Table 3.

Toxicity in dose escalation phase for cycle 1.

Adverse event	Dose level
	Level −I				Level I				Level II				Level III				Level IV
	N=6				N=3				N=7				N=6				N=7
Grade of adverse event	1	2	3	4	1	2	3	4	1	2	3	4	1	2	3	4	1	2	3	4
Allergy		1
Auditory															1a
Blood/bone marrow
Hemoglobin	4	2			2				5	2			3	1			5	1
Neutrophils		3	2			1		2	1	1		3	1	1		4	3		1	2
Platelets	1								1				1		1	1a	1
Cardiac									1
Coagulation
Constitutional	3	2			1	2			1	2	2		4			1a	3	2
Dermatology	5	1			1				5				3				6	1
Endocrine		1							2
Gastrointestinal	3	2				3			2	2	2		3	1	1a		6
Genitourinary									2	1			1				1
Hemorrhage					1				1				1				1	1
Hepatobiliary									2
Infection														1	1a			3
Metabolic	2	1			1					1		1b	2			1a	3	1	1c
Musculoskeletal																	1
Neurologic		1							5								1
Ocular/visual						1			2				1				2
Pain	2	3			1				3	1			2				1	1
Pulmonary					1				2				1				1	1

^aDose Level III: DLT with all toxicities occurring in a single patient.

^bDose Level II: Grade 3 toxicity in an inevaluable patient taken off study during cycle 1.

^cDose Level IV: DLT.