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
| 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 |
NIHSS National Institutes of Health Stroke Score, EQ-5D-5 L EuroQoL quality-of-life scale, NR not relevant
aAssumed values