Table 2.
Operating characteristics of the PRT and TITE-CRM designs
| True Probability(T < 3 months|dk) | ||||||||||
| d1 | d2 | d3 | d4 | d5 | d6 | |||||
| Scenario 1 (late onset) | 0.25 | 0.35 | 0.50 | 0.60 | 0.68 | 0.73 | None | Total | Duration | |
| PRT | ||||||||||
| % Selected | 41 | 43 | 4 | 0 | 0 | 0 | 12 | — | 1.5 | |
| No. of patients | 13.1 | 15.2 | 4.4 | 0.5 | 0.0 | 0.0 | 33.2 | — | ||
| No. of toxicities | 3.3 | 5.3 | 2.2 | 0.3 | 0.0 | 0.0 | 11.1 | — | ||
| TITE-CRM | ||||||||||
| % Selected | 46 | 42 | 8 | 0 | 0 | 0 | 4 | — | 1.0 | |
| No. of patients | 10.6 | 11.0 | 7.8 | 4.0 | 1.4 | 0.6 | 35.5 | — | ||
| No. of toxicities |
2.6 |
3.8 |
3.9 |
2.4 |
1.0 |
0.5 |
14.1 |
— |
||
| Scenario 2 (late onset) |
0.03 |
0.05 |
0.10 |
0.30 |
0.50 |
0.60 |
||||
| PRT | ||||||||||
| % Selected | 0 | 1 | 26 | 64 | 9 | 0 | 0 | — | 1.8 | |
| No. of patients | 3.5 | 4.8 | 9.8 | 12.5 | 4.6 | 0.8 | 36.0 | — | ||
| No. of toxicities | 0.1 | 0.3 | 1.0 | 3.7 | 2.2 | 0.5 | 7.8 | — | ||
| TITE-CRM | ||||||||||
| % Selected | 0 | 0 | 12 | 70 | 19 | 0 | 0 | — | 1.0 | |
| No. of patients | 3.0 | 3.2 | 4.5 | 11.2 | 9.4 | 4.7 | 36.0 | — | ||
| No. of toxicities |
0.1 |
0.2 |
0.4 |
3.4 |
4.7 |
2.8 |
11.6 |
— |
||
| Scenario 3 (late onset) |
0.50 |
0.60 |
0.68 |
0.73 |
0.76 |
0.78 |
||||
| PRT | ||||||||||
| % Selected | 11 | 0 | 0 | 0 | 0 | 0 | 89 | — | 0.8 | |
| No. of patients | 13.0 | 5.1 | 0.5 | 0.0 | 0.0 | 0.0 | 18.6 | — | ||
| No. of toxicities | 5.6 | 2.6 | 0.3 | 0.0 | 0.0 | 0.0 | 8.6 | — | ||
| TITE-CRM | ||||||||||
| % Selected | 18 | 0 | 0 | 0 | 0 | 0 | 82 | — | 0.7 | |
| No. of patients | 15.1 | 5.6 | 3.7 | 1.8 | 0.7 | 0.3 | 27.2 | — | ||
| No. of toxicities |
5.7 |
3.1 |
2.2 |
1.2 |
0.5 |
0.2 |
12.8 |
— |
||
| Scenario 4 (late onset) |
0.01 |
0.02 |
0.03 |
0.05 |
0.50 |
0.60 |
||||
| PRT | ||||||||||
| % Selected | 0 | 0 | 0 | 67 | 32 | 1 | 0 | — | 1.8 | |
| No. of patients | 3.1 | 3.5 | 4.5 | 13.1 | 9.4 | 2.4 | 36.0 | — | ||
| No. of toxicities | 0.0 | 0.1 | 0.1 | 0.6 | 4.7 | 1.5 | 7.0 | — | ||
| TITE-CRM | ||||||||||
| % Selected | 0 | 0 | 1 | 45 | 54 | 0 | 0 | — | 1.0 | |
| No. of patients | 3.0 | 3.0 | 3.1 | 5.9 | 13.1 | 7.8 | 36.0 | — | ||
| No. of toxicities |
0.0 |
0.1 |
0.1 |
0.3 |
6.6 |
4.7 |
11.8 |
— |
||
| Scenario 5 (late onset) |
0.05 |
0.06 |
0.08 |
0.11 |
0.19 |
0.34 |
None |
Total |
Duration |
|
| PRT | ||||||||||
| Selected | 0 | 0 | 5 | 16 | 49 | 30 | 0 | — | 1.8 | |
| Patients | 3.5 | 4.8 | 6.2 | 7.5 | 7.8 | 6.2 | 36.0 | — | ||
| Toxicities | 0.2 | 0.3 | 0.5 | 0.8 | 1.5 | 2.1 | 5.4 | — | ||
| TITE-CRM | ||||||||||
| Selected | 0 | 0 | 0 | 13 | 58 | 29 | 0 | — | 1.0 | |
| Patients | 3.1 | 3.3 | 3.9 | 7.1 | 9.9 | 8.6 | 36.0 | — | ||
| Toxicities |
0.1 |
0.2 |
0.3 |
0.8 |
1.9 |
2.8 |
6.2 |
— |
||
| Scenario 6 (early onset) |
0.250 |
0.350 |
0.500 |
0.600 |
0.680 |
0.730 |
||||
| PRT | ||||||||||
| % Selected | 44 | 38 | 3 | 0 | 0 | 0 | 14 | — | 1.0 | |
| No. of patients | 16.6 | 12.6 | 2.7 | 0.3 | 0.0 | 32.1 | — | |||
| No. of toxicities | 4.4 | 4.7 | 1.6 | 0.2 | 0.0 | 10.9 | — | |||
| TITE-CRM | ||||||||||
| % Selected | 40 | 41 | 6 | 1 | 0 | 0 | 12 | — | 0.9 | |
| No. of patients | 17.0 | 11.4 | 3.8 | 0.6 | 0.0 | 0.0 | 32.8 | — | ||
| No. of toxicities | 4.2 | 4.0 | 1.9 | 0.3 | 0.0 | 0.0 | 10.5 | — | ||