Table 4.
More frequent adverse events from the retrospective integrated safety analysis of data from 1,035 SOF/VEL for 12 Weeks patients and control/placebo patients in ASTRAL-1, -2, and -3
Patients, n (%) | SOF/VEL 12 weeks N=1035 | Placebo 12 weeks N=116 |
Headache | 296 (29) | 33 (28) |
Fatigue | 217 (21) | 23 (20) |
Nausea | 135 (13) | 13 (11) |
Insomnia | 87 (8) | 11 (9) |
Nasopharyngitis | 121 (12) | 12 (10) |
Cough | 57 (6) | 4 (3) |
Irritability | 49 (5) | 4 (3) |
Pruritus | 33 (3) | 5 (4) |
Dyspepsia | 33 (2) | 4 (3) |