Evaluation of Adverse Events from Pooled Studies of Different Durations
*Ellen S Snyder, Merck & Co., Inc 

Keywords: Pooled Safety Data, Adverse Event Reporting, Life Tables

The evaluation of adverse event (AE) data from pooled studies in a drug development program is typically performed for the integrated summary of safety (ISS) for new drug submissions. More recently, continuous meta-analysis (CMA) of safety data is being performed in advance of the ISS for the purpose of routine monitoring of unblinded trials during the clinical development phase of a compound to detect potential safety signals earlier in development. An important issue to consider when pooling AE data for these and other purposes is that the studies to be pooled often have follow-up periods of different durations. This presentation will review the pitfalls of ignoring follow-up time when summarizing AEs and proposes using clinical life table methods for the evaluation of AEs from pooled studies of different lengths and when patients in a single study differ with respect to length of follow-up time. The advantages of this approach will be discussed and the use of two displays for the AE data when using this approach will be proposed.