Table 3.

Grade ≥3 Adverse Events at Least Possibly Related to Any Study Agent

Treatment	Dose Level 1 (N=3)				Dose Level 2 (N=6)			Dose Level 3 (N=3)			Total
Grade, N (%)	3	4	5	3+	3	4	3+	3	4	3+	3+
Neutrophil count decreased	0	1	0	1 (33)	1	5	6 (100)	0	1	1 (33)	8 (67)
White blood cell decreased	1	0	0	1 (33)	4	0	4 (67)	1	0	1 (33)	6 (50)
Anemia	1	0	0	1 (33)	2	0	2 (33)	1	0	1 (33)	4 (33)
Lymphocyte count decreased	1	0	0	1 (33)	1	0	1 (17)	1	1	2 (67)	4 (33)
Hypophosphatemia	0	0	0	0 (0)	2	0	2 (33)	1	0	1 (33)	3 (25)
Hyponatremia	0	0	0	0 (0)	1	0	1 (17)	2	0	2 (67)	3 (25)
Abdominal pain	0	0	0	0 (0)	1	0	1 (17)	0	0	0 (0)	1 (8)
Acidosis	1	0	0	1 (33)	0	0	0 (0)	0	0	0 (0)	1 (8)
Pneumonitis	0	0	1	1 (33)	0	0	0 (0)	0	0	0 (0)	1 (8)
Aspartate aminotransferase increased	0	0	0	0 (0)	1	0	1 (17)	0	0	0 (0)	1 (8)
Hypokalemia	0	0	0	0 (0)	1	0	1 (17)	0	0	0 (0)	1 (8)
Nausea	0	0	0	0 (0)	0	0	0 (0)	1	0	1 (33)	1 (8)
Vomiting	0	0	0	0 (0)	0	0	0 (0)	1	0	1 (33)	1 (8)
Fatigue	0	0	0	0 (0)	0	0	0 (0)	1	0	1 (33)	1 (8)
Hyperglycemia	0	0	0	0 (0)	0	0	0 (0)	0	1	1 (33)	1 (8)
Hypertension	1	0	0	1 (33)	0	0	0 (0)	0	0	0 (0)	1 (8)
Colitis	0	0	0	0 (0)	1	0	1 (17)	0	0	0 (0)	1 (8)
Weight loss	0	0	0	0 (0)	1	0	1 (17)	0	0	0 (0)	1 (8)
Constipation	0	0	0	0 (0)	0	0	0 (0)	1	0	1 (33)	1 (8)
Bone pain	0	0	0	0 (0)	0	0	0 (0)	1	0	1 (33)	1 (8)

Dose level 1: 1.2 mg/kg BV on D1 and 5 mg/kg CsA BID on D1–5; Dose level 2: 1.8 mg/kg BV on D1 and 5 mg/kg CsA BID on D1–5; Dose level 3: 1.8 mg/kg BV on D1 and 7.5 mg/kg CsA BID on D1–5.