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.