Skip to main content
. 2024 Feb 16;24:42. doi: 10.1186/s12874-024-02174-w

Table 3.

START:REACTS study planning and observed trial data. Numbers of participants providing outcome data at 3, 6 and 12 months, information (I=1/var(βs)) and test statistic (Z=βs/sd(βs)) 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 N3 50 70 188 47 - -
6 months N2 90 110 188 86 - -
3 months N1 120 140 188 112 - -
Information I 0.102 0.139 0.326 0.110 - -
Information fraction τ 0.311 0.426 1.000 - - -
Test statistic Z - - - -0.881 - -
Boundary lower -0.706 0.581 1.909 - - -
upper 3.090 1.909 - - -