Table 4.
AESI occurring in any treatment groups (integrated clinical studies)
| AE of special interest (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) |
| Local steroid effects | 15 (2) | 7 (2) | 122 (7) | 48 (8) | 8 (4) | 18 (8) | 25 (8) |
| Oropharyngeal pain | 11 (1) | 2 (<1) | 71 (4) | 19 (3) | 4 (2) | 6 (3) | 11 (4) |
| Dysphonia | 4 (<1) | 1 (<1) | 23 (1) | 11 (2) | 3 (1) | 6 (3) | 6 (2) |
| Oral candidiasis | 0 | 4 (1) | 18 (1) | 8 (1) | 1 (<1) | 4 (2) | 4 (1) |
| Oropharyngeal candidiasis | 1 (<1) | 1 (<1) | 7 (<1) | 9 (1) | 1 (<1) | 2 (<1) | 6 (2) |
| LRTI excluding pneumonia | 16 (2) | 1 (<1) | 114 (7) | 19 (3) | 3 (1) | 5 (2) | 7 (2) |
| Bronchitis | 15 (2) | 0 | 98 (6) | 15 (2) | 3 (1) | 5 (2) | 7 (2) |
| Hypersensitivityb | 13 (2) | 3 (<1) | 41 (2) | 6 (<1) | 2 (<1) | 2 (<1) | 6 (2) |
| Bone disordersb | 0 | 2 (<1) | 21 (1) | 2 (<1) | 1 (<1) | 0 | 4 (1) |
| Pneumoniab | 2 (<1) | 0 | 10 (<1) | 4 (<1) | 1 (<1) | 0 | 0 |
| Effects on glucoseb | 0 | 0 | 11 (<1) | 2 (<1) | 0 | 0 | 0 |
| Ocular effectsb | 0 | 0 | 6 (<1) | 0 | 0 | 0 | 0 |
| Exposure-adjusted incidence rate per 1000 patient-years | |||||||
| AE of special interest (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 |
| Local steroid effects | 80.8 | 80.0 | 103.4 | 283.8 | 131.1 | 298.6 | 261.2 |
| Oropharyngeal pain | 59.3 | 22.9 | 60.2 | 112.3 | 65.6 | 99.5 | 114.9 |
| Dysphonia | 21.6 | 11.4 | 19.5 | 65.0 | 49.2 | 99.5 | 62.7 |
| Oral candidiasis | 0 | 45.7 | 15.3 | 47.3 | 16.4 | 66.4 | 41.8 |
| Oropharyngeal candidiasis | 5.4 | 11.4 | 5.9 | 53.2 | 16.4 | 33.2 | 62.7 |
| LRTI excluding pneumonia | 86.2 | 11.4 | 96.7 | 112.3 | 49.2 | 82.9 | 73.1 |
| Bronchitis | 80.8 | 0 | 83.1 | 88.7 | 49.2 | 82.9 | 73.1 |
| Hypersensitivityb | 70.0 | 34.3 | 34.8 | 35.5 | 32.8 | 33.2 | 62.7 |
| Bone disordersb | 0 | 22.9 | 17.8 | 11.8 | 16.4 | 0 | 41.8 |
| Pneumoniab | 10.8 | 0 | 8.5 | 23.6 | 16.4 | 0 | 0 |
| Effects on glucoseb | 0 | 0 | 9.3 | 11.8 | 0 | 0 | 0 |
| Ocular effectsb | 0 | 0 | 5.1 | 0 | 0 | 0 | 0 |
AE adverse event, BD twice daily, FF fluticasone furoate, FP fluticasone propionate, LRTI lower respiratory tract infection, OD once daily
aNumbers represent the number of patients with an event per 1000 patient-years of exposure
bNo individual event occurred in ≥1% of patients