Table 4 SubQStim study: sample size and power calculations
Analysis | Expected difference between groups | Power (1-β) | Nominal error risk (α) | Proportion of responders | Sample size | ||
|---|---|---|---|---|---|---|---|
OMM arm | SQS arm | Evaluable patientsa | Enrolled (20% attrition rate) | ||||
Interim 1 | 30% | 80% | 1% | 35% | 65% | 140 | 176 |
Interim 2 | 25% | 85% | 1% | 37.5% | 62.5% | 220 | 276 |
Final | 20% | 90% | 3% | 40% | 60% | 314 | 392 |
For reference: one-shot analysis | 20% | 90% | 5% | 40% | 60% | 280 | 350 |