Table 4.
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 6 dose levels over toxic*** | 0 | 0 | 0 | 0 | 0 | 37 | |
1 | 6 | 1 | 0 | 6 | 0 | 59 | |
2 | 24 | 12 | 5 | 45 | 0 | 4 | |
3 | 46 | 65 | 24 | 42 | 1 | 0 | |
4 | 22 | 22 | 65 | 7 | 31 | 0 | |
5 | 2 | 0 | 6 | 0 | 65 | 0 | |
6 | 0 | 0 | 0 | 0 | 3 | 0 | |
All 6 dose levels under toxic**** | 0 | 0 | 0 | 0 | 0 | 0 | |
Sample size Mean (SD) | 25.8 (7.7) | 22.7 (6.1) | 21.9 (4.8) | 23.4 (6.9) | 22.5 (6.6) | 23.4 (5.7) |
EWOC is targeted with TTL ≤ 0.33.
EWOC-NETS is targeted with same TNETS for all 5 scenarios.
: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).