Table 4.

Adverse Events.^*

Adverse Event	Both Phases		Induction Phase		Maintenance Phase
	Any Grade	Grade ≥3	Any Grade	Grade ≥3	Any Grade	Grade ≥3
	number of patients (percent)
Hematologic
Neutropenia	28 (74)	19 (50)	27 (71)	16 (42)	21 (55)	12 (32)
Anemia	23 (60)	4 (11)	18 (47)	3 (8)	11 (29)	1 (3)
Thrombocytopenia	15 (39)	5 (13)	11 (29)	4 (11)	11 (29)	2 (5)
Febrile neutropenia	2 (5)	2 (5)	1 (3)	1 (3)	1 (3)	1 (3)
Infectious
Upper respiratory tract infection	15 (39)	0	9 (24)	0	11 (29)	0
Urinary tract infection	7 (18)	0	4 (11)	0	4 (11)	0
Sinusitis	4 (11)	0	1 (3)	0	3 (8)	0
Cellulitis	3 (8)	0	2 (5)	0	1 (3)	0
Pneumonia	3 (8)	3 (8)	1 (3)	1 (3)	2 (5)	2 (5)
Other
Fatigue	28 (74)	3 (8)	25 (66)	3 (8)	12 (32)	0
Rash	25 (66)	11 (29)	25 (66)	11 (29)	0	0
Fever	22 (58)	0	19 (50)	0	4 (11)	0
Cough	21 (55)	0	18 (47)	0	6 (16)	0
Diarrhea	21 (55)	0	20 (53)	0	14 (37)	0
Hyperglycemia	19 (50)	2 (5)	12 (32)	2 (5)	14 (37)	0
Constipation	17 (45)	0	17 (45)	0	4 (11)	0
Edema	16 (42)	0	14 (37)	0	3 (8)	0
Inflammatory syndrome (tumor flare)	13 (34)	4 (11)	13 (34)	4 (11)	0	0
Infusion reaction	13 (34)	1 (3)	13 (34)	1 (3)	0	0
Nausea	12 (32)	0	12 (32)	0	1 (3)	0
Anorexia	11 (29)	0	10 (26)	0	3 (8)	0
Dyspnea	11 (29)	1 (3)	10 (26)	1 (3)	1 (3)	0
Elevated alanine aminotransferase level	13 (34)	2 (5)	9 (24)	1 (3)	4 (11)	1 (3)
Elevated aspartate aminotransferase level	11 (29)	2 (5)	8 (21)	1 (3)	4 (11)	1 (3)
Hypothyroidism	6 (16)	0	6 (16)	0	0	0

^*The table includes all treatment-related hematologic and infectious adverse events, as well as other adverse events that occurred in more than 15% of the 38 patients.