The Interventions Distribution report is a comprehensive tool that allows for the analysis of interventions (such as concomitant medication or substance use) and demographic variables across treatment groups in clinical trials. It ensures that each subject is reported only once per intervention, irrespective of the number of incidents.
Note: this video was recorded in JMP Clinical version 17.2, but applies to version 18 as well.
Transcript:
The Interventions Distribution report is critical for analyzing counts or percentages of interventions that occur across different treatment arms or other comparator in a clinical study. This report considers each subject only once per intervention, and not multiple occurrences.
Interventions include data domains like concomitant medications, treatment exposure, and so on. If you expand the Data option, you can select an intervention from the Domain drop-down menu. In this example, there are only two intervention domains available, and we’ll use the Concomitant Medication data.
The default view for this report shows a bar chart that summarizes the subject counts for each intervention by treatment group. You can switch between counts and percentages by clicking the option above the graph.
You can place your cursor over a bar in the chart to display summary information for that bar.
The bar chart provides a visual summary of the data while the Tabulate section below the bar chart presents the subject counts and percentages for each treatment group and intervention as a table, for a more detailed view.
The data in the Bar Chart and Tabulate sections are linked. If you select a bar in the graph, the corresponding subjects are selected in the table. And this works the other way too – you can select subjects in the table, and they’ll also be selected in the graph.
You can click in a blank area of the graph to deselect the subjects.
In addition to specifying domains, you can tailor your analysis using the other drop-down menus in the Data Options on the left. You can define term and group levels and specify intervention types. JMP Clinical can also determine treatment emergent interventions if you select the option Ignore available treatment emergent flags.
There are also various demographic grouping options that can provide a more nuanced view of your data if you want to use demographic characteristics instead of treatment.
The Display options include the report data filters, which allow you to subset and view subjects based on specific criteria. The default filters in this report are Overall Percent Occurrence, Original Category for Medication, and Standardized Medication Name, and you can add other filters from the data using the And button at the bottom of the panel.
The graph and summary table update as you make selections in the data filters. For numeric filters, you can change the filter by dragging the slider bar or by typing a lower or upper value. For categorical filters, you can select individual categories, or select multiple categories by holding the Ctrl key.
Both the graph and the table reflect the selections in the data filters.
You can also click and drag to select adjacent categories.
You can clear individual filter selections using the red triangle menu, or clear all of your selections with the Clear button.
JMP Clinical makes it easy to analyze interventions data with highly interactive and customizable reports.
For more information about the Interventions Distribution report, please click the question mark icon in the upper right corner of the report tab, or contact support@jmp.com.