Table 1.
Summary of Adverse Events (Japanese Safety Population)
| TEAEs, 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 |
|---|---|---|---|---|
| Patients with ≥1 TEAE | 115 (82.7) | 114 (82.6) | 58 (82.9) | 57 (82.6) |
| Mild | 66 (47.5) | 60 (43.5) | 36 (51.4) | 31 (44.9) |
| Moderate | 34 (24.5) | 33 (23.9) | 17 (24.3) | 17 (24.6) |
| Severe | 15 (10.8) | 21 (15.2) | 5 (7.1) | 9 (13.0) |
| Patients with TEAEs relateda to study treatment | 34 (24.5) | 16 (11.6) | 16 (22.9) | 9 (13.0) |
| Patients with TEAEs that led to early discontinuation | 10 (7.2) | 12 (8.7) | 4 (5.7) | 6 (8.7) |
| Patients with serious TEAEs | 21 (15.1) | 30 (21.7) | 11 (15.7) | 14 (20.3) |
| Patients with serious TEAEs relateda to study treatment | 3 (2.2) | 7 (5.1) | 2 (2.9) | 3 (4.3) |
| Patients with confirmedb MACE | 1 (0.7) | 1 (0.7) | 0 | 2 (2.9) |
| Patients with confirmedb pneumonia | 13 (9.4) | 5 (3.6) | 4 (5.7) | 2 (2.9) |
| At or before 24 weeks | 7 (5.0) | 1 (0.7) | 0 | 0 |
| During weeks 25–52 | 6 (4.3) | 4 (2.9) | 4 (5.7) | 2 (2.9) |
| Deaths (all causes) | 3 (2.2) | 1 (0.7) | 1 (1.4) | 1 (1.4) |
Notes: aPossibly, probably, or definitely related in the opinion of the investigator. bConfirmed by clinical endpoint committee.
Abbreviations: BFF, budesonide/formoterol fumarate; BGF, budesonide/glycopyrrolate/formoterol fumarate; BUD/FORM DPI, budesonide/formoterol fumarate dry powder inhaler; GFF, glycopyrrolate/formoterol fumarate; MACE, major adverse cardiovascular events; MDI, metered dose inhaler; TEAE, treatment-emergent adverse event.