2.4 Comparison of simulated results among ROCKET AF, XANTUS, and two observational studies
The simulated outcomes for hypothetical cohorts of patients with the marginal covariate distributions similar to XANTUS, and two observational studies were predicted, respectively. Hypothetical cohorts of 7000 rivaroxaban patients were simulated for XANTUS. Similarly, 7000 rivaroxaban patients and 7000 warfarin patients were simulated for the other two observational studies, respectively. The DES model developed and validated in RCT patients was used to estimated outcomes for the three observational study populations. This process was conducted by replacing the baseline characteristics of RCT cohorts with the simulated cohorts of the observational studies. The event rates, RDs, HRs and RHRs were estimated.