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Table 2 Power (based on an α = 0.05) of the secondary outcomes and serious adverse events provided inclusion of 800 patients into the EuroHYP-1 trial

From: Statistical analysis plan for the EuroHYP-1 trial: European multicentre, randomised, phase III clinical trial of the therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke

Outcome Proportion or mean value in control group Standard deviation in the control group for continuous outcome Minimal relevant intervention effect - absolute risk reduction relative to control group Power
Score of NIHSS at 91 +/-14 days (sample size = 800) 8 pointsa 5 pointsa 2 pointsa 1.00
Serious adverse events at 91 +/-14 days (sample size = 800) 20% NR 10% 0.98
Death or dependency, defined as modified Rankin score > 2 at 91 +/-14 days (sample size = 800) 63% NR 7.25% 0.55
Brain infarct size at 48 +/-24 hours (sample size = 800) 10 mla 15 mla 2 mla 0.47
EQ-5D-5 L score at 91 +/-14 days (sample size = 800) 0.50 points 0.40 points 0.05 points 0.42
Death at 91 +/-14 days (sample size = 800) 17% NR 3.84% 0.33
  1. NIHSS National Institutes of Health Stroke Score, EQ-5D-5 L EuroQoL quality-of-life scale, NR not relevant
  2. aAssumed values
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