Table 2.
Summary of the AE profile for the integrated clinical studies
| AE (preferred term), n (%) | 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) |
| Any drug-related AE | 22 (3) | 8 (2) | 103 (6) | 36 (6) | 10 (5) | 18 (8) | 24 (8) |
| Any SAE | 7 (<1) | 1 (<1) | 38 (2) | 7 (1) | 3 (1) | 1 (<1) | 4 (1) |
| Any drug-related SAE | 0 | 0 | 3 (<1) | 0 | 0 | 0 | 1 (<1) |
| Any AE leading to discontinuation of study drug | 8 (<1) | 2 (<1) | 28 (2) | 10 (2) | 4 (2) | 4 (2) | 6 (2) |
| Deaths | 0 | 0 | 2 (<1)a | 0 | 0 | 0 | 0 |
AE adverse event, BD twice daily, FF fluticasone furoate, OD once daily, FP fluticasone propionate, SAE serious adverse event
aNeither death was determined by the investigator to be related to study medication