Toxicity scenario | Type of scenario | Dose Levels |
|---|
D1 | D2 | D3 | D4 | D5 |
|---|
T1 | Linear, very high | 10 | 20 |
30
| 40 | 50 |
T2 | Linear, high | 10 | 20 | 25 |
30
| 40 |
T3 | Linear, anticipated | 10 | 15 | 20 | 25 |
30
|
T4 | Linear, low | 5 | 10 | 12 | 15 | 20 |
T5 | Non-linear, variable | 5 | 15 |
30
| 50 | 70 |
- 1. Rates of recruitment scenarios (R): patients recruited randomly, with two (Poisson process) arrival rates considered:
- a. R1: routine average arrival 1 patient per week and
- b. R2: accelerated average arrival rate 1.5 patients per week.
- 2 Toxicity occurrence scenarios (T)
- 3. The DLT times (for those with a DLT) were simulated using 4 timing (DT) scenarios:
- a. DT1: uniformly between 8 and 21 days after recruitment: most plausible based on clinical experience [16]
- b. DT2: uniformly between 11 and 28 days after recruitment
- c. DT3: at either 11 or 21 days with probabilities of 25 and 75%
- d. DT4: at either 11 or 21 days with probabilities 30 and 70%.
- Bold typeface signifies acceptable DLT to declare MTD.
