Mixed response and time-to-event endpoints for multistage single-arm phase II design

Table 3 Sensitivity analysis with Weibull distribution assumed for TTE

Null		Alternative		Corr	Sample size		Shape parameter
P₀	T₀	P₁	T₁	ρ	n₁	n	K^a	α	1-β	PET
0.05	3	0.2	4.5	0.8	20	40	1.0	0.048	0.808	0.891
							1.5	0.033	0.855	0.912
							1.2	0.036	0.823	0.901
							0.8	0.058	0.782	0.863
							0.5	0.128	0.719	0.794
0.05	3	0.2	4.5	0.8	30	60	1.0	0.030	0.817	0.958
							1.5	0.013	0.871	0.978
							1.2	0.028	0.846	0.959
							0.8	0.040	0.796	0.930
							0.5	0.115	0.782	0.825
0.05	3	0.2	4.5	0.8	40	80	1.0	0.016	0.847	0.977
							1.5	0.005	0.888	0.991
							1.2	0.008	0.863	0.990
							0.8	0.033	0.827	0.955
							0.5	0.102	0.818	0.855
0.3	4	0.5	8	0.8	20	40	1	0.047	0.817	0.884
							1.5	0.020	0.873	0.949
							1.2	0.035	0.834	0.912
							0.8	0.062	0.786	0.875
							0.5	0.121	0.710	0.793
0.3	4	0.5	8	0.8	30	60	1.0	0.020	0.837	0.965
							1.5	0.009	0.881	0.989
							1.2	0.014	0.851	0.983
							0.8	0.032	0.790	0.949
							0.5	0.090	0.742	0.849
0.3	4	0.5	8	0.8	40	80	1.0	0.020	0.857	0.975
							1.5	0.005	0.930	0.992
							1.2	0.008	0.881	0.990
							0.8	0.030	0.833	0.954
							0.5	0.096	0.803	0.852

^aShape parameter of Weibull distribution assumed for TTE: constant hazard if K = 1; increase hazard if K >1; decrease hazard if K <1

ISSN: 1745-6215