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The analysis of adverse events (AEs) is a key component in the assessment ofa drug's safety profile. Inappropriate analysis methods may result inmisleading conclusions about a therapy's safety and consequently itsbenefit-risk ratio. The statistical analysis of AEs is complicated by the factthat the follow-up times can vary between the patients included in a clinicaltrial. This paper takes as its focus the analysis of AE data in the presence ofvarying follow-up times within the benefit assessment of therapeuticinterventions. Instead of approaching this issue directly and solely from ananalysis point of view, we first discuss what should be estimated in thecontext of safety data, leading to the concept of estimands. Although thecurrent discussion on estimands is mainly related to efficacy evaluation, theconcept is applicable to safety endpoints as well. Within the framework ofestimands, we present statistical methods for analysing AEs with the focusbeing on the time to the occurrence of the first AE of a specific type. We giverecommendations which estimators should be used for the estimands described.Furthermore, we state practical implications of the analysis of AEs in clinicaltrials and give an overview of examples across different indications. We alsoprovide a review of current practices of health technology assessment (HTA)agencies with respect to the evaluation of safety data. Finally, we describeproblems with meta-analyses of AE data and sketch possible solutions.

On estimands and the analysis of adverse events in the presence of varying follow-up times within the benefit assessment of therapies