Table 1.
Adverse events reported after repeated dose administration of CHF 4227, expressed as number of treatment emergent adverse events (AE), number (n) and percentage (%) of subjects with at least one adverse event
| CHF 4227 dose | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5 mg (n = 9) | 10 mg (n = 9) | 25 mg (n = 9) | 50 mg (n = 9) | 100 mg (n = 6) | Placebo (n = 14) | |||||||
| AE | n | AE | n | AE | n | AE | n | AE | n | AE | n | |
| Overall | 10 | 8 | 14 | 8 | 24 | 8 | 37 | 9 | 10 | 6 | 51 | 11 |
| (88.9%) | (88.9%) | (88.9%) | (100.0%) | (100.0%) | (78.8%) | |||||||
| Abdominal pain | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 6 | 2 |
| (11.1%) | (11.1%) | (11.1%) | (0.0%) | (0.0%) | (14.3%) | |||||||
| Muscle cramp | 1 | 1 | 2 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 10 | 3 |
| (11.1%) | (11.1%) | (0.0%) | (11.1%) | (0.0%) | (21.4%) | |||||||
| Myalgia | 0 | 0 | 1 | 1 | 5 | 4 | 1 | 1 | 0 | 0 | 5 | 3 |
| (0.0%) | (11.1%) | (44.4%) | (11.1%) | (0.0%) | (21.4%) | |||||||
| Headache | 1 | 1 | 1 | 1 | 3 | 3 | 3 | 3 | 2 | 2 | 5 | 3 |
| (11.1%) | (11.1%) | (33.3%) | (33.3%) | (33.3%) | (21.4%) | |||||||
| Leucorrhoea | 2 | 2 | 0 | 0 | 6 | 4 | 2 | 2 | 3 | 1 | 5 | 4 |
| (22.2%) | (0.0%) | (44.4%) | (22.2%) | (16.7%) | (28.6%) | |||||||
| Hot flushes | 0 | 0 | 0 | 0 | 2 | 2 | 6 | 4 | 1 | 1 | 4 | 2 |
| (0.0%) | (0.0%) | (22.2%) | (44.4%) | (16.7%) | (14.3%) | |||||||