The Adverse Events Distribution report offers a comprehensive analysis of adverse events across treatment arms, focusing on subgroups defined by demographics like age, sex, and race. Each subject is reported only once per adverse event, regardless of the incident count.
Note: this video was recorded in JMP Clinical version 17.2, but applies to version 18 as well.
Transcript:
This tutorial on the Adverse Events Distribution report in JMP Clinical demonstrates the use of this important report for analysis of counts or percentages of adverse events across treatment groups, or segmented by demographic variables like age, sex, or race.
This report considers each subject only once per adverse event.
I’ve limited the adverse events that are displayed in the report to only those that occur in at least two percent of the subjects. You’ll see how to use the data filters later in the video.
The graph visually summarizes the unique subject count distributions by demographic groups. You can click the option above the graph if you want to display the percent occurrence instead of counts.
Below the bar chart, the Tabulate section provides a more detailed view, presenting subject counts and percentages for each treatment group and adverse event, categorized by body system or organ class. Like the bar chart, the Tabulate report responds to selections made in the data filter, and indicates any filter selections that you’ve made.
Selecting a bar in the bar chart will also select those subjects in the table.
And selecting a cell in the table will select the corresponding bar in the chart.
To deselect subjects, you can simply click in a blank area of the graph.
The bar chart is dynamic in other ways too. If you place your cursor over any bar in the chart, you can see summary information for that bar.
You can customize the analysis using various widgets found under the Data options. For example, you can specify the Term and Group Level and the Event Type. If you select the option Ignore Available Treatment Emergent Flags, JMP Clinical can determine treatment emergent events.
The Demographic Grouping allows you to view the data using demographic characteristics other than planned treatment if you choose.
Stacking enables you to modify the display of the data in both the graph and the table. For example, if you select Serious Event, both the graph and table update to reflect that choice.
Other stacking options are severity or intensity… outcome of adverse event… causality… and action taken with study treatment.
The By Variables option lets you run subgroup analyses by any variables included in the data table. In this study, there’s an AGE variable that divides the subjects into two groups: below 65 years and 65 years and older.
The report data filters in the Display section allow you to subset and view subjects based on specific criteria and categories of adverse events. Rerunning the report to update it with the By variable cleared the selection I made at the beginning of the video, so this view includes all of the adverse events, not just those occurring in two percent or more of the subjects.
It’s easy to use the filters to drill down into the data based on one or more variables. For example, you might be interested in adverse events that were serious, and related to the study.
You can add filters to the report using the And button at the bottom, and you can clear selections using the Clear button at the top.
This report is essential for understanding adverse event profiles in clinical trials. For more information about the Adverse Events Distribution report in JMP Clinical, please click the question mark icon in the upper right corner of the report tab, or contact support@jmp.com.
