TABLE 5.

Treatment-Related ≥Grade 3 Adverse Events

	Arm I			Arm II			Arm III
	Grade 3	Grade 4	Grade 5	Grade 3	Grade 4	Grade 5	Grade 3	Grade 4	Grade 5
Overall AEs	9 (22%)	3 (7%)	0	24 (55%)	3 (7%)	2 (5%)	18 (46%)	10 (26%)	3 (8%)
Hematologic AEs	6 (15%)	1 (2%)	0	8 (18%)	2 (5%)	0	8 (21%)	10 (26%)	0
Low hemoglobin	1 (2%)	0	0	3 (7%)	0	0	3 (8%)	0	0
Low ANC	2 (5%)	0	0	2 (5%)	1 (2%)	0	3 (7%)	8 (21%)	0
Low platelets	1 (2%)	1 (2%)	0	2 (5%)	1 (2%)	0	6 (15%)	2 (5%)	0
Febrile neutropenia	0 (0%)	0	0	0	0	0	1 (3%)	0	0
Nonhematologic AEs	5 (12%)	3 (7%)	0	23 (52%)	1 (2%)	2 (5%)	20 (51%)	1 (3%)	3 (8%)
Constitutional
Fatigue	3 (7%)	1 (2%)	0	12 (27%)	0	0	9 (23%)	0	0
Infection	1 (2%)	0	0	2 (4%)	0	0	0	0	2 (6%)
Gastrointestinal
Nausea	0	0	0	1 (2%)	0	0	3 (8%)	0	0
Vomiting	0	0	0	0	0	0	2 (5%)	0	0
Mucositis	0	0	0	1 (2%)	0	0	3 (8%)	0	0
Diarrhea	1 (2%)	0	0	0	0	0	0	0	0
Elevated ALT	0	0	0	1 (2%)	0	0	1 (3%)	0	0
Elevated AST	1 (2%)	0	0	2 (5%)	0	0	0	0	0
Dermatologic
Rash (hand-foot)	0	0	0	3 (7%)	0	0	0	0	0
Cardiovascular
Cardiac ischemia	0	0	0	0	0	1 (2%)	0	0	0
Hypertension	1 (2%)	0	0	2 (5%)	0	0	2 (5%)	0	0
Pulmonary hemorrhage	0	0	0	0	0	1 (2%)	0	0	0
Other hemorrhage	0	0	0	0	0	0	1 (3%)	0	0
Thrombosis/embolism	0	0	0	0	0	0	1 (3%)	0	1 (3%)

ANC, absolute neutrophil count; ALT, alanine aminotransferase; AST, aspartate transaminase; AEs, adverse events.