{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T03:25:00Z","timestamp":1790220300105,"version":"4.1.0"},"reference-count":43,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2020,1,1]],"date-time":"2020-01-01T00:00:00Z","timestamp":1577836800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100011096","name":"Jazz Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011096","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clin Appl Thromb Hemost"],"published-print":{"date-parts":[[2020,1,1]]},"abstract":"<jats:p>Defibrotide is approved to treat hepatic veno-occlusive disease\/sinusoidal obstruction syndrome (VOD\/SOS) with renal\/pulmonary dysfunction following hematopoietic cell transplantation (HCT) in adult and pediatric patients in the United States, and to treat severe hepatic VOD\/SOS post-HCT in adult and pediatric patients aged &gt;1 month in the European Union. The defibrotide prescribing information warns that defibrotide may increase bleeding risk in VOD\/SOS patients. To broaden our understanding of the incidence of bleeding with defibrotide, we performed a meta-analysis of the published literature of defibrotide use outside of the post-HCT VOD\/SOS setting. Of 1857 records identified, 125 reported on defibrotide; 23 contained data on bleeding events. The estimated overall incidence of bleeding events was 1% (95% confidence interval [CI]: 0%-2%) and 8% (95% CI: 3%-14%) in studies using intravenous defibrotide and studies with controls, respectively. The risk ratio for bleeding events with intravenous defibrotide versus controls was 0.36 (95% CI: 0.24-0.52; P &lt; .00001) among studies with data on intravenous defibrotide and controls. This meta-analysis of defibrotide use outside of the post-HCT VOD\/SOS setting suggests that the incidence of bleeding with defibrotide is lower than controls.<\/jats:p>","DOI":"10.1177\/1076029620935202","type":"journal-article","created":{"date-parts":[[2020,7,20]],"date-time":"2020-07-20T13:09:50Z","timestamp":1595250590000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["A Meta-Analysis Evaluating the Incidence of Bleeding Events With Intravenous Defibrotide Treatment Outside the Veno-Occlusive Disease\/Sinusoidal Obstruction Syndrome Setting"],"prefix":"10.1177","volume":"26","author":[{"given":"William","family":"Tappe","sequence":"first","affiliation":[{"name":"Jazz Pharmaceuticals, Palo Alto, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6273-0346","authenticated-orcid":false,"given":"Saurabh","family":"Aggarwal","sequence":"additional","affiliation":[{"name":"NOVEL Health Strategies, Bethesda, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ozlem","family":"Topaloglu","sequence":"additional","affiliation":[{"name":"NOVEL Health Strategies, Bethesda, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimo","family":"Iacobelli","sequence":"additional","affiliation":[{"name":"Techitra s.r.l., Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2020,7,20]]},"reference":[{"key":"bibr1-1076029620935202","doi-asserted-by":"publisher","DOI":"10.1517\/14740338.2012.749855"},{"key":"bibr2-1076029620935202","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2017008375"},{"key":"bibr3-1076029620935202","doi-asserted-by":"publisher","DOI":"10.1016\/j.vph.2013.05.001"},{"key":"bibr4-1076029620935202","doi-asserted-by":"publisher","DOI":"10.1089\/oli.2006.16.105"},{"key":"bibr5-1076029620935202","doi-asserted-by":"publisher","DOI":"10.1177\/1060028017732586"},{"key":"bibr6-1076029620935202","doi-asserted-by":"publisher","DOI":"10.1038\/sj.leu.2403004"},{"key":"bibr7-1076029620935202","unstructured":"European Medicines Agency. 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Defibrotide treatment in adults with severe or very severe veno-occlusive disease\/sinusoidal obstruction syndrome after haematopoietic cell transplantation: DEFIFrance study interim results. 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