Deves

Abstract

Drug-drug interaction related adverse events (DIAE) signals are a major public health issue. Drug safety analysts must sift through thousands of adverse event reports submitted daily to U.S. Food and Drug Administration (FDA) to discover unexpected DIAE signals, which if addressed can lead to life-saving actions. To facilitate the DIAE discovery from these massive data sets, we design several technological innovations that together are integrated into an interactive visual analytics system called DEVES 1. First, our stateof-the-art DIAE mining algorithm efficiently infers potential DIAE signals from these reports, and then ranks them based on their significance score. For interpretability of these inferred DIAE signals, domain knowledge of adverse events and already known drug interactions is extracted from external authoritative data sources and then seamlessly integrated with the inferred signal set. Guided by this augmented signal model, DEVES supports advanced signal analytics-empowering the analyst to interact with linked visualizations offering complementary perspectives into the signal set and its supporting evidence in the form of reports. Our demonstration showcases the technological innovations of DEVES using real-world FDA datasets, demonstrating that DEVES effectively supports the core regulatory tasks from signal screening, signal prioritization to signal validation.