The Adverse Events Incidence Rates report provides a detailed analysis of adverse events in clinical trials, focusing on their frequency and incidence rates.
Transcript:
In this tutorial, we'll be covering the Adverse Events Incidence Rates report. This report calculates the counts of adverse events, as well as the incidence rates. Incidence rates are calculated as the total number of occurrences of a given event, say, 25, per patient years of exposure. For example, a 4 month study of 450 patients would be equivalent to 150 patient years. The incidence rate for the event would be the number of occurrences divided by 150. A common multiplier of incidence rates is 100, so in this example, the incidence rate would be 17 per 100 patient years. These rates can then be analyzed across different treatment groups or another comparator.
The information in the Adverse Events Incidence Rates report is displayed as both a bar chart and in tabular form.
By default, the counts of the total number of events that have occurred are shown on the Y axis, and the adverse events are shown on the X axis in order from highest count to lowest count . The graph is segmented into the treatment groups, which are Nicardipine and placebo in this example.
To display the incidence rates instead of the counts, you can click the option above the graph.
Below the bar chart is a tabular summary of the results, with the dictionary-derived terms grouped by body system or organ class, or SOCs. For each group and term, the table displays the number of events that occurred and the incidence rate per 100 patient years, segmented by treatment group, and the overall totals.
You might want to customize the report to change the underlying data used to create it, or to focus on a subset of the results.
Let’s expand the Data section and take a look at the options.
In the Term and Group Level menu, you can choose different types of grouping levels or term definitions, and the available options depend on the variables in the study data. If I choose Reported Term for the Adverse Event Grouped by High Level Group Term, the report will refresh and display the updated calculations.
Some of the other options relate to time at risk, like specifying patient years of exposure or on study, the multiplier used for patient years, how to determine time at risk and adverse event inclusion, an offset option, and determining ongoing subjects.
There are also various options for the demographic grouping. For example, if I select SEX from the drop-down menu, the graph and table update to display the data with that grouping.
Stacking can add more information to the report. When you choose one of the stacking options, like Severity or Intensity, the bars in the graph are colored by the levels – in this case, mild, moderate, and severe. The table also updates to reflect your choice.
The Display section includes data filters to help focus the report. Instead of seeing all the results, you can filter using the variables in your data.
For example, in the filter for High Level Group Term, I can select the term Arteriosclerosis, stenosis. vascular insufficiency, and necrosis, and now the report only displays terms related to that group.
JMP Clinical automatically includes several filter variables by default, but you can add other demographic or adverse event variables from the study data using the AND button at the bottom of the Report Filter list.
In summary, the Adverse Events Incidence Rate report enables you to explore counts or rates of adverse events that occurred in the study in both graphical and tabular views. The report options can be modified, and the data can be subset by filtering to provide additional perspectives on the adverse event data.
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.
