Table 4.

Summary of adverse events (safety population).

Preferred term	Pegylated IFN-α2b + SOC (N=120) n (%)	SOC (N=130) n (%)	Overall (N=250) n (%)
Number of subjects with at least one treatment emergent adverse event	8 (6.67)	13 (10.00)	21 (8.40)
Chest pain	1 (0.77)	1 (0.83)	2 (0.80)
Constipation	0 (0.00)	2 (1.67)	2 (0.80)
Diarrhoea	0 (0.00)	1 (0.83)	1 (0.40)
Gastritis	0 (0.00)	1 (0.83)	1 (0.40)
Nausea	0 (0.00)	1 (0.83)	1 (0.40)
Asthenia	1 (0.77)	1 (0.83)	2 (0.80)
Back pain	0 (0.00)	1 (0.83)	1 (0.40)
Myalgia	1 (0.77)	0 (0.00)	1 (0.40)
Headache	3 (2.31)	0 (0.00)	3 (1.20)
Cough	0 (0.00)	1 (0.83)	1 (0.40)
Respiratory distress	1 (0.77)	2 (1.67)	3 (1.20)
Pruritus	1 (0.77)	1 (0.83)	2 (0.80)

IFN, interferon; SOC, standard of care; N, number of subjects on treatment; n, number of subjects in specified category.

%=(n/number of subjects in safety population for whom specific safety endpoint data is available)*100.

If a subject had multiple occurrences of an adverse event, the subject is only included once for the corresponding adverse event.