Table 3.
Summary of Adverse Events by Time Period (Japanese Safety Population)
| Patients with TEAEs, n (%) | Weeks 0–12 | Weeks 13–24 | Weeks 25–36 | Weeks 37–52 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BGF MDI N=139 | GFF MDI N=138 | BFF MDI N=70 | BUD/FORM DPI N=69 | BGF MDI N=134 | GFF MDI N=124 | BFF MDI N=65 | BUD/ FORM DPI N=65 | BGF MDI N=118 | GFF MDI N=113 | BFF MDI N=59 | BUD/ FORM DPI N=62 | BGF MDI N=114 | GFF MDI N=107 | BFF MDI N=58 | BUD/ FORM DPI N=58 | |
| ≥1 TEAE | 78 (56.1) | 62 (44.9) | 38 (54.3) | 28 (40.6) | 59 (44.0) | 48 (38.7) | 31 (47.7) | 25 (38.5) | 49 (41.5) | 48 (42.5) | 21 (35.6) | 26 (41.9) | 54 (47.4) | 55 (51.4) | 27 (46.6) | 28 (48.3) |
| TEAEs relateda to study treatment | 21 (15.1) | 7 (5.1) | 10 (14.3) | 4 (5.8) | 11 (8.2) | 4 (3.2) | 5 (7.7) | 0 | 5 (4.2) | 4 (3.5) | 5 (8.5) | 4 (6.5) | 7 (6.1) | 1 (0.9) | 3 (5.2) | 2 (3.4) |
| TEAEs leading to early discontinuation | 5 (3.6) | 3 (2.2) | 1 (1.4) | 2 (2.9) | 2 (1.5) | 3 (2.4) | 1 (1.5) | 0 | 2 (1.7) | 5 (4.4) | 0 | 1 (1.6) | 2 (1.8) | 1 (0.9) | 2 (3.4) | 3 (5.2) |
| Serious TEAEs | 6 (4.3) | 7 (5.1) | 5 (7.1) | 4 (5.8) | 5 (3.7) | 10 (8.1) | 2 (3.1) | 2 (3.1) | 7 (5.9) | 12 (10.6) | 2 (3.4) | 5 (8.1) | 7 (6.1) | 8 (7.5) | 2 (3.4) | 5 (8.6) |
| Serious TEAEs relateda to study treatment | 0 | 2 (1.4) | 0 | 0 | 1 (0.7) | 2 (1.6) | 0 | 0 | 1 (0.8) | 2 (1.8) | 1 (1.7) | 3 (4.8) | 1 (0.9) | 1 (0.9) | 1 (1.7) | 0 |
| Deaths (all causes) | 0 | 0 | 0 | 0 | 0 | 1 (0.8) | 1 (1.5) | 0 | 2 (1.7) | 0 | 0 | 0 | 1 (0.9) | 0 | 0 | 1 (1.7) |
Note: aPossibly, probably, or definitely related in the opinion of the investigator.
Abbreviations: 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; TEAE, treatment-emergent adverse event.