Summary of adverse events: combined analysis (treated set)
| Olodaterol 5 µg | Tiotropium 2.5 µg | Tiotropium 5 µg | Tiotropium+olodaterol 2.5/5 µg | Tiotropium+olodaterol 5/5 µg | |
| Patients n | 1038 | 1032 | 1033 | 1030 | 1029 |
| All adverse events | 795 (76.6) | 758 (73.4) | 757 (73.3) | 769 (74.7) | 761 (74.0) |
| Treatment-related adverse events | 69 (6.6) | 62 (6.0) | 63 (6.1) | 62 (6.0) | 73 (7.1) |
| Adverse events leading to discontinuation | 103 (9.9) | 90 (8.7) | 93 (9.0) | 57 (5.5) | 76 (7.4) |
| Serious adverse events | 181 (17.4) | 156 (15.1) | 172 (16.7) | 168 (16.3) | 169 (16.4) |
| Fatal | 14 (1.3) | 12 (1.2) | 17 (1.6) | 14 (1.4) | 18 (1.7) |
| Life-threatening | 3 (0.3) | 5 (0.5) | 2 (0.2) | 5 (0.5) | 5 (0.5) |
| Disabling/incapacitating | 1 (0.1) | 3 (0.3) | 2 (0.2) | 0 (0.0) | 3 (0.3) |
| Requiring hospitalisation | 162 (15.6) | 144 (14.0) | 155 (15.0) | 149 (14.5) | 153 (14.9) |
| Prolonging hospitalisation | 12 (1.2) | 10 (1.0) | 3 (0.3) | 7 (0.7) | 6 (0.6) |
| Other | 20 (1.9) | 16 (1.6) | 18 (1.7) | 18 (1.7) | 12 (1.2) |
| Specific adverse events with an incidence >3% | |||||
| Respiratory, thoracic and mediastinal disorders | 470 (45.3) | 453 (43.9) | 441 (42.7) | 393 (38.2) | 405 (39.4) |
| COPD | 370 (35.6) | 352 (34.1) | 340 (32.9) | 301 (29.2) | 332 (32.3) |
| Cough | 31 (3.0) | 46 (4.5) | 45 (4.4) | 43 (4.2) | 40 (3.9) |
| Dyspnoea | 38 (3.7) | 44 (4.3) | 51 (4.9) | 37 (3.6) | 39 (3.8) |
| Infections and infestations | 393 (37.9) | 363 (35.2) | 348 (33.7) | 394 (38.3) | 374 (36.3) |
| Nasopharyngitis | 131 (12.6) | 123 (11.9) | 121 (11.7) | 134 (13.0) | 128 (12.4) |
| Upper respiratory tract infection | 56 (5.4) | 61 (5.9) | 57 (5.5) | 69 (6.7) | 54 (5.2) |
| Pneumonia | 36 (3.5) | 24 (2.3) | 26 (2.5) | 31 (3.0) | 34 (3.3) |
| Bronchitis | 33 (3.2) | 23 (2.2) | 23 (2.2) | 28 (2.7) | 31 (3.0) |
| Gastrointestinal disorders | 165 (15.9) | 152 (14.7) | 154 (14.9) | 146 (14.2) | 143 (13.9) |
| Diarrhoea | 33 (3.2) | 23 (2.2) | 27 (2.6) | 29 (2.8) | 24 (2.3) |
| Musculoskeletal and connective tissue disorders | 124 (11.9) | 119 (11.5) | 117 (11.3) | 155 (15.0) | 156 (15.2) |
| Back pain | 35 (3.4) | 23 (2.2) | 19 (1.8) | 40 (3.9) | 37 (3.6) |
| Nervous system disorders | 87 (8.4) | 93 (9.0) | 101 (9.8) | 100 (9.7) | 84 (8.2) |
| Headache | 31 (3.0) | 23 (2.2) | 41 (4.0) | 30 (2.9) | 27 (2.6) |
| Vascular disorders | 72 (6.9) | 54 (5.2) | 50 (4.8) | 58 (5.6) | 62 (6.0) |
| Hypertension | 48 (4.6) | 28 (2.7) | 30 (2.9) | 35 (3.4) | 30 (2.9) |
Data are presented as n (%), unless otherwise stated. COPD: chronic obstructive pulmonary disease.