Table 2. Response rates according to RECIST criteria (ITT and PP populations).

	ITT population				PP population
	Capecitabine (N=46)		S-1 (N=45)		Capecitabine (N=44)		S-1 (N=45)
	INV	EIR	INV	EIR	INV	EIR	INV	EIR
Response, n
CR	2	0	1	1	2	0	1	1
PR	11	12	11	12	11	12	11	12
SD	19	18	20	18	19	18	20	18
PD	8	10	9	10	8	10	9	10
NA	6	6	4	4	4	4	4	4
ORR, n (%)		12 (26.1)		13 (28.9)		12 (27.2)		13 (28.9)
95% CI		13.4–38.8		15.6–42.1		14.1–40.4		15.6–42.1

INV=investigator assessment; EIR=external independent review; ORR=overall response rate; CR=complete response; PR=partial response; SD=stable disease; PD=progressive disease; NA=not assessable; CI=confidence interval.