This report is designed to analyze the distribution of events across treatment arms in clinical studies, focusing on demographics such as age, sex, and race. It considers multiple occurrences of events per subject and reports the number of events per term.
Note: this video was recorded in JMP Clinical version 17.2, but applies to version 18 as well.
Transcript:
In this video, you’ll learn about the Adverse Events Multiple Occurrences Distribution report. This report is essential for understanding the distribution of the total number of adverse events across different treatment arms, including repeated occurrences.
You can compare the distribution of adverse events across the treatment arms, or grouped by demographics such as age, sex and race. This report counts each incident of an adverse event, rather than only counting events once per subject.
At the top of the report, there’s a bar chart showing the distribution of the adverse events. Below the bar chart, the Tabulate section reports the counts for each treatment arm by dictionary-derived term, grouped by body system or organ class. The table displays the total number of adverse events, counting every event even if they occurred multiple times for a given subject.
You can select a bar in the graph or a value in the table, and the selected subjects will be highlighted in both places. You can also place your cursor over a bar in the graph to view summary information, including the total number of occurrences for a given adverse event.
Expanding the Data section on the left reveals options for choosing term and group level settings, selecting event types, specifying the demographic grouping, and stacking the data to add information about the adverse events to the graph and table, such as seriousness, severity, outcome, causality, and action taken. These options provide a flexible approach for your data analysis.
The report data filters let you subset and view subjects based on specific criteria and categories of adverse events. For example, you could filter on serious events where the outcome was coded as Recovered or Resolved with Sequelae.
You can click the And button to add additional filters using the variables in your data.
The Adverse Events Multiple Occurrences Distribution report is an interactive, customizable report that facilitates a detailed understanding of patterns of adverse events in clinical trials.
For more information about this report in JMP Clinical, please click the question mark icon in the upper right corner of the report tab, or contact support@jmp.com.
