W-41: Targeted Review of Adverse Events of Special Interest (AESI)

Poster Presenter

Mary Nilsson

Researcher, Safety Analytics Group
Eli Lilly and Company
United States

Objectives

Demonstrating an example of how to use interactive visualization for the review of adverse event of special interest (AESI)

Method

Interactive data visualizations are an amazing way to review data. Much software and tools have been developed to review clinical safety data.

Results

When reviewing Adverse Events of Special Interest (AESIs), targeted displays for each AESI is preferred over the general safety displays found in most off-the-shelf review tools. In this poster, we will show an example of an interactive data visualization package we developed to review adverse events of special interest. This package provides a guided user interface. Users can pick an event of special interest and access a set of analyses specifically designed to help answer the clinical questions related to that topic. Through a simple and intuitive user interface, reviewers can easily navigate from summary level analyses to patient level information. Both summary and patient level displays are tailored to help reviewers focus on the information relevant to the AESI.

Conclusion

Guidance interactive visualizations are a great way statisticians can help medical reviewers to reduce their review time and have a great review experience.