Table 2.
Adverse Events Occurring in ≥3% of Patients in Any Treatment Group (Japanese Safety Population)
| Preferred Term, n (%) | BGF MDI 320/18/9.6 µg N=139 | GFF MDI 18/9.6 µg N=138 | BFF MDI 320/9.6 µg N=70 | BUD/FORM DPI 400/12 µg N=69 |
|---|---|---|---|---|
| Nasopharyngitis | 45 (32.4) | 43 (31.2) | 22 (31.4) | 24 (34.8) |
| Bronchitis | 15 (10.8) | 11 (8.0) | 8 (11.4) | 7 (10.1) |
| Muscle spasms | 16 (11.5) | 6 (4.3) | 6 (8.6) | 3 (4.3) |
| Pneumoniaa | 14 (10.1) | 5 (3.6) | 4 (5.7) | 4 (5.8) |
| Dysphonia | 10 (7.2) | 1 (0.7) | 9 (12.9) | 3 (4.3) |
| COPDb | 7 (5.0) | 11 (8.0) | 2 (2.9) | 2 (2.9) |
| Upper respiratory tract infection | 10 (7.2) | 8 (5.8) | 1 (1.4) | 2 (2.9) |
| Influenza | 5 (3.6) | 7 (5.1) | 3 (4.3) | 6 (8.7) |
| Upper respiratory tract inflammation | 5 (3.6) | 7 (5.1) | 5 (7.1) | 0 |
| Constipation | 6 (4.3) | 5 (3.6) | 4 (5.7) | 2 (2.9) |
| Pharyngitis | 3 (2.2) | 5 (3.6) | 3 (4.3) | 2 (2.9) |
| Eczema | 1 (0.7) | 3 (2.2) | 4 (5.7) | 4 (5.8) |
| Oral candidiasis | 5 (3.6) | 0 | 3 (4.3) | 3 (4.3) |
| Pyrexia | 3 (2.2) | 6 (4.3) | 0 | 0 |
| Oropharyngeal pain | 5 (3.6) | 1 (0.7) | 1 (1.4) | 1 (1.4) |
| Contusion | 5 (3.6) | 1 (0.7) | 0 | 1 (1.4) |
Notes: aSpontaneously reported as AEs; not confirmed by clinical endpoint committee. bWorsening of COPD.
Abbreviations: AE, adverse event; BFF, budesonide/formoterol fumarate; BGF, budesonide/glycopyrrolate/formoterol fumarate; BUD/FORM DPI, budesonide/formoterol fumarate dry powder inhaler; GFF, glycopyrrolate/formoterol fumarate; MDI, metered dose inhaler.