Table 3.

Clinically significant^* adverse events on S-1-based treatment according to treatment regimen, more than one line present per patient (Safety cohort, N = 78)

	S-1 monotherapy** n = 42 (%)	SOX† n = 47 (%)	IRIS‡ n = 38 (%)
Number of cycles, median (range)	4 (1–31)	6 (1–25)	7 (1–41)
Anemia	-	-	1 (3)
Neutropenia	1 (2)	2 (5)	5 (13)
Thrombocytopenia	-	1 (2)	-
Stomatitis	1 (2)	-	1 (3)
Diarrhea	1 (2)	1 (2)	4 (11)
Nausea	-	-	2 (5)
Infection	3 (7)	1 (2)	2 (5)
Neuropathy	-	7 (17)	-
Hand-foot syndrome	1 (2)	-	-
Thromboembolism	-	1 (2)	1 (3)
Rash	-	-	1 (3)
Lung toxicity	-	-	1 (3)
Fatigue	-	-	1 (3)

SOX: S-1 plus oxaliplatin; IRIS: S-1 plus irinotecan.

^*Clinically significant defined as Grade 2–4, except for hematological for which grade 3–4 are shown.

^**± bevacizumab.

^†S-1 plus oxaliplatin ± bevacizumab.

^‡S-1 plus irinotecan ± bevacizumab.