Table 2.
Adverse events and serious adverse events (safety population)
| Number (%) of patients | Overall population | China subgroup | ||
|---|---|---|---|---|
| BDP/FF/G (N = 352) | BUD/FF (N = 355) | BDP/FF/G (N = 287) | BUD/FF (N = 290) | |
| Adverse events | 215 (61.1) | 238 (67.0) | 173 (60.3) | 195 (67.2) |
| COPD exacerbation | 66 (18.8) | 110 (31.0) | 49 (17.1) | 93 (32.1) |
| Upper respiratory tract infection | 58 (16.5) | 49 (13.8) | 55 (19.2) | 45 (15.5) |
| Nasopharyngitis | 22 (6.3) | 23 (6.5) | 16 (5.6) | 17 (5.9) |
| Hypertension | 12 (3.4) | 24 (6.8) | 10 (3.5) | 19 (6.6) |
| Productive cough | 9 (2.6) | 9 (2.5) | 8 (2.8) | 8 (2.8) |
| Pneumonia | 8 (2.3) | 13 (3.7) | 4 (1.4) | 7 (2.4) |
| Cough | 8 (2.3) | 8 (2.3) | 4 (1.4) | 7 (2.4) |
| Bronchitis | 6 (1.7) | 3 (0.8) | 5 (1.7) | 1 (0.3) |
| Pharyngitis | 5 (1.4) | 3 (0.8) | 5 (1.7) | 3 (1.0) |
| Dyspnoea | 4 (1.1) | 8 (2.3) | 3 (1.0) | 5 (1.7) |
| Gamma-glutamyltransferase increased | 2 (0.6) | 6 (1.7) | 2 (0.7) | 4 (1.4) |
| Hepatic function abnormal | 2 (0.6) | 6 (1.7) | 2 (0.7) | 6 (2.1) |
| Alanine aminotransferase increased | 2 (0.6) | 6 (1.7) | 1 (0.3) | 3 (1.0) |
| Back pain | 0 | 8 (2.3) | 0 | 8 (2.8) |
| Hypokalaemia | 0 | 7 (2.0) | 0 | 5 (1.7) |
| Neutrophil count increased | 6 (1.7) | 2 (0.6) | 6 (2.1) | 1 (0.3) |
| Anaemia | 4 (1.1) | 5 (1.4) | 4 (1.4) | 5 (1.7) |
| Lung infection | 2 (0.6) | 5 (1.4) | 2 (0.7) | 5 (1.7) |
| Blood pressure increased | 1 (0.3) | 5 (1.4) | 1 (0.3) | 5 (1.7) |
| Serious adverse events | 40 (11.4) | 60 (16.9) | 30 (10.5) | 49 (16.9) |
| COPD exacerbation | 20 (5.7) | 43 (12.1) | 16 (5.6) | 38 (13.1) |
| Pneumonia | 4 (1.1) | 9 (2.5) | 1 (0.3) | 4 (1.4) |
| Pneumothorax spontaneous | 2 (0.6) | 0 | 2 (0.7) | 0 |
| Influenza | 2 (0.6) | 0 | 0 | 0 |
| Treatment-related adverse events | 9 (2.6) | 16 (4.5) | 8 (2.8) | 14 (4.8) |
| Muscle spasms | 2 (0.6) | 2 (0.6) | 2 (0.7) | 2 (0.7) |
| Blood pressure increased | 0 | 2 (0.6) | 0 | 2 (0.7) |
| Treatment-related serious adverse events | 1 (0.3) | 0 | 1 (0.3) | 0 |
| Severe adverse events | 31 (8.8) | 56 (15.8) | 23 (8.0) | 48 (16.6) |
| COPD exacerbation | 22 (6.3) | 46 (13.0) | 18 (6.3) | 41 (14.1) |
| Pneumonia | 3 (0.9) | 8 (2.3) | 2 (0.7) | 4 (1.4) |
| Influenza | 2 (0.6) | 0 | 0 | 0 |
| Lung infection | 1 (0.3) | 2 (0.6) | 1 (0.3) | 2 (0.7) |
| Adverse events leading to study drug discontinuation | 8 (2.3) | 13 (3.7) | 8 (2.8) | 10 (3.4) |
| COPD exacerbation | 1 (0.3) | 7 (2.0) | 1 (0.3) | 5 (1.7) |
| Adverse events leading to death | 1 (0.3) | 3 (0.8) | 1 (0.3) | 3 (1.0) |
Data are n (%). ≥ 1.5% in either group of the overall population for adverse events and ≥ 0.5% in either group of the overall population for serious adverse events, treatment-related adverse events, and adverse events leading to study drug discontinuation. BDP beclometasone dipropionate, FF formoterol fumarate, G glycopyrronium, BUD budesonide, COPD chronic obstructive pulmonary disease