Skip to main content

Table 3 Re-analysis of original trial data in trials showing evidence of an effect on the final outcome.

From: How do multi-stage, multi-arm trials compare to the traditional two-arm parallel group design – a reanalysis of 4 trials

one-sided significance

ICON4

RE01

FOCUS A vs C

level at stage 1

δ I

HR

decision

δ I

HR

decision

δ I

HR

decision

0.5

1

0.553

1

0.683

1

0.821

0.4

0.964

0.624

0.964

0.729

0.961

0.789

0.3

0.936

0.760

0.924

0.660

0.930

0.921

0.2

0.911

0.737

0.902

0.649

0.902

0.824

0.1

0.885

0.760

0.874

0.674

0.874

0.840

  1. δ I gives the cut-off hazard ratio for the intermediate outcome at a given one-sided significance level, HR gives the observed hazard ratio at that point in time, denotes that the trial would have been correctly carried on to the next stage, ✗ denotes that the trial would have been incorrectly stopped at stage 1