Most frequent adverse events (at least 5 patients in any treatment group), serious adverse events (at least 2 patients in any treatment group), death and discontinuations due to adverse events (safety set)
| Glycopyrronium +SAL/FP | Tiotropium +SAL/FP | Placebo +SAL/FP | |
|---|---|---|---|
| N=257 | N=258 | N=257 | |
| Patients with AEs | 150 (58.4%) | 165 (64.0%) | 148 (57.6%) |
| Upper respiratory tract infection | 17 (6.6%) | 13 (5.0%) | 11 (4.3%) |
| Oral candidiasis | 12 (4.7%) | 13 (5.0%) | 9 (3.5%) |
| Lower respiratory tract infection | 7 (2.7%) | 5 (1.9%) | 4 (1.6%) |
| Nasopharyngitis | 3 (1.2%) | 7 (2.7%) | 5 (1.9%) |
| Viral upper respiratory tract infection | 3 (1.2%) | 4 (1.6%) | 5 (1.9%) |
| Sinusitis | 2 (0.8%) | 2 (0.8%) | 5 (1.9%) |
| Cough | 16 (6.2%) | 15 (5.8%) | 11 (4.3%) |
| Oropharyngeal pain | 9 (3.5%) | 10 (3.9%) | 8 (3.1%) |
| Dyspnoea | 7 (2.7%) | 9 (3.5%) | 10 (3.9%) |
| Dysphonia | 6 (2.3%) | 15 (5.8%) | 5 (1.9%) |
| Rhinorrhoea | 6 (2.3%) | 1 (0.4%) | 3 (1.2%) |
| COPD | 0 | 4 (1.6%) | 6 (2.3%) |
| Diarrhoea | 5 (1.9%) | 2 (0.8%) | 2 (0.8%) |
| Dry mouth | 5 (1.9%) | 9 (3.5%) | 2 (0.8%) |
| Nausea | 3 (1.2%) | 9 (3.5%) | 3 (1.2%) |
| Muscle spasms | 11 (4.3%) | 9 (3.5%) | 5 (1.9%) |
| Back pain | 4 (1.6%) | 8 (3.1%) | 5 (1.9%) |
| Fatigue | 0 | 5 (1.9%) | 2 (0.8%) |
| Headache | 3 (1.2%) | 4 (1.6%) | 13 (5.1%) |
| Hypertension | 3 (1.2%) | 6 (2.3%) | 5 (1.9%) |
| Number of SAE(s) | 18 | 36 | 18 |
| Patients with SAE(s) | 15 (5.8%) | 22 (8.5%) | 15 (5.8%) |
| Small intestinal obstruction | 2 (0.8%) | 0 | 0 |
| Chronic obstructive pulmonary disease | 0 | 1 (0.4%) | 2 (0.8%) |
| Atrial fibrillation | 0 | 2 (0.8%) | 1 (0.4%) |
| Pneumonia | 0 | 2 (0.8%) | 2 (0.8%) |
| Death | 0 | 0 | 1 (0.4%) |
| Discontinued due to AE(s) | 14 (5.4%) | 17 (6.6%) | 17 (6.6%) |
AE, adverse event; COPD, chronic obstructive pulmonary disease; FP, fluticasone propionate; SAL, salmeterol; SAE, serious adverse event.