Details Basic Details Status Ongoing Last Updated Monday, September 24, 2018 Health Outcome(s) venous thromboembolism (VTE), arterial thromboembolism (ATE) Purpose Drug and Outcome Analysis Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR Yes Result(s) (1) Venous and Arterial Thromboembolism among New Users of NuvaRing and Other Combined Hormonal Contraceptives: A Descriptive Analysis Regulatory Link(s) (1) FDA Approval Package Materials