Table 3.

Incidence of drug-related adverse events

	Part I							Part II
mg/kg	50		83.5	139.5	210	315		2 doses at 210		5 doses at 210
AEs CTCAE grade	1–2	3–4	1–2	1–2	1–2	1–2	3–4	1–2	3–4	1–2
Number possible, probable or definitive drug-related AEs (number of patients)	11 (4)	3 (2)	5 (2)	1 (1)	4 (3)	15 (3)	3 (2)	9 (3)	1 (1)	21 (3)
Investigations
Alanine aminotransferase increased	2 (1)
Blood bilirubin increased	1 (1)					1 (1)
Blood creatinine increased							1 (1)			3 (2)
Platelet count decreased	1 (1)	1 (1)
Nervous system disorders
Headache	1 (1)					1 (1)		1 (1)		1 (1)
Dizziness						1 (1)				1 (1)
Paresthesia	1 (1)
Presyncope						1 (1)
Metabolism and nutrition disorders
Hyperglycemia	1 (1)	1 (1)
Hyperkalemia			1 (1)		1 (1)
Hyperuricemia		1 (1)
Hypoglycemia			1 (1)
Hypokalemia						1 (1)
Tumor lysis syndrome							1 (1)
Gatrointestinal disorders
Diarrhea			2 (1)			1 (1)				1 (1)
Nausea						2 (2)		1 (1)		5 (2)
Gastric disorder
Vomiting						1 (1)		1 (1)
Abdominal pain										1 (1)
Vascular disorders
Hypotension					1 (1)	1 (1)		1 (1)
Hypertension	1 (1)
Hematoma						1 (1)
Blood and lymphatic disorders
Anemia (or hemoglobin decreased)	1 (1)		1 (1)			3 (1)		3 (2)		6 (2)
Thrombocytopenia								2 (2)
Neutropenia									1 (1)
Renal and urinary disorders
Renal failure acute							1 (1)
Other non-hematological AEs
Other AEs	2 (2)			1 (1)	2 (2)	1 (1)				3 (1)

Only possible, probable, or definitive drug-related AEs are shown here. In the cohorts 83.5, 139.5, 210 mg/kg in Part I, and in the cohort with 5 doses at 210 mg/kg in Part II, any CTCAE grade 3 or 4 was reported. The number of patient that reported the AEs is indicated in brackets for each event