November 3, 2010Open Access
View Full PaperNewly Identified Events in the RE-LY Trial
Key Result
Re-evaluation of the RE-LY trial database identified additional primary efficacy and safety outcome events, including two systemic embolic events and nine major hemorrhages.
Structured PICO
P
Population
Patients in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial
I
Intervention
Long-Term Anticoagulation Therapy
O
Outcome
Primary efficacy and safety outcome events (including systemic embolic events and major hemorrhages)hard clinical
An update to the RE-LY trial identified additional efficacy and safety events after database lock, prompting a reevaluation of the study database for possible underreporting.
Abstract
To the Editor: We wish to update our article about the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial (Sept. 17, 2009, issue).1 After the database was locked on August 15, 2009, we identified several additional primary efficacy and safety outcome events during routine clinical site closure visits. These events included two systemic embolic events and nine major hemorrhages. Subsequently, after discussions with the Food and Drug Administration, the primary and secondary efficacy and safety data were checked for consistency, and the study database was reevaluated for possible underreporting of events. To achieve this, all free text, outcomes, and adverse . . .