Reporting Clinical End Points and Safety Events in an Acute Coronary Syndrome Trial: Results With Integrated Collection
BackgroundEnd 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 ResultsIn the Apixaban for Prev...
Main Authors: | Patrícia O. Guimarães, Renato D. Lopes, Susanna R. Stevens, André Zimerman, Lisa Wruck, Stefan K. James, Ghazala Haque, Roberto Rocha C. V. Giraldez, John H. Alexander, Karen P. Alexander |
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Format: | Article |
Language: | English |
Published: |
Wiley
2017-04-01
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Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
Subjects: | |
Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.117.005490 |
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