Table 3.

Adverse events reported in >10% of the patients

Adverse events	All patients (n = 106)				60 mg (n = 51)				80 mg (n = 55)
	Grade ≥ 3		Any grade		Grade ≥ 3		Any grade		Grade ≥ 3		Any grade
	No.	%	No.	%	No.	%	No.	%	No.	%	No.	%
Diarrhoea	21	19.8	100	94.3	6	11.8	48	94.1	15	27.3	52	94.5
Rash	18	17.0	92	86.8	7	13.7	42	82.4	11	20.0	50	90.9
Paronychia	4	3.8	57	53.8	2	3.9	20	39.2	2	3.6	37	67.3
Weight decreased	2	1.9	51	48.1	1	2.0	24	47.1	1	1.8	27	49.1
Mouth ulceration	5	4.7	39	36.8	1	2.0	21	41.2	4	7.3	18	32.7
Decreased appetite	4	3.8	37	34.9	3	5.9	19	37.3	1	1.8	18	32.7
Anaemia	4	3.8	36	34.0	2	3.9	13	25.5	2	3.6	23	41.8
Ureterolithiasis	2	1.9	33	31.1	0	0	0	0	2	3.6	19	34.5
Stomatitis	5	4.7	31	29.2	1	2	12	23.5	4	7.3	19	34.5
Upper respiratory tract infection	0	0	31	29.2	0	0	14	27.5	0	0	17	30.9
Dry skin	1	0.9	27	25.5	0	0	14	27.5	1	1.8	13	23.6
Vomiting	1	0.9	26	24.5	0	0	11	21.6	1	1.8	15	27.3
Alopecia	0	0	24	22.6	0	0	13	25.5	0	0	11	20.0
Nausea	0	0	24	22.6	0	0	10	19.6	0	0	14	25.5
Hypokalaemia	4	3.8	23	21.7	2	3.9	13	25.5	2	3.6	10	18.2
Asthenia	0	0	22	20.8	0	0	11	21.6	0	0	11	20.0
Conjunctivitis	1	0.9	20	18.9	0	0	10	19.6	1	1.8	10	18.2
Urinary tract infection	1	0.9	19	17.9	0	0	7	13.7	1	1.8	12	21.8
Palmar-plantar erythrodysaesthesia syndrome	1	0.9	17	16.0	0	0	0	0	0	0	12	21.8
Angular cheilitis	0	0	16	15.1	0	0	6	11.8	0	0	10	18.2
Nasal dryness	0	0	15	14.2	0	0	0	0	0	0	10	18.2
Hepatic function abnormal	0	0	14	13.2	0	0	9	17.6	0	0	0	0
Alanine aminotransferase increased	1	0.9	13	12.3	1	2	7	13.7	0	0	6	10.9
Hypoalbuminaemia	1	0.9	12	11.3	1	2	6	11.8	0	0	6	10.9
Insomnia	0	0	12	11.3	0	0	7	13.7	0	0	0	0
Skin fissures	0	0	12	11.3	0	0	0	0	0	0	7	12.7
Constipation	0	0	11	10.4	0	0	6	11.8	0	0	0	0
Proteinuria	0	0	11	10.4	0	0	6	11.8	0	0	0	0
Supraventricular extrasystoles	0	0	11	10.4	0	0	0	0	0	0	6	10.9