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The 21st Century Cures Act allows the US Food and Drug Administration (FDA) to utilize real-world data (RWD) to create real-world evidence (RWE) for new indications or post approval study requirements. We compared central adjudication with two insurance claims data sources to understand how endpoint accuracy differences impact RWE results. We developed a decision analytic model to compare differences in efficacy (all-cause death, stroke and myocardial infarction) and safety (bleeding requiring transfusion) results for a simulated acute

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In multivariate only cesarean delivery (odds ratio [OR], 2.68; 95% confidence interval [CI], 1.05-6.86) and gestational age at delivery (OR, 0.39; 95% CI, 0.22-0.67) maintain association with outcomes. The area under the curve for the mWHO risk is 0.75. Conclusions There is a high rate of adverse events in patients with heart disease during pregnancy. Gestational age and cesarean delivery behaved as predictors of adverse maternal-fetal outcomes. The mWHO risk classification had an acceptable prediction of adverse outcomes.Inherited mutat