Table 6.
Adverse events occurring overall and in >1 patient in any deleobuvir dosage group
| AE | No. (%) of patients with indicated treatment and AE(s) |
|||||||
|---|---|---|---|---|---|---|---|---|
| Without cirrhosis |
With cirrhosis |
|||||||
| Placebo (n = 14) | 100 mg deleobuvir (n = 9) | 200 mg deleobuvir (n = 9) | 400 mg deleobuvir (n = 9) | 800 mg deleobuvir (n = 9) | 1,200 mg deleobuvir (n = 10) | 400 mg deleobuvir (n = 8)a | 600 mg deleobuvir (n = 5) | |
| Total | 4 (28.6) | 2 (22.2) | 3 (33.3) | 7 (77.8) | 6 (66.7) | 9 (90.0) | 5 (62.5) | 4 (80.0) |
| GI disorder(s)b | 2 (14.3) | 2 (22.2) | 2 (22.2) | 5 (55.6) | 3 (33.3) | 8 (80.0) | 1 (12.5) | 3 (60.0) |
| Nervous system disorder(s)c | 3 (21.4) | 1 (11.1) | 2 (22.2) | 0 (0.0) | 2 (22.2) | 5 (50.0) | 2 (25.0) | 1 (20.0) |
| Skin/subcutaneousd | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (11.1) | 2 (22.2) | 5 (50.0) | 0 (0.0) | 1 (20.0) |
| Generale | 1 (7.1) | 0 (0.0) | 0 (0.0) | 3 (33.3) | 1 (11.1) | 4 (40.0) | 1 (12.5) | 2 (40.0) |
a
Includes one treatment-naive patient.
b
Included nausea, diarrhea, flatulence, and vomiting.
c
Included headache, hyperesthesia, and paresthesia.
d
Included erythema and rash.
e
Included fatigue, pain, gait disturbance, influenza-type illness, and irritability.