Boceprevir early-access for advanced-fibrosis/cirrhosis in Asia-pacific hepatitis C virus genotype 1 non-responders/relapsers

Table 2 Serious adverse events, adverse events and discontinuations n (%)

	Asian n = 86	Caucasian n = 63	P-value	Total1n = 150
SAEs	15 (17.4)	13 (20.6)	0.613	28 (18.6)
Death	0 (0)	0 (0)	NA	0 (0)
Sepsis	0 (0)	3 (4.8)	0.038	3 (2)
Decompensation	1 (1.2)	3 (4.8)	0.168	4 (2.6)
Blood transfusions	16 (18.6)	5 (7.9)	0.076	21 (14)
AEs
Anemia (< 10 g/dL)	40 (46.5)	38 (60.3)	0.088	78 (52)
Anemia (< 8 g/dL)	14 (16.3)	11 (17.5)	0.839	25 (16.7)
Neutropenia (< 500 cells/dL)	1 (1.2)	7 (11.1)	0.008	8 (5.3)
Neutropenia (< 100 cells/dL)	12 (13.9)	10 (15.9)	0.736	22 (14.7)
Thrombocytopenia (< 30000/dL)	2 (2.3)	5 (7.9)	0.108	7 (4.7)
Skin Rash	8 (9.3)	19 (30.2)	0.001	27 (18)
Weight loss	25 (29.1)	30 (47.6)	0.003	55 (36.7)
Dysgusia	21 (24.4)	48 (76.2)	< 0.0001	69 (46)
Diarrhea	1 (1.2)	5 (7.9)	0.037	6 (4)
Nausea	9 (10.5)	12 (19.0)	0.134	21 (14)
Discontinuations	19 (22)	26 (41)	0.023	46 (30.6)
Due to AEs	4 (4.6)	9 (14.2)	0.052	13 (8.6)
Fulfilled stopping rules	15 (17.4)	12 (19)	0.175	28 (18.6)
Others	0 (0)	5 (7.9)	0.033	5 (3.3)

¹One patient had missing data on ethnic background and hence could not be classified as Asian or Caucasian. The rate of serious adverse events (SAE), adverse events (AE) and discontinuations comparing Asians with Caucasians. Univariate analysis shows significant differences between Asians and Caucasians.