Table 3.

AEs during study regardless of cause

AE	All (N = 46)		Grade 3/4 (n = 31 [67%])		Grade 1/2 (n = 36 [78%])
	No.	%	No.	%	No.	%
Nonhematologic
Infection	15	33	5	11	10	22
Constipation	10	22	—		10	22
Nausea	7	15	1	2	6	13
Elevated ALT, AST	5	11	1	2	4	9
Diarrhea	4	9	1	2	3	7
Fatigue	3	7	1	2	2	4
Fever	3	7	2	4	1	2
Insomnia	2	4	—		2	4
Pruritus	2	4	1	2	1	2
Dizziness	2	4	—		2	4
Elevated creatinine	2	4	—		2	4
Chest pain, hypertension, CHF	2	4	1	2	1	2
Hemorrhage	2	4	1	2	1	2
Neuropathy	1	2	—		1	2
Hyperuricemia	1	2	—		1	2
Anorexia	1	2	—		1	2
Weight loss	1	2	—		1	2
Hematologic
Neutropenia	16	35	11	14	5	11
Anemia	33	72	21	46	12	26
Thrombocytopenia	29	63	14	30	15	33
New onset anemia	26	57	16	35	10	22
New onset neutropenia	13	28	11	24	2	4
New onset thrombocytopenia	17	37	12	26	5	11

Only 1 AE of similar type is counted in the same patient regardless of total episodes; only the highest grade of AE is reported in a patient who experienced repeated similar AEs of different grades; and percentage is calculated from all patients enrolled on the study.

ALT, alanine aminotransferase; AST, aspartate aminotransferase; CHF, congestive heart failure.