Newly Identified Events in the RE-LY Trial

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 . . .