Table 2.
Summary of most frequently reported adverse eventsa
| Preferred term | No. (%) of events |
|||||
|---|---|---|---|---|---|---|
| Part 1, healthy subjects |
Part 2, healthy subjects |
Part 3, subjects with HCV |
||||
| Total SD active (n = 12) | Total SD placebo (n = 4) | Total RD active (n = 24) | Total RD placebo (n = 6) | Total SD active (n = 17) | Total SD placebo (n = 6) | |
| Adverse event | 1 (8) | 1 (25) | 9 (38) | 1 (17) | 10 (59) | 2 (33) |
| Headache | 1 (8) | 0 | 2 (8) | 0 | 2 (12) | 1 (17) |
| Dizziness | 0 | 0 | 0 | 0 | 3 (18) | 0 |
| ALT increased | 0 | 0 | 0 | 0 | 2 (12) | 1 (17) |
| AST increased | 0 | 0 | 0 | 0 | 2 (12) | 1 (17) |
| Diarrhea | 0 | 1 (25) | 1 (4) | 0 | 0 | 0 |
| Upper RTI | 0 | 0 | 2 (8) | 0 | 0 | 0 |
a
ALT, alanine aminotransferase; AST, aspartate aminotransferase; RTI, respiratory tract infection; SD, single dose; RD, repeat dose.