Table 5.

Non-hematologic adverse events during the first cycle

	Level 0	(n = 3)	Level 1	(n = 6)	Level 2	(n = 3)
	Gr 1-2	Gr 3-4	Gr 1-2	Gr 3-4	Gr 1-2	Gr 3-4
Anorexia	2	0	1	0	2	0
Nausea	1	0	1	0	0	0
Vomiting	1	0	0	0	0	0
Fatigue	0	0	0	0	2	0
Constipation	1	0	1	0	0	0
Fever	1	0	2	0	0	0
Biliary tract infection	NA	3	NA	0	NA	1
Infections (others)	0	0	0	2	0	0
AST	3	0	2	0	0	0
ALT	2	0	2	0	0	0
Hyperbilirubinemia	2	0	1	0	1	0
Creatinine	0	0	3	0	0	0

NA: Not applicable; AST: Aspartate aminotransferase; ALT: Alanine aminotransferase.