A targeted review of deaths in the RE-LY trial was conducted by the sponsor to identify previously unreported concurrent events such as fatal bleeding or hemorrhagic strokes.
To the Editor: Boehringer Ingelheim recently conducted a targeted review of the 1387 deaths that occurred during the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial, 1 which evaluated the effects of two doses of dabigatran, as compared with warfarin, on rates of stroke or systemic embolism and major bleeding. Also included in this review were the deaths of 6 patients who did not undergo randomization and 10 deaths that occurred after the end of the study. This review was conducted to determine whether a concurrent event may have occurred with respect to each death, even though such an event was not originally reported. In addition, all fatal bleeding episodes, hemorrhagic strokes, and hospitalizations for trauma were similarly
No takes yet. Share an insight, caveat, or question.
Connolly et al. (2014) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: