Number of patients per dose level and decision rules
| No. of evaluable patients . | No. of patients with DLT . | And/Or . | No. of patients with TRM . | Action . |
|---|---|---|---|---|
| 5 | 0-1 | And | 0 | Go to dose level N+1 with entry of 5 patients |
| 5 | 5 | Or | ≥2 | STOP; dose level N not feasible* |
| 5 | 2-4 | Or | 1 | Enter 5 more patients at dose level N |
| 10 | 0-2 | And | 0 | Go to dose level N+1 with entry of 5 patients |
| 10 | ≥5 | Or | ≥2 | STOP; dose level N not feasible* |
| 10 | 3-4 | Or | 1 | Enter 10 more patients at dose level N |
| 15 | 0-3 | And | 0 | Go to dose level N+1 with entry of 5 patients |
| 15 | ≥5 | Or | ≥2 | STOP; dose level N not feasible* |
| 15 | 4 | Or | 1 | Enter 5 more patients at dose level N |
| 20 | 0-4 | And | 0-1 | Go to dose level N+1 with entry of 5 patients |
| 20 | ≥5 | Or | ≥2 | STOP; dose level N not feasible* |
| No. of evaluable patients . | No. of patients with DLT . | And/Or . | No. of patients with TRM . | Action . |
|---|---|---|---|---|
| 5 | 0-1 | And | 0 | Go to dose level N+1 with entry of 5 patients |
| 5 | 5 | Or | ≥2 | STOP; dose level N not feasible* |
| 5 | 2-4 | Or | 1 | Enter 5 more patients at dose level N |
| 10 | 0-2 | And | 0 | Go to dose level N+1 with entry of 5 patients |
| 10 | ≥5 | Or | ≥2 | STOP; dose level N not feasible* |
| 10 | 3-4 | Or | 1 | Enter 10 more patients at dose level N |
| 15 | 0-3 | And | 0 | Go to dose level N+1 with entry of 5 patients |
| 15 | ≥5 | Or | ≥2 | STOP; dose level N not feasible* |
| 15 | 4 | Or | 1 | Enter 5 more patients at dose level N |
| 20 | 0-4 | And | 0-1 | Go to dose level N+1 with entry of 5 patients |
| 20 | ≥5 | Or | ≥2 | STOP; dose level N not feasible* |
N indicates current dose level.
Enter a total of 20 patients at dose level N-1; continue entry according to the decision rules for dose level N-1.