Tiotropium (n = 2986) | Control (n = 3006) | Tiotropium/control | ||||||
---|---|---|---|---|---|---|---|---|
Event by year | N (%) | Patient-year | IRa | N (%) | Patient-year | IRa | RR-year | p-value |
(95 % CI) | ||||||||
Fatal event | ||||||||
1 | 162 (5) | 2675.7 | 6.1 | 182 (6) | 2576.8 | 7.1 | 0.86 | 0.1538 |
(0.69-1.06) | ||||||||
2 | 238 (8) | 5067.4 | 4.7 | 261 (9) | 4797.4 | 5.4 | 0.86 | 0.1010 |
(0.72-1.03) | ||||||||
3 | 307 (10) | 7222.9 | 4.3 | 339 (11) | 6741.5 | 5.0 | 0.85 | 0.0328 |
(0.72-0.99) | ||||||||
4 | 376 (13) | 9169.5 | 4.1 | 408 (14) | 8459.5 | 4.8 | 0.85 | 0.0232 |
(0.74-0.98) | ||||||||
Serious adverse event: Respiratory failure | ||||||||
1 | 31 (1) | 2726.9 | 1.1 | 51 (2) | 2626.3 | 1.9 | 0.59 | 0.0187 |
(0.37-0.91) | ||||||||
2 | 48 (2) | 5152.6 | 0.9 | 67 (2) | 4866.5 | 1.4 | 0.68 | 0.0389 |
(0.47-0.98) | ||||||||
3 | 68 (2) | 7324.4 | 0.9 | 88 (3) | 6809.8 | 1.3 | 0.72 | 0.0406 |
(0.52-0.99) | ||||||||
4 | 83 (3) | 9267.4 | 0.9 | 112 (4) | 8513.8 | 1.3 | 0.68 | 0.0079 |
(0.51-0.90) | ||||||||
Serious adverse event: Hospitalization due to exacerbation | ||||||||
1 | 272 (9) | 2630.9 | 10.3 | 326 (11) | 2513.9 | 13.0 | 0.80 | 0.0058 |
(0.68-0.94) | ||||||||
2 | 440 (15) | 4825.7 | 9.1 | 507 (17) | 4515.4 | 11.2 | 0.81 | 0.0014 |
(0.71-0.92) | ||||||||
3 | 573 (19) | 6701.1 | 8.6 | 641 (21) | 6161.6 | 10.4 | 0.82 | 0.0006 |
(0.73-0.92) | ||||||||
4 | 681 (23) | 8308.8 | 8.2 | 735 (25) | 7555.3 | 9.7 | 0.84 | 0.0013 |
(0.76-0.94) | ||||||||
Trial discontinuation due to worsening of COPD | ||||||||
1 | 92 (3) | 2741.3 | 3.4 | 178 (6) | 2644.4 | 6.7 | 0.50 | <0.0001 |
(0.39-0.64) | ||||||||
2 | 146 (5) | 5179.9 | 2.8 | 250 (8) | 4906.4 | 5.1 | 0.55 | <0.0001 |
(0.45-0.68) | ||||||||
3 | 202 (7) | 7366.6 | 2.7 | 317 (11) | 6871.0 | 4.6 | 0.59 | <0.0001 |
(0.50-0.71) | ||||||||
4 | 237 (8) | 9326.7 | 2.5 | 367 (12) | 8598.9 | 4.3 | 0.60 | <0.0001 |
(0.51-0.70) |