Table 3.

Treatment-Emergent Drug-Related Adverse Events Reported for >1 Patient

	Dose (mg/m2)
																									Total (N = 41)
	1 (n = 3)			2 (n = 3)			2H* (n = 2)			3.3 (n =3)			5 (n = 6)			7 (n = 8)			9† (n = 10)			12 (n = 6)			Any
Adverse Event	All		Gr 3	All		Gr 3	All		Gr 3	All		Gr 3	All		Gr 3	All		Gr 3	All		Gr 3–4	All		Gr 3–4	No.	%
Hematologic/Coagulation
Neutropenia		0			0			0			0		1		0	1		1	5		2	3		3	10	24
Anemia		0			0			0			0		1		0	1		0	2		0	1		1	5	12
aPTT prolonged		0			0		1		0		0		1		0	1		0		0			0		3	7
Leukopenia		0			0			0			0			0		1		0	1		1	1		0	3	7
Gastrointestinal toxicity
Nausea	1		0	2		0	1		0	2		0	1		0	3		0	8		0	3		0	21	51
Diarrhea	3		0		0		1		0	1		0		0		6		0	5		1	3		0	19	46
Vomiting		0			0		1		0		0		2		0	2		0	2		0	2		0	9	22
Constipation		0		1		0		0		1		0		0		3		0		0		1		0	6	15
Dyspepsia		0		2		0		0			0			0		1		0		0			0		3	7
Abdominal pain		0			0			0			0			0		2		1		0			0		2	5
OtheNonhematologic toxicity
Fatigue	1		0	1		0	1		0	1		0	1		0	3		0	6		2	3		0	17	41
Alopecia		0			0			0			0		1		0	3		0	6		0	2		0	12	29
Anorexia		0		1		0	1		0	1		0		0		2		0	2		0	1		0	8	20
Dysgeusia		0			0		1		0		0			0		1		0	1		0		0		3	7
Dehydration	1		0		0		1		1		0			0			0			0			0		2	5
Dizziness		0			0			0			0			0		1		0	1		0		0		2	5
Hypokalemia		0			0			0			0		1		0		0		1		0		0		2	5
Hypomagnesemia		0			0			0			0			0			0		2		0		0		2	5
Peripheral neuropathy		0			0			0			0			0		1		1	1		1		0		2	5
Skin hyperpigmentation		0			0			0			0			0		1		0		0		1		0	2	5

Abbreviation: aPTT, activated partial thromboplastin time; Gr, grade.

Note: Two patients (one in the 9-mg/m² and one in the 12-mg/m² cohort) had grade 4 neutropenia; all other patients had grade 3 events.

^aPatients with homozygous (*28/*28) UGT1A1 genotype.