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 |