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

Hawkey 2007.

Methods RCT comparing lumiracoxib versus nonsteroidal anti‐inflammatory drugs (naproxen or ibuprofen) in patients with osteoarthritis.
Data 18,325 patients were randomised and 18,244 received at least 1 dose of study medication: lumiracoxib (9117 patients), naproxen (4730 patients), oribuprofen (4397 patients) .
Comparisons Onsite assessment (local investigator blinded) versus assessment by an AC blinded to allocated treatment.
Outcomes The outcome selected was all definite or probable ulcer complications. 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.