Table 3.

Summary of most common (≥10%) treatment-related AE by maximum grade for any treatment.

Preferred term	Grade 1	Grade 2	Grade 3	Grade 4	Grade 5	Grade 3+4+5	Total (N = 123)
Nausea	41 (33%)	21 (17%)	2 (2%)	0	0	2 (2%)	64 (52%)
Dysgeusia	39 (32%)	21 (17%)	0	0	0	0	60 (49%)
Fatigue	17 (14%)	31 (25%)	7 (6%)	0	0	7 (6%)	55 (45%)
Decreased appetite	22 (18%)	23 (19%)	3 (2%)	0	0	3 (2%)	48 (39%)
Diarrhea	37 (30%)	8 (7%)	2 (2%)	0	0	2 (2%)	47 (38%)
Hyperglycemia	21 (17%)	11 (9%)	5 (4%)	0	0	5 (4%)	37 (30%)
Platelet count decreased	8 (7%)	8 (7%)	15 (12%)	0	0	15 (12%)	31 (25%)
Blood bilirubin increased	12 (10%)	15 (12%)	2 (2%)	0	0	2 (2%)	29 (24%)
ALT increased	23 (19%)	1 (<1%)	2 (2%)	0	0	2 (2%)	26 (21%)
AST increased	21 (17%)	4 (3%)	0	0	0	0	25 (20%)
Anemia	12 (10%)	9 (7%)	3 (2%)	0	0	3 (2%)	24 (20%)
Thrombocytopenia	10 (8%)	7 (6%)	8 (7%)	0	0	8 (7%)	25 (20%)
Dyspnea	12 (10%)	6 (5%)	1 (<1%)	0	0	1 (<1%)	19 (15%)
Vomiting	17 (14%)	4 (3%)	0	0	0	0	21 (17%)
Dry mouth	19 (15%)	1 (<1%)	0	0	0	0	20 (16%)
Rash	18 (15%)	2 (2%)	0	0	0	0	20 (16%)
Pruritus	12 (10%)	4 (3%)	0	0	0	0	16 (13%)
Asthenia	6 (5%)	5 (4%)	4 (3%)	0	0	4 (3%)	15 (12%)
Headache	10 (8%)	4 (3%)	1 (<1%)	0	0	1 (<1%)	15 (12%)
Cough	9 (7%)	5 (4%)	0	0	0	0	14 (11%)
Stomatitis	9 (7%)	4 (3%)	0	0	0	0	13 (11%)
Amylase increased	5 (4%)	4 (3%)	3 (2%)	0	0	3 (2%)	12 (10%)
Dry skin	12 (10%)	0	0	0	0	0	12 (10%)
Epistaxis	12 (10%)	0	0	0	0	0	12 (10%)
Hot flush	12 (10%)	0	0	0	0	0	12 (10%)
Weight decreased	9 (7%)	2 (2%)	1 (<1%)	0	0	1 (<1%)	12 (10%)

Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase.