Analyzing serious AEs

ICH Guidance E2A (1994) provides the following definition of a serious event A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose  

A similar analysis can be performed to address another question of interest How likely is it that an individual will experience an adverse effect that is potentially life threatening The data used to answer this question include all of the AEs that were rated as serious at the time of reporting. We would estimate the probability by calculating the proportion of participants treated in each group who experienced a serious AE. The proportions (or, equivalently, the percentages) of patients could be compared across groups to see if there was an increased risk of a serious AE associated with the new treatment. 

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