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. |