DOAC Reanalysis Dataset

Welcome to the direct oral anticoagulant (DOAC) Reanalysis Dataset. 

Sheet 1: Exact references to the FDA reviews from which we extracted all data points. You will also find links to the FDA drug approval packages, where one also finds all other published documents pertaining to the approvals, such as statistical reviews. In Sheet 1, we also cite the primary trial reports for each of the four pivotal DOAC trials. 

Sheet 2: Basic overview of the 4 pivotal DOAC trials with an emphasis on time in therapeutic range (TTR) characteristics.

ISheet 3: Summary results from each of the 4 DOAC trials for the outcomes of stroke/systemic embolism, major bleed, and mortality (including outcome definitions from each trial).

Sheet 4: The full TTR dataset with outcome results stratified into quartiles (Q1 to Q4), including exact references to each data point in the FDA reviews.