Table 2.
Randomization sequence
| Accrual | Treatment assignment |
Probability of randomization* |
Outcome at 100 days |
Probability of success† |
|---|---|---|---|---|
| 1 | 7.5 mg/kg | --- | Failure | -- |
| 2 | 4.5 mg/kg | --- | Success | -- |
| 3 | 4.5 mg/kg | --- | Success | -- |
| 4 | 4.5 mg/kg | --- | Success | -- |
| 5 | 7.5 mg/kg | --- | Success | -- |
| 6 | 7.5 mg/kg | --- | Failure | -- |
| 7 | 4.5 mg/kg | --- | Success | -- |
| 8 | 7.5 mg/kg | --- | Failure | -- |
| 9 | 7.5 mg/kg | --- | Success | -- |
| 10 | 4.5 mg/kg | --- | Success | 0.94 |
| 11 | 4.5 mg/kg | 0.9 | Success | 0.94 |
| 12 | 4.5 mg/kg | 0.9 | Success | 0.93 |
| 13 | 4.5 mg/kg | 0.9 | Failure | 0.93 |
| 14 | 4.5 mg/kg | 0.9 | Success | 0.93 |
| 15 | 4.5 mg/kg | 0.9 | Success | 0.93 |
| 16 | 4.5 mg/kg | 0.9 | Success | 0.93 |
| 17 | 4.5 mg/kg | 0.9 | Success | 0.95 |
| 18 | 4.5 mg/kg | 0.9 | Success | 0.95 |
| 19 | 4.5 mg/kg | 0.9 | Failure | 0.93 |
| 20 | 4.5 mg/kg | 0.9 | Failure | 0.93 |
*
The first 10 patients were assigned to treatment by sampling without replacement from a pool of 5 slots for 4.5 mg/kg and 5 slots for 7.5 mg/kg. The maximum randomization probability for either treatment arm is 0.9 per the study design.
†
Success defined as: 4.5 mg/kg is better than 7.5 mg/kg