Table 4.

Treatment-Related Adverse Events by System Organ Class, Preferred Term, and Maximum CTCAE Grades 3 and 4 in ≥ 5%of Patients

System Organ Class Preferred Term	ITT Population (N = 65)
	All Grades		Grade 3		Grade 4
	No. of Patients	%	No. of Patients	%	No. of Patients	%
Any treatment-related adverse event	53	82	25	39	12	19
Nervous system disorders	41	63	12	19	1	2
Neuropathy peripheral	19	29	10	15	0	0
Hypoesthesia	16	25	1	2	0	0
Paraesthesia	13	20	1	2	0	0
Areflexia	6	9	1	2	0	0
Hyporeflexia	5	8	0	0	0	0
GI disorders	33	51	8	12	0	0
Constipation	22	34	2	3	0	0
Nausea	14	22	0	0	0	0
Vomiting	7	11	0	0	0	0
Abdominal pain	6	9	2	3	0	0
Diarrhea	4	6	1	2	0	0
Blood and lymphatic system disorders	19	29	6	9	8	12
Neutropenia	11	17	5	8	5	8
Anemia	8	12	3	5	0	0
Thrombocytopenia	6	9	1	2	3	5
Febrile neutropenia	5	8	2	3	0	0
General disorders and administration site conditions	16	25	5	8	0	0
Fatigue	7	11	2	3	0	0
Asthenia	6	9	2	3	0	0
Pyrexia	6	9	1	2	0	0
Metabolism and nutrition disorders	14	22	4	6	2	3
Decreased appetite	8	12	1	2	0	0
Tumor lysis syndrome	5	8	1	2	2	3
Investigations	12	19	5	8	1	2
Weight decreased	7	11	0	0	0	0

Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events; ITT, intention-to-treat.