Table 4.
Proportion of trials each dose was recommended as the MTD. The CRM with the safety rule added is denoted by CRM+S. The length of follow-up for DLT is 35 days, one patients is enrolled every two weeks. The target DLT rate is 0.20 and the total sample size is n = 30. Numbers at the true MTD are in bold.
| d1 | d2 | d3 | d4 | d5 | d6 | |
|---|---|---|---|---|---|---|
| Scenario 1 | 0.05 | 0.10 | 0.20 | 0.30 | 0.50 | 0.70 |
| TITE-CRM | 0.01 | 0.19 | 0.51 | 0.28 | 0.01 | 0.00 |
| CRM with mitigation | 0.02 | 0.27 | 0.52 | 0.18 | 0.01 | 0.00 |
| CRM+S with mitigation | 0.05 | 0.30 | 0.48 | 0.17 | 0.01 | 0.00 |
| RED with mitigation | 0.09 | 0.28 | 0.41 | 0.20 | 0.02 | 0.00 |
| Scenario 2 | 0.01 | 0.05 | 0.50 | 0.60 | 0.70 | 0.80 |
| TITE-CRM | 0.00 | 0.65 | 0.34 | 0.00 | 0.00 | 0.00 |
| CRM with mitigation | 0.00 | 0.67 | 0.33 | 0.00 | 0.00 | 0.00 |
| CRM+S with mitigation | 0.01 | 0.90 | 0.09 | 0.00 | 0.00 | 0.00 |
| RED with mitigation | 0.02 | 0.87 | 0.12 | 0.00 | 0.00 | 0.00 |
| Scenario 3 | 0.05 | 0.06 | 0.08 | 0.11 | 0.19 | 0.34 |
| TITE-CRM | 0.00 | 0.02 | 0.08 | 0.32 | 0.54 | 0.05 |
| CRM with mitigation | 0.01 | 0.06 | 0.19 | 0.30 | 0.34 | 0.09 |
| CRM+S with mitigation | 0.01 | 0.07 | 0.20 | 0.30 | 0.32 | 0.09 |
| RED with mitigation | 0.06 | 0.05 | 0.12 | 0.31 | 0.34 | 0.12 |
| Scenario 4 | 0.06 | 0.08 | 0.12 | 0.18 | 0.40 | 0.71 |
| TITE-CRM | 0.01 | 0.06 | 0.22 | 0.60 | 0.11 | 0.00 |
| CRM with mitigation | 0.02 | 0.14 | 0.35 | 0.40 | 0.10 | 0.00 |
| CRM+S with mitigation | 0.03 | 0.14 | 0.34 | 0.41 | 0.07 | 0.00 |
| RED with mitigation | 0.09 | 0.11 | 0.26 | 0.45 | 0.09 | 0.00 |
| Scenario 5 | 0.00 | 0.00 | 0.03 | 0.05 | 0.11 | 0.22 |
| TITE-CRM | 0.00 | 0.00 | 0.00 | 0.05 | 0.62 | 0.33 |
| CRM with mitigation | 0.00 | 0.00 | 0.00 | 0.07 | 0.43 | 0.50 |
| CRM+S with mitigation | 0.00 | 0.00 | 0.01 | 0.09 | 0.42 | 0.48 |
| RED with mitigation | 0.00 | 0.00 | 0.02 | 0.12 | 0.40 | 0.46 |