Number (%) of patients with adverse events
| Indacaterol 300 μg | Indacaterol 600 μg | Formoterol | Placebo | |
| n=437 | n=425 | n=434 | n=432 | |
| Any adverse event | 310 (70.9) | 276 (64.9) | 283 (65.2) | 267 (61.8) |
| Events occurring in >5% of any group | ||||
| COPD worsening* | 140 (32.0) | 117 (27.5) | 134 (30.9) | 150 (34.7) |
| Nasopharyngitis | 73 (16.7) | 80 (18.8) | 62 (14.3) | 56 (13.0) |
| Cough | 32 (7.3) | 27 (6.4) | 17 (3.9) | 19 (4.4) |
| Upper respiratory tract bacterial infection | 29 (6.6) | 25 (5.9) | 23 (5.3) | 36 (8.3) |
| Lower respiratory tract infection | 27 (6.2) | 23 (5.4) | 22 (5.1) | 22 (5.1) |
| Muscle spasms | 23 (5.3) | 25 (5.9) | 12 (2.8) | 6 (1.4) |
| Adverse events leading to discontinuation | 36 (8.2) | 24 (5.6) | 42 (9.7) | 40 (9.3) |
| Events leading to discontinuation occurring in >0.5% of any group | ||||
| COPD worsening | 5 (1.1) | 4 (0.9) | 17 (3.9) | 17 (3.9) |
| Dyspnoea | 4 (0.9) | 2 (0.5) | 1 (0.2) | 3 (0.7) |
| Asthenia | 3 (0.7) | 0 | 0 | 0 |
| Lower respiratory tract infection | 2 (0.5) | 1 (0.2) | 4 (0.9) | 1 (0.2) |
| Sudden death | 1 (0.2) | 0 | 0 | 3 (0.7) |
| Respiratory failure | 0 | 0 | 4 (0.9) | 1 (0.2) |
↵* Including COPD exacerbations.
COPD, chronic obstructive pulmonary disease.