TABLE 4.

Summary of treatment-emergent adverse events and grade 3 or 4 laboratory parameters^a

Parameter or conditionb	Value (n = 24)e
No. of patients with ≥1 AE (%)	24 (100)
No. of AEs	145
No. of withdrawals due to AE(s) (%)	2 (8)
No. of treatment-emergent AEs (%)c
Headache	15 (63)
Fatigue	6 (25)
Pyrexia	6 (25)
Nausea	6 (25)
Arthralgia	6 (25)
Myalgia	6 (25)
Neutropenia	6 (25)
Anemia	4 (17)
Influenza-like illness	4 (17)
Abdominal pain	3 (13)
Hemorrhoids	3 (13)
Asthenia	3 (13)
Injection site erythema	2 (8)
Formication	2 (8)
Diarrhea	2 (8)
Mouth ulceration	2 (8)
Bronchitis	2 (8)
Upper respiratory tract infection	2 (8)
Depressed mood	2 (8)
Insomnia	2 (8)
Rash	2 (8)
Cough	2 (8)
Weight decreased	2 (8)
Hypothyroidism	2 (8)
No. of SAEs (%)d	2 (8)
No. of deaths (%)	0 (0)
No. of grade 3 or 4 laboratory abnormalities (%)
ALT	0 (0)
AST	1 (4)
Bilirubin	1 (4)
Hemoglobin	1 (4)
Neutrophil count	8 (33)
Platelet count	0 (0)

^aPatients received ritonavir-boosted danoprevir (DNVr; 100 mg of ritonavir and 100 mg of danoprevir) every 12 hours plus PegIFN alfa-2a–RBV.

^bAE, adverse event; SAE, serious adverse event.

^cAEs reported by at least two patients.

^dSAEs were cryoglobulinemia (n = 1) on day 178; cellulitis (n = 1) on day 94. Both SAEs were considered unrelated to treatment by the investigator.

^en, number of patients.