Table 5 Summary of most frequent on-treatment AEs and serious AEs (safety population)
FF 100 μg | FF 200 μg | |
|---|---|---|
(N = 119) | (N = 119) | |
AEs | ||
On-treatment | 70 (59) | 75 (63) |
On-treatment, treatment-related* | 1 (< 1) | 6 (5) |
On-treatment, leading to withdrawal | 2 (2) | 2 (2) |
Serious AEs | ||
On-treatment | 3 (3) | 4 (3) |
On-treatment AEs occurring in ≥ 5% patients in either treatment group | ||
Nasopharyngitis | 14 (12) | 15 (13) |
Headache | 12 (10) | 15 (13) |
Bronchitis | 14 (12) | 8 (7) |
Influenza | 5 (4) | 8 (7) |
Sinusitis | 8 (7) | 5 (4) |
Pharyngitis | 7 (6) | 4 (3) |
Upper respiratory tract infection | 2 (2) | 7 (6) |