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Table 3 Probability of rejecting the null hypothesis at two sided 0.05 level (n = 500 subjects per arm) in simulation study II

From: Evaluating antimalarial efficacy in single-armed and comparative drug trials using competing risk survival analysis: a simulation study

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)
  1. aHazard ratio for recrudescence and new infections derived as the ratio of the respective cause-specific hazard function (Fig. 5.6)
  2. HRrc Hazard ratio for recrudescence for drug B relative to drug A
  3. HRni Hazard ratio for new infection for drug B relative to drug A
  4. bmedian observed proportion from 1000 simulation runs
  5. RC Recrudescence, NI New infection