I and D outcomes are OSa | I outcome is PFSb, D outcome is OSa | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
%Stop | Estimated H R D for trials stopped at stage 1 | %Stop | Estimated H R D for trials stopped at stage 1 | ||||||||||
at | At interim point | After follow-up | at | At interim point | After follow-up | ||||||||
α 1 c | δ 1 d | e 1 e | stage 1 | Mean (centiles) | %Bias | Mean (centile) | %Bias | e 1 e | stage 1 | Mean (centiles) | %Bias | Mean (centiles) | %Bias |
a) ICON3 – | H R D (95% bootstrap CI): 0.97(0.87–1.09) | ||||||||||||
0.50 | 1.00 | 118 | 38 | 1.12(1.00,1.40) | 15 | 0.96(0.84,1.10) | 1 | 116 | 55 | 1.27(0.88,1.83) | 31 | 0.93(0.79,1.10) | − 4 |
0.40 | 0.97 | 153 | 55 | 1.08(0.97,1.31) | 11 | 0.98(0.86,1.11) | 1 | 152 | 52 | 1.15(0.83,1.56) | 19 | 0.95(0.81,1.10) | − 2 |
0.30 | 0.94 | 195 | 52 | 1.03(0.94,1.22) | 6 | 0.98(0.87,1.10) | 1 | 194 | 33 | 1.09(0.81,1.45) | 12 | 0.97(0.85,1.11) | 0 |
0.20 | 0.91 | 252 | 42 | 0.99(0.91,1.15) | 2 | 0.99(0.89,1.10) | 2 | 250 | 12 | 1.16(0.89,1.46) | 20 | 1.00(0.89,1.12) | 3 |
0.10 | 0.89 | 342 | 44 | 0.95(0.89,1.08) | − 2 | 0.99(0.90,1.10) | 2 | 339 | 29 | 1.06(0.86,1.31) | 9 | 1.00(0.90,1.12) | 3 |
b) RE04 – | H R D (95% bootstrap CI): 1.05(0.90–1.21) | ||||||||||||
0.50 | 1.00 | 118 | 34 | 1.09(1.00,1.27) | 4 | 1.10(0.95,1.26) | 5 | 116 | 33 | 0.92(0.66,1.32) | − 12 | 1.07(0.89,1.30) | 2 |
0.40 | 0.97 | 155 | 36 | 1.06(0.97,1.26) | 1 | 1.09(0.96,1.24) | 4 | 152 | 67 | 0.89(0.67,1.19) | − 15 | 1.02(0.86,1.23) | −3 |
0.30 | 0.95 | 199 | 71 | 1.05(0.95,1.23) | 0 | 1.05(0.93,1.20) | 0 | 196 | 79 | 0.95(0.74,1.23) | − 10 | 1.05(0.90,1.24) | 0 |
0.20 | 0.93 | 259 | 84 | 1.05(0.95,1.23) | 0 | 1.06(0.94,1.21) | 1 | 255 | 73 | 0.96(0.78,1.19) | − 9 | 1.04(0.90,1.21) | − 1 |
0.10 | 0.91 | 355 | 79 | 1.05(0.92,1.26) | 0 | 1.06(0.92,1.22) | 1 | 351 | 97 | 1.02(0.86,1.22) | − 3 | 1.03(0.89,1.20) | − 2 |