Table A2.
Case Study: Trial Three
| Patient No. | Treatment |
Initial Curve: Actual Recommendation* |
Updated DLT Rate at 50-mg Dose | Correct Curve: Correct Recommendation† |
|||||
|---|---|---|---|---|---|---|---|---|---|
| Dose (mg) | Level | DLT | Dose (mg) | Level | Dose (mg) | Level | DLT | ||
| 1 | 1 | 1 | No | 50 | 10 | 21 | 1 | 1 | No |
| 2 | 1 | 1 | No | 50 | 10 | 17 | 5 | 3 | No |
| 3 | 1 | 1 | No | 50 | 10 | 15 | 15 | 5 | No |
| 4 | 2.5 | 2 | No | 50 | 10 | 13 | 20 | 6 | No |
| 5 | 2.5 | 2 | No | 50 | 10 | 11 | 25 | 7 | Yes |
| 6 | 2.5 | 2 | No | 50 | 10 | 10 | 15 | 5 | No |
| 7 | 2.5 | 2 | No | 50 | 10 | 9 | 20 | 6 | No |
| 8 | 5 | 3 | No | 50 | 10 | 8 | 20 | 6 | No |
| 9 | 5 | 3 | No | 50 | 10 | 8 | 25 | 7 | Yes |
| 10 | 5 | 3 | No | 50 | 10 | 7 | 20 | 6 | No |
| 11 | 5 | 3 | No | 50 | 10 | 7 | 20 | 6 | No |
| 12 | 5 | 3 | No | 50 | 10 | 6 | 25 | 7 | Yes |
| 13 | 10 | 4 | No | 50 | 10 | 6 | 20 | 6 | No |
| 14 | 10 | 4 | No | 50 | 10 | 6 | 20 | 6 | No |
| 15 | 10 | 4 | No | 50 | 10 | 6 | 20 | 6 | No |
| 16 | 10 | 4 | No | 50 | 10 | 5 | 25 | 7 | Yes |
| 17 | 25 | 7 | Yes | 40 | 9 | 38 | 20 | 6 | No |
| 18 | 25 | 7 | Yes | 40 | 9 | 47 | 20 | 6 | No |
| Recommended dose | 40 | 9 | 25 | 7 | |||||
NOTE. Initial curve assigns 30% DLT rate at level 10 (50 mg) and low rates at all remaining levels (rates for each respective dose level: 0.01, 0.015, 0.02, 0.025, 0.03, 0.04, 0.05, 0.1, 0.17, and 0.3). Correct curve assigns 30% initial DLT rate (before seeing data) at dose one so that experimentation starts at dose one. Rates under correct curve for each dose level: 0.30, 0.40, 0.48, 0.56, 0.64, 0.72, 0.80, 0.88, 0.92, and 0.99.
Abbreviation: DLT, dose-limiting toxicity.
*
Prior/initial values: 50 mg, level 10.
†
Prior/initial values: 1 mg, level one.