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

Elena TassistroDavide Paolo BernasconiMaria Grazia ValsecchiLaura Antolini
Published in: BMC medical research methodology (2024)
We demonstrated through simulations that one can handle patients selection in the risk sets due to the competing event, and thus obtain conditional independence between the two potential times, adjusting for all the observed covariates that induce dependence.
Keyphrases
  • clinical trial
  • end stage renal disease
  • ejection fraction
  • newly diagnosed
  • chronic kidney disease
  • prognostic factors
  • peritoneal dialysis
  • molecular dynamics
  • patient reported outcomes
  • patient reported