Table 3.
Dose level | Percent of Trials Recommending Dose Level d as the MTD | |||||
---|---|---|---|---|---|---|
All scenarios (1 to 5) | Scenario 1 | Scenario 2 | Scenario 3 | Scenario 4 | Scenario 5 | |
EWOC* | EWOC-NETS** | |||||
All dose levels over toxic*** | 0 | 0 | 0 | 0 | 19 | |
1 | 6 | 1 | 1 | 0 | 1 | 6 |
2 | 24 | 12 | 20 | 20 | 15 | 7 |
3 | 46 | 65 | 47 | 55 | 54 | 56 |
4 | 22 | 22 | 32 | 25 | 26 | 12 |
5 | 2 | 0 | 0 | 0 | 4 | 0 |
6 | 0 | 0 | 0 | 0 | 0 | 0 |
All dose levels under toxic**** | 0 | 0 | 0 | 0 | 0 | 0 |
Sample size Mean (SD) | 25.8 (7.7) | 22.7 (6.1) | 24.6 (8.7) | 23.1 (6.3) | 24.6 (7.8) | 47.4 (14.9) |
EWOC is targeted with TTL ≤ 0.33.
EWOC-NETS is targeted with different TNETS for Scenario 1 (0.476), 2 (0.41), 3 (0.526), 4 (0.25), and 5 (0.69), respectively.
:All the 6 pre-specified dose levels are determined to be over toxic and the recommend MTD from simulation trial is a dose lower than the lowest pre-specified dose level (level 1).
: All the 6 pre-specified dose levels are determined to be under toxic and the recommend MTD from simulation trial is a dose higher than the highest pre-specified dose level (level 6).