Treatment-emergent adverse events (TEAEs) (safety population)
| BFF MDI 320/10 μg | BFF MDI 160/10 μg | FF MDI 10 μg | All patients | |
| Patients, n | 619 | 617 | 607 | 1843 |
| ≥1 TEAE | 297 (48.0), 819 | 314 (50.9), 919 | 305 (50.2), 932 | 916 (49.7), 2670 |
| Mild | 124 (20.0) | 116 (18.8) | 106 (17.5) | 346 (18.8) |
| Moderate | 118 (19.1) | 135 (21.9) | 119 (19.6) | 372 (20.2) |
| Severe | 55 (8.9) | 63 (10.2) | 80 (13.2) | 198 (10.7) |
| Drug-related TEAEs# | 31 (5.0), 43 | 26 (4.2), 35 | 24 (4.0), 33 | 81 (4.4), 111 |
| Serious TEAEs¶ | 60 (9.7), 88 | 78 (12.6), 110 | 83 (13.7), 151 | 221 (12.0), 349 |
| Drug-related serious TEAEs | 1 (0.2), 2 | 1 (0.2), 1 | 1 (0.2), 1 | 3 (0.2), 4 |
| TEAEs leading to early discontinuation | 28 (4.5), 35 | 21 (3.4), 29 | 33 (5.4), 42 | 82 (4.4), 106 |
| Serious TEAEs leading to early discontinuation | 17 (2.7), 18 | 16 (2.6), 17 | 22 (3.6), 25 | 55 (3.0), 60 |
| Deaths (all causes) | ||||
| On-treatment | 3 (0.5) | 4 (0.6) | 8 (1.3) | 15 (0.8) |
| Post-treatment | 3 (0.5) | 4 (0.6) | 0 (0.0) | 7 (0.4) |
| TEAEs occurring in ≥4% of patients in any treatment arm (preferred term) | ||||
| Nasopharyngitis | 41 (6.6), 53 | 53 (8.6), 61 | 36 (5.9), 43 | 130 (7.1), 157 |
| COPD | 27 (4.4), 32 | 30 (4.9), 33 | 50 (8.2), 65 | 107 (5.8), 130 |
| Upper respiratory tract infection | 28 (4.5), 29 | 14 (2.3), 18 | 24 (4.0), 28 | 66 (3.6), 75 |
| Confirmed MACE as determined by CEC | 0 (0.0), 0 | 3 (0.5), 3 | 6 (1.0), 6 | 9 (0.5), 9 |
| Confirmed pneumonia as determined by CEC | 10 (1.6), 11 | 15 (2.4), 15 | 14 (2.3), 15 | 39 (2.1), 41 |
| Serious confirmed pneumonia events | 8 (1.3), 8 | 11 (1.8), 11 | 8 (1.3), 9 | 27 (1.5), 28 |
Data are presented as n (%), events or n (%), unless otherwise stated. BFF: budesonide/formoterol fumarate dihydrate; MDI: metered dose inhaler; FF: formoterol fumarate dihydrate; COPD: chronic obstructive pulmonary disease; MACE: major adverse cardiovascular event; CEC: Clinical Endpoint Committee. #: relationship determined by investigator assessment; ¶: TEAE leading to death, hospitalisation or a life-threatening TEAE.