Table 2.

Drug-related adverse events in ≥10% of patients during double-blind treatment period

	Regorafenib			Placebo
Adverse event	Any grade n (%)	Grade 3 n (%)	Grade 4 n (%)	Any grade n (%)	Grade 3 n (%)	Grade 4 n (%)
Any event	130 (98·5)	77 (58·3)	2 (1·5)	45 (68·2)	5 (7·6)	1 (1·5)
Hand–foot skin reaction	74 (56·1)	26 (19·7)	0	9 (13·6)	0	0
Hypertension	64 (48·5)	30 (22·7)	1 (0·8)	11 (16·7)	2 (3·0)	0
Diarrhoea	53 (40·2)	7 (5·3)	0	3 (4·5)	0	0
Fatigue	51 (38·6)	3 (2·3)	0	18 (27·3)	0	0
Oral mucositis	50 (37·9)	2 (1·5)	0	5 (7·6)	1 (1·5)	0
Alopecia	31 (23·5)	2 (1·5)	0	1 (1·5)	0	0
Hoarseness	29 (22·0)	0	0	3 (4·5)	0	0
Anorexia	27 (20·5)	0	0	5 (7·6)	0	0
Rash, maculopapular	24 (18·2)	3 (2·3)	0	2 (3·0)	0	0
Nausea	21 (15·9)	1 (0·8)	0	6 (9·1)	1 (1·5)	0
Constipation	20 (15·2)	1 (0·8)	0	4 (6·1)	0	0
Myalgia	18 (13·6)	1 (0·8)	0	6 (9·1)	0	0
Voice alteration	14 (10·6)	0	0	2 (3·0)	0	0