Central adjudication of serious adverse events did not affect trial’s safety results: Data from the Efficacy of Nitric Oxide in Stroke (ENOS) trial

BACKGROUND AND PURPOSE: Central adjudication of serious adverse events (SAEs) can be undertaken in clinical trials, especially for open-label studies where outcome assessment may be at risk of bias. This study explored the effect of central adjudication of SAEs on the safety results of the Efficacy...

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Detalhes bibliográficos
Publicado no:PLoS One
Main Authors: Godolphin, Peter J., Montgomery, Alan A., Woodhouse, Lisa J., Bereczki, Daniel, Berge, Eivind, Collins, Rónán, Díez-Tejedor, Exuperio, Gommans, John, Lees, Kennedy R., Ozturk, Serefnur, Phillips, Stephen, Pocock, Stuart, Prasad, Kameshwar, Szatmari, Szabolcs, Wang, Yongjun, Bath, Philip M., Sprigg, Nikola
Formato: Artigo
Idioma:Inglês
Publicado em: Public Library of Science 2018
Assuntos:
Research Article
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6258247/
https://ncbi.nlm.nih.gov/pubmed/30475912
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1371/journal.pone.0208142
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