Table 3.

AEs^a in all treated patients.

	Patients
	N = 51
n (%)	Any grade	Grade 3–5
Treatment-emergent AEs	49 (96)	32 (63)
Treatment-related AEs	28 (55)	8 (16)b
Serious AEs	21 (41)	21 (41)

	Patients
	N = 51
Common AEs (incidence ≥10% of patients, any grade)	Any grade	Grade 3c
Fatigue	21 (41)	0
Edema peripheral	14 (28)	1 (2)
Diarrhea	13 (26)	1 (2)
Abdominal pain	9 (18)	2 (4)
Cough	8 (16)	1 (2)
Decreased appetite	8 (16)	0
Asthenia	7 (14)	2 (4)
Ascites	6 (12)	5 (10)
Dyspnea	6 (12)	2 (4)
Hypothyroidism	6 (12)	0
Pruritus	6 (12)	1 (2)
Pyrexia	6 (12)	0
Rash	6 (12)	1 (2)

^aGraded on the basis of the NCI Common Terminology Criteria for Adverse Events version 4.0.

^bAll were grade 3 except in 1 patient, who had treatment-related grade 4 increased blood bilirubin, grade 4 encephalopathy, and grade 5 myocarditis.

^cNo grade 4 or 5 event was reported among common treatment-emergent AEs.