Table 1 Adverse events, serious adverse events, deaths and discontinuations over the 26-weeks treatment period
Placebo | QVA149110/50 μg | Indacaterol 150 μg | Glycopyrronium 50 μg | Tiotropium 18 μg | |
|---|---|---|---|---|---|
Subjects, n | 232 | 474 | 476 | 473 | 480 |
Patients with any adverse events | 134 (57.8) | 261 (55.1) | 291 (61.1) | 290 (61.3) | 275 (57.3) |
COPD | 91 (39.2) | 137 (28.9) | 153 (32.1) | 150 (31.7) | 138 (28.8) |
Nasopharyngitis | 23 (9.9) | 31 (6.5) | 35 (7.4) | 46 (9.7) | 40 (8.3) |
Cough | 8 (3.4) | 26 (5.5) | 38 (8.0) | 18 (3.8) | 21 (4.4) |
Upper respiratory tract infection | 13 (5.6) | 20 (4.2) | 32 (6.7) | 20 (4.2) | 24 (5.0) |
Oropharyngeal pain | 7 (3.0) | 17 (3.6) | 7 (1.5) | 10 (2.1) | 10 (2.1) |
Viral upper respiratory tract infection | 7 (3.0) | 15 (3.2) | 11 (2.3) | 13 (2.7) | 12 (2.5) |
Upper respiratory tract infection bacterial | 13 (5.6) | 10 (2.1) | 13 (2.7) | 15 (3.2) | 22 (4.6) |
Lower respiratory tract infection | 5 (2.2) | 9 (1.19) | 15 (3.2) | 7 (1.5) | 12 (2.5) |
Back pain | 5 (2.2) | 8 (1.17) | 11 (2.3) | 17 (3.6) | 8 (1.7) |
Serious adverse events | 13 (5.6) | 22 (4.6) | 26 (5.5) | 29 (6.1) | 19 (4.0) |
Adjudicated CCV events | |||||
Atrial fibrillation/flutter (new onset) | 0 | 2 (0.4) | 3 (0.6) | 2 (0.4) | 1 (0.2) |
Serious CCV events | 1 (0.4) | 0 | 6 (1.3) | 7 (1.5) | 4 (0.8) |
MACE | 0 | 0 | 2 (0.4) | 3 (0.6) | 3 (0.6) |