TABLE 3.

TRAE

Event	Any Grade, No. (%)	Grade 3-4, No. (%)	Grade 3, No. (%)	Grade 4, No. (%)
At least one TRAE	51 (98.1)	25 (48.1)	25 (48.1)	3 (5.8)
Peripheral edema	43 (82.7)	7 (13.5)	7 (13.5)	0 (0.0)
QT prolongation	16 (30.8)	1 (1.9)	1 (1.9)	0 (0.0)
Elevated serum creatinine	15 (28.8)	1 (1.9)	1 (1.9)	0 (0.0)
Hypoalbuminemia	14 (26.9)	0 (0.0)	0 (0.0)	0 (0.0)
Hypoproteinemia	13 (25.0)	0 (0.0)	0 (0.0)	0 (0.0)
Anemia	13 (25.0)	2 (3.8)	2 (3.8)	0 (0.0)
Elevated aspartate ALT	12 (23.1)	4 (7.7)	4 (7.7)	0 (0.0)
Weight gain	12 (23.1)	0 (0.0)	0 (0.0)	0 (0.0)
Pruritus	12 (23.1)	0 (0.0)	0 (0.0)	0 (0.0)
Elevated lipase	11 (21.2)	3 (5.8)	3 (5.8)	0 (0.0)
Hypocalcemia	9 (17.3)	0 (0.0)	0 (0.0)	0 (0.0)
Weakness	8 (15.4)	0 (0.0)	0 (0.0)	0 (0.0)
Abnormal liver function	8 (15.4)	5 (9.6)	5 (9.6)	1 (1.9)
Ventricular premature contraction	8 (15.4)	0 (0.0)	0 (0.0)	0 (0.0)
Elevated AST	8 (15.4)	3 (5.8)	3 (5.8)	0 (0.0)
Elevated bilirubin	8 (15.4)	0 (0.0)	0 (0.0)	0 (0.0)
Decreased platelet count	8 (15.4)	2 (3.8)	1 (1.9)	1 (1.9)
Hypokalemia	7 (13.5)	1 (1.9)	0 (0.0)	1 (1.9)
Nausea	7 (13.5)	0 (0.0)	0 (0.0)	0 (0.0)
Elevated conjugated bilirubin	7 (13.5)	1 (1.9)	1 (1.9)	0 (0.0)
Sinus tachycardia	7 (13.5)	0 (0.0)	0 (0.0)	0 (0.0)
Decreased white cell count	6 (11.5)	0 (0.0)	0 (0.0)	0 (0.0)
Hyponatremia	6 (11.5)	0 (0.0)	0 (0.0)	0 (0.0)
Elevated amylase	6 (11.5)	1 (1.9)	1 (1.9)	0 (0.0)
Hyperuricaemia	6 (11.5)	0 (0.0)	0 (0.0)	0 (0.0)
Vomiting	6 (11.5)	0 (0.0)	0 (0.0)	0 (0.0)
Decreased neutrophil count	4 (7.7)	1 (1.9)	1 (1.9)	0 (0.0)
Infectious pneumonia	2 (3.8)	1 (1.9)	1 (1.9)	0 (0.0)
Peripheral swelling	2 (3.8)	1 (1.9)	1 (1.9)	0 (0.0)
Decreased renal creatinine clearance rate	1 (1.9)	1 (1.9)	1 (1.9)	0 (0.0)
GI diseases	1 (1.9)	1 (1.9)	1 (1.9)	0 (0.0)

NOTE. TRAEs of any grade considered to be related to study drug by the investigators in at least 10% of patients, or any grade 3 or 4 events reported in any patient are shown. No grade 5 TRAE occurred.

Abbreviation: TRAE, treatment-related adverse event.