Table 3.

Treatment-related adverse events

	All patients (N=171)
	Any grade	Grade 1	Grade 2	Grade 3	Grade 4
Any	120 (70%)	34 (20%)	49 (29%)	27 (16%)	7 (4%)
Aspartate aminotransferase increased	40 (23%)	30 (18%)	5 (3%)	4 (2%)	1 (<1%)
Alanine aminotransferase increased	29 (17%)	22 (13%)	5 (3%)	1 (<1%)	1 (<1%)
Anemia	26 (15%)	9 (5%)	12 (7%)	5 (3%)	0
Hypothyroidism	19 (11%)	9 (5%)	10 (6%)	0	0
Rash	18 (11%)	10 (6%)	4 (2%)	4 (2%)	0
Blood bilirubin increased	18 (11%)	13 (8%)	4 (2%)	1 (<1%)	0
Protein urine present	15 (9%)	6 (4%)	9 (5%)	0	0
Bilirubin conjugated increased	14 (8%)	9 (5%)	3 (2%)	2 (1%)	0
Asthenia	13 (8%)	8 (5%)	4 (2%)	1 (<1%)	0
Gamma-glutamyltransferase increased	12 (7%)	3 (2%)	3 (2%)	5 (3%)	1 (<1%)
Decreased appetite	12 (7%)	9 (5%)	3 (2%)	0	0
Pyrexia	11 (6%)	7 (4%)	4 (2%)	0	0
Pruritus	10 (6%)	7 (4%)	2 (1%)	1 (<1%)	0
Hyponatremia	9 (5%)	4 (2%)	0	4 (2%)	1 (<1%)
Blood alkaline phosphatase increased	9 (5%)	5 (3%)	3 (2%)	1 (<1%)	0
Platelet count decreased	9 (5%)	5 (3%)	4 (2%)	0	0
Gingival bleeding	9 (5%)	5 (3%)	4 (2%)	0	0
Proteinuria	9 (5%)	7 (4%)	2 (1%)	0	0

Data are present as n (%). Treatment-related adverse events that occurred in at least 5% of all treated patients are listed. Three (2%) grade 5 events were considered to be treatment related by the investigators, including one (<1%) caused by pneumonia and two (1%) unknown deaths