Table 7.

Adverse events in the 12M group during cycles 1–8 and 9–16

	During cycles 1–8 (n = 636)		During cycles 9–16 (n = 417)
	Any grade (%)	Grade ≥3 (%)	Any grade (%)	Grade ≥3 (%)
Hemoglobin	34.9	0	31.7	0.5
Leukocytes	19.3	0.3	21.1	0
Neutrophils	17.6	2.8	12.9	2.2
Platelets	9.6	0.5	12.7	0
Total bilirubin	32.5	0.6	36.0	0.5
AST	16.2	0.3	17.5	0.5
ALT	15.4	0.3	14.1	0.2
Creatinine	5.2	0	7.7	0
Anorexia	18.4	0.9	9.1	0
Nausea	12.4	0.6	4.1	0
Vomiting	4.2	0.5	1.7	0
Stomatitis	18.9	0.9	10.6	0
Diarrhea	11.6	1.7	6.7	0.5
Fatigue	13.1	0.9	7.9	0.5
Rash	7.5	0.2	6.7	0
Hyperpigmentation	20.8	0.5	18.7	0
Alopecia	1.9	0	1.4	0.2
Hand-foot syndrome	71.1	19.0	66.7	8.6

AST aspartate aminotransferase, ALT alanine aminotransferase