Table 4 Simulation results for the trials which stop at stage 1
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Design | Under- | %Stop | Estimated H R D for trials stopped at stage 1 | %Stop | Estimated H R D for trials stopped at stage 1 | |||||||
lying | at | At interim point | After follow-up | at | At interim point | After follow-up | ||||||
H R D | stage 1 | Mean (centilesa) | %Bias | Mean (centilesa) | %Bias | stage 1 | Mean (centilesa) | %Bias | Mean (centilesa) | %Bias | ||
I outcome: OSb | ||||||||||||
1 | 1.10 | 70 | 1.19(1.01,1.52) | 8 | 1.14(0.95,1.39) | 4 | 83 | 1.13(1.01,1.33) | 3 | 1.12(0.99,1.28) | 2 | |
1.00 | 50 | 1.14(1.00,1.42) | 14 | 1.06(0.89,1.29) | 6 | 50 | 1.08(1.00,1.24) | 8 | 1.05(0.93,1.18) | 5 | ||
0.88 | 22 | 1.10(1.00,1.32) | 25 | 0.98(0.81,1.19) | 11 | 10 | 1.04(1.00,1.16) | 18 | 0.97(0.88,1.08) | 10 | ||
0.75 | 4 | 1.06(1.00,1.23) | 41 | 0.89(0.75,1.09) | 19 | 0.2 | 1.03(1.00,1.12) | 37 | 0.90(0.82,1.03) | 20 | ||
2 | 1.10 | 95 | 1.11(0.93,1.36) | 1 | 1.11(0.94,1.32) | 1 | 99 | 1.10(0.98,1.24) | 0 | 1.10(0.99,1.22) | 0 | |
1.00 | 80 | 1.04(0.92,1.25) | 4 | 1.03(0.89,121) | 3 | 80 | 1.02(0.95,1.14) | 2 | 1.02(0.94,1.13) | 2 | ||
0.88 | 37 | 0.98(0.91,1.13) | 11 | 0.95(0.84,1.09) | 8 | 13 | 0.98(0.95,1.05) | 11 | 0.95(0.90,1.03) | 8 | ||
0.75 | 5 | 0.95(0.91,1.05) | 27 | 0.89(0.80,1.00) | 19 | 0 | − | − | − | − | ||
I outcome: PFSc | ||||||||||||
1 | 1.10 | 71 | 1.17(0.81,1.68) | 6 | 1.11(0.92,1.38) | 1 | 83 | 1.13(0.92,1.41) | 3 | 1.11(0.98,1.29) | 1 | |
1.00 | 51 | 1.12(0.79,1.59) | 12 | 1.05(0.87,1.28) | 5 | 50 | 1.07(0.88,1.31) | 7 | 1.04(0.91,1.19) | 4 | ||
0.88 | 22 | 1.06(0.77,1.53) | 20 | 0.96(0.80,1.17) | 9 | 9 | 1.01(0.83,1.19) | 15 | 0.95(0.84,1.09) | 8 | ||
0.75 | 4 | 1.03(0.72,1.44) | 37 | 0.88(0.71,1.04) | 17 | 0 | − | − | ||||
2 | 1.10 | 96 | 1.11(0.85,1.44) | 1 | 1.09(0.93,1.30) | 1 | 99 | 1.10(0.95,1.28) | 0 | 1.10(0.99,1.24) | 0 | |
1.00 | 79 | 1.04(0.81,1.34) | 4 | 1.02(0.87,1.20) | 2 | 79 | 1.02(0.90,1.16) | 2 | 1.01(0.92,1.13) | 1 | ||
0.88 | 39 | 0.97(0.76,1.23) | 10 | 0.94(0.81,1.09) | 7 | 13 | 0.96(0.85,1.07) | 9 | 0.94(0.86,1.04) | 7 | ||
0.75 | 4 | 0.92(0.74,1.13) | 23 | 0.87(0.75,0.99) | 16 | 0 | − | − | − | − | ||