Table 3.

Summary of treatment-related and serious adverse events

	50 mg (N = 2)	100 mg (N = 1)	200 mg (N = 1)		400 mg (N = 1)	800 mg (N = 3)	1,200 mg (N = 4)	1,800 mg (N = 10)	2,400 mg (N = 12)	3,000 mg (N = 7)	Total (N = 41)
Any event (all patients)	2 (100)	1 (100)	1 (100)		1 (100)	3 (100)	4 (100)	10 (100)	12 (100)	7 (100)	41 (100)
Treatment-related AEs
Any event	1 (50)	1 (100)	1 (100)		1 (100)	3 (100)	3(75)	9 (90)	11 (92)	7 (100)	37 (90)
Fatigue	0	1 (100)	1 (100)		1 (100)	2(67)	1 (25)	6 (60)	6 (50)	2 (29)	20 (49)
Nausea	1 (50)	0	0		0	1 (33)	0	3 (30)	8(67)	3 (43)	16 (39)
Vomiting	0	0	0		0	1 (33)	1 (25)	2 (20)	2 (17)	3 (43)	9 (22)
Anemia	0	0	0		0	2 (67)	0	1 (10)	4 (34)	1 (14)	8 (20)
Alanine aminotransferase increased	0	0	0		0	0	0	1 (10)	3 (25)	3 (43)	7(17)
Infusion-related reaction	0	0	0		0	1 (33)	1 (25)	0	2 (17)	3 (43)	7 (17)
Oral paresthesia	0	0	0		0	1 (33)	0	1 (10)	2 (17)	1 (14)	5 (12)
Diarrhea	0	0	0		0	0	1 (25)	0	2 (17)	1 (14)	4 (10)
Pruritus	0	1 (100)	0		0	1 (33)	0	0	1 (8)	1 (14)	4 (10)
Aspartate aminotransferase increased	0	0	0		0	0	0	0	1 (8)	2 (29)	3 (7)
Blood alkaline phosphatase increased	0	0	0		0	1 (33)	0	0	1 (8)	1 (14)	3 (7)
Constipation	1 (50)	0	0		0	1 (33)	0	0	0	1 (14)	3 (7)
Serious AEs (≥Grade 3)
Any event	1 (50)	0	0		0	1 (33)	2 (50)	1 (10)	5 (42)	3 (43)	13 (32)
Pyrexia	0	0	0		0	0	1 (25)	0	1 (8)	1 (14)	3 (7)
Respiratory tract infection	1 (50)	0	0		0	0	0	0	1 (8)	0	2 (5)
Back pain	0	0	0		0	0	0	0	0	1 (14)	1 (2)
Bronchitis	0	0	0		0	0	1 (25)	0	0	0	1 (2)
Campylobacter infection	0	0	0		0	1 (33)	0	0	0	0	1 (2)
Enterocolitis	0	0	0		0	1 (33)	0	0	0	0	1 (2)
Hemoptysis	0	0	0		0	0	0	1 (10)	0	0	1 (2)
Hypokalemia	0	0	0	0		0	0	0	1 (8)	0	1 (2)
Intestinal obstruction	0	0	0	0		0	0	0	1 (8)	0	1 (2)
Pneumonia	0	0	0	0		0	0	0	1 (8)	0	1 (2)
Skin bacterial infection	0	0	0	0		0	0	0	1 (8)	0	1 (2)
Tumor pain	0	0	0	0		1 (33)	0	0	0	0	1 (2)
Vomiting	0	0	0	0		0	0	0	0	1 (14)	1 (2)