Generating Adverse Event (AE) narratives manually can be time-consuming and repetitive work. The Adverse Events Narrative report in JMP Clinical enables medical reviewers and writers to generate narratives quickly and efficiently by automating the process of collecting data from various domains and summarizing it for each participant.
Transcript:
Welcome to this tutorial on the Adverse Events Narrative report in JMP Clinical. This report creates detailed narratives for clinical study reports, focusing on adverse events. This is a key tool for medical writers, enabling them to efficiently document and analyze adverse events in clinical trials, with comprehensive and customizable narratives.
We’ll use the Nicardipine study, which is the sample data set that’s installed with JMP Clinical.
When you add the Adverse Events Narrative report to a study review, the report doesn’t run automatically. That gives you the chance to specify various options for the report. For now, though, let’s run it with the default options.
In just a few seconds, the report generates a 473 page rich text document containing adverse events narratives for over 300 subjects. Using the default options, the document only includes serious adverse events, so these are subjects who experienced at least one serious event.
The narratives include patient demographics in addition to descriptions of the adverse events. Let’s take a look at the components of a narrative for one of the subjects.
The first paragraph contains demographic and medical history information, which comes from the SDTM data. For example, the first subject in the document was 79 years old, white, and male. These terms came from the demographics, or DM, data. The terms in the second sentence came from the medical history, or MH, data.
The subject’s end-of-study status is described using terms from the disposition, or DS, data.
Following the subject summary, the narrative has a description of each adverse event – in this example, each serious adverse event – that the subject experienced.
Each event section consists of the name and occurrence of the event, followed by three paragraphs.
The first paragraph describes the adverse event, with information like the date the event occurred, whether it was considered serious or not, the action taken with study medication as a result of the event, and other available details.
The second paragraph reports other adverse events, along with their severity, that occur close to the start of the event of interest, with a default window of three days before or after the event. Any concomitant medications taken at the time of the event are listed here as well.
Finally, the third paragraph describes the causal relation of the study medication to the adverse event, and the final outcome of the event.
Each additional serious adverse event observed for this subject is described in its own section, and the narrative for the next subject starts at the top of a new page.
Let’s return to the review builder window and briefly explore some of the report options. You can use these options to customize the narratives with respect to the adverse events, exposure, concomitant medications, medical history, findings, and more.
By default, the narratives are not generated until you click Run this report, so that you can change options from the defaults if you need to. If you’re creating a saved review template for use in future analyses or with a different study, you can check the Auto-run option to enable the report to run when the review template is launched.
The report has built-in narrative templates that define the layout and/or style of the output. The default template option produces a report with all of the events grouped by subject, as you just saw. You can select one of the other templates from the drop-down menu, or even create custom templates as needed for different types of studies or regulatory requests. And there are a few additional options, like requesting a table of contents, or specifying how the subjects are referenced in the document.
In the Adverse Events section, you can select which category of adverse events to include in the narratives, and which types of events. Other options include specifying an end-of-dosing offset or which related events are reported.
The other available options are:
- Including dosage exposure or a findings domain
- Choosing how concomitant medications or medical history terms are reported
- And using additional filters to restrict your analysis to subjects meeting specific criteria at the domain level.
Finally, there are options to automatically open the generated narrative, which is checked by default, and to save the narrative to a location you specify.
Adverse event narratives are a critical component of a clinical study report submitted to regulatory agencies. In this video, you’ve seen how to use the JMP Clinical Adverse Events Narrative report to quickly and easily generate standardized narratives that summarize relevant clinical information for each subject, and can be customized or edited as needed.
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.
