31 citations · 63 across the 5 of their papers we have counts for
4 papers · 1 filter
Patient-reported outcomes in the context of the benefit assessment in Germany
Sarah Böhme, Christoph Gerlinger, Susanne Huschens +7
Since the 2011 Act on the Reform of the Market for Medicinal Products, benefit dossiers are submitted by pharmaceutical companies to facilitate the Health Technology Assessment (HT…
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)…
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…