1. Comparison of the ESMO-MCBS dual rule and the dual rule with PE thresholds exhibiting similar behaviour: %acceptance of maximal RB (solid line: RB rule) and maximal preliminary grade (dotted line: dual rule) over significant trials for different true HRs.  (A-B) PFS, 80% power - 90% power.
Comparison of the ESMO-MCBS dual rule and the dual rule with PE thresholds exhibiting similar behaviour: %acceptance of maximal RB (solid line: RB rule) and maximal preliminary grade (dotted line: dual rule) over significant trials for different true HRs.  (A-B) PFS, 80% power - 90% power. Note: Median control PFS ≤6 months: LL95%CI ≤0.65 rule vs PE<0.75 and PE<0.80; and gain ≥1.5 months.  Median control PFS >6 months: LL95%CI ≤0.65 rule vs PE<0.75 and PE<0.80; and gain ≥3 months. (C-D) OS, 80% power - 90% power. Note:  Median control OS ≤12 months: LL95%CI ≤0.65 rule vs PE<0.75 and PE<0.80; and gain ≥3 months. Median control OS >12 months (24 months): LL95%CI ≤0.70 rule vs PE<0.80 and PE<0.83; and gain ≥5 months.
Urania Dafni et al. ESMO Open 2017;2:e000216
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