number of patients in treated group = 7770 number of patients in control group = 7770 true probability of death in control = 0.01 true probability of death in treated = 0.008016032 true OR for death = 0.8 guess of OR for death used in sample size calculation = 0.6 power used in sample size calculation = 0.8 significance level used in sample size calculation = 0.05 true power = 0.2586539 true probability of mild adverse event in control = 0.05 true probability of mild adverse event in treated = 0.15 true probability of severe adverse event in control = 0.001 true probability of severe adverse event in treated = 0.002 number of deaths in control = 76 (proportion = 0.00978121 ) number of deaths in treated = 60 (proportion = 0.007722008 ) number of mild adverse events in control = 384 (proportion = 0.04942085 ) number of mild adverse events in treated = 1225 (proportion = 0.1576577 ) number of severe adverse events in control = 7 (proportion = 0.0009009009 ) number of severe adverse events in treated = 16 (proportion = 0.002059202 ) OR estimate for death (median and 95% quantile credible interval) = 0.8002109 [ 0.5890961 , 1.078902 ] probability of superiority of treatment for mortality = 0.9270833 Frequentist analysis of death (Fisher exact test output): Fisher's Exact Test for Count Data data: rbind(c(edeath_treat, edeath_contr), c(ntreat - edeath_treat, ncontr - edeath_contr)) p-value = 0.1962 alternative hypothesis: true odds ratio is not equal to 1 95 percent confidence interval: 0.5511907 1.1217086 sample estimates: odds ratio 0.7878493 Frequentist analysis of mild adverse events (Fisher exact test output): Fisher's Exact Test for Count Data data: rbind(c(emild_treat, emild_contr), c(ntreat - emild_treat, ncontr - emild_contr)) p-value < 2.2e-16 alternative hypothesis: true odds ratio is not equal to 1 95 percent confidence interval: 3.191619 4.067165 sample estimates: odds ratio 3.599732 Frequentist analysis of severe adverse events (Fisher exact test output): Fisher's Exact Test for Count Data data: rbind(c(esevere_treat, esevere_contr), c(ntreat - esevere_treat, ncontr - esevere_contr)) p-value = 0.0929 alternative hypothesis: true odds ratio is not equal to 1 95 percent confidence interval: 0.8900592 6.5817122 sample estimates: odds ratio 2.288388 Utility for death = -1e+05 Utility for mild adverse event = -20 Utility for severe adverse event = -1000 Utility for price of drug = -100 Expected utility for control = -976.5022 (Monte Carlo standard error = -0.8220013 ) Expected utility for treated = -887.946 (Monte Carlo standard error = -0.5626052 ) Stan summary for deaths: mean se_mean sd 2.5% 25% pcontr 9.744744e-03 8.202189e-06 0.0009520442 7.947041e-03 9.091815e-03 logOR -2.235005e-01 1.330956e-03 0.1545998622 -5.291659e-01 -3.270854e-01 ptreat 7.829594e-03 5.594629e-06 0.0009594336 6.043938e-03 7.162160e-03 lp__ -9.185370e+02 8.076847e-03 1.0001784746 -9.212281e+02 -9.189180e+02 50% 75% 97.5% n_eff Rhat pcontr 9.718294e-03 1.036431e-02 1.166952e-02 13472.70 1.000061 logOR -2.228799e-01 -1.190260e-01 7.594341e-02 13492.45 1.000137 ptreat 7.793224e-03 8.459702e-03 9.800119e-03 29409.47 1.000066 lp__ -9.182272e+02 -9.178262e+02 -9.175724e+02 15334.56 1.000083 Stan summary for mild adverse events: mean se_mean sd 2.5% 25% pcontr 4.991837e-02 2.409989e-05 0.002369968 4.537036e-02 4.832306e-02 logOR 1.267531e+00 5.939491e-04 0.058479929 1.153431e+00 1.227995e+00 ptreat 1.571718e-01 2.347532e-05 0.004102295 1.492425e-01 1.543825e-01 lp__ -5.012514e+03 9.303786e-03 0.995471932 -5.015218e+03 -5.012892e+03 50% 75% 97.5% n_eff Rhat pcontr 0.0498842 5.148643e-02 5.468757e-02 9670.634 1.000230 logOR 1.2674556 1.307074e+00 1.382512e+00 9694.272 1.000246 ptreat 0.1571442 1.599173e-01 1.652995e-01 30537.294 1.000018 lp__ -5012.2108801 -5.011807e+03 -5.011553e+03 11448.236 1.000438 Stan summary for severe adverse events: mean se_mean sd 2.5% 25% pcontr 1.029441e-03 1.300353e-06 0.0001736924 7.215372e-04 9.063884e-04 logOR 5.682298e-01 2.235959e-03 0.2809966822 1.179573e-02 3.806623e-01 ptreat 1.843205e-03 2.672755e-06 0.0004452985 1.079140e-03 1.524032e-03 lp__ -3.701874e+02 8.189203e-03 1.0205518343 -3.729378e+02 -3.705796e+02 50% 75% 97.5% n_eff Rhat pcontr 1.019349e-03 1.140045e-03 1.401689e-03 17841.83 1.000151 logOR 5.704921e-01 7.586599e-01 1.108408e+00 15793.36 1.000125 ptreat 1.808450e-03 2.120049e-03 2.819151e-03 27757.75 1.000029 lp__ -3.698775e+02 -3.694641e+02 -3.691940e+02 15530.55 1.000163