Dosing Regimen Prediction and Confirmation With Rivaroxaban for Thromboprophylaxis in Children After the Fontan Procedure: Insights From the Phase III UNIVERSE Study
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B. McCrindle | L. Lesko | A. Michelson | Jennifer S. Li | P. Zhu | S. Willmann | D. Kubitza | K. Harris | P. Zannikos | Wangda Zhou | L. Pina | Traci Weber | Haitao Yang | Kimberly Nessel | Wangda Zhou | Lawrence J. Lesko | W. Zhou
[1] S. Y. Amy Cheung,et al. Pediatric Extrapolation in Type 2 Diabetes: Future Implications of a Workshop , 2020, Clinical pharmacology and therapeutics.
[2] M. Prins,et al. Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein‐Jr phase 3 dose‐exposure‐response evaluation , 2019, Journal of thrombosis and haemostasis : JTH.
[3] M. Prins,et al. Bodyweight-adjusted rivaroxaban for children with venous thromboembolism (EINSTEIN-Jr): results from three multicentre, single-arm, phase 2 studies. , 2019, The Lancet. Haematology.
[4] B. McCrindle,et al. Rivaroxaban, a direct Factor Xa inhibitor, versus acetylsalicylic acid as thromboprophylaxis in children post-Fontan procedure: Rationale and design of a prospective, randomized trial (the UNIVERSE study). , 2019, American heart journal.
[5] P. Monagle,et al. Exploratory evaluation of pharmacodynamics, pharmacokinetics and safety of rivaroxaban in children and adolescents: an EINSTEIN-Jr phase I study , 2018, Thrombosis Journal.
[6] J. Lippert,et al. Pharmacokinetics of rivaroxaban in children using physiologically based and population pharmacokinetic modelling: an EINSTEIN-Jr phase I study , 2018, Thrombosis Journal.
[7] M. Prins,et al. Rivaroxaban versus standard anticoagulation for acute venous thromboembolism in childhood. Design of the EINSTEIN-Jr phase III study , 2018, Thrombosis Journal.
[8] M. Sharland,et al. Pharmacokinetic–Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance , 2018, Clinical Pharmacokinetics.
[9] S. Willmann,et al. Integrated Population Pharmacokinetic Analysis of Rivaroxaban Across Multiple Patient Populations , 2018, CPT: pharmacometrics & systems pharmacology.
[10] D. Murphy,et al. Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned. , 2018 .
[11] A. Agarwal,et al. Thrombosis and Thromboembolic Complications in Fontan Patients , 2014, Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis.
[12] J. L. Todd,et al. Prevention and treatment of thrombosis in pediatric and congenital heart disease: a scientific statement from the American Heart Association. , 2013, Circulation.
[13] W. Mueck,et al. Clinical Pharmacokinetic and Pharmacodynamic Profile of Rivaroxaban , 2013, Clinical Pharmacokinetics.
[14] J. Lippert,et al. Development of a Paediatric Population-Based Model of the Pharmacokinetics of Rivaroxaban , 2013, Clinical Pharmacokinetics.
[15] B. McCrindle,et al. Thrombotic complications and thromboprophylaxis across all three stages of single ventricle heart palliation. , 2012, The Journal of pediatrics.
[16] S. Vesely,et al. Antithrombotic therapy in neonates and children: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. , 2012, Chest.
[17] Sean M. O'Brien,et al. Center variation in patient age and weight at Fontan operation and impact on postoperative outcomes. , 2011, The Annals of thoracic surgery.
[18] M. Gent,et al. Rivaroxaban for the prevention of venous thromboembolism after hip or knee arthroplasty , 2010, Thrombosis and Haemostasis.
[19] B. Eriksson,et al. Oral, direct Factor Xa inhibition with BAY 59‐7939 for the prevention of venous thromboembolism after total hip replacement , 2006, Journal of thrombosis and haemostasis : JTH.
[20] Michael Becka,et al. Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939—an oral, direct Factor Xa inhibitor—after multiple dosing in healthy male subjects , 2005, European Journal of Clinical Pharmacology.
[21] M. Gent,et al. BAY 59‐7939: an oral, direct Factor Xa inhibitor for the prevention of venous thromboembolism in patients after total knee replacement. A phase II dose‐ranging study , 2005, Journal of thrombosis and haemostasis : JTH.
[22] G. Wensing,et al. Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59‐7939, an oral, direct factor Xa inhibitor , 2005, Clinical pharmacology and therapeutics.
[23] J. Hess,et al. Intracardiac thrombus formation after the Fontan operation. , 2000, The Journal of thoracic and cardiovascular surgery.
[24] P. Gillette,et al. Transesophageal echocardiography detects thrombus formation not identified by transthoracic echocardiography after the Fontan operation. , 1991, Journal of the American College of Cardiology.
[25] D. Siegal,et al. Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants: A Systematic Review , 2017, Chest.