Table 4.
Summary of TEAEs (Safety Population)
| Parameter | BGF MDI 320/14.4/10 μg (n = 64) | BFF MDI 320/10 μg (n = 66) | BUD/FORM DPI 320/9 μg (n = 66) | All Subjects (N = 72) |
|---|---|---|---|---|
| Subjects with at least 1 TEAE, n (%) | 8 (12.5) | 13 (19.7) | 9 (13.6) | 24 (33.3) |
| Subjects with TEAE related to study drug, n (%)a | 7 (10.9) | 9 (13.6) | 5 (7.6) | 18 (25.0) |
| TEAEs occurring in ≥2 subjects, n (%) | ||||
| Headache | 3 (4.7) | 0 | 1 (1.5) | 4 (5.6) |
| Hypertension | 0 | 2 (3.0) | 2 (3.0) | 4 (5.6) |
| Systolic hypertension | 0 | 2 (3.0) | 0 | 2 (2.8) |
| Blood pressure (diastolic) decreased | 1 (1.6) | 0 | 1 (1.5) | 2 (2.8) |
| Dizziness | 1 (1.6) | 0 | 1 (1.5) | 2 (2.8) |
| Hypokalemia | 0 | 2 (3.0) | 0 | 2 (2.8) |
BFF, budesonide/formoterol fumarate dihydrate; BGF, budesonide/glycopyrronium/formoterol fumarate dihydrate; BUD/FORM, budesonide/formoterol fumarate dihydrate; DPI, dry powder inhaler; MDI, metered dose inhaler; TEAE, treatment‐emergent adverse event.
a
Related = possibly, probably, or definitely (in the opinion of the investigator).