Table 5.
Summary of Adverse Events (Japanese Safety Population)
| 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 | |
|---|---|---|---|---|
| TEAEs, n (%) | ||||
| Patients with ≥1 TEAE | 93 (66.9) | 92 (66.7) | 51 (72.9) | 41 (59.4) |
| Patients with TEAEs relateda to study treatment | 29 (20.9) | 11 (8.0) | 12 (17.1) | 4 (5.8) |
| Patients with serious TEAEs | 11 (7.9) | 14 (10.1) | 7 (10.0) | 6 (8.7) |
| Patients with serious TEAEs relateda to study treatment | 1 (0.7) | 4 (2.9) | 0 | 0 |
| Patients with TEAEs that led to early discontinuation | 6 (4.3) | 6 (4.3) | 2 (2.9) | 2 (2.9) |
| Patients with confirmedb MACE | 0 | 1 (0.7) | 0 | 2 (2.9) |
| Patients with confirmedb,c pneumonia | 7 (5.0) | 1 (0.7) | 0 | 0 |
| Deaths (all causes) | 0 | 1 (0.7) | 1 (1.4) | 0 |
| TEAEs occurring in ≥3% of patients in any treatment arm, preferred term, n (%) | ||||
| Nasopharyngitis | 29 (20.9) | 23 (16.7) | 14 (20.0) | 16 (23.2) |
| Bronchitis | 6 (4.3) | 6 (4.3) | 7 (10.0) | 3 (4.3) |
| Dysphonia | 9 (6.5) | 1 (0.7) | 8 (11.4) | 3 (4.3) |
| Muscle spasms | 12 (8.6) | 2 (1.4) | 5 (7.1) | 2 (2.9) |
| Upper respiratory tract infection | 7 (5.0) | 5 (3.6) | 1 (1.4) | 1 (1.4) |
| Upper respiratory tract inflammation | 4 (2.9) | 6 (4.3) | 3 (4.3) | 0 |
| COPDd | 4 (2.9) | 5 (3.6) | 2 (2.9) | 1 (1.4) |
| Influenza | 1 (0.7) | 4 (2.9) | 1 (1.4) | 4 (5.8) |
| Eczema | 1 (0.7) | 2 (1.4) | 2 (2.9) | 3 (4.3) |
| Pneumoniac,e | 6 (4.3) | 1 (0.7) | 1 (1.4) | 0 |
Notes: aPossibly, probably, or definitely related in the opinion of the investigator. bConfirmed by clinical endpoint committee. cOne confirmed case of pneumonia in the BGF MDI group was reported under the preferred term of interstitial lung disease, and therefore was not categorized as a TEAE of pneumonia. dWorsening of COPD. eSpontaneously reported as adverse events; not confirmed by clinical endpoint committee.
Abbreviations: BFF, budesonide/formoterol fumarate; BGF, budesonide/glycopyrrolate/formoterol fumarate; BUD/FORM DPI, budesonide/formoterol fumarate dry powder inhaler; COPD, chronic obstructive pulmonary disease; GFF, glycopyrrolate/formoterol fumarate; MACE, major adverse cardiovascular events; MDI, metered dose inhaler; TEAE, treatment-emergent adverse event.