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

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...

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Bibliographic Details
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
Format: Article
Language:English
Published: Wiley 2017-04-01
Series:Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
Subjects:
acute coronary syndrome
clinical end points
clinical events classification
safety
serious adverse events
Online Access:https://www.ahajournals.org/doi/10.1161/JAHA.117.005490

Internet

https://www.ahajournals.org/doi/10.1161/JAHA.117.005490

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