Survival analysis for AdVerse events with VarYing follow-up times (SAVVY): Rationale and statistical concept of a meta-analytic study.

@article{Stegherr2020SurvivalAF,
  title={Survival analysis for AdVerse events with VarYing follow-up times (SAVVY): Rationale and statistical concept of a meta-analytic study.},
  author={Regina Stegherr and Jan Beyersmann and Valentine Jehl and Kaspar Rufibach and Friedhelm Leverkus and Claudia Schmoor and Tim Friede},
  journal={Biometrical journal. Biometrische Zeitschrift},
  year={2020}
}
The assessment of safety is an important aspect of the evaluation of new therapies in clinical trials, with analyses of adverse events being an essential part of this. Standard methods for the analysis of adverse events such as the incidence proportion, that is the number of patients with a specific adverse event out of all patients in the treatment groups, do not account for both varying follow-up times and competing risks. Alternative approaches such as the Aalen-Johansen estimator of the… Expand

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