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Reporting Clinical End Points and Safety Events in an Acute Coronary Syndrome Trial: Results With Integrated Collection

BACKGROUND: End points and adverse events (AEs) are collected separately in clinical trials, yet regulatory requirements for serious AE reporting vary across regions, so classifying end points according to seriousness criteria can be useful in global trials. METHODS AND RESULTS: In the Apixaban for...

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Detalles Bibliográficos
Autores principales: Guimarães, Patrícia O., Lopes, Renato D., Stevens, Susanna R., Zimerman, André, Wruck, Lisa, James, Stefan K., Haque, Ghazala, Giraldez, Roberto Rocha C. V., Alexander, John H., Alexander, Karen P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5533035/
https://www.ncbi.nlm.nih.gov/pubmed/28438739
http://dx.doi.org/10.1161/JAHA.117.005490