https://www.selleckchem.com/pr....oducts/pf-2545920.ht
Detecting safety signals in clinical trial safety data is known to be challenging due to high dimensionality, rare occurrence, weak signal, and complex dependence. We propose a new hierarchical testing approach for analyzing safety data from a typical randomized clinical trial. This approach accounts for the hierarchical structure of adverse events (AEs), that is, AEs are categorized by system organ class (SOC). Our approach contains two steps the first step tests, for each SOC, whether any AEs within this SOC are differently distrib