Table 3.
Most frequent on-treatment AEs reported with ≥ 3% incidence in any treatment groups (integrated clinical studies)
| AE (preferred term), n a (%) | Placebo (n = 858) | FF 50 μg OD (n = 338) | FF 100 μg OD (n = 1663) | FF 200 μg OD (n = 608) | FP 100 μg BD (n = 217) | FP 250 μg BD (n = 214) | FP 500 μg BD (n = 305) |
| Any AE | 278 (32) | 121 (36) | 912 (55) | 256 (42) | 94 (43) | 90 (42) | 136 (45) |
| Headache | 66 (8) | 29 (9) | 228 (14) | 44 (7) | 24 (11) | 15 (7) | 25 (8) |
| Nasopharyngitis | 45 (5) | 15 (4) | 181 (11) | 53 (9) | 14 (6) | 11 (5) | 43 (14) |
| URTI | 16 (2) | 8 (2) | 111 (7) | 15 (2) | 7 (3) | 12 (6) | 7 (2) |
| Bronchitis | 15 (2) | 0 | 98 (6) | 15 (2) | 3 (1) | 5 (2) | 7 (2) |
| Oropharyngeal pain | 11 (1) | 2 (<1) | 71 (4) | 19 (3) | 4 (2) | 6 (3) | 11 (4) |
| Cough | 9 (1) | 3 (<1) | 68 (4) | 13 (2) | 2 (<1) | 5 (2) | 15 (5) |
| Pharyngitis | 24 (3) | 14 (4) | 55 (3) | 8 (1) | 5 (2) | 2 (<1) | 7 (2) |
| Sinusitis | 8 (<1) | 5 (1) | 53 (3) | 15 (2) | 6 (3) | 5 (2) | 6 (2) |
| Influenza | 9 (1) | 5 (1) | 45 (3) | 17 (3) | 6 (3) | 0 | 7 (2) |
| Back pain | 4 (<1) | 7 (2) | 52 (3) | 11 (2) | 4 (2) | 2 (<1) | 4 (1) |
| Dysphonia | 4 (<1) | 1 (<1) | 23 (1) | 11 (2) | 3 (1) | 6 (3) | 6 (2) |
| Rhinitis | 7 (<1) | 1 (<1) | 27 (2) | 7 (1) | 3 (1) | 0 | 8 (3) |
| Viral respiratory tract infection | 0 | 2 (<1) | 18 (1) | 8 (1) | 0 | 0 | 8 (3) |
| Exposure-adjusted incidence rate per 1000 patient-years | |||||||
| AE (preferred term), n (%) |
Placebo | FF 50 μg OD | FF 100 μg OD | FF 200 μg OD | FP 100 μg BD | FP 250 μg BD | FP 500 μg BD |
| Patient-years | 185.6 | 87.5 | 1179.4 | 169.2 | 61.0 | 60.3 | 95.7 |
| Headache | 355.6 | 331.5 | 193.3 | 260.1 | 393.4 | 248.8 | 261.2 |
| Nasopharyngitis | 242.5 | 171.5 | 153.5 | 313.3 | 229.5 | 182.5 | 449.3 |
| URTI | 86.2 | 91.4 | 94.1 | 88.7 | 114.8 | 199.1 | 73.1 |
| Bronchitis | 80.8 | 0 | 83.1 | 88.7 | 49.2 | 82.9 | 73.1 |
| Oropharyngeal pain | 59.3 | 22.9 | 60.2 | 112.3 | 65.6 | 99.5 | 114.9 |
| Cough | 48.5 | 34.3 | 57.7 | 76.9 | 32.8 | 82.9 | 156.7 |
| Pharyngitis | 129.3 | 160.0 | 46.6 | 47.3 | 82.0 | 33.2 | 73.1 |
| Sinusitis | 43.1 | 57.2 | 44.9 | 88.7 | 98.4 | 82.9 | 62.7 |
| Influenza | 48.5 | 57.2 | 38.2 | 100.5 | 98.4 | 0 | 73.1 |
| Back pain | 21.6 | 80.0 | 44.1 | 65.0 | 65.6 | 33.2 | 41.8 |
| Dysphonia | 21.6 | 11.4 | 19.5 | 65.0 | 49.2 | 99.5 | 62.7 |
| Rhinitis | 37.7 | 11.4 | 22.9 | 41.4 | 49.2 | 0 | 83.6 |
| Viral respiratory tract infection | 0 | 22.9 | 15.3 | 47.3 | 0 | 0 | 83.6 |
AE adverse event, BD twice daily, FF fluticasone furoate, FP fluticasone propionate, OD once daily, URTI upper respiratory tract infection
aNumbers represent the number of patients with an event per 1000 patient-years of exposure