Research Article

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

Table 4

Estimated proportions of patients exhibiting DLTs, treated above the MTD, MSE, and bias of the MTD under designs 1 and 3 for small values of and selected values of .

Sample size
12182430
1 3 Diff. 1 3 Diff. 1 3 Diff. 1 3 Diff.

=
 Proportion of DLTs 0.3389 0.3456 −0.0067 0.3271 0.3346 −0.0075 0.3192 0.3254 −0.0062 0.3136 0.3173 −0.0037
 Proportion above the MTD 0.4694 0.5095 −0.0401 0.4493 0.4701 −0.0208 0.4274 0.4419 −0.0145 0.4052 0.4140 −0.0088
 MSE 0.0457 0.0467 −0.0010 0.0389 0.0365 0.0024 0.0338 0.0311 0.0027 0.0311 0.0274 0.0036
 Bias 0.2013 0.1907 0.0106 0.1857 0.1676 0.0181 0.1738 0.1556 0.0182 0.1663 0.1467 0.0196
=
 Proportion of DLTs 0.3346 0.3289 0.0058 0.3305 0.3311 −0.0006 0.3262 0.3306 −0.0044 0.3211 0.3279 −0.0068
 Proportion above the MTD 0.5219 0.5436 −0.0217 0.5185 0.5512 −0.0327 0.5073 0.5376 −0.0303 0.4928 0.5293 −0.0366
 MSE 0.0558 0.0661 −0.0102 0.0468 0.0542 −0.0074 0.0402 0.0447 −0.0045 0.0367 0.0393 −0.0026
 Bias 0.2164 0.2315 −0.0151 0.1972 0.2076 −0.0104 0.1825 0.1878 −0.0054 0.1741 0.1760 −0.0019
=
 Proportion of DLTs 0.3200 0.3121 0.0080 0.3210 0.3164 0.0047 0.3200 0.3183 0.0017 0.3181 0.3190 −0.0009
 Proportion above the MTD 0.5573 0.5505 0.0069 0.5618 0.5766 −0.0148 0.5470 0.5839 −0.0369 0.5527 0.5836 −0.0310
 MSE 0.0734 0.0849 −0.0115 0.0636 0.0742 −0.0106 0.0559 0.0672 −0.0113 0.0513 0.0593 −0.0080
 Bias 0.2403 0.2625 −0.0222 0.2206 0.2416 −0.0210 0.2049 0.2271 −0.0222 0.1952 0.2126 −0.0174
=
 Proportion of DLTs 0.2461 0.2222 0.0239 0.2545 0.2414 0.0131 0.2594 0.2511 0.0082 0.2630 0.2581 0.0049
 Proportion above the MTD 0.2444 0.1786 0.0658 0.2803 0.2474 0.0329 0.2807 0.2701 0.0105 0.2954 0.2843 0.0111
 MSE 0.0276 0.0316 −0.0040 0.0262 0.0291 −0.0029 0.0243 0.0266 −0.0023 0.0232 0.0242 −0.0011
 Bias 0.1371 0.1493 −0.0122 0.1353 0.1403 −0.0050 0.1311 0.1342 −0.0031 0.1302 0.1292 0.0010
=
 Proportion of DLTs 0.2583 0.2408 0.0175 0.2626 0.2548 0.0078 0.2669 0.2607 0.0063 0.2689 0.2646 0.0043
 Proportion above the MTD 0.2202 0.1352 0.0850 0.2493 0.1917 0.0576 0.2663 0.2294 0.0369 0.2673 0.2489 0.0184
 MSE 0.0278 0.0308 −0.0030 0.0269 0.0291 −0.0022 0.0254 0.0279 −0.0025 0.0237 0.0266 −0.0029
 Bias 0.1167 0.1336 −0.0169 0.1153 0.1266 −0.0113 0.1107 0.1218 −0.0111 0.1070 0.1194 −0.0124
=
 Proportion of DLTs 0.2749 0.2692 0.0057 0.2798 0.2737 0.0060 0.2803 0.2761 0.0042 0.2809 0.2782 0.0027
 Proportion above the MTD 0.2047 0.1037 0.1010 0.2216 0.1646 0.0570 0.2447 0.1987 0.0461 0.2461 0.2098 0.0364
 MSE 0.0291 0.0281 0.0009 0.0275 0.0290 −0.0015 0.0284 0.0298 −0.0014 0.0273 0.0284 −0.0012
 Bias 0.0941 0.1089 −0.0148 0.0833 0.1051 −0.0219 0.0814 0.0997 −0.0184 0.0758 0.0942 −0.0184