{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T17:15:41Z","timestamp":1793294141898,"version":"4.5.0"},"reference-count":42,"publisher":"American Society of Hematology","issue":"7","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2020,2,13]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>This open-label, single-arm, prospective cohort trial is the first phase 3 safety study to describe outcomes in children treated with dabigatran etexilate for secondary venous thromboembolism (VTE) prevention. Eligible children aged 12 to &amp;lt;18 years (age stratum 1), 2 to &amp;lt;12 years (stratum 2), and &amp;gt;3 months to &amp;lt;2 years (stratum 3) had an objectively confirmed diagnosis of VTE treated with standard of care (SOC) for \u22653 months, or had completed dabigatran or SOC treatment in the DIVERSITY trial (NCT01895777) and had an unresolved clinical thrombosis risk factor requiring further anticoagulation. Children received dabigatran for up to 12 months, or less if the identified VTE clinical risk factor resolved. Primary end points included VTE recurrence, bleeding events, and mortality at 6 and 12 months. Overall, 203 children received dabigatran, with median exposure being 36.3 weeks (range, 0-57 weeks); 171 of 203 (84.2%) and 32 of 203 (15.8%) took capsules and pellets, respectively. Overall, 2 of 203 children (1.0%) experienced on-treatment VTE recurrence, and 3 of 203 (1.5%) experienced major bleeding events, with 2 (1.0%) reporting clinically relevant nonmajor bleeding events, and 37 (18.2%) minor bleeding events. There were no on-treatment deaths. On-treatment postthrombotic syndrome was reported for 2 of 162 children (1.2%) who had deep vein thrombosis or central-line thrombosis as their most recent VTE. Pharmacokinetic\/pharmacodynamic relationships of dabigatran were similar to those in adult VTE patients. In summary, dabigatran showed a favorable safety profile for secondary VTE prevention in children aged from &amp;gt;3 months to &amp;lt;18 years with persistent VTE risk factor(s). This trial was registered at www.clinicaltrials.gov as #NCT02197416.<\/jats:p>","DOI":"10.1182\/blood.2019000998","type":"journal-article","created":{"date-parts":[[2019,12,5]],"date-time":"2019-12-05T17:48:46Z","timestamp":1575568126000},"page":"491-504","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":96,"title":["Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children"],"prefix":"10.1182","volume":"135","author":[{"given":"Leonardo R.","family":"Brand\u00e3o","sequence":"first","affiliation":[{"name":"The Hospital for Sick Children, Toronto, ON, Canada;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuela","family":"Albisetti","sequence":"first","affiliation":[{"name":"Hematology Department, University Children\u2019s Hospital, Z\u00fcrich, Switzerland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacqueline","family":"Halton","sequence":"first","affiliation":[{"name":"Children\u2019s Hospital of Eastern Ontario, University of Ottawa, Ottawa, ON, Canada;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Bomgaars","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Texas Children\u2019s Cancer and Hematology Centers, Baylor College of Medicine, Houston, TX;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Chalmers","sequence":"first","affiliation":[{"name":"Royal Hospital for Children, Glasgow, Scotland, United Kingdom;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lesley G.","family":"Mitchell","sequence":"first","affiliation":[{"name":"Department of Pediatrics, University of Alberta, Edmonton, AB, Canada;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1023-1158","authenticated-orcid":false,"given":"Ildar","family":"Nurmeev","sequence":"first","affiliation":[{"name":"Pediatric Hospital, Republic of Tatarstan, Kazan Medical University, Kazan, Russian Federation;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pavel","family":"Svirin","sequence":"first","affiliation":[{"name":"Pediatric Hematology Department, Municipal Children\u2019s Hospital \u201cMorozovskaya,\u201d Moscow, Russian Federation;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3800-670X","authenticated-orcid":false,"given":"Tomas","family":"Kuhn","sequence":"first","affiliation":[{"name":"Pediatric Hematology\/Oncology Department, University Hospital Ostrava, Ostrava, Czech Republic;"},{"name":"Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ondrej","family":"Zapletal","sequence":"first","affiliation":[{"name":"Pediatric Hematology Department, University Hospital Brno, Brno, Czech Republic;"},{"name":"Masaryk University, Brno, Czech Republic;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Igor","family":"Tartakovsky","sequence":"first","affiliation":[{"name":"Therapeutic Area Cardiometabolic Medicine, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monika","family":"Simetzberger","sequence":"first","affiliation":[{"name":"Department of Clinical Development, Boehringer Ingelheim RCV GmbH & Co KG, Vienna, Austria;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fenglei","family":"Huang","sequence":"first","affiliation":[{"name":"Translational Medicine and Clinical Pharmacology and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhichao","family":"Sun","sequence":"first","affiliation":[{"name":"Biostatistics and Data Sciences, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00f6rg","family":"Kreuzer","sequence":"first","affiliation":[{"name":"Boehringer Ingelheim Singapore Pte Ltd, Singapore;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Savion","family":"Gropper","sequence":"first","affiliation":[{"name":"Therapeutic Area Cardiometabolic Medicine, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martina","family":"Brueckmann","sequence":"first","affiliation":[{"name":"Therapeutic Area Cardiometabolic Medicine, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany;"},{"name":"Faculty of Medicine Mannheim of the University of Heidelberg, Mannheim, Germany; 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