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

RECORD 2009.

Methods RCT comparing rosiglitazone versus metformin plus sulphonylurea in patients with type 2 diabetes.
Data 4447 patients were randomised (2220/2227, respectively in each treatment group).
Comparisons Onsite assessment (local investigator non blinded) versus assessment by an AC blinded to allocated treatment.
Outcomes The outcome selected was myocardial infarction. The study's primary outcome was cardiovascular hospitalisation or cardiovascular death..
Notes The study was identified because it was included in a review (Serebruany 2012). Data related to the number of events in each treatment group resulting from onsite‐assessor and AC assessments were extracted from this review.
Risk of bias
Item Authors' judgement Description
Method for selecting cases to adjudicate? Yes All suspect events adjudicated were identified by onsite assessor who was blinded to allocated treatment.