Table 2.

Grade ≥3 treatment-related adverse events classified by study phase, crizotinib dose, and grade.

Phase	Dose Escalation Phase
Crizotinib dose	200 mg/QD	250 mg/QD	200 mg/BID	250 mg/QD	Any
Grade	Grade ≥3	Grade ≥3	Grade ≥3	Grade ≥3	Grade ≥3
Number of patients n (%)	3 (100%)	6 (100%)	3 (100%)	25 (100%)	37 (100%)
Fatigue	1 (33.3)	0 (0.0)	0 (0.0)	0 (0.0)	1 (2.7)
Transaminitis	1 (33.3)	1 (16.7) *	1 (33.3) *	5 (20.0)	8 (21.6)
Neutrophil count decreased	2 (66.7)	2 (33.3)	1 (33.3) *	1 (4.0)	6 (16.2)
Platelet count decreased	1 (33.3)	1 (16.7)	0 (0.0)	2 (8.0)	4 (10.8)
Constipation	0 (0.0)	0 (0.0)	1 (33.3) *	0 (0.0)	1 (2.7)
Lymphocyte count decreased	1 (33.3)	0 (0.0)	0 (0.0)	1 (4.0)	2 (5.4)
White blood cell decreased	0 (0.0)	0 (0.0)	0 (0.0)	1 (4.0)	1 (2.7)
Alanine aminotransferase increased	0 (0.0)	0 (0.0)	0 (0.0)	2 (8.0)	2 (5.4)

* Dose limiting toxicities (DLTs). Data cut-off at 10%. Toxicities reported here were causally related to any investigational medicinal product.