Survival Analysis for AdVerse Events with VarYing Follow-Up
Times
Description
The SAVVY (Survival Analysis for AdVerse Events with VarYing Follow-Up Times)
project is a consortium of academic and pharmaceutical
industry partners that aims to improve the analyses of adverse event (AE)
data in clinical trials through the use of survival techniques appropriately
dealing with varying follow-up times and competing events, see
Stegherr, Schmoor, Beyersmann, et al. (2021) .
Although statistical methodologies have advanced,
in AE analyses often the incidence proportion, the incidence density or a
non-parametric Kaplan-Meier estimator are used, which either ignore censoring or
competing events. This package contains functions to easily conduct the
proposed improved AE analyses.