Survival analysis for AdVerse events with VarYing follow-up times (SAVVY)—estimation of adverse event risks

Abstract Background The SAVVY project aims to improve the analyses of adverse events (AEs), whether prespecified or emerging, in clinical trials through the use of survival techniques appropriately dealing with varying follow-up times and competing events (CEs). Although statistical methodologies ha...

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Bibliographic Details
Main Authors: Regina Stegherr, Claudia Schmoor, Jan Beyersmann, Kaspar Rufibach, Valentine Jehl, Andreas Brückner, Lewin Eisele, Thomas Künzel, Katrin Kupas, Frank Langer, Friedhelm Leverkus, Anja Loos, Christiane Norenberg, Florian Voss, Tim Friede
Format: Article
Language:English
Published: BMC 2021-06-01
Series:Trials
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Online Access:https://doi.org/10.1186/s13063-021-05354-x