| NVA237 50 μg q.d. | Placebo | Tiotropium 18 μg q.d. | |
| Subjects n | 525 | 268 | 267 |
| Patients with adverse events | 402 (76.6) | 205 (76.5) | 198 (74.2) |
| COPD worsening# | 191 (36.4) | 116 (43.3) | 90 (33.7) |
| Upper respiratory tract infection | 57 (10.9) | 33 (12.3) | 30 (11.2) |
| Nasopharyngitis | 47 (9.0) | 15 (5.6) | 21 (7.9) |
| Sinusitis | 28 (5.3) | 14 (5.2) | 10 (3.7) |
| Upper respiratory tract infection, bacterial | 28 (5.3) | 28 (10.4) | 21 (7.9) |
| Back pain | 25 (4.8) | 10 (3.7) | 12 (4.5) |
| Headache | 25 (4.8) | 14 (5.2) | 12 (4.5) |
| Lower respiratory tract infection | 23 (4.4) | 9 (3.4) | 10 (3.7) |
| Bronchitis | 22 (4.2) | 10 (3.7) | 12 (4.5) |
| Cough | 21 (4.0) | 13 (4.9) | 12 (4.5) |
| Hypertension | 21 (4.0) | 12 (4.5) | 14 (5.2) |
| Dry mouth | 16 (3.0) | 5 (1.9) | 4 (1.5) |
| Dyspnoea | 14 (2.7) | 13 (4.9) | 6 (2.2) |
| Pneumonia | 14 (2.7) | 12 (4.5) | 7 (2.6) |
| Urinary tract infection | 14 (2.7) | 8 (3.0) | 16 (6.0) |
| Peripheral oedema | 9 (1.7) | 6 (2..2) | 8 (3.0) |
| Upper respiratory tract infection viral | 9 (1.7) | 13 (4.9) | 11 (4.1) |
| Patients with serious adverse events | 66 (12.6)¶ | 43 (16.0) | 41 (15.4)¶ |
| COPD worsening# | 19 (3.6) | 16 (6.0) | 13 (4.9) |
| Pneumonia | 7 (1.3) | 7 (2.6) | 4 (1.5) |
| Atrial fibrillation | 4 (0.8) | 0 | 0 |
| Dehydration | 4 (0.8) | 2 (0.7) | 0 |
| Syncope | 3 (0.6) | 1 (0.4) | 0 |
| Transient ischemic attack | 3 (0.6) | 1 (0.4) | 0 |
| Bronchitis | 3 (0.6) | 1 (0.4) | 0 |
| Deaths | 3 (0.6)+ | 2 (0.7) | 2 (0.7) |
| Discontinuation due to adverse events | 42 (8.0) | 31 (11.6) | 20 (7.5) |
| Electrocardiographic abnormalities | |||
| Total notable | 23 (4.4) | 16 (6.0) | 14 (5.3) |
| QTc >500 ms | 2 (0.4) | 2 (0.7) | 0 |
| Increase from baseline of 30–60 ms | 83 (15.8) | 39 (14.6) | 43 (16.2) |
| Increase from baseline of >60 ms | 1 (0.2) | 1 (0.4) | 0 |
Data are presented as n (%), unless otherwise stated. #: includes chronic obstructive pulmonary disease (COPD) exacerbation; ¶: includes one serious adverse event in the 30-day follow-up period; +: includes one death in the 30-day follow-up period.