Table 2.

Treatment-related adverse events

Grade	0.1 mg/kg (N=20)					1.0 mg/kg (N=19)
	1	2	3	4		1	2	3	4
Cases	16	12	6	1		10	14	4	2
Total events	34	23	7	1		23	20	4	2
Non-hematological
General
Fever	1					1	2
Fatigue	1					2
Appetite loss	1							1
Edema	1
Weight loss		1
Skin and subcutaneous tissue
Rash	8	5	1			5	5
Pruritus	1
Drug eruption							1
Gastrointestinal
Diarrhea						1	1
Nausea						1
Vomiting						1
Ear and labyrinth
Vertigo positional		1
Ear discomfort		1
Cardiac disorders
Arrhythmia	1					2
Electrocardiogram T wave inversion						1
Hypertension							1
Thoracic disorders
Pleural effusion						1
Nervous system disorders
Dizziness	1
Dysgeusia	1
Headache						3
Neuropathy peripheral						1
Infections
Oral candidiasis							1
Upper respiratory tract Inflammation							1
Cheilitis		1
Endocrine
Hypothyroidism	1					1
Gynecomastia	1
Hematological
Leukopenia	2						1
Lymphopenia	1	10	3	1			7	2	2
Thrombocytopenia						1
Eosinophilia	1
Hypokalemia	1	2
Hyponatremia	1
Hypophosphatemia	1
Hypoalbuminemia	1							1
GGT increased			1
ALT increased	3		1
AST increased	2		1
Amylase increased		1
LDH increased	1					1
ALP increased	1	1
TSH increased						1
Glucose urine present	1

ALT: alanine aminotransferase

AST: aspartate aminotransferase

LDH: lactate dehydrogenase

TSH: thyroid-stimulating hormone

GGT: gamma-glutamyltransferase

ALP: alkaline phosphatase