Table 2b.

Results of the resampling simulations for single arm (AE941 only) and randomized (AE941 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	0.9 (0.6–1.2)	75.1
Randomized, n = 20/arm	RR by RECIST at 6 weeks	6.9 (6.1–7.6)	6.2
	log ratio at 6 weeks	24.7 (23.5–26.0)	33.7
	PFS-90	15.2 (14.4–16.3)	33.7
	PFS	9.3 (8.5–10.1)	--
Randomized, n = 25/arm	RR by RECIST at 6 weeks	9.5 (8.7–10.4)	7.9
	log ratio at 6 weeks	25.1 (23.9–26.3)	32.2
	PFS-90	16.9 (15.9–18.0)	36.4
	PFS	8.0 (7.3–8.8)	--
Randomized, n = 30/arm	RR by RECIST at 6 weeks	11.3 (10.4–12.2)	7.6
	log ratio at 6 weeks	27.1 (25.9–28.4)	31.2
	PFS-90	17.6 (16.5–18.6)	33.7
	PFS	8.2 (7.4–9.0)	--
Randomized, n = 35/arm	RR by RECIST at 6 weeks	14.2 (13.2–15.2)	8.3
	log ratio at 6 weeks	29.7 (28.4–31.0)	28.4
	PFS-90	19.6 (18.5–20.7)	35.4
	PFS	7.6 (6.8–8.3)	--