Table 2.

Adverse events

Listing of grade 1+ adverse events occurring in ≥ 10%
Max grade per patient per event
At least possibly related
Number of evaluable patients: 65
	Grade of adverse event
	1—Mild		2—Mod		3—Severe		4—LifeThr
	n	(%)	n	(%)	n	(%)	n	(%)
Hematologic adverse events
Lymphocyte count decreased	18	(28)	19	(29)	6	(9)	0	(0)
Neutrophil count decreased	17	(26)	5	(8)	10	(15)	4	(6)
Platelet count decreased	27	(42)	1	(2)	0	(0)	1	(2)
Anemia	25	(38)	0	(0)	0	(0)	0	(0)
Nonhematologic adverse events
Gastrointestinal
Diarrhea	22	(34)	2	(3)	1	(2)	0	(0)
Constipation	13	(20)	3	(5)	1	(2)	0	(0)
Nausea	11	(17)	5	(8)	0	(0)	0	(0)
Mucositis oral	3	(5)	5	(8)	0	(0)	0	(0)
General
Fatigue	34	(52)	17	(26)	4	(6)	0	(0)
Infusion-related reaction	11	(17)	13	(20)	0	(0)	0	(0)
Pain	4	(6)	5	(8)	1	(2)	1	(2)
Infections and infestations
Sinus/respiratory infection	0	(0)	11	(26)	1	(2)	0	(0)
Other infection	0	(0)	7	(11)	6	(9)		(0)
Investigations
Alanine aminotransferase increased	25	(38)	3	(5)	1	(2)	0	(0)
Alkaline phosphatase increased	13	(20)	1	(2)	0	(0)	0	(0)
Aspartate aminotransferase increased	18	(28)	1	(2)	1	(2)	0	(0)
Blood bilirubin increased	7	(11)	2	(3)	1	(2)	0	(0)
Metabolic
Hyperglycemia	12	(18)	4	(6)	2	(3)	0	(0)
Hypocalcemia	7	(11)	1	(2)	1	(2)	0	(0)
Anorexia	6	(9)	1	(2)	0	(0)	0	(0)
Nervous system
Peripheral sensory neuropathy	9	14)	0	(0)	1	(2)	0	(0)
Headache	6	(9)	1	(2)	1	(2)	0	(0)
Skin and subcutaneous tissue
Rash maculo-papular	10	(15)	11	(17)	5	(8)	0	(0)
Pruritus	10	(15)	1	(2)	0	(0)	0	(0)
Dry skin	8	(12)	1	(2)	0	(0)	0	(0)