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An Approach to Integrated Safety Analyses from Clinical Studies

The analysis of safety data of clinical studies poses specific problems that are related to a multiplicity of usually not explicitly specified hypotheses. Furthermore, individual studies are generally not capable of providing a comprehensive picture of the safety profile of a drug. Therefore, data from different studies have to be combined to reach conclusions. Based on a generalized linear mixed effects model, I present an approach that can address both aspects under plausible assumptions. The method is applied to a real example.