Table 2.
Number of adverse events per subject during multiple dosing for 35 or 56 days for those events with a frequency ≥0.5 in one dose group.
Multiple dose (Number of subjects with advise event) | |||||
---|---|---|---|---|---|
Placebo | 20 mg (n = 6) | 40 mg (n = 12) | 80 mg (n = 18) | 160 mg (n = 6) | |
Headache | 1.1 (7) | 1.7 (5) | 0.8 (5) | 0.4 (4) | 2.5 (5) |
Abdominal pain | 0.1 (2) | 0.2 (1) | 0.6 (6) | 0.7 (6) | 1.7 (3) |
Pharyngitis | 0.2 (3) | 0.2 (2) | 0.4 (5) | 0.2 (4) | 0.5 (3) |
Fatigue | – | – | 0.3 (4) | 0.1 (2) | 0.5 (2) |
Nausea | 0.1 (1) | – | 0.3 (3) | 0.2 (2) | 0.5 (2) |
Hot flushes | 0.3 (2) | – | 0.6 (5) | 0.1 (2) | 0.2 (1) |
Leukorrhea | – | 0.2 (1) | 0.3 (4) | 0.2 (3) | 1.0 (5) |
Myalgia | 0.1 (1) | 0.5 (3) | 0.2 (1) | 0.1 (1) | – |
Number of adverse events per subject | 4.0 | 5.0 | 7.4 | 4.3 | 11.8 |