5 papers
Survival analysis for AdVerse events with VarYing follow-up times (SAVVY): summary of findings and a roadmap for the future of safety analyses in clinical trials
Kaspar Rufibach, Jan Beyersmann, Tim Friede +2
The SAVVY project aims to improve the analyses of adverse events (AEs) in clinical trials through the use of survival techniques appropriately dealing with varying follow-up times…
Survival analysis for AdVerse events with VarYing follow-up times (SAVVY) -- estimation of adverse event risks
Regina Stegherr, Claudia Schmoor, Jan Beyersmann +12
The SAVVY project 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 tim…
Survival analysis for AdVerse events with VarYing follow-up times (SAVVY) -- comparison of adverse event risks in randomized controlled trials
Kaspar Rufibach, Regina Stegherr, Claudia Schmoor +12
Analyses of adverse events (AEs) are an important aspect of the evaluation of experimental therapies. The SAVVY (Survival analysis for AdVerse events with Varying follow-up times)…
Estimating and comparing adverse event probabilities in the presence of varying follow-up times and competing events
Regina Stegherr, Claudia Schmoor, Michael Lübbert +2
Safety analyses in terms of adverse events (AEs) are an important aspect of benefit-risk assessments of therapies. Compared to efficacy analyses AE analyses are often rather simpli…
Survival analysis for AdVerse events with VarYing follow-up times (SAVVY): Rationale and statistical concept of a meta-analytic study
Regina Stegherr, Jan Beyersmann, Valentine Jehl +4
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 met…