Table 4.

Adverse events of the study population, n (%)

AEs	Add-on, n = 91	Monotherapy, n = 104	P value
Neutropenia	80 (87.9)	8 (7.7)	< 0.001
Thrombocytopenia	82 (90.1)	9 (8.7)	< 0.001
Fever	75 (82.4)	0 (0)	< 0.001
Fatigue	53 (58.2)	10 (9.6)	< 0.001
Anorexia	49 (53.8)	3 (2.9)	< 0.001
Weight loss	15 (16.5)	0 (0)	< 0.001
Alopecia	10 (11.0)	0 (0)	< 0.001
Thyroid dysfunction	6 (6.6)	0 (0)	0.009
ALT flares	7 (7.7)	0 (0)	0.004
Rash	5 (5.5)	0 (0)	0.021
HCC	0 (0)	1 (1.0)	1.000
Virological breakthrough	0 (0)	2 (1.9)	0.500

AEs: Adverse events; ALT: alanine aminotransferase; HCC: Hepatocellular carcinoma.