Journal of Probability and Statistics

Research Article

Number of Patients per Cohort and Sample Size Considerations Using Dose Escalation with Overdose Control

Table 5

Estimated proportions of patients exhibiting DLTs, treated above the MTD, MSE, and bias of the MTD under designs 1 and 3 for high values of and selected values of .
 Sample size
12182430
1 3 Diff. 1 3 Diff. 1 3 Diff. 1 3 Diff.
=             
 Proportion of DLTs 0.1866 0.1657 0.0209 0.2010 0.1863 0.0147 0.2108 0.1996 0.0112 0.2168 0.2080 0.0088
 Proportion above the MTD 0.0258 0.0001 0.0257 0.0529 0.0341 0.0188 0.0787 0.0603 0.0185 0.0974 0.0817 0.0157
 MSE 0.0099 0.0092 0.0008 0.0102 0.0104 −0.0002 0.0103 0.0102 0.0001 0.0098 0.0107 −0.0008
 Bias 0.0065 0.0097 −0.0033 0.0195 0.0238 −0.0043 0.0287 0.0331 −0.0044 0.0397 0.0401 −0.0003
=             
 Proportion of DLTs 0.2250 0.2121 0.0129 0.2286 0.2226 0.0059 0.2342 0.2270 0.0072 0.2369 0.2341 0.0027
 Proportion above the MTD 0.0184 0.0000 0.0184 0.0384 0.0188 0.0197 0.0535 0.0339 0.0196 0.0666 0.0450 0.0216
 MSE 0.0178 0.0140 0.0038 0.0169 0.0152 0.0017 0.0167 0.0152 0.0015 0.0168 0.0153 0.0015
 Bias−0.0449−0.0356−0.0092−0.0317−0.0278−0.0039−0.0271−0.0177−0.0093−0.0223−0.0173−0.0050
=             
 Proportion of DLTs 0.2609 0.2570 0.0039 0.2604 0.2593 0.0011 0.2643 0.2601 0.0042 0.2632 0.2636 −0.0004
 Proportion above the MTD 0.0132 0.0001 0.0132 0.0291 0.0120 0.0171 0.0392 0.0236 0.0156 0.0481 0.0323 0.0158
 MSE 0.0289 0.0228 0.0061 0.0306 0.0251 0.0055 0.0321 0.0250 0.0071 0.0327 0.0267 0.0060
 Bias−0.0898−0.0794−0.0104−0.0870−0.0762−0.0109−0.0905−0.0718−0.0186−0.0863−0.0746−0.0117
=             
 Proportion of DLTs 0.1549 0.1387 0.0162 0.1678 0.1541 0.0136 0.1774 0.1663 0.0111 0.1846 0.1762 0.0084
 Proportion above the MTD 0.0000 0.0000 0.0000 0.0001 0.0000 0.0001 0.0022 0.0009 0.0013 0.0052 0.0032 0.0020
 MSE 0.0347 0.0349 −0.0003 0.0276 0.0273 0.0003 0.0226 0.0221 0.0004 0.0184 0.0192 −0.0008
 Bias−0.1575−0.1622 0.0047 −0.1323−0.1326 0.0003 −0.1128−0.1125−0.0003−0.0977−0.0996 0.0019
=             
 Proportion of DLTs 0.2042 0.1933 0.0109 0.2099 0.2026 0.0073 0.2143 0.2083 0.0060 0.2179 0.2135 0.0044
 Proportion above the MTD 0.0000 0.0000 0.0000 0.0000 0.0000 0.0000 0.0012 0.0003 0.0008 0.0020 0.0013 0.0007
 MSE 0.0641 0.0592 0.0049 0.0578 0.0542 0.0037 0.0543 0.0503 0.0040 0.0514 0.0464 0.0050
 Bias−0.2192−0.2159−0.0034−0.2025−0.1983−0.0042−0.1911−0.1869−0.0041−0.1818−0.1776−0.0042
=             
 Proportion of DLTs 0.2502 0.2469 0.0032 0.2533 0.2505 0.0028 0.2555 0.2522 0.0033 0.2548 0.2532 0.0016
 Proportion above the MTD 0.0000 0.0000 0.0000 0.0000 0.0000 0.0000 0.0004 0.0002 0.0001 0.0013 0.0008 0.0005
 MSE 0.0979 0.0877 0.0102 0.0995 0.0900 0.0095 0.1011 0.0883 0.0128 0.0989 0.0887 0.0102
 Bias−0.2760−0.2673−0.0087−0.2750−0.2640−0.0110−0.2747−0.2595−0.0152−0.2685−0.2564−0.0121