Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein‐Jr phase 3 dose‐exposure‐response evaluation-Reference-Cited by-同舟云学术

Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein‐Jr phase 3 dose‐exposure‐response evaluation

Published:2020-06-04 Issue:7 Volume:18 Page:1672-1685
ISSN:1538-7933
Container-title:Journal of Thrombosis and Haemostasis
language:en
Short-container-title:J Thromb Haemost

Author:

Young Guy¹^ORCID,Lensing Anthonie W. A.²,Monagle Paul³⁴,Male Christoph⁵,Thelen Kirstin²,Willmann Stefan²,Palumbo Joseph S.⁶⁷,Kumar Riten⁸,Nurmeev Ildar⁹,Hege Kerry¹⁰,Bajolle Fanny¹¹,Connor Philip¹²,Hooimeijer Hélène L.¹³,Torres Marcela¹⁴,Chan Anthony K. C.¹⁵^ORCID,Kenet Gili¹⁶¹⁷,Holzhauer Susanne¹⁸,Santamaría Amparo¹⁹,Amedro Pascal²⁰,Beyer‐Westendorf Jan²¹,Martinelli Ida²²^ORCID,Massicotte M. Patricia²³,Smith William T.²⁴,Berkowitz Scott D.²⁴^ORCID,Schmidt Stephan²⁵,Price Victoria²⁶,Prins Martin H.²⁷,Kubitza Dagmar²,

Affiliation:

1. Children's Hospital Los Angeles University of Southern California Keck School of Medicine Los Angeles CA USA

2. Bayer AG Wuppertal Germany

3. Department of Clinical Haematology Royal Children's Hospital Haematology Research Murdoch Children's Research Institute Parkville Vic. Australia

4. Department of Paediatrics University of Melbourne Parkville Vic. Australia

5. Department of Paediatrics Medical University of Vienna Vienna Austria

6. Cancer and Blood Diseases Institute Cincinnati Children's Hospital Medical Center Cincinnati OH USA

7. Department of Pediatrics University of Cincinnati College of Medicine Cincinnati OH USA

8. Nationwide Children's Hospital The Ohio State University Columbus OH USA

9. Kazan State Medical University Kazan Russia

10. Riley Hospital For Children at IU Health Indianapolis IN USA

11. M3C‐Necker Enfants malades Université Paris DescartesSorbonne Paris Cité Paris France

12. The Noah's Ark Children's Hospital for Wales Cardiff UK

13. Department of Hematology and Oncology Beatrix Children's Hospital University Medical Center Groningen Groningen The Netherlands

14. Department of Hematology and Oncology Cook Children's Medical Center Fort Worth TX USA

15. McMaster Children's Hospital Hamilton ON Canada

16. Sackler Faculty of Medicine Tel Aviv University Tel Aviv Israel

17. The Israeli National Hemophilia Center and Thrombosis Unit The Amalia Biron Thrombosis Research Institute Sheba Medical Center Tel Hashomer Israel

18. Department of Pediatric Hematology and Oncology Charité University Medicine Berlin Germany

19. Hemostasis and Thrombosis Unit Department of Hematology University Hospital Vall d'Hebron Barcelona Spain

20. Paediatric and Congenital Cardiology Department M3C Regional Reference Centre Montpellier University Hospital PhyMedExp INSERMCNRS Montpellier France

21. Division of Haematology and Haemostaseology Department of Medicine I Department of Haematology University Hospital "Carl Gustav Carus" Dresden King's Thrombosis Service King's College London London UK

22. A. Bianchi Bonomi Hemophilia and Thrombosis Center Fondazione IRCCS Ca' Granda ‐ Ospedale Maggiore Policlinico Milano Italy

23. Department of Paediatrics University of Alberta Edmonton AB Canada

24. Bayer U.S., LLC Whippany NJ USA

25. Department of Pharmaceutics Center for Pharmacometrics and Systems Pharmacology University of Florida OR USA

26. Division of Pediatric Hematology/Oncology Department of Pediatrics Dalhousie UniversityIWK Health Centre Halifax NS Canada

27. Department of Clinical Epidemiology and Medical Technology Assessment Maastricht University Medical Center Maastricht The Netherlands

Funder

Janssen Research and Development

Bayer

Publisher

Wiley

Subject

Hematology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/jth.14813

Reference24 articles.

1. Antithrombotic Therapy for VTE Disease

2. Antithrombotic Therapy in Neonates and Children

3. An open-label randomized controlled trial of low molecular weight heparin compared to heparin and coumadin for the treatment of venous thromboembolic events in children: the REVIVE trial

4. European Medicines Agency.Rivaroxaban paediatric investigation plan.2017.http://www.ema.europa.eu/docs/en_GB/document_library/PIP_decision/WC500232013.pdf. Accessed April 2019.

5. FDA list of pediatric written requests issued.https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050002.htm. Accessed April 2019.

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