Most common on-treatment adverse events (occurring in 3% or more patients in any treatment group) (intent-to-treat population)
| No. of patients (%) | FF | FP | ||||
| Placebo (n=103) | 200 μg OD (n=99) | 400 μg OD (n=101) | 600 μg OD (n=107) | 800 μg OD (n=102) | 500 μg BD (n=110) | |
| Patients with any on-treatment adverse event | 23 (22) | 31 (31) | 34 (34) | 37 (35) | 36 (35) | 39 (35) |
| Oral candidiasis* | 1 (<1) | 6 (6) | 6 (6) | 2 (2) | 12 (12) | 4 (4) |
| Headache | 10 (10) | 3 (3) | 10 (10) | 12 (11) | 10 (10) | 10 (9) |
| Nasopharyngitis | 4 (4) | 3 (3) | 5 (5) | 2 (2) | 7 (7) | 4 (4) |
| Dysphonia | 1 (<1) | 4 (4) | 5 (5) | 1 (<1) | 4 (4) | 2 (2) |
| Pharyngolaryngeal pain | 1 (<1) | 2 (2) | 0 | 3 (3) | 1 (<1) | 4 (4) |
| Upper respiratory tract infection | 1 (<1) | 2 (2) | 0 | 3 (3) | 1 (<1) | 3 (3) |
| Back pain | 1 (<1) | 1 (1) | 1 (<1) | 4 (4) | 2 (2) | 0 |
| Influenza | 1 (<1) | 1 (1) | 2 (2) | 3 (3) | 0 | 0 |
| Nausea | 0 | 0 | 3 (3) | 0 | 2 (2) | 0 |
| Pain in extremity | 0 | 0 | 0 | 3 (3) | 1 (<1) | 0 |
↵* Incidences of oral candidiasis were mutually exclusively reported as ‘oropharyngeal candidasis’, ‘oral candidiasis’ or ‘candidiasis’.
BD, twice daily; FF, fluticasone furoate; FP, fluticasone propionate; OD, once daily.