"AoSEberg Journey: Analysis of Similar Events as an Important Tool of Signal Detection and Safety Surveillance of Investigational Medicinal Products"

Reporting of adverse events is mandatory in the clinical development of investigational medicinal products (IMPs). While most reporting requirements have been globally harmonized, some local ones are vaguely formulated. Analysis of Similar Events (AoSE) may serve as an example of such vague requirement. Here, we advocate the AoSE as a useful tool for signal detection and strongly recommend including both non-serious and serious treatment-emergent adverse events (TEAEs) in the analysis.