Table 6.
Summary of TEAEs (safety population)
| TEAEs, n (%) | BGF MDI 320/18/9.6 μg (N = 194) | BFF MDI 320/9.6 μg (N = 88) | GFF MDI 18/9.6 μg (N = 174) | All patients (N = 456) |
|---|---|---|---|---|
| Patients with ≥1 TEAE | 144 (74.2) | 64 (72.7) | 133 (76.4) | 341 (74.8) |
| Mild | 50 (25.8) | 27 (30.7) | 46 (26.4) | 123 (27.0) |
| Moderate | 63 (32.5) | 29 (33.0) | 65 (37.4) | 157 (34.4) |
| Severe | 31 (16.0) | 8 (9.1) | 22 (12.6) | 61 (13.4) |
| Patients with treatment-related TEAEs# | 35 (18.0) | 17 (19.3) | 29 (16.7) | 81 (17.8) |
| Patients with serious TEAEs§ | 33 (17.0) | 7 (8.0) | 22 (12.6) | 62 (13.6) |
| COPD+ | 12 (6.2) | 1 (1.1) | 9 (5.2) | 22 (4.8) |
| Pneumonia | 2 (1.0) | 0 | 4 (2.3) | 6 (1.3) |
| Patients with treatment-related serious TEAEs#,§ | 2 (1.0) | 0 | 2 (1.1) | 4 (0.9) |
| Patients with TEAEs leading to early discontinuation | 16 (8.2) | 6 (6.8) | 12 (6.9) | 34 (7.5) |
| Patients with confirmed MACE¶ | 3 (1.5) | 0 | 3 (1.7) | 6 (1.3) |
| Patients with confirmed pneumonia¶ | 4 (2.1) | 1 (1.1) | 6 (3.4) | 11 (2.4) |
| Deaths (all causes) | 3 (1.5) | 0 | 1 (0.6) | 4 (0.9) |
| TEAEs occurring in ≥4% of patients in any treatment arm | ||||
| Upper respiratory tract infection | 18 (9.3) | 6 (6.8) | 18 (10.3) | 42 (9.2) |
| Bronchitis | 12 (6.2) | 2 (2.3) | 8 (4.6) | 22 (4.8) |
| COPD+ | 12 (6.2) | 1 (1.1) | 9 (5.2) | 22 (4.8) |
| Urinary tract infection | 10 (5.2) | 5 (5.7) | 6 (3.4) | 21 (4.6) |
| Muscle spasms | 6 (3.1) | 9 (10.2) | 5 (2.9) | 20 (4.4) |
| Viral upper respiratory tract infection | 9 (4.6) | 6 (6.8) | 5 (2.9) | 20 (4.4) |
| Sinusitis | 11 (5.7) | 2 (2.3) | 6 (3.4) | 19 (4.2) |
| Hypertension | 8 (4.1) | 4 (4.5) | 6 (3.4) | 18 (3.9) |
| Back pain | 9 (4.6) | 1 (1.1) | 7 (4.0) | 17 (3.7) |
| Nasopharyngitis | 7 (3.6) | 4 (4.5) | 6 (3.4) | 17 (3.7) |
| Diarrhea | 5 (2.6) | 2 (2.3) | 9 (5.2) | 16 (3.5) |
| Dyspnea | 4 (2.1) | 5 (5.7) | 5 (2.9) | 14 (3.1) |
| Pneumonia | 5 (2.6) | 1 (1.1) | 8 (4.6) | 14 (3.1) |
| Dysphonia | 6 (3.1) | 5 (5.7) | 2 (1.1) | 13 (2.9) |
| Bone- and ocular-related TEAEs occurring in ≥1% of patients | ||||
| Cataract | 6 (3.1) | 2 (2.3) | 0 | 8 (1.8) |
| IOP increased | 2 (1.0) | 1 (1.1) | 4 (2.3) | 7 (1.5) |
| Osteoarthritis | 2 (1.0) | 0 | 4 (2.3) | 6 (1.3) |
| Osteoporosis | 2 (1.0) | 1 (1.1) | 2 (1.1) | 5 (1.1) |
BFF Budesonide/formoterol fumarate, BGF Budesonide/glycopyrrolate/formoterol fumarate, COPD Chronic obstructive pulmonary disease, GFF Glycopyrrolate/formoterol fumarate, IOP Intraocular pressure, MACE Major adverse cardiovascular event, MDI Metered dose inhaler, TEAE Treatment-emergent adverse event. #: possibly, probably, or definitely related in the opinion of the investigator, ¶: confirmed by clinical endpoint committee, §: TEAEs were classified as serious in the opinion of the investigator if they resulted in hospitalization or substantial disruption of the ability to conduct normal life functions, or were life-threatening/fatal), +: classified as a TEAE only if meeting criteria for a serious TEAE