Table 5.

Re-analysis over two stages of trials with final result showing evidence of a difference employing PFS as an intermediate outcome.

	ICON4			RE01
one-sided sig.	eI	%	ρ	eI	%	ρ
level at stage 1		err.			err.
0.5	75	0.04	0.27	53	3.18	0.27
0.4	97	0.20	0.29	69	4.58	0.31
0.3	125	0.03	0.36	88	1.08	0.34
0.2	162	0.26	0.39	114	0.26	0.39
0.1	221	0.12	0.44	155	0.46	0.46

e_I gives the number of control arm events for the significance level at stage 1, % err. gives the percentage of trials out of 5000 which were stopped, ρ gives the correlation between the test statistic at stage 1 on the intermediate outcome and at the final analysis on the primary outcome