Table 3.

Adverse events

	Interferon-gamma group (N = 55)	Placebo group (N = 54)	P-values
Serious adverse events, n (%)
Number of patients with 1 or more event	24 (43.6)	17 (31.5)	0.19
Numbers of event/patient, mean (SD)	0.9 (1.3)	0.5 (0.8)	0.14
Adverse events, n (%)
Number of patients with 1 or more event	52 (94.5)	51 (94.4)	1.00
Numbers of event/patient, mean (SD)	4.1 (3.1)	2.8 (1.8)	0.06
General disorder, n (%)
Pyrexia	3 (5.5)	3 (5.6)	1.00
Systemic inflammatory response	1 (1.8)	0 (0)	1.00
Skin and subcutaneous disorders, n (%)
Drug eruption	1 (1.8)	0 (0)	1.00
Systemic rash	0 (0)	1 (1.9)	0.50
Digestive adverse events, n (%)
Liver cytolysis (enzymes > 5 Normal values)	9 (16.4)	7 (13)	0.62
Cholestasis	4 (7.3)	3 (5.6)	1.00
Pancreatitis (lipase > 3 Normal values)	12 (21.8)	7 (13)	0.22
Cardiac adverse events, n (%)
Atrial fibrillation	3 (5.5)	2 (3.7)	1.00
Bradycardia	1 (1.8)	0 (0)	1.00
Nervous system disorders, n (%)
Altered level of consciousness	2 (3.6)	1 (1.9)	1.00
Psychiatric disorders
Agitation, confusion	3 (5.5)	2 (3.7)	1.00
Vascular disorders, n (%)
Vein thrombosis	1 (1.8)	0 (0)	1.00
Hypotension	2 (3.6)	0 (0)	0.50