Table 4. Adverse events in patients who received different dose levels of the combination of FU and IRI.

	Level 1 (27 cycles)	Level 2 (29 cycles)	Level 3 (45 cycles)	Level 4 (55 cycles)	Level 5 (47 cycles)	Total (203 cycles)
Hematological
Anaemia
Grade I–II	0	0	0	1 (1.8%)	0	1 (0.5%)
Grade III–IV	0	0	0	0	0	0
Neutropoenia
Grade I–II	1 (3.7%)	0	0	0	0	1 (0.5%)
Grade III–IV	0	0	3 (6.6%)	1 (1.8%)	0	4 (2.0%)
Nonhaematological
Nausea/Vomiting
Grade I–II	3 (11.1%)	4 (13.8%)	10 (22.2%)	10 (18.2%)	9 (19.1%)	36 (17.7%)
Grade III–IV	0	0	0	1 (1.8%)	0	1 (0.5%)
Diarrhoea
Grade I–II	8 (29.6%)	6 (20.7%)	11 (24.4%)	7 (12.7%)	9 (19.1%)	41 (20.2%)
Grade III–IV	0	0	1 (2.2%)	1 (1.8%)	1 (2.1%)	3 (1.5%)
Stipsis
Grade I–II	0	0	0	4 (7.3%)	0	4 (2.0%)
Grade III–IV	0	0	0	0	0	0
Stomatitis
Grade I–II	1 (3.7%)	1 (3.4%)	9 (20.0%)	7 (12.7%)	2 (3.6%)	20 (9.8%)
Grade III–IV	0	0	0	0	0	0
Fatigue
Grade I–II	4 (14.8%)	1 (3.4%)	1 (2.2%)	2 (3.6%)	2 (3.6%)	10 (4.9%)
Grade III–IV	0	0	0	0	0	0
Flu-like syndrome
Grade I–II	1 (3.7%)	0	1 (2.2%)	1 (1.8%)	0	3 (1.5%)