Table 3.

Drug-related adverse events reported in ≥10 % of patients receiving regorafenib or placebo in the Japanese and non-Japanese subpopulations

	Japanese subpopulation, n (%)				Non-Japanese subpopulation, n (%)
	Regorafenib (n = 65)		Placebo (n = 32)		Regorafenib (n = 435)		Placebo (n = 221)
Adverse event, n (%)	Any grade	Grade ≥3	Any grade	Grade ≥3	Any grade	Grade ≥3	Any grade	Grade ≥3
Any adverse event	64 (99)	52 (80)	19 (59)	7 (22)	401 (92)	223 (51)	135 (61)	28 (13)
Hand–foot skin reaction	52 (80)	18 (28)	1 (3)	0	181 (42)	65 (15)	18 (8)	1 (<1)
Hypertension	39 (60)	7 (11)	1 (3)	0	100 (23)	29 (7)	14 (6)	2 (<1)
Anorexia	28 (43)	6 (9)	8 (25)	3 (9)	124 (29)	10 (2)	31 (14)	4 (2)
Fatigue	28 (43)	5 (8)	8 (25)	3 (9)	209 (48)	43 (10)	63 (29)	10 (5)
Proteinuria	26 (40)	4 (6)	2 (6)	0	9 (2)	3 (<1)	2 (<1)	1 (<1)
Thrombocytopenia	25 (39)	4 (6)	2 (6)	0	38 (9)	10 (2)	3 (1)	1 (<1)
Rash/desquamation	23 (35)	2 (3)	4 (13)	0	107 (25)	27 (6)	6 (3)	0
Voice changes	21 (32)	0	0	0	126 (29)	1 (<1)	14 (6)	0
Fever	17 (26)	2 (3)	1 (3)	0	35 (8)	2 (<1)	6 (3)	0
Lipase elevation	16 (25)	9 (14)	0	0	8 (2)	7 (2)	1 (<1)	1 (<1)
Diarrhea	14 (22)	1 (2)	2 (6)	0	155 (36)	35 (8)	19 (9)	2 (<1)
Hypophosphatemia	13 (20)	9 (14)	0	0	12 (3)	10 (2)	1 (<1)	1 (<1)
Oral mucositis	13 (20)	1 (2)	0	0	123 (28)	14 (3)	9 (4)	0
Aspartate aminotransferase elevation	12 (19)	4 (6)	1 (3)	0	7 (2)	2 (<1)	4 (2)	2 (<1)
Nausea	11 (17)	1 (2)	4 (13)	0	61 (14)	1 (<1)	24 (11)	0
Epistaxis	10 (15)	0	1 (3)	0	26 (6)	0	4 (2)	0
Hyperbilirubinemia	10 (15)	1 (2)	2 (6)	1 (3)	35 (8)	9 (2)	2 (<1)	1 (<1)
Weight loss	10 (15)	0	1 (3)	0	59 (14)	0	5 (2)	0
Amylase elevation	9 (14)	2 (3)	0	0	5 (1)	2 (<1)	0	0
Constipation	9 (14)	0	0	0	33 (8)	0	12 (5)	0
Alanine aminotransferase elevation	8 (12)	3 (5)	1 (3)	0	4 (<1)	2 (<1)	1 (<1)	0
Taste alteration	7 (11)	0	0	0	28 (6)	0	5 (2)	0