Table 4.
Percentages of adaptive trial simulations that demonstrated futility in the overall cohort and proceed to subsequent subgroup selection
| Analysis stage at subgroup selection |
Total % of simulations that result in subgroup selection by stage |
Subgroup selected | |||||
|---|---|---|---|---|---|---|---|
| C1 | C1–2 | C1–3 | C1–4 | C1–5 | |||
| Cat #1 | 1st interim | 34.6% | 20.5% | 1.1% | 1.2% | 4.1% | 7.8% |
| 2nd interim | 16.9% | 8.2% | 0.2% | 0.3% | 2.1% | 6.1% | |
| Final | 23.9% | 8.6% | 0.1% | 0.3% | 2.5% | 12.5% | |
| Total | 75.4% | 37.3% | 1.4% | 1.8% | 8.7% | 26.3% | |
| Cat #2 | 1st interim | 29.4% | 1.6% | 24.6% | 1.0% | 0.0% | 2.2% |
| 2nd interim | 15.1% | 0.1% | 13.3% | 0.4% | 0.0% | 1.3% | |
| Final | 22.5% | 0.0% | 19.8% | 0.4% | 0.0% | 2.2% | |
| Total | 67.0% | 1.8% | 57.8% | 1.8% | 0.0% | 5.7% | |
Cat #1 indicates categorization scheme #1 in which patients are categorized based on time and location of the arterial occlusion. Cat #2 indicates categorization scheme #2 in which patients are categorized only based on time. C1-y indicates a subgroup that consists of consecutive patient categories. See figure 1 for the exact criteria that define each patient category in scheme #1 and #2.