Table 1.
Potential scenarios for sample size and power for Mega-ROX Brains.
Control event ratea | Sample size | Absolute mortality effect (i.e., percentage reduction) detectable with 90% power and a two-sided significance level of 0.05 |
---|---|---|
20% | 7500 | 2.91 |
20% | 8000 | 2.82 |
20% | 8500 | 2.74 |
20% | 9000 | 2.66 |
20% | 9500 | 2.59 |
25% | 7500 | 3.17 |
25% | 8000 | 3.07 |
25% | 8500 | 2.98 |
25% | 9000 | 2.90 |
25% | 9500 | 2.82 |
30% | 7500 | 3.37 |
30% | 8000 | 3.27 |
30% | 8500 | 3.17 |
30% | 9000 | 3.08 |
30% | 9500 | 3.00 |
35% | 7500 | 3.53 |
35% | 8000 | 3.41 |
35% | 8500 | 3.31 |
35% | 9000 | 3.22 |
35% | 9500 | 3.14 |
40% | 7500 | 3.64 |
40% | 8000 | 3.52 |
40% | 8500 | 3.42 |
40% | 9000 | 3.32 |
40% | 9500 | 3.23 |
The control event rate is assumed in-hospital all-cause mortality up to 90 d from the date of randomisation in participants allocated to conservative oxygen therapy (the comparator arm). No loss to follow-up is assumed.