Maximum observed HR to achieve statistical significance (two-sided alpha=0.05) and maximum observed HR that satisfies the LL95%CI rule for maximal RB,

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Maximum observed HR to achieve statistical significance (two-sided alpha=0.05) and maximum observed HR that satisfies the LL95%CI rule for maximal RB, for a range of design HRs . Maximum observed HR to achieve statistical significance (two-sided alpha=0.05) and maximum observed HR that satisfies the LL95%CI rule for maximal RB, for a range of design HRs . Note: design HR=true HR. (A) OS, median control ≤12 months; PFS, all medians: LL95%CI ≤0.65. (B) OS: median control >12 months: LL95%CI ≤0.70. Annotation: Symbols and shaded area: red for power 80%, blue for power 90%. Stars: maximum observed HR to achieve statistical significance (two-sided significance level 0.05). Circles: maximum observed HR that would satisfy the LL95%CI rule for maximal RB score for significant trials. Progressively smaller vertical linear segments: corresponding estimated 95% CIs (for observed HR). Dotted horizontal lines with median control/gain values listed on the right y-axis: observed HR that would correspond to required AB gains and control medians, that is, HR=0.80 broadly corresponds to a 3-month gain for a 12-month median control. Non-shaded area in the figures: range for design HR for which stars and circles are identical, representing trials targeting relatively big benefit. Shaded area in the figures: range for design HR starting above a certain value, beyond which circles are progressively lower than stars, representing trials targeting smaller benefit. Urania Dafni et al. ESMO Open 2017;2:e000216 Copyright © European Society for Medical Oncology. All rights reserved.