Table 3.

Adverse events

Term	All grades	Grade 3	Grade 4
	n (%)
Patients with at least 1 adverse event	91 (100)	58 (63.7)	8 (8.8)
Hematologic events
Neutropeniaa	63 (69.2)	34 (37.4)	6 (6.6)
Thrombocytopeniab	38 (41.8)	13 (14.3)	1 (1.1)
Anemiac	27 (29.7)	8 (8.8)	0
Leukopeniad	19 (20.9)	6 (6.6)	0
Nonhematologic events
Upper respiratory tract infection	41 (45.1)	9 (9.9)	0
Hematuria/blood urine present	36 (39.6)	0	0
Petechiae, purpura, or contusion	32 (35.2)	0	0
Hypokalemia	23 (25.3)	6 (6.6)	0
Cough	22 (24.2)	1 (1.1)	0
Carbon dioxide increased	19 (20.9)	0	0
Hyperglycemia	19 (20.9)	2 (2.2)	0
Diarrhea	18 (19.8)	2 (2.2)	0
Lung infection/pneumonia	20 (22.0)	11 (12.1)	0e
Urinary tract infection	15 (16.5)	1 (1.1)	0
Rash	13 (14.3)	0	0
Urobilinogen increased	12 (13.2)	0	0
Alanine amino transferase increased	11 (12.1)	1 (1.1)	0
Hypoalbuminemia	11 (12.1)	1 (1.1)	0
Aspartate amino transferase increased	10 (11.0)	1 (1.1)	0
Hyperuricemia	10 (11.0)	1 (1.1)	1 (1.1)
Pyrexia	10 (11.0)	0	0
Hyponatremia	9 (9.9)	4 (4.4)	0
Hypocalcemia	9 (9.9)	2 (2.2)	0
Hypertensionf	9 (9.9)	2 (2.2)	0
Skin infection	8 (8.8)	2 (2.2)	0
Bronchitis	6 (6.6)	2 (2.2)	0
Gastroenteritis	5 (5.5)	2 (2.2)	0
Hepatitis B reactivation	3 (3.3)	2 (2.2)	0
Infectious enteritis	2 (2.2)	2 (2.2)	0

Data are for treatment-emergent adverse events in the 91 patients included in the study. Listed events occurred in at least 10% of patients, or for grade ≥ 3 in at least 2% of patients

MedDRA Medical Dictionary for Regulatory Activities

^aIncludes the MedDRA preferred terms neutropenia and neutrophil count decreased

^bIncludes the MedDRA preferred terms thrombocytopenia and platelet count decreased

^cIncludes the MedDRA preferred terms anemia and hemoglobin decreased

^dIncludes the MedDRA preferred term white blood cell count decreased

^eOne patient had a grade 5 lung infection (see text)

^fIncludes the MedDRA preferred terms hypertension and blood pressure increased