{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T21:11:13Z","timestamp":1792789873374,"version":"4.5.0"},"reference-count":24,"publisher":"Elsevier BV","issue":"7","license":[{"start":{"date-parts":[[2020,7,1]],"date-time":"2020-07-01T00:00:00Z","timestamp":1593561600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2020,7,1]],"date-time":"2020-07-01T00:00:00Z","timestamp":1593561600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2022,11,3]],"date-time":"2022-11-03T00:00:00Z","timestamp":1667433600000},"content-version":"vor","delay-in-days":855,"URL":"http:\/\/www.elsevier.com\/open-access\/userlicense\/1.0\/"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research and Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004326","name":"Bayer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004326","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["jthjournal.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Thrombosis and Haemostasis"],"published-print":{"date-parts":[[2020,7]]},"DOI":"10.1111\/jth.14813","type":"journal-article","created":{"date-parts":[[2020,4,4]],"date-time":"2020-04-04T06:31:12Z","timestamp":1585981872000},"page":"1672-1685","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":85,"title":["Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein\u2010Jr phase 3 dose\u2010exposure\u2010response evaluation"],"prefix":"10.1016","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6013-1254","authenticated-orcid":false,"given":"Guy","family":"Young","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthonie W.A.","family":"Lensing","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Monagle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christoph","family":"Male","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kirstin","family":"Thelen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Willmann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph S.","family":"Palumbo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Riten","family":"Kumar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ildar","family":"Nurmeev","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kerry","family":"Hege","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fanny","family":"Bajolle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Connor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H\u00e9l\u00e8ne L.","family":"Hooimeijer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcela","family":"Torres","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1551-3995","authenticated-orcid":false,"given":"Anthony K.C.","family":"Chan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gili","family":"Kenet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susanne","family":"Holzhauer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amparo","family":"Santamar\u00eda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pascal","family":"Amedro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Beyer\u2010Westendorf","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9218-3622","authenticated-orcid":false,"given":"Ida","family":"Martinelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. Patricia","family":"Massicotte","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William T.","family":"Smith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9428-4408","authenticated-orcid":false,"given":"Scott D.","family":"Berkowitz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephan","family":"Schmidt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victoria","family":"Price","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin H.","family":"Prins","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dagmar","family":"Kubitza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1111\/jth.14813_bb0010","doi-asserted-by":"crossref","first-page":"315","DOI":"10.1016\/j.chest.2015.11.026","article-title":"Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report","volume":"149","author":"Kearon","year":"2016","journal-title":"Chest"},{"issue":"2 Suppl","key":"10.1111\/jth.14813_bb0015","doi-asserted-by":"crossref","first-page":"e737S","DOI":"10.1378\/chest.11-2308","article-title":"Antithrombotic therapy in neonates and children: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence\u2010Based Clinical Practice Guidelines","volume":"141","author":"Monagle","year":"2012","journal-title":"Chest"},{"issue":"2\u20103","key":"10.1111\/jth.14813_bb0020","doi-asserted-by":"crossref","first-page":"85","DOI":"10.1016\/S0049-3848(03)00059-8","article-title":"An open\u2010label 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","volume":"109","author":"Massicotte","year":"2003","journal-title":"Thromb Res"},{"key":"10.1111\/jth.14813_bb0025","unstructured":"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."},{"key":"10.1111\/jth.14813_bb0030","unstructured":"FDA list of pediatric written requests issued. https:\/\/www.fda.gov\/Drugs\/DevelopmentApprovalProcess\/DevelopmentResources\/ucm050002.htm. Accessed April 2019."},{"issue":"1","key":"10.1111\/jth.14813_bb0035","doi-asserted-by":"crossref","first-page":"e18","DOI":"10.1016\/S2352-3026(19)30219-4","article-title":"Randomised controlled trial of rivaroxaban compared to standard anticoagulants for the treatment of acute venous thromboembolism in children","volume":"7","author":"Male","year":"2020","journal-title":"Lancet Haematol"},{"key":"10.1111\/jth.14813_bb0040","doi-asserted-by":"crossref","first-page":"675","DOI":"10.2165\/11595320-000000000-00000","article-title":"Rivaroxaban: population pharmacokinetic analyses in patients treated for acute deep vein thrombosis and exposure simulations in patients with atrial fibrillation treated for stroke prevention","volume":"50","author":"Mueck","year":"2011","journal-title":"Clin Pharmacokinet"},{"key":"10.1111\/jth.14813_bb0045","doi-asserted-by":"crossref","first-page":"2499","DOI":"10.1056\/NEJMoa1007903","article-title":"Oral rivaroxaban for symptomatic venous thromboembolism","volume":"363","year":"2010","journal-title":"N Engl J Med"},{"key":"10.1111\/jth.14813_bb0050","doi-asserted-by":"crossref","first-page":"1287","DOI":"10.1056\/NEJMoa1113572","article-title":"Oral rivaroxaban for the treatment of symptomatic pulmonary embolism","volume":"366","year":"2012","journal-title":"N Engl J Med"},{"key":"10.1111\/jth.14813_bb0055","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1186\/1477-9560-11-21","article-title":"Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN\u2010DVT and PE randomized studies","volume":"11","author":"Prins","year":"2013","journal-title":"Thromb J"},{"key":"10.1111\/jth.14813_bb0060","doi-asserted-by":"crossref","first-page":"32","DOI":"10.1186\/s12959-018-0185-1","article-title":"Pharmacokinetics of rivaroxaban in children using physiologically based and population pharmacokinetic modelling: an EINSTEIN\u2010Jr phase I study","volume":"16","author":"Willmann","year":"2018","journal-title":"Thromb J"},{"key":"10.1111\/jth.14813_bb0065","doi-asserted-by":"crossref","first-page":"89","DOI":"10.1007\/s40262-013-0090-5","article-title":"Development of a paediatric population\u2010based model of the pharmacokinetics of rivaroxaban","volume":"53","author":"Willmann","year":"2014","journal-title":"Clin Pharmacokinet"},{"key":"10.1111\/jth.14813_bb0070","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1186\/s12959-018-0186-0","article-title":"Exploratory evaluation of pharmacodynamics, pharmacokinetics and safety of rivaroxaban in children and adolescents: an EINSTEIN\u2010Junior phase I study","volume":"16","author":"Kubitza","year":"2018","journal-title":"Thromb J"},{"key":"10.1111\/jth.14813_bb0075","doi-asserted-by":"crossref","first-page":"e500","DOI":"10.1016\/S2352-3026(19)30161-9","article-title":"Bodyweight\u2010adjusted rivaroxaban for children with venous thromboembolism (EINSTEIN\u2010Jr): results from three multicenter, single\u2010arm, phase 2 studies","volume":"6","author":"Monagle","year":"2019","journal-title":"Lancet Haematol"},{"key":"10.1111\/jth.14813_bb0080","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1186\/s12959-018-0188-y","article-title":"Rivaroxaban versus standard anticoagulation for acute venous thromboembolism in childhood. Design of the EINSTEIN\u2010Jr phase III study","volume":"16","author":"Lensing","year":"2018","journal-title":"Thromb J"},{"key":"10.1111\/jth.14813_bb0085","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1186\/s12959-018-0182-4","article-title":"Clinical presentation and therapeutic management of venous thrombosis in young children: a retrospective analysis","volume":"16","author":"Chan","year":"2018","journal-title":"Thromb J"},{"key":"10.1111\/jth.14813_bb0090","doi-asserted-by":"crossref","first-page":"692","DOI":"10.1111\/j.1538-7836.2005.01204.x","article-title":"Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non\u2010surgical patients","volume":"3","author":"Schulman","year":"2005","journal-title":"J Thromb Haemost"},{"key":"10.1111\/jth.14813_bb0095","doi-asserted-by":"crossref","first-page":"2119","DOI":"10.1111\/jth.13140","article-title":"Definition of clinically relevant non\u2010major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non\u2010surgical patients: communication from the SSC of the ISTH","volume":"13","author":"Kaatz","year":"2015","journal-title":"J Thromb Haemost"},{"key":"10.1111\/jth.14813_bb0100","doi-asserted-by":"crossref","first-page":"309","DOI":"10.1002\/psp4.12288","article-title":"Integrated population pharmacokinetic analysis of rivaroxaban across multiple patient populations","volume":"5","author":"Willmann","year":"2018","journal-title":"CPT Pharmacometrics Syst Pharmacol"},{"key":"10.1111\/jth.14813_bb0105","doi-asserted-by":"crossref","first-page":"56","DOI":"10.1016\/j.ijpharm.2005.05.006","article-title":"Paediatric formulations \u2010 getting to the heart of the problem","volume":"300","author":"Standing","year":"2005","journal-title":"Int J Pharm"},{"key":"10.1111\/jth.14813_bb0110","doi-asserted-by":"crossref","first-page":"81","DOI":"10.1186\/1471-2431-13-81","article-title":"Manipulation of drugs to achieve the required dose is intrinsic to paediatric practice but is not supported by guidelines or evidence","volume":"13","author":"Richey","year":"2013","journal-title":"BMC Pediatr"},{"key":"10.1111\/jth.14813_bb0115","doi-asserted-by":"crossref","first-page":"155","DOI":"10.1016\/j.ijpharm.2016.12.032","article-title":"A systematic review of the use of dosage form manipulation to obtain required doses to inform use of manipulation in paediatric practice","volume":"518","author":"Richey","year":"2017","journal-title":"Int J Pharm"},{"key":"10.1111\/jth.14813_bb0120","first-page":"83","article-title":"Self\u2010reported fears of hospitalized school\u2010age children","volume":"2","author":"Hart","year":"1994","journal-title":"J Pediatr Nurs"},{"key":"10.1111\/jth.14813_bb0125","doi-asserted-by":"crossref","first-page":"213","DOI":"10.1177\/1367493506066482","article-title":"\u2018The most disgusting ever\u2019: children's descriptions and views of the purpose of pain","volume":"10","author":"Kortesluoma","year":"2006","journal-title":"J Child Health Care"}],"container-title":["Journal of Thrombosis and Haemostasis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fjth.14813","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jth.14813","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/jth.14813","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1538783622013290?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1538783622013290?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jth.14813","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T03:28:10Z","timestamp":1761535690000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1538783622013290"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,7]]},"references-count":24,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2020,7]]}},"alternative-id":["S1538783622013290"],"URL":"https:\/\/doi.org\/10.1111\/jth.14813","relation":{},"ISSN":["1538-7836"],"issn-type":[{"value":"1538-7836","type":"print"}],"subject":[],"published":{"date-parts":[[2020,7]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein\u2010Jr phase 3 dose\u2010exposure\u2010response evaluation","name":"articletitle","label":"Article Title"},{"value":"Journal of Thrombosis and Haemostasis","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1111\/jth.14813","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"Copyright \u00a9 2020 International Society on Thrombosis and Haemostasis. Published by Elsevier Inc. All rights reserved.","name":"copyright","label":"Copyright"}]}}