Table 3 START:REACTS study planning and observed trial data. Numbers of participants providing outcome data at 3, 6 and 12 months, information (\(\text {I}=1/\text {var}(\beta _{s})\)) and test statistic (\(Z=\beta _{s}/\text {sd}(\beta _{s})\)) 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 | Â | Interim | End | Interim | End | ||
| Â | Â | 1 | 2 | Â | 1 | 2 | Â |
12 months | \(N_{3}\) | 50 | 70 | 188 | 47 | - | - |
6 months | \(N_{2}\) | 90 | 110 | 188 | 86 | - | - |
3 months | \(N_{1}\) | 120 | 140 | 188 | 112 | - | - |
Information | I | 0.102 | 0.139 | 0.326 | 0.110 | - | - |
Information fraction | \(\tau\) | 0.311 | 0.426 | 1.000 | - | - | - |
Test statistic | Z | - | - | - | -0.881 | - | - |
Boundary | lower | -0.706 | 0.581 | 1.909 | - | - | - |
| Â | upper | \(\infty\) | 3.090 | 1.909 | - | - | - |