Adverse events in single-arm clinical trials with non-fatal time-to-event efficacy endpoint: from clinical questions to methods for statistical analysis

Adverse events in single-arm clinical trials with non-fatal time-to-event efficacy endpoint: from clinical questions to methods for statistical analysis

Abstract Background In any single-arm trial on novel treatments, assessment of toxicity plays an important role as occurrence of adverse events (AEs) is relevant for application in clinical practice. In the presence of a non-fatal time-to-event(s) efficacy endpoint, the analysis should be broadened...

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Bibliographic Details
Main Authors: Elena Tassistro, Davide Paolo Bernasconi, Maria Grazia Valsecchi, Laura Antolini
Format: Article
Language:English
Published: BMC 2024-01-01
Series:BMC Medical Research Methodology
Subjects:
Survival analysis
Adverse events
Competing risks
Dependent censoring
IPCW
Online Access:https://doi.org/10.1186/s12874-023-02123-z

Internet

https://doi.org/10.1186/s12874-023-02123-z

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