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. 2016 Mar 10;2016(3):MR000043. doi: 10.1002/14651858.MR000043.pub2

Schulman 2009.

Methods RCT comparing dabigatran versus warfarin in patients with acute venous thromboembolism.
Data 2564 patients were randomised (1274/1265, respectively in each treatment group).
Comparisons Onsite assessment (local investigator blinded) versus assessment by an AC blinded to allocated treatment.
Outcomes The primary selected was a composite outcome of symptomatic venous thromboembolism or related death. This was the study's primary outcome.
Notes  
Risk of bias
Item Authors' judgement Description
Method for selecting cases to adjudicate? No All suspect events adjudicated were identified by onsite assessor who was blinded to allocated treatment.