Table 3.

Adverse events of regorafenib treatment.

	Monotherapy group (n = 116)			Chemo group (n = 28)			Immune group (n = 33)			p-value#
	Any grade	Grade1–2	Grade ≥3	Any grade	Grade1–2	Grade ≥3	Any grade	Grade1–2	Grade ≥3
Any event*	100 (86.2%)	52 (44.8%)	48 (41.3%)	25 (89.3%)	12 (42.8%)	13 (46.4%)	29 (87.9%)	15 (45.4%)	14 (42.4%)	0.89
Hand–foot skin reaction	45 (38.8%)	29 (25%)	16 (13.8%)	13 (46.4%)	8 (28.6%)	5 (17.8%)	13 (39.4%)	9 (27.3%)	4 (12.1%)	0.75
Rash	6 (5.2%)	5 (4.3%)	1 (0.8%)	2 (7.1%)	1 (3.5%)	1 (3.5%)	1 (3%)	0 (0)	1 (3%)	0.76
Oral mucositis	4 (3.4%)	3 (2.6%)	1 (0.8%)	1 (3.5%)	1 (3.5%)	0 (0)	0 (0)	0 (0)	0 (0)	0.55
Fatigue	23 (19.8%)	18 (15.5%)	5 (4.3%)	6 (21.4%)	6 (21.4%)	0 (0)	10 (30.3%)	8 (24.2%)	2 (6.1%)	0.43
Hypertension	11 (9.5%)	7 (6%)	4 (3.4%)	1 (3.6%)	1 (3.5%)	0 (0)	6 (18.2%)	5 (15.2%)	1 (3%)	0.15
Proteinuria	8 (6.9%)	6 (5.2%)	2 (1.7%)	2 (7.1%)	2 (7.1%)	0 (0)	1 (3%)	1 (3%)	0 (0)	0.70
Elevated liver enzymes	22 (18.9%)	15 (12.9%)	7 (6%)	6 (21.4%)	3 (10.7%)	3 (10.7%)	7 (21.2%)	4 (12.1%)	3 (9.1%)	0.93
Diarrhea	3 (2.6%)	2 (1.7%)	1 (0.8%)	1 (3.5%)	1 (3.5%)	0 (0)	0 (0)	0 (0)	0 (0)	0.59
Decreased appetite	12 (10.3%)	10 (8.6%)	2 (1.7%)	3 (10.7%)	3 (10.7%)	0 (0)	3 (9.1%)	3 (9.1%)	0 (0)	0.97
Leucopenia	10 (8.6%)	7 (6%)	3 (2.6%)	5 (17.8%)	3 (10.7%)	2 (7.1%)	2 (6.1%)	1 (3%)	1 (3%)	0.24
Thrombocytopenia	8 (6.9%)	5 (4.3%)	3 (2.6%)	5 (17.8%)	3 (10.7%)	2 (7.1%)	2 (6.1%)	1 (3%)	1 (3%)	0.14
Other†	5 (4.3%)	2 (1.7%)	3 (2.6%)	0 (0)	0 (0)	0 (0)	4 (12.1%)	3 (9.1%)	1(3%)	0.08

Data presented as No. (%).

*For patients with more than one adverse event, only the highest grade of the most severe event is shown.

^†Others include ileus (n = 2), hoarseness (n = 2) and myalgia (n = 1) in the monotherapy group; hypothyroidism (n = 1), hoarseness (n = 1), lipase elevate (n = 1) and myocardial enzyme elevation (n = 1) in the immune group.

^#p-value was calculated using any grade of AEs.