Table 6 Adverse events reported during the study, overall and most common preferred term (≥ 1% in either group) (safety set)
Number (%) of patients | LABA/LAMA FDC (N = 340) | Triple therapy (N = 784) |
|---|---|---|
At least one non-serious adverse event | 44 (12.9) | 118 (15.1) |
COPD | 10 (2.9) | 32 (4.1) |
Nasopharyngitis | 4 (1.2) | 16 (2.0) |
Forced expiratory volume decreased | 4 (1.2) | 8 (1.0) |
Dyspnoea | 4 (1.2) | 6 (0.8) |
Chest discomfort | 1 (0.3) | 9 (1.1) |
Chest pain | 1 (0.3) | 9 (1.1) |
At least one non-serious adverse event considered related to study treatment | 12 (3.5) | 49 (6.3) |
COPD | 1 (0.3) | 13 (1.7) |
At least one serious adverse event | 27 (7.9) | 108 (13.8) |
COPD | 6 (1.8) | 55 (7.0) |
Infective exacerbation of COPD | 6 (1.8) | 7 (0.9) |
Pneumonia | 4 (1.2) | 7 (0.9) |
Dyspnoea at rest | 2 (0.6) | 15 (1.9) |
Death | 2 (0.6) | 8 (1.0) |
Cardiac failure | 1 (0.3) | 9 (1.1) |
At least one serious adverse event considered related to study treatment | 5 (1.5) | 31 (4.0) |
COPD | 1 (0.3) | 15 (1.9) |