Estimation of the cardiovascular events required to fall below the FDA target cut-off in the design of a cardiovascular safety non-inferiority trial as a function of the expected true HR of the intervention (for 90% power)8
| True HR | Upper HR boundary | <1.8 | <1.3 |
|---|---|---|---|
| 0.70 | 48 | 110 | |
| 0.75 | 55 | 139 | |
| 0.80 | 64 | 179 | |
| 0.85 | 75 | 233 | |
| 0.90 | 88 | 311 | |
| 0.95 | 103 | 428 | |
| 1.0 | 122 | 611 | |
| 1.05 | 145 | 921 | |
| 1.1 | 174 | 1507 |
Non-inferiority margin.
FDA, Food and Drug Administration.