Table 3 Results for ibuprofen-specific adverse events (nocebo effect)
Number | Adverse events, n (%) | RR (95% CI) | |
|---|---|---|---|
Intention-to-treat population (conservative), adjusted for minimisation variables | |||
Simplified-PIL | 35 | 6 (17.1) | 0.801 (0.268–1.894) |
No-PIL | 33 | 4 (12.1) | 0.497 (0.138–1.456) |
Standard-PIL | 34 | 8 (23.5) | Reference |
Intention-to-treat population (multiple imputation), adjusted for minimisation variables | |||
Simplified-PIL | 35 | NA | 0.731 (0.250–1.736) |
No-PIL | 33 | NA | 0.500 (0.144–1.431) |
Standard-PIL | 34 | NA | Reference |
Intention-to-treat population (conservative), unadjusted | |||
Simplified-PIL | 35 | 6 (17.1) | 0.728 (0.253–1.714) |
No-PIL | 33 | 4 (12.1) | 0.515 (0.153–1.439) |
Standard-PIL | 34 | 8 (23.5) | Reference |
Population who read PIL, adjusted for minimisation variables | |||
Simplified-PIL | 24 | 3 (12.5) | 0.461 (0.101–1.587) |
Standard-PIL | 28 | 7 (25.0) | Reference |