Parameter | ICON3 | ICON4 | RE01 | FOCUS |
---|---|---|---|---|
Number of arms | 2 | 2 | 2 | 5 |
Targeted hazard ratio intermediate outcome | 0.75 | 0.75 | 0.71 | 0.73 |
Targeted hazard ratio final outcome | 0.75 | 0.74 | 0.71 | 0.73 |
Power at 1st stage | 95% | 95% | 95% | 95% |
Power at 2nd stage | 90% | 90% | 90% | 90% |
Overall power (given by nstage.ado program) | 87.4% | 87.4% | 87.4% | 87.4% |
Significance level at 2nd stage (one-sided) | 2.5% | 2.5% | 2.5% | 0.5% |
Overall significance level (for stage 1 α = 0.1) | 1.39% | 1.39% | 1.39% | 0.35% |
Allocation ratio (control:experimental) | 2:1 | 1:1 | 1:1 | 2:1:1:1:1 |
Intermediate outcome (median survival) | 1.5 years | 10 months | 2.5 months | 9 months |
Final outcome (median survival) | 3 years | 23 months | 10 months | 9 months |