| Placebo (n = 11,626) | Tiotropium (n = 12,929) | RR (95% CI) | |||
|---|---|---|---|---|---|
| n (%) | IR | n (%) | IR | ||
| AEs | 7619 (65.5) | 152.85 | 8093 (62.6) | 140.35 | 0.90 (0.87, 0.93)* |
| Serious AEs | 2654 (22.8) | 23.08 | 2802 (21.7) | 21.73 | 0.94 (0.89, 0.99)* |
| Fatal AEs | 523 (4.5) | 3.71 | 515 (4.0) | 3.27 | 0.90 (0.79, 1.01) |
| MACE | 358 (3.1) | 2.56 | 345 (2.7) | 2.20 | 0.87 (0.75, 1.01) |
| Fatal MACE† | 192 (1.7) | 1.35 | 190 (1.5) | 1.20 | 0.90 (0.74, 1.10) |
*Significantly different to 1; †including death unknown. IR per 100 patient-years