Is dose modification or discontinuation of nilotinib necessary in nilotinib-induced hyperbilirubinemia?

Table 1 Incidence of biochemical abnormalities across the second-line and frontline nilotinib trials

Patients (%)	Second-line trials				Frontline trials
	Phase 2		Phase 3		Phase 2				Phase 3
	2101[35] (n = 321)		ENACT[36,37] (n = 1422)		MDACC[38] (n = 61)		GIMEMA[17] (n = 76)		ENESTnd[39] 300 mg twice daily (n = 279)		ENESTnd[39] 400 mg twice daily (n = 277)
	All grades	Grade 3/4	All grades	Grade 3/4	All grades	Grade 3/4	All grades	Grade 3/4	All grades	Grade 3/4	All grades	Grade 3/4
Bilirubin elevation (total)	72	7	25	4	39	7	53	16	53	4	62	8
ALT elevation	69	4	14	2	48	0	42	8	66	4	73	9
AST elevation	55	3	9	1	46	0	29	3	40	1	48	3

ALT: Alanine aminotransferase; AST: Aspartate aminotransferase.