Table 3:
Selection percentage and the average number of patients treated at each dose for the two subgroups under the BIPSE design and the two conventional designs which ignore the immune response Y or the subgroup Z. The numbers in boldface are target doses.
| Z=0 |
Z=1 |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Scenario 1 | ||||||||||
| Sel % (BIPSE) | 0.075 | 0.615 | 0.254 | 0.038 | 0.019 | 0.092 | 0.752 | 0.156 | 0.000 | 0.000 |
| # of patients | 7.9 | 8.3 | 7.4 | 4.4 | 2.1 | 10.2 | 10.8 | 6.3 | 2.0 | 0.6 |
| Sel % (conventional I) | 0.036 | 0.338 | 0.462 | 0.150 | 0.014 | 0.100 | 0.536 | 0.338 | 0.024 | 0.002 |
| # of patients | 8.3 | 8.7 | 7.8 | 3.9 | 1.1 | 9.6 | 9.9 | 7.6 | 2.6 | 0.6 |
| Sel % (conventional II) | 0.042 | 0.664 | 0.286 | 0.002 | 0.006 | 0.042 | 0.664 | 0.286 | 0.002 | 0.006 |
| # of patients | 9.2 | 10.0 | 7.1 | 2.5 | 1.0 | 9.2 | 10.2 | 7.1 | 2.5 | 1.0 |
| Scenario 2 | ||||||||||
| Sel % (BIPSE) | 0.000 | 0.046 | 0.738 | 0.181 | 0.035 | 0.000 | 0.110 | 0.765 | 0.098 | 0.027 |
| # of patients | 6.0 | 7.2 | 7.3 | 6.0 | 3.9 | 6.2 | 7.6 | 7.1 | 5.5 | 3.2 |
| Sel % (conventional I) | 0.000 | 0.018 | 0.104 | 0.308 | 0.570 | 0.000 | 0.032 | 0.212 | 0.472 | 0.284 |
| # of patients | 6.1 | 6.6 | 7.0 | 6.2 | 3.9 | 6.8 | 7.4 | 7.1 | 5.9 | 3.0 |
| Sel % (conventional II) | 0.000 | 0.060 | 0.792 | 0.110 | 0.038 | 0.000 | 0.060 | 0.792 | 0.110 | 0.038 |
| # of patients | 5.9 | 7.6 | 7.5 | 5.6 | 3.6 | 6.0 | 7.7 | 7.1 | 5.8 | 3.3 |
| Scenario 3 | ||||||||||
| Sel % (BIPSE) | 0.000 | 0.002 | 0.004 | 0.021 | 0.967 | 0.000 | 0.000 | 0.000 | 0.019 | 0.979 |
| # of patients | 3.5 | 6.7 | 6.9 | 6.7 | 6.0 | 5.0 | 6.0 | 6.6 | 6.5 | 5.8 |
| Sel % (conventional I) | 0.000 | 0.004 | 0.002 | 0.004 | 0.990 | 0.000 | 0.000 | 0.000 | 0.008 | 0.992 |
| # of patients | 4.8 | 5.6 | 6.4 | 6.6 | 6.2 | 5.2 | 5.7 | 6.4 | 6.6 | 6.2 |
| Sel % (conventional II) | 0.000 | 0.000 | 0.002 | 0.006 | 0.988 | 0.000 | 0.000 | 0.002 | 0.006 | 0.988 |
| # of patients | 4.3 | 6.2 | 6.6 | 6.6 | 6.2 | 4.4 | 6.0 | 6.7 | 6.7 | 6.1 |
| Scenario 4 | ||||||||||
| Sel % (BIPSE) | 0.004 | 0.129 | 0.633 | 0.185 | 0.046 | 0.062 | 0.785 | 0.142 | 0.002 | 0.006 |
| # of patients | 6.2 | 6.9 | 6.7 | 5.9 | 4.2 | 6.7 | 7.0 | 6.7 | 5.6 | 4.0 |
| Sel % (conventional I) | 0.004 | 0.092 | 0.472 | 0.380 | 0.052 | 0.118 | 0.454 | 0.384 | 0.040 | 0.004 |
| # of patients | 6.3 | 6.6 | 6.8 | 5.9 | 4.1 | 6.8 | 6.8 | 6.9 | 5.9 | 3.9 |
| Sel % (conventional II) | 0.004 | 0.338 | 0.590 | 0.048 | 0.018 | 0.004 | 0.338 | 0.590 | 0.048 | 0.018 |
| # of patients | 6.4 | 6.9 | 6.7 | 5.5 | 4.2 | 6.5 | 6.8 | 6.6 | 5.9 | 4.4 |
| Scenario 5 | ||||||||||
| Sel % (BIPSE) | 0.000 | 0.002 | 0.033 | 0.210 | 0.750 | 0.000 | 0.042 | 0.656 | 0.169 | 0.129 |
| # of patients | 5.1 | 6.5 | 7.0 | 6.2 | 4.9 | 5.8 | 7.5 | 7.2 | 5.5 | 4.0 |
| Sel % (conventional I) | 0.000 | 0.000 | 0.048 | 0.344 | 0.608 | 0.000 | 0.006 | 0.444 | 0.528 | 0.022 |
| # of patients | 5.3 | 6.4 | 7.1 | 6.6 | 4.6 | 6.2 | 7.4 | 7.2 | 5.7 | 3.6 |
| Sel % (conventional II) | 0.000 | 0.002 | 0.124 | 0.454 | 0.420 | 0.000 | 0.002 | 0.124 | 0.454 | 0.420 |
| # of patients | 5.2 | 6.9 | 7.1 | 6.0 | 4.7 | 5.4 | 6.8 | 7.1 | 6.0 | 4.8 |
| Scenario 6 | ||||||||||
| Sel % (BIPSE) | 0.040 | 0.415 | 0.369 | 0.117 | 0.058 | 0.112 | 0.727 | 0.156 | 0.000 | 0.002 |
| # of patients | 7.5 | 7.9 | 7.2 | 4.8 | 2.7 | 10.6 | 10.8 | 5.8 | 2.0 | 0.5 |
| Sel % (conventional I) | 0.012 | 0.210 | 0.454 | 0.272 | 0.052 | 0.112 | 0.518 | 0.350 | 0.020 | 0.000 |
| # of patients | 7.9 | 8.4 | 7.6 | 4.5 | 1.5 | 9.9 | 10.2 | 6.9 | 2.6 | 0.5 |
| Sel % (conventional II) | 0.032 | 0.602 | 0.330 | 0.018 | 0.014 | 0.032 | 0.602 | 0.330 | 0.018 | 0.014 |
| # of patients | 9.5 | 10.0 | 6.4 | 2.7 | 1.3 | 9.6 | 10.1 | 6.6 | 2.7 | 1.1 |
| Scenario 7 | ||||||||||
| Sel % (BIPSE) | 0.000 | 0.010 | 0.450 | 0.406 | 0.131 | 0.000 | 0.031 | 0.631 | 0.273 | 0.062 |
| # of patients | 5.4 | 6.9 | 6.9 | 6.1 | 4.5 | 5.7 | 7.0 | 6.9 | 6.1 | 4.4 |
| Sel % (conventional I) | 0.000 | 0.000 | 0.010 | 0.078 | 0.912 | 0.000 | 0.010 | 0.120 | 0.456 | 0.414 |
| # of patients | 5.2 | 6.1 | 6.6 | 6.4 | 5.7 | 6.0 | 6.7 | 6.7 | 6.0 | 4.6 |
| Sel % (conventional II) | 0.000 | 0.000 | 0.384 | 0.494 | 0.122 | 0.000 | 0.000 | 0.384 | 0.494 | 0.122 |
| # of patients | 5.2 | 6.9 | 6.7 | 6.3 | 4.6 | 5.5 | 6.6 | 7.0 | 6.4 | 4.9 |
| Scenario 8 | ||||||||||
| Sel % (BIPSE) | 0.000 | 0.000 | 0.006 | 0.188 | 0.806 | 0.000 | 0.000 | 0.029 | 0.350 | 0.621 |
| # of patients | 4.7 | 6.4 | 6.8 | 6.7 | 5.5 | 5.0 | 6.5 | 6.9 | 6.2 | 5.3 |
| Sel % (conventional I) | 0.000 | 0.000 | 0.000 | 0.008 | 0.992 | 0.000 | 0.000 | 0.000 | 0.020 | 0.980 |
| # of patients | 4.6 | 5.7 | 6.4 | 6.7 | 6.4 | 5.3 | 6.1 | 6.7 | 6.5 | 5.6 |
| Sel % (conventional II) | 0.000 | 0.000 | 0.006 | 0.256 | 0.732 | 0.000 | 0.000 | 0.006 | 0.256 | 0.732 |
| # of patients | 4.8 | 6.2 | 6.6 | 6.4 | 5.6 | 4.9 | 6.2 | 6.9 | 6.3 | 5.7 |
| Scenario 9 | ||||||||||
| Sel % (BIPSE) | 0.000 | 0.002 | 0.144 | 0.333 | 0.521 | 0.008 | 0.498 | 0.383 | 0.013 | 0.098 |
| # of patients | 5.6 | 6.8 | 7.0 | 6.1 | 4.8 | 6.4 | 7.3 | 6.6 | 5.4 | 3.9 |
| Sel % (conventional I) | 0.000 | 0.006 | 0.084 | 0.598 | 0.312 | 0.008 | 0.176 | 0.668 | 0.144 | 0.004 |
| # of patients | 6.2 | 6.7 | 6.6 | 6.0 | 4.6 | 6.9 | 7.4 | 6.7 | 5.5 | 3.5 |
| Sel % (conventional II) | 0.000 | 0.036 | 0.426 | 0.208 | 0.330 | 0.000 | 0.036 | 0.426 | 0.208 | 0.330 |
| # of patients | 5.9 | 6.8 | 6.8 | 5.9 | 4.7 | 6.0 | 7.3 | 6.5 | 5.7 | 4.3 |
| Scenario 10 | ||||||||||
| Sel % (BIPSE) | 0.000 | 0.000 | 0.000 | 0.000 | 0.000 | 0.000 | 0.000 | 0.000 | 0.000 | 0.000 |
| # of patients | 1.8 | 1.0 | 0.3 | 0.0 | 0.0 | 1.9 | 1.5 | 0.3 | 0.0 | 0.0 |
| Sel % (conventional I) | 0.020 | 0.006 | 0.000 | 0.000 | 0.000 | 0.010 | 0.000 | 0.000 | 0.000 | 0.000 |
| # of patients | 5.8 | 3.2 | 0.9 | 0.1 | 0.0 | 10.7 | 2.8 | 0.5 | 0.1 | 0.0 |
| Sel % (conventional II) | 0.000 | 0.000 | 0.000 | 0.000 | 0.000 | 0.000 | 0.000 | 0.000 | 0.000 | 0.000 |
| # of patients | 1.9 | 1.1 | 0.3 | 0.0 | 0.0 | 1.7 | 1.1 | 0.3 | 0.0 | 0.0 |