Table 1.
Impact of Variation in Observed Versus Estimated Control Arm Median on 1) Absolute Difference That Can Be Detected With Designed Study Power and 2) the Power to Detect Target Absolute Improvement
Estimated Control Arm Median, Months | Target Hazard Ratio (HR) | Target Absolute Improvement, Months | Designed Study Power to Detect Target HR | Observed Control Arm Median (Ratio to Original Estimate) | Absolute Difference That Can Be Detected With Designed Study Power, Months | Power to Detect Target Absolute Improvement |
---|---|---|---|---|---|---|
15 | 0.833 | 3 | 80 | 15 (1) | 3.0 | 80 |
15 | 0.833 | 3 | 80 | 16.875 (1.125) | 3.375 | 71 |
15 | 0.833 | 3 | 80 | 18.75 (1.25) | 3.75 | 63 |
15 | 0.833 | 3 | 90 | 15 (1) | 3.0 | 90 |
15 | 0.833 | 3 | 90 | 16.875 (1.125) | 3.375 | 83 |
15 | 0.833 | 3 | 90 | 18.75 (1.25) | 3.75 | 75 |
30 | 0.833 | 6 | 80 | 30 (1) | 6.0 | 80 |
30 | 0.833 | 6 | 80 | 33.75 (1.125) | 6.75 | 71 |
30 | 0.833 | 6 | 80 | 37.5 (1.25) | 7.5 | 63 |
30 | 0.833 | 6 | 90 | 30 (1) | 6.0 | 90 |
30 | 0.833 | 6 | 90 | 33.75 (1.125) | 6.75 | 83 |
30 | 0.833 | 6 | 90 | 37.5 (1.25) | 7.5 | 75 |
Abbreviation: HR, hazard ratio.