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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...
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. |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2017
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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 |
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