Table 3 Probability of rejecting the null hypothesis at two sided 0.05 level (n = 500 subjects per arm) in simulation study II
Scenario | True effect size from which data was simulated a | Median observed proportions of RC and NI in drug A b | Median observed proportions of RC and NI in drug B b | Rejection probability from 1000 simulation runs (10,000 simulation runs) | |
|---|---|---|---|---|---|
1. Drug B has same effect on RC as Drug A |  |  |  | Log-rank test | Gray’s k-sample test |
 A. Drug B has same effect on NI | HRrc = 1.00, HRni = 1.00 | 2.5% RC; 21.4% NI | 2.5% RC; 21.4% NI | 0.047 (0.045) | 0.0470 (0.045) |
 B. Drug B Increases NI | HRrc = 1.00, HRni = 2.72 | 2.5% RC; 21.4% NI | 1.9% RC; 38.6% NI | 0.052 (0.048) | 0.119 (0.125) |
 C. Drug B Decreases NI | HRrc = 1.00, HRni = 0.37 | 2.5% RC; 21.4% NI | 2.8% RC; 9.4% NI | 0.045 (0.047) | 0.062 (0.062) |
2.Drug B has same effect on NI as Drug A | |||||
 A. Drug B increases RC | HRrc = 2.72, HRni = 1.00 | 2.5% RC; 21.4% NI | 6.5% RC; 20.0% NI | 0.991 (0.996) | 0.995 (0.996) |
 B. Drug B decreases RC | HRrc = 0.37, HRni = 1.00 | 2.5% RC; 21.4% NI | 0.9% RC; 22.0% NI | 0.801 (0.797) | 0.804 (0.797) |
3. Drug B has different effect on both RC and NI relative to Drug A | |||||
 A. Drug B increases RC and increases NI | HRrc = 2.72, HRni = 2.72 | 2.5% RC; 21.4% NI | 5.1% RC; 36.3% NI | 0.991 (0.990) | 0.897 (0.896) |
 B. Drug B increases RC and decreases NI | HRrc = 2.72, HRni = 0.37 | 2.5% RC; 21.4% NI | 7.2% RC; 8.7% NI | 0.996 (0.723) | 0.999 (1.000) |
 C. Drug B decreases RC and increases NI | HRrc = 0.37, HRni = 2.72 | 2.5% RC; 21.4% NI | 0.7% RC; 39.5% NI | 0.714 (0.723) | 0.903 (0.910) |
 D. Drug B decreases RC and decreases NI | HRrc = 0.37, HRni = 0.37 | 2.5% RC; 21.4% NI | 1.0% RC; 9.6% NI | 0.828 (0.820) | 0.713 (0.718) |