RE-LY re-analysis reveals AE statistical conundrum

A second look at the data uncovers "scores" of previously unreported and sometimes serious adverse events from the RE-LY trial's published outcomes data. The re-analysis of Boehringer Ingelheim's anti-coagulant, approved in October, follows an FDA request for the re-check. Yet the additional reports of neurologic events, bleeding, and infarctions had no substantial effect on the primary end point of stroke or peripheral embolic events. The events actually strengthen the findings, says lead investigator Stuart Connolly, because they "show the robustness of the overall results." Story

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