Table 9 Bootstrap results for the stopped trials based on ICON4 and RE01 in a two-stage design
I and D outcomes are OSa | I outcome is PFSb, D outcome is OSa | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Estimated H R D for trials stopped at stage 1 | Estimated H R D for trials stopped at stage 1 | ||||||||||||
% | At interim point | After follow-up | At interim point | After follow-up | |||||||||
α 1 c | δ 1 d | e 1 e | %Stop | Mean (centiles) | %Bias | Mean (centiles) | %Bias | e 1 e | %Stop | Mean (centiles) | %Bias | Mean (centiles) | %Bias |
a) ICON4 – | H R D (95% bootstrap CI): 0.82(0.67,0.99) | ||||||||||||
0.50 | 1.00 | 75 | 1 | 1.05(1.00,1.20) | 28 | 0.98(0.81,1.18) | 20 | 75 | 1 | 1.17(0.80,1.66) | 43 | 0.91(0.73,1.16) | 11 |
0.40 | 0.96 | 98 | 3 | 1.01(0.97,1.18) | 23 | 0.99(0.86,1.21) | 21 | 97 | 1 | 0.99(0.71,1.31) | 21 | 0.94(0.76,1.15) | 15 |
0.30 | 0.94 | 126 | 4 | 0.98(0.94,1.12) | 20 | 1.01(0.88,1.18) | 23 | 125 | 2 | 0.87(0.66,1.12) | 6 | 0.97(0.84,1.18) | 18 |
0.20 | 0.91 | 163 | 8 | 0.96(0.91,1.09) | 17 | 0.97(0.88,1.10) | 18 | 162 | 5 | 0.89(0.70,1.12) | 9 | 0.96(0.82,1.13) | 17 |
0.10 | 0.89 | 222 | 14 | 0.99(0.89,1.55) | 21 | 0.91(0.68,1.10) | 11 | 221 | 12 | 0.86(0.70,1.05) | 5 | 0.96(0.82,1.13) | 17 |
b) RE01 – | H R D (95% bootstrap CI): 0.75(0.60,0.93) | ||||||||||||
0.50 | 1.00 | 51 | 13 | 1.10(1.00,1.37) | 47 | 0.96(0.76,1.21) | 28 | 49 | 7 | 1.21(0.80,1.80) | 61 | 1.11(0.77,1.56) | 48 |
0.40 | 0.96 | 66 | 11 | 1.04(0.96,1.27) | 39 | 0.91(0.74,1.16) | 21 | 64 | 8 | 1.06(0.76,1.50) | 41 | 0.97(0.69,1.37) | 29 |
0.30 | 0.92 | 85 | 6 | 0.99(0.93,1.14) | 32 | 0.92(0.77,1.14) | 23 | 83 | 4 | 1.02(0.77,1.31) | 36 | 0.91(0.71,1.22) | 21 |
0.20 | 0.89 | 110 | 6 | 0.95(0.89,1.09) | 27 | 0.90(0.77,1.06) | 20 | 108 | 1 | 0.97(0.68,1.24) | 29 | 0.93(0.69,1.23) | 24 |
0.10 | 0.86 | 150 | 11 | 0.91(0.86,1.04) | 21 | 0.88(0.72,0.95) | 17 | 148 | 2 | 0.90(0.76,1.10) | 20 | 0.86(0.73,1.05) | 15 |