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Table 5 Re-analysis over two stages of trials with final result showing evidence of a difference employing PFS as an intermediate outcome.

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

 

ICON4

RE01

one-sided sig.

e I

%

ρ

e I

%

ρ

level at stage 1

 

err.

  

err.

 

0.5

75

0.04

0.27

53

3.18

0.27

0.4

97

0.20

0.29

69

4.58

0.31

0.3

125

0.03

0.36

88

1.08

0.34

0.2

162

0.26

0.39

114

0.26

0.39

0.1

221

0.12

0.44

155

0.46

0.46

  1. e I gives the number of control arm events for the significance level at stage 1, % err. gives the percentage of trials out of 5000 which were stopped, ρ gives the correlation between the test statistic at stage 1 on the intermediate outcome and at the final analysis on the primary outcome