All Times EDT
Keywords: long term safety, incidence rate, event rate, exposure adjusted, correlation
How to analyze and present long-term safety data in an informative and appropriate way taking into consideration potential correlation due to patient switching treatment, correction for cumulative exposure time, constant hazard ratio assumption, etc. For example, exposure adjusted incidence rate (EAIR) and exposure adjusted event rate (EAER) are two common metrics for reporting adverse event risks in clinical trials. However, in clinical trials with treatment crossover, due to the presence of within subject correlation, EAIR and EAER need to be correctly estimated by considering the correlation information.