Table 3.
START:REACTS study planning and observed trial data. Numbers of participants providing outcome data at 3, 6 and 12 months, information () and test statistic () boundaries in [a] the expected (planned) study design based on extensive simulations and [b] observed in the trial itself. Note that the trial was stopped at the first interim analysis for futility, as the test statistic fell below the lower boundary
| [a] Expected | [b] Observed | ||||||
|---|---|---|---|---|---|---|---|
| Outcome | Interim | End | Interim | End | |||
| 1 | 2 | 1 | 2 | ||||
| 12 months | 50 | 70 | 188 | 47 | - | - | |
| 6 months | 90 | 110 | 188 | 86 | - | - | |
| 3 months | 120 | 140 | 188 | 112 | - | - | |
| Information | I | 0.102 | 0.139 | 0.326 | 0.110 | - | - |
| Information fraction | 0.311 | 0.426 | 1.000 | - | - | - | |
| Test statistic | Z | - | - | - | -0.881 | - | - |
| Boundary | lower | -0.706 | 0.581 | 1.909 | - | - | - |
| upper | 3.090 | 1.909 | - | - | - | ||