Table 2a.

Results of the resampling simulations for single arm (sorafenib only) and randomized (sorafenib vs. placebo) phase II designs with various endpoints. PFS-90: PFS rate at 90 days.

Design	Endpoint	% positive (95%CI)	% stop early
Single arm, n = 37	RR by RECIST at 6 weeks	55.2 (53.8–56.6)	26.3
Randomized, n = 20/arm	RR by RECIST at 6 weeks	55.0 (53.6–56.4)	3.3
	log ratio at 6 weeks	87.7 (86.8–88.6)	3.9
	PFS-90	63.5 (62.2–64.9)	11.1
	PFS	68.5 (67.2–69.8)	--
Randomized, n = 25/arm	RR by RECIST at 6 weeks	63.3 (61.9–64.6)	3.1
	log ratio at 6 weeks	91.9 (91.1–92.6)	2.7
	PFS-90	70.5 (69.2–71.8)	9.8
	PFS	74.9 (73.7–76.1)	--
Randomized, n = 30/arm	RR by RECIST at 6 weeks	70.8 (69.5–72.1)	2.9
	log ratio at 6 weeks	95.1 (94.5–95.7)	1.2
	PFS-90	76.2 (75.0–77.4)	7.2
	PFS	82.6 (81.5–83.7)	--
Randomized, n = 35/arm	RR by RECIST at 6 weeks	76.0 (74.8–77.2)	3.0
	log ratio at 6 weeks	96.5 (96.0–97.0)	1.1
	PFS-90	79.0 (77.8–80.2)	6.8
	PFS	85.2 (84.2–86.2)	--