, represented by n, are the number of subjects who experienced the given adverse event. The All row at the bottom of the table is the number of subjects who experienced at least one adverse event.

Options

Data

Use the drop-downs on this panel to customize your analysis.

Term and Group Level

Term and Group Levels are determined by the coding dictionary for the Event or Intervention domain of interest, typically these levels follow the MedDRA dictionary. Use this widget to indicate how each adverse event is named and the level at which the event is considered. For example, selecting Reported Term for the Adverse Event, grouped by Body System or Organ Class as theTerm and Group Level reports the event specified by the actual event term as reported in the AE domain on the affected organ or body system.

The term level will determine which term is displayed on the x-axis of the bar chart. Both the term and group level will be shown in the table with term level nested within group level.

Event Type

Analysis can consider all events or only those that emerge at specific times before, during, or after the trial period. For example, selecting On treatment events as the Event Type includes only those events that occur on or after the first dose of study drug and at or before the last dose of drug (+ the offset for end of dosing).

Ignore available treatment emergent flags

If you choose to Ignore available treatment emergent flags, the analysis includes all adverse events that occur on or after day 1 of the study when the event type is Treatment emergent events.

Demographic Grouping and Stacked

Results can be viewed as a whole or they can either be split out by Demographic Grouping or Stacked to show different levels within each event. Demographic Grouping will change the variable displayed on the y-axis of the bar chart, as well as change the variable used across the top of the table to split the columns. Stack impacts both the bar chart by stacking the bars according to the levels of the chosen variable with corresponding effects in the table. For example, if severity is chosen, the bars will be stacked by mild, moderate, and severe events.

By Variables

You can subdivide the subjects and run analyses for distinct groups by specifying one or more By Variables.

Display

Report Data Filters

These filters enable you to subset and view subjects based on demographic characteristics and other criteria. Refer to Data Filter for more information.

Note: Filter specifications are reapplied when any widget options are changed.

General and Drill Down Buttons

Action buttons, provide you with an easy way to drill down into your data. The following action buttons are generated by this report:

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Click to rerun the report using default settings.

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Click to view the associated data tables. Refer to Show Tables/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 generate a JMP Live report. Refer to Create Live Report for more information.

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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 to open and view the Review Subject Filter.

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Click to specify Derived Population Flags that enable you to divided the subject population into two distinct groups based on whether they meet very specific criteria.

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?.

Default Settings

Refer to Set Study Preferences for default Subject Level settings.

Methodology

No testing is performed. Analysis is restricted to tabulating counts/percentages of subjects experiencing adverse events. The unique record to display for each event is determined by sorting the data by Unique Subject Identifier (USUBJID), the group level, the term level, seriousness(AESER), severity(AETOXGR/AESEV), and the day the event started(AESTDY) and picking the first record for each term level.