Results
The results showed lower predicted rates of stroke/ systemic embolism (SE) and major bleeding in three observational studies than those in simulated ROCKET AF. The simulated stroke/SE incidence was 1.097-1.318 per 100 patient-years and simulated major bleeding incidence was 2.804-3.238 per 100 patient-years in observational studies. The risk difference of stroke/SE and major bleeding was similar among predicted outcomes of the three observational studies. Most simulated hazard ratios (HRs) were close to the corresponding observed HRs.