Table 2.

Reasons for discontinuation of telaprevir and the incidence of the most common grade 2–4 drug-related AEs and serious AEs

Variable	Bridging fibrosis (F3)* (N=752)	Cirrhosis (F4) (N=835)	Overall (N=1587)	p Value
Grade 2–4 drug-related AE†—no. (%)
Patients with one or more AE	453 (60)	561 (67)	1014 (64)	<0.01
Anaemia‡	307 (41)	391 (47)	698 (44)	0.02
Rash‡	90 (12)	111 (13)	201 (13)	NS
Thrombocytopenia‡	37 (5)	83 (10)	120 (8)	<0.01
Pruritus‡	37 (5)	58 (7)	95 (6)	NS
Asthenia	44 (6)	47 (6)	91 (6)	NS
Nausea	24 (3)	36 (4)	60 (4)	NS
Anorectal‡	26 (3)	35 (4)	61 (4)	NS
Serious AEs§—no. (%)
Patients with one or more serious AEs	76 (10)	110 (13)	186 (12)	NS
Anaemia‡	32 (4)	43 (5)	75 (5)	NS
Rash‡	12 (2)	16 (2)	28 (2)	NS
Infection	6 (1)	20 (2)	26 (2)	NS
Pyrexia	4 (1)	8 (1)	12 (1)	NS
Reason for discontinuation¶—no. (%)
Any AE	80 (11)	113 (14)	193 (12)	NS
Rash‡	36 (5)	36 (4)	72 (5)	NS
Anaemia‡	14 (2)	31 (4)	45 (3)	0.01
Vomiting	8 (1)	9 (1)	17 (1)	NS
Asthenia	6 (1)	10 (1)	16 (1)	NS
Nausea	7 (1)	9 (1)	16 (1)	NS
Pruritus‡	3 (0)	10 (1)	13 (1)	NS
Abdominal pain	1 (0)	8 (1)	9 (1)	NS

*Includes three F1 patients and three F2 patients.

†Listed are grade 2–4 drug-related AEs that occurred in at least 4% of the overall population.

‡Included in this category are all related events that were described with a variety of descriptive terms.

§Listed are serious AEs that occurred in at least 0.5% of the overall population.

¶Listed are discontinuations that occurred in at least 1% of the overall population. These figures are the number of patients who discontinued telaprevir; patients may have continued treatment with pegylated interferon plus ribavirin.

AE, adverse event.