Bresalier 2005.
Methods | RCT comparing rofecoxib versus placebo for the prevention of colorectal adenoma. | |
Data | A total of 3260 patients were screened for the study, of whom 2586 were deemed to be eligible (1287/1299 were randomised 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 the total number of thrombotic cardiovascular events. | |
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. |