Table 3.
Overall adverse events and drug-related adverse events (safety population)
| CHF6001 | Budesonide 800 μg (N = 187) | Placebo (N = 193) | ||||
|---|---|---|---|---|---|---|
| 400 μg BID (N = 190) | 800 μg BID (N = 179) | 1200 μg BID (N = 188) | 1600 μg BID (N = 193) | |||
| Adverse events | 91 (47.9) | 96 (53.6) | 94 (50.0) | 84 (43.5) | 94 (50.3) | 103 (53.4) |
| Drug-related adverse events | 10 (5.3) | 3 (1.7) | 6 (3.2) | 6 (3.1) | 8 (4.3) | 14 (7.3) |
| Severe adverse events | 8 (4.2) | 10 (5.6) | 7 (3.7) | 4 (2.1) | 6 (3.2) | 5 (2.6) |
| Serious adverse events | 11 (5.8) | 13 (7.3) | 12 (6.4) | 7 (3.6) | 10 (5.3) | 7 (3.6) |
| Serious drug-related adverse events | 0 | 0 | 0 | 0 | 0 | 0 |
| Adverse events leading to study drug discontinuation | 5 (2.6) | 3 (1.7) | 4 (2.1) | 8 (4.1) | 2 (1.1) | 5 (2.6) |
| Adverse events leading to death | 1 (0.5) | 1 (0.6) | 1 (0.5) | 2 (1.0) | 0 | 0 |
BID twice daily