| BGF | GFF |
---|---|---|
320/18/9.6 µg | 18/9.6 µg | |
(N = 22) | (N = 23) | |
Any AEs, n (%) | 4 (18.2) | 6 (26.1) |
 Allergy to arthropod sting | 0 | 1 (4.3) |
 Aphonia | 1 (4.5) | 0 |
 Bronchiolitis | 0 | 1 (4.3) |
 Colon cancer | 1 (4.5) | 0 |
 Cough | 1 (4.5) | 0 |
 Dyspnea | 0 | 2 (8.7) |
 Edema peripheral | 0 | 1 (4.3) |
 Hypertension | 1 (4.5) | 0 |
 Pruritus | 0 | 1 (4.3) |
Any AEs with an outcome of death, n (%) | 0 | 0 |
Any serious TEAEs (including events with outcome of death), n (%) | 1 (4.5) | 0 |
 Colon cancer | 1 (4.5) | 0 |
Any AE leading to discontinuation of study treatment, n (%) | 0 | 1 (4.3) |
 Dyspnea | 0 | 1 (4.3) |
Any AEs related to study treatmentb, n (%) | 1 (4.5) | 3 (13.0) |
 Aphonia | 1 (4.5) | 0 |
 Bronchiolitis | 0 | 1 (4.3) |
 Dyspnea | 0 | 1 (4.3) |
 Pruritus | 0 | 1 (4.3) |
Any serious AEs related to study treatmentb, n (%) | 0 | 0 |