Table 4.
Most commonly observed treatment emergent adverse events
| 800 mg (n = 6) | 1600 mg (n = 6) | 2400 mg (n = 6) | 3200 mg (n = 6) | Placebo (n = 8) | Total (n = 32) | |
|---|---|---|---|---|---|---|
| Headache | 3 | 2 | 1 | 4 (1) | 3 (1) | 13 (2) |
| Abdominal pain | 1 | 0 | 3 (1) | 5 (1) | 2 | 11 (2) |
| Nausea | 0 | 1 | 2 | 1 | 3 | 7 |
| Sore throat | 0 | 0 | 2 | 3 | 1 | 6 |
| Liver function tests abnormal* | 0 | 1 | 0 | 4 (2) | 0 | 5 (2) |
| Nasal congestion | 2 | 0 | 1 | 0 | 2 | 5 |
| Alopecia | 1 | 0 | 2 (1) | 0 | 2 | 5 (1) |
| Dizziness (postural) | 0 | 2 | 1 | 0 | 1 | 4 |
| Urinary frequency | 0 | 0 | 0 | 3 | 1 | 4 |
| Dizziness (excluding vertigo) | 2 | 0 | 0 | 0 | 2 | 4 |
| Lethargy | 2 | 1 | 0 | 0 | 0 | 3 |
| Back pain | 1 | 0 | 0 | 2 | 0 | 3 |
| Constipation | 0 | 1 | 0 | 0 | 2 | 3 |
*
Liver enzymes were considered elevated if the peak concentration during the study period was greater than twice of the upper limit of normal ranges.
Tabulated are treatment emergent adverse events reported by more than two subjects per dose level and total. Provided are the numbers of subjects who reported adverse events. All adverse events were reported as mild except for the ones given in the parentheses, which were of moderate severity.