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

OASIS‐6 2006.

Methods RCT analysing the effects of fondaparinux, a factor Xa inhibitor, versus usual care on mortality and reinfarction in patients with acute ST‐segment elevation myocardial infarction.
Data 12,092 patients randomised (6056/6036, respectively in each treatment group).
Comparisons Onsite assessment (local investigator blinded) versus assessment by an AC blinded to allocated treatment.
Outcomes The outcome selected was reinfarction at 30 days or death.
Notes The study was identified because it was included in a pooled analysis of 10 RCTs (Pogue 2009). Data related to the number of events in each treatment group resulting from onsite‐assessor and AC assessments were extracted from this meta‐analysis on the primary outcomes of the included studies.
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.