The NMSOAP collected serial patient reported survey data, medical records, pharmacy data and claims data. All patients were prescribed FDA-approved novel oral anticoagulants [NOACs: Xarelto® (rivaroxaban), Pradaxa® (dabigatran), or Eliquis® (apixaban)] or standard-of-care Coumadin® (warfarin or generics). Indications for oral anticoagulation (OAC) therapy included prevention of cardiac thrombi and stroke associated with atrial fibrillation (AFib), deep venous thrombo-embolism and pulmonary embolism, or other physician prescribed uses of oral anticoagulants. Clinical outcomes including gastro-intestinal bleeding, all-cause mortality and stroke were reported to the FDA.
The data confirmed that the NMSOAP program:
The real-world post-marketing data collected in the NMSOAP demonstrated that: