Automated summaries of serious adverse events in the hepatitis C antiviral long-term treatment against cirrhosis trial

@article{Bell2009AutomatedSO,
  title={Automated summaries of serious adverse events in the hepatitis C antiviral long-term treatment against cirrhosis trial},
  author={Margaret C. Bell and Patricia R. Robuck and Elizabeth Cox Wright and Marina Mihova and Charlotte M. Hofmann and Jennifer L De Santo and Susan L Milstein and Pamela A Richtmyer and Janel Shelton and Maureen Cormier and Debra King and Choon J Park and Wallis A Molchen and Yoon Park and Michelle Kelley},
  journal={Clinical Trials},
  year={2009},
  volume={6},
  pages={618 - 627}
}
Background Even though adverse event (AE) collection and official accounting are mandatory for clinical trials, there are limited detailed guidelines specifying how to summarize the event for reporting in a timely and expeditious manner. This article details the AE and serious adverse event (SAE) reporting summary developed for a large multi-center National Institutes of Health (NIH)-sponsored clinical trial. Purpose To review and analyze the large volume of AE data reported by 10 sites (806… CONTINUE READING

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