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Results of a reevaluation of cardiovascular outcomes in the RECORD trial
Mahaffey, Kenneth W. Hafley, Gail Dickerson, Sheila Burns, Shana Tourt-Uhlig, Sandra White, Jennifer Newby, L. Kristin Komajda, Michel McMurray, John Bigelow, Robert
Mahaffey, Kenneth W.
Hafley, Gail
Dickerson, Sheila
Burns, Shana
Tourt-Uhlig, Sandra
White, Jennifer
Newby, L. Kristin
Komajda, Michel
McMurray, John
Bigelow, Robert
Abstract
The US Food and Drug Administration ( FDA ) required a reevaluation of cardiovascular ( CV ) outcomes in the RECORD trial. This provided an opportunity to assess the implications of event adjudication by 2 groups and quantify the differences as well as to use new FDA end point definitions in development.
Keywords
Date
2013
Type
Journal article
Journal
American Heart Journal
Book
Volume
166
Issue
2
Page Range
240-249
Article Number
ACU Department
Collections
Relation URI
Source URL
Event URL
Open Access Status
Published as ‘gold’ (paid) open access
License
File Access
Open
Notes
© 2013, The Authors. Published by Mosby, Inc. Open access under CC BY-NC-ND license