Selection percentage and the average number of patients treated at each dose under DROID designs that allow adding dose to TDR/RP2S in Stage II.
| Dose level . | 1 . | 2 . | 3 . | 4 . | 5 . | 1 . | 2 . | 3 . | 4 . | 5 . |
|---|---|---|---|---|---|---|---|---|---|---|
| Scenario 1 | Scenario 2 | |||||||||
| DROID-BOIN Sel % | 0.021 | 0.764 | 0.204 | 0.000 | 0.000 | 0.000 | 0.139 | 0.850 | 0.002 | 0.000 |
| No. patients | 20.2 | 19.8 | 18.5 | 15.0 | 4.3 | 6.7 | 20.0 | 19.6 | 18.7 | 11.7 |
| DROID-CRM Sel % | 0.011 | 0.787 | 0.192 | 0.000 | 0.000 | 0.000 | 0.187 | 0.797 | 0.000 | 0.000 |
| No. patients | 20.2 | 19.8 | 18.2 | 14.0 | 3.7 | 16.5 | 19.9 | 19.0 | 17.3 | 9.2 |
| Scenario 3 | Scenario 4 | |||||||||
| DROID-BOIN Sel % | 0.007 | 0.020 | 0.755 | 0.211 | 0.000 | 0.000 | 0.000 | 0.003 | 0.744 | 0.240 |
| No. patients | 20.2 | 19.9 | 19.6 | 18.5 | 12.1 | 4.2 | 11.8 | 19.8 | 19.8 | 19.0 |
| DROID-CRM Sel % | 0.003 | 0.037 | 0.733 | 0.211 | 0.000 | 0.000 | 0.000 | 0.008 | 0.750 | 0.233 |
| No. patients | 20.2 | 19.9 | 19.2 | 17.6 | 10.3 | 5.3 | 12.9 | 19.9 | 19.7 | 18.2 |
| Scenario 5 | Scenario 6 | |||||||||
| DROID-BOIN Sel % | 0.000 | 0.018 | 0.076 | 0.841 | 0.051 | 0.026 | 0.797 | 0.166 | 0.001 | 0.000 |
| No. patients | 7.4 | 19.2 | 19.6 | 18.7 | 12.5 | 20.1 | 19.8 | 11.7 | 1.4 | 0.1 |
| DROID-CRM Sel % | 0.000 | 0.018 | 0.087 | 0.814 | 0.038 | 0.012 | 0.808 | 0.154 | 0.000 | 0.000 |
| No. patients | 6.6 | 19.4 | 19.3 | 17.8 | 10.6 | 20.2 | 19.5 | 11.9 | 2.3 | 0.1 |
| Scenario 7 | Scenario 8 | |||||||||
| DROID-BOIN Sel % | 0.000 | 0.000 | 0.001 | 0.056 | 0.929 | 0.787 | 0.184 | 0.001 | 0.000 | 0.000 |
| No. patients | 3.7 | 7.8 | 17.7 | 19.8 | 19.0 | 24.1 | 12.3 | 2.4 | 0.3 | 0.0 |
| DROID-CRM Sel % | 0.000 | 0.000 | 0.004 | 0.093 | 0.884 | 0.690 | 0.279 | 0.003 | 0.000 | 0.000 |
| No. patients | 5.2 | 7.2 | 17.8 | 19.7 | 18.0 | 21.8 | 15.5 | 3.5 | 0.5 | 0.0 |
| Scenario 9 | ||||||||||
| DROID-BOIN Sel % | 0.001 | 0.004 | 0.001 | 0.000 | 0.000 | |||||
| No. patients | 20.1 | 19.8 | 19.6 | 18.5 | 5.8 | |||||
| DROID-CRM Sel % | 0.000 | 0.003 | 0.001 | 0.000 | 0.000 | |||||
| No. patients | 20.0 | 19.8 | 19.6 | 18.7 | 6.8 | |||||
| Dose level . | 1 . | 2 . | 3 . | 4 . | 5 . | 1 . | 2 . | 3 . | 4 . | 5 . |
|---|---|---|---|---|---|---|---|---|---|---|
| Scenario 1 | Scenario 2 | |||||||||
| DROID-BOIN Sel % | 0.021 | 0.764 | 0.204 | 0.000 | 0.000 | 0.000 | 0.139 | 0.850 | 0.002 | 0.000 |
| No. patients | 20.2 | 19.8 | 18.5 | 15.0 | 4.3 | 6.7 | 20.0 | 19.6 | 18.7 | 11.7 |
| DROID-CRM Sel % | 0.011 | 0.787 | 0.192 | 0.000 | 0.000 | 0.000 | 0.187 | 0.797 | 0.000 | 0.000 |
| No. patients | 20.2 | 19.8 | 18.2 | 14.0 | 3.7 | 16.5 | 19.9 | 19.0 | 17.3 | 9.2 |
| Scenario 3 | Scenario 4 | |||||||||
| DROID-BOIN Sel % | 0.007 | 0.020 | 0.755 | 0.211 | 0.000 | 0.000 | 0.000 | 0.003 | 0.744 | 0.240 |
| No. patients | 20.2 | 19.9 | 19.6 | 18.5 | 12.1 | 4.2 | 11.8 | 19.8 | 19.8 | 19.0 |
| DROID-CRM Sel % | 0.003 | 0.037 | 0.733 | 0.211 | 0.000 | 0.000 | 0.000 | 0.008 | 0.750 | 0.233 |
| No. patients | 20.2 | 19.9 | 19.2 | 17.6 | 10.3 | 5.3 | 12.9 | 19.9 | 19.7 | 18.2 |
| Scenario 5 | Scenario 6 | |||||||||
| DROID-BOIN Sel % | 0.000 | 0.018 | 0.076 | 0.841 | 0.051 | 0.026 | 0.797 | 0.166 | 0.001 | 0.000 |
| No. patients | 7.4 | 19.2 | 19.6 | 18.7 | 12.5 | 20.1 | 19.8 | 11.7 | 1.4 | 0.1 |
| DROID-CRM Sel % | 0.000 | 0.018 | 0.087 | 0.814 | 0.038 | 0.012 | 0.808 | 0.154 | 0.000 | 0.000 |
| No. patients | 6.6 | 19.4 | 19.3 | 17.8 | 10.6 | 20.2 | 19.5 | 11.9 | 2.3 | 0.1 |
| Scenario 7 | Scenario 8 | |||||||||
| DROID-BOIN Sel % | 0.000 | 0.000 | 0.001 | 0.056 | 0.929 | 0.787 | 0.184 | 0.001 | 0.000 | 0.000 |
| No. patients | 3.7 | 7.8 | 17.7 | 19.8 | 19.0 | 24.1 | 12.3 | 2.4 | 0.3 | 0.0 |
| DROID-CRM Sel % | 0.000 | 0.000 | 0.004 | 0.093 | 0.884 | 0.690 | 0.279 | 0.003 | 0.000 | 0.000 |
| No. patients | 5.2 | 7.2 | 17.8 | 19.7 | 18.0 | 21.8 | 15.5 | 3.5 | 0.5 | 0.0 |
| Scenario 9 | ||||||||||
| DROID-BOIN Sel % | 0.001 | 0.004 | 0.001 | 0.000 | 0.000 | |||||
| No. patients | 20.1 | 19.8 | 19.6 | 18.5 | 5.8 | |||||
| DROID-CRM Sel % | 0.000 | 0.003 | 0.001 | 0.000 | 0.000 | |||||
| No. patients | 20.0 | 19.8 | 19.6 | 18.7 | 6.8 | |||||
Notes: The boldface numbers are optimal doses.
BOIN, Bayesian optimal interval design; CRM, continuous reassessment method; DROID, dose-ranging approach to optimizing dose; RP2S, recommended phase 2 dose set; TDR, therapeutic dose range.
Selection percentage and the average number of patients treated at each dose under DROID designs that allow adding dose to TDR/RP2S in Stage II.
| Dose level . | 1 . | 2 . | 3 . | 4 . | 5 . | 1 . | 2 . | 3 . | 4 . | 5 . |
|---|---|---|---|---|---|---|---|---|---|---|
| Scenario 1 | Scenario 2 | |||||||||
| DROID-BOIN Sel % | 0.021 | 0.764 | 0.204 | 0.000 | 0.000 | 0.000 | 0.139 | 0.850 | 0.002 | 0.000 |
| No. patients | 20.2 | 19.8 | 18.5 | 15.0 | 4.3 | 6.7 | 20.0 | 19.6 | 18.7 | 11.7 |
| DROID-CRM Sel % | 0.011 | 0.787 | 0.192 | 0.000 | 0.000 | 0.000 | 0.187 | 0.797 | 0.000 | 0.000 |
| No. patients | 20.2 | 19.8 | 18.2 | 14.0 | 3.7 | 16.5 | 19.9 | 19.0 | 17.3 | 9.2 |
| Scenario 3 | Scenario 4 | |||||||||
| DROID-BOIN Sel % | 0.007 | 0.020 | 0.755 | 0.211 | 0.000 | 0.000 | 0.000 | 0.003 | 0.744 | 0.240 |
| No. patients | 20.2 | 19.9 | 19.6 | 18.5 | 12.1 | 4.2 | 11.8 | 19.8 | 19.8 | 19.0 |
| DROID-CRM Sel % | 0.003 | 0.037 | 0.733 | 0.211 | 0.000 | 0.000 | 0.000 | 0.008 | 0.750 | 0.233 |
| No. patients | 20.2 | 19.9 | 19.2 | 17.6 | 10.3 | 5.3 | 12.9 | 19.9 | 19.7 | 18.2 |
| Scenario 5 | Scenario 6 | |||||||||
| DROID-BOIN Sel % | 0.000 | 0.018 | 0.076 | 0.841 | 0.051 | 0.026 | 0.797 | 0.166 | 0.001 | 0.000 |
| No. patients | 7.4 | 19.2 | 19.6 | 18.7 | 12.5 | 20.1 | 19.8 | 11.7 | 1.4 | 0.1 |
| DROID-CRM Sel % | 0.000 | 0.018 | 0.087 | 0.814 | 0.038 | 0.012 | 0.808 | 0.154 | 0.000 | 0.000 |
| No. patients | 6.6 | 19.4 | 19.3 | 17.8 | 10.6 | 20.2 | 19.5 | 11.9 | 2.3 | 0.1 |
| Scenario 7 | Scenario 8 | |||||||||
| DROID-BOIN Sel % | 0.000 | 0.000 | 0.001 | 0.056 | 0.929 | 0.787 | 0.184 | 0.001 | 0.000 | 0.000 |
| No. patients | 3.7 | 7.8 | 17.7 | 19.8 | 19.0 | 24.1 | 12.3 | 2.4 | 0.3 | 0.0 |
| DROID-CRM Sel % | 0.000 | 0.000 | 0.004 | 0.093 | 0.884 | 0.690 | 0.279 | 0.003 | 0.000 | 0.000 |
| No. patients | 5.2 | 7.2 | 17.8 | 19.7 | 18.0 | 21.8 | 15.5 | 3.5 | 0.5 | 0.0 |
| Scenario 9 | ||||||||||
| DROID-BOIN Sel % | 0.001 | 0.004 | 0.001 | 0.000 | 0.000 | |||||
| No. patients | 20.1 | 19.8 | 19.6 | 18.5 | 5.8 | |||||
| DROID-CRM Sel % | 0.000 | 0.003 | 0.001 | 0.000 | 0.000 | |||||
| No. patients | 20.0 | 19.8 | 19.6 | 18.7 | 6.8 | |||||
| Dose level . | 1 . | 2 . | 3 . | 4 . | 5 . | 1 . | 2 . | 3 . | 4 . | 5 . |
|---|---|---|---|---|---|---|---|---|---|---|
| Scenario 1 | Scenario 2 | |||||||||
| DROID-BOIN Sel % | 0.021 | 0.764 | 0.204 | 0.000 | 0.000 | 0.000 | 0.139 | 0.850 | 0.002 | 0.000 |
| No. patients | 20.2 | 19.8 | 18.5 | 15.0 | 4.3 | 6.7 | 20.0 | 19.6 | 18.7 | 11.7 |
| DROID-CRM Sel % | 0.011 | 0.787 | 0.192 | 0.000 | 0.000 | 0.000 | 0.187 | 0.797 | 0.000 | 0.000 |
| No. patients | 20.2 | 19.8 | 18.2 | 14.0 | 3.7 | 16.5 | 19.9 | 19.0 | 17.3 | 9.2 |
| Scenario 3 | Scenario 4 | |||||||||
| DROID-BOIN Sel % | 0.007 | 0.020 | 0.755 | 0.211 | 0.000 | 0.000 | 0.000 | 0.003 | 0.744 | 0.240 |
| No. patients | 20.2 | 19.9 | 19.6 | 18.5 | 12.1 | 4.2 | 11.8 | 19.8 | 19.8 | 19.0 |
| DROID-CRM Sel % | 0.003 | 0.037 | 0.733 | 0.211 | 0.000 | 0.000 | 0.000 | 0.008 | 0.750 | 0.233 |
| No. patients | 20.2 | 19.9 | 19.2 | 17.6 | 10.3 | 5.3 | 12.9 | 19.9 | 19.7 | 18.2 |
| Scenario 5 | Scenario 6 | |||||||||
| DROID-BOIN Sel % | 0.000 | 0.018 | 0.076 | 0.841 | 0.051 | 0.026 | 0.797 | 0.166 | 0.001 | 0.000 |
| No. patients | 7.4 | 19.2 | 19.6 | 18.7 | 12.5 | 20.1 | 19.8 | 11.7 | 1.4 | 0.1 |
| DROID-CRM Sel % | 0.000 | 0.018 | 0.087 | 0.814 | 0.038 | 0.012 | 0.808 | 0.154 | 0.000 | 0.000 |
| No. patients | 6.6 | 19.4 | 19.3 | 17.8 | 10.6 | 20.2 | 19.5 | 11.9 | 2.3 | 0.1 |
| Scenario 7 | Scenario 8 | |||||||||
| DROID-BOIN Sel % | 0.000 | 0.000 | 0.001 | 0.056 | 0.929 | 0.787 | 0.184 | 0.001 | 0.000 | 0.000 |
| No. patients | 3.7 | 7.8 | 17.7 | 19.8 | 19.0 | 24.1 | 12.3 | 2.4 | 0.3 | 0.0 |
| DROID-CRM Sel % | 0.000 | 0.000 | 0.004 | 0.093 | 0.884 | 0.690 | 0.279 | 0.003 | 0.000 | 0.000 |
| No. patients | 5.2 | 7.2 | 17.8 | 19.7 | 18.0 | 21.8 | 15.5 | 3.5 | 0.5 | 0.0 |
| Scenario 9 | ||||||||||
| DROID-BOIN Sel % | 0.001 | 0.004 | 0.001 | 0.000 | 0.000 | |||||
| No. patients | 20.1 | 19.8 | 19.6 | 18.5 | 5.8 | |||||
| DROID-CRM Sel % | 0.000 | 0.003 | 0.001 | 0.000 | 0.000 | |||||
| No. patients | 20.0 | 19.8 | 19.6 | 18.7 | 6.8 | |||||
Notes: The boldface numbers are optimal doses.
BOIN, Bayesian optimal interval design; CRM, continuous reassessment method; DROID, dose-ranging approach to optimizing dose; RP2S, recommended phase 2 dose set; TDR, therapeutic dose range.
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