A gated group sequential design for seamless Phase II/III trial with subpopulation selection

Table 3 Family-wise error rate for three simulation settings

Weight(\({w}_{1k},{w}_{2k}\))		Design	Setting 1	Setting 2/3
PFS	OS	GSD	0.014	0.017
(\({w}_{1k}^{PFS},{w}_{2k}^{PFS}\))^a	(\({w}_{1k}^{OS},{w}_{2k}^{OS}\))^a	AD	0.009	0.011
(\({w}_{1k}^{PFS},{w}_{2k}^{PFS}\))^a	(\({w}_{1k}^{OS},{w}_{2k}^{OS}\))^a	gGSD	0.011	0.012
(\(\sqrt{0.2},\sqrt{0.8}\))	(\(\sqrt{0.2},\sqrt{0.8}\))	AD	0.007	0.009
(\(\sqrt{0.2},\sqrt{0.8}\))	(\(\sqrt{0.2},\sqrt{0.8}\))	gGSD	0.010	0.011
(\(\sqrt{0.3},\sqrt{0.7}\))	(\(\sqrt{0.3},\sqrt{0.7}\))	AD	0.008	0.010
(\(\sqrt{0.3},\sqrt{0.7}\))	(\(\sqrt{0.3},\sqrt{0.7}\))	gGSD	0.010	0.012
(\(\sqrt{0.5},\sqrt{0.5}\))	(\(\sqrt{0.5},\sqrt{0.5}\))	AD	0.009	0.011
(\(\sqrt{0.5},\sqrt{0.5}\))	(\(\sqrt{0.5},\sqrt{0.5}\))	gGSD	0.011	0.013
(\(\sqrt{0.5},\sqrt{0.5}\))	(\(\sqrt{0.7},\sqrt{0.3}\))	AD	0.009	0.011
(\(\sqrt{0.5},\sqrt{0.5}\))	(\(\sqrt{0.7},\sqrt{0.3}\))	gGSD	0.012	0.013
(\(\sqrt{0.7},\sqrt{0.3}\))	(\(\sqrt{0.7},\sqrt{0.3}\))	AD	0.009	0.011
(\(\sqrt{0.7},\sqrt{0.3}\))	(\(\sqrt{0.7},\sqrt{0.3}\))	gGSD	0.011	0.012
(\(\sqrt{0.8},\sqrt{0.2}\))	(\(\sqrt{0.8},\sqrt{0.2}\))	AD	0.009	0.011
(\(\sqrt{0.8},\sqrt{0.2}\))	(\(\sqrt{0.8},\sqrt{0.2}\))	gGSD	0.011	0.012
(\(\sqrt{0.6},\sqrt{0.4}\))	(\(\sqrt{0.6},\sqrt{0.4}\))	AD	0.009	0.011
(\(\sqrt{0.6},\sqrt{0.4}\))	(\(\sqrt{0.6},\sqrt{0.4}\))	gGSD	0.011	0.013

^aWeights defined in Simulations section (4^th paragraph) based on observed interim events and planned final events

ISSN: 1471-2288