Most frequent (≥5%) on-treatment AEs, intent-to-treat population
| AE (preferred term) | Number (%) of patients | |
|---|---|---|
| FF 100 μg (N=1010) | FF/VI 100/25 μg (N=1009) | |
| Any on-treatment AE | 652 (65) | 636 (63) |
| Treatment-related AE* | 67 (7) | 69 (7) |
| AE leading to withdrawal* | 19 (2) | 16 (2) |
| Any on-treatment SAE | 29 (3) | 41 (4) |
| Treatment-related SAE* | 3 (<1) | 1 (<1) |
| Asthma-related SAE | 7 (<1) | 10 (<1) |
| Headache | 179 (18) | 188 (19) |
| Nasopharyngitis | 131 (13) | 155 (15) |
| Upper respiratory tract infection | 93 (9) | 73 (7) |
| Bronchitis | 74 (7) | 59 (6) |
| Cough | 64 (6) | 55 (5) |
| Oropharyngeal pain | 55 (5) | 41 (4) |
| Influenza | 38 (4) | 50 (5) |
*On-treatment and post-treatment.
AE, adverse event; FF, fluticasone furoate; SAE, serious adverse event; VI, vilanterol.