Table 4.

Treatment-related adverse events occurring in mCRC patients during the study in the safety analysis set

Adverse event	Famitinib group [cases (%)] (n = 99)		Placebo group [cases (%)] (n = 55)
	Any grade	Grade 3–4	Any grade	Grade 3–4
Any eventa	92 (92.9)	51 (51.5)	42 (76.4)	20 (36.4)
Clinical adverse event
Hypertension	38 (38.4)	11 (11.1)	4 (7.3)	1 (1.8)
Hand-foot syndrome	27 (27.3)	10 (10.1)	1 (1.8)	0 (0.0)
Diarrhea	15 (15.2)	1 (1.0)	3 (5.5)	0 (0.0)
Fatigue	14 (14.1)	3 (3.0)	9 (16.4)	2 (3.6)
Rash	8 (8.1)	2 (2.0)	0 (0.0)	0 (0.0)
Hypothyroidism	7 (7.1)	0 (0.0)	1 (1.8)	0 (0.0)
Oral mucositis	7 (7.1)	0 (0.0)	0 (0.0)	0 (0.0)
Nausea	6 (6.1)	0 (0.0)	4 (7.3)	1 (1.8)
Decrease appetite	6 (6.1)	0 (0.0)	5 (9.1)	0 (0.0)
Headache	6 (6.1)	1 (1.0)	2 (3.6)	1 (1.8)
Vomit	5 (5.1)	1 (1.0)	2 (3.6)	1 (1.8)
Dizziness	5 (5.1)	0 (0.0)	2 (3.6)	0 (0.0)
Backache	3 (3.0)	0 (0.0)	3 (5.5)	0 (0.0)
Abdominal distension	2 (2.0)	0 (0.0)	3 (5.5)	0 (0.0)
Cough	2 (2.0)	0 (0.0)	5 (9.1)	0 (0.0)
Laboratory abnormalities
Proteinuria	42 (42.4)	6 (6.1)	9 (16.4)	0 (0.0)
Neutropenia	41 (41.4)	9 (9.1)	1 (1.8)	1 (1.8)
Leukopenia	36 (36.4)	3 (3.0)	1 (1.8)	0 (0.0)
Thrombocytopenia	31 (31.3)	10 (10.1)	1 (1.8)	1 (1.8)
Increased γ-GT	20 (20.2)	7 (7.1)	11 (20.0)	7 (12.7)
Increased ALT	17 (17.2)	3 (3.0)	8 (14.5)	1 (1.8)
Increased AST	16 (16.2)	2 (2.0)	7 (12.7)	0 (0.0)
Increased ALP	14 (14.1)	0 (0.0)	6 (10.9)	2 (3.6)
Hypercholesterolemia	11 (11.1)	0 (0.0)	2 (3.6)	0 (0.0)
Hypertriglyceridemia	11 (11.1)	0 (0.0)	2 (3.6)	0 (0.0)
Anemia	7 (7.1)	0 (0.0)	4 (7.3)	1 (1.8)
Increase bilirubin	5 (5.1)	1 (1.0)	1 (1.8)	0 (0.0)
Hyperglycemia	1 (1.0)	0 (0.0)	3 (5.5)	1 (1.8)

γ-GT γ-glutamyltranspeptidase, ALT alanine transaminase, AST aspartate transaminase, ALP alkaline phosphatase

^aSome patients had experienced several AEs