{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,7]],"date-time":"2026-02-07T04:31:42Z","timestamp":1770438702204,"version":"3.49.0"},"reference-count":14,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2015,1,14]],"date-time":"2015-01-14T00:00:00Z","timestamp":1421193600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Cardiology"],"published-print":{"date-parts":[[2015,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>In nonvalvular atrial fibrillation (<jats:styled-content style=\"fixed-case\">NVAF<\/jats:styled-content>), rivaroxaban is used to prevent stroke and systemic embolism.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate major bleeding (MB) in NVAF patients treated with rivaroxaban in a real\u2010world clinical setting.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>From January 1, 2013, to March 31, 2014, <jats:styled-content style=\"fixed-case\">US<\/jats:styled-content> Department of Defense electronic health care records were queried to describe <jats:styled-content style=\"fixed-case\">MB<\/jats:styled-content> rates and demographics. Major bleeding was identified using a validated algorithm.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 27 467 patients receiving rivaroxaban, 496 <jats:styled-content style=\"fixed-case\">MB<\/jats:styled-content> events occurred in 478 patients, an incidence of 2.86 per 100 person\u2010years (95% confidence interval: 2.61\u20103.13). The <jats:styled-content style=\"fixed-case\">MB<\/jats:styled-content> patients were older, mean (<jats:styled-content style=\"fixed-case\">SD<\/jats:styled-content>) age of 78.4 (7.7) vs 75.7 (9.7) years, compared with non\u2010<jats:styled-content style=\"fixed-case\">MB<\/jats:styled-content> patients. Patients with <jats:styled-content style=\"fixed-case\">MB<\/jats:styled-content> had higher rates of hypertension (95.6% vs 75.8%), coronary artery disease (64.2% vs 36.7%), heart failure (48.5% vs 23.7%), and renal disease (38.7% vs 16.7%). Of <jats:styled-content style=\"fixed-case\">MB<\/jats:styled-content> patients, 63.2% were taking 20 mg, 32.2% 15 mg, and 4.6% 10 mg of rivaroxaban. Four percent of <jats:styled-content style=\"fixed-case\">MB<\/jats:styled-content> patients took warfarin within the prior 30 days. Major bleeding was most commonly gastrointestinal (88.5%) or intracranial (7.5%). Although 46.7% of <jats:styled-content style=\"fixed-case\">MB<\/jats:styled-content> patients received a transfusion, none had sufficient evidence of receiving any type of clotting factor. Fourteen died during their <jats:styled-content style=\"fixed-case\">MB<\/jats:styled-content> hospitalization, yielding a fatal bleeding incidence rate of 0.08 per 100 person\u2010years (95% confidence interval: 0.05\u20100.14). Mean age at death was 82.4 years.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In this large observational study, the <jats:styled-content style=\"fixed-case\">MB<\/jats:styled-content> rate was generally consistent with the registration trial results, and fatal bleeds were rare.<\/jats:p><\/jats:sec>","DOI":"10.1002\/clc.22373","type":"journal-article","created":{"date-parts":[[2015,1,14]],"date-time":"2015-01-14T22:46:09Z","timestamp":1421275569000},"page":"63-68","source":"Crossref","is-referenced-by-count":124,"title":["Characterizing Major Bleeding in Patients With Nonvalvular Atrial Fibrillation: A Pharmacovigilance Study of 27 467 Patients Taking Rivaroxaban"],"prefix":"10.1002","volume":"38","author":[{"given":"Sally","family":"Tamayo","sequence":"first","affiliation":[{"name":"Department of Cardiology, Naval Medical Center  Portsmouth, Virginia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"W.","family":"Frank Peacock","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, Baylor College of Medicine  Houston, Texas"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manesh","family":"Patel","sequence":"additional","affiliation":[{"name":"Department of Cardiology Duke University Health System and Duke Clinical Research Institute  Durham, North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicholas","family":"Sicignano","sequence":"additional","affiliation":[{"name":"Department of Clinical Epidemiology, Health ResearchTx  Trevose, Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kathleen P.","family":"Hopf","sequence":"additional","affiliation":[{"name":"Department of Clinical Epidemiology, Health ResearchTx  Trevose, Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Larry E.","family":"Fields","sequence":"additional","affiliation":[{"name":"Department of US Medical Affairs, Janssen Scientific Affairs, LLC  Raritan, New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Troy","family":"Sarich","sequence":"additional","affiliation":[{"name":"Department of Real World Evidence, Janssen Scientific Affairs, LLC  Titusville, New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shujian","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Global Medical Organization, Janssen Research and Development, LLC  Raritan, New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Yannicelli","sequence":"additional","affiliation":[{"name":"Department of US Medical Affairs, Janssen Scientific Affairs, LLC  Raritan, New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhong","family":"Yuan","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Janssen Research and Development, LLC  Titusville, New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,1,14]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCRESAHA.114.303211"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.2165\/11538620-000000000-00000"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000000040"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1107039"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0905561"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1009638"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1160\/TH10-09-0601"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2013.11.013"},{"key":"e_1_2_7_10_1","unstructured":"US Census Bureau. Age and sex composition in the United States:2011.http:\/\/www.census.gov\/population\/age\/data\/2011comp.html. Updated November 28 2012. Accessed May 19 2014."},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.2109"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.113.004834"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.285.22.2864"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1378\/chest.09-1584"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehu083"}],"container-title":["Clinical Cardiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fclc.22373","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/clc.22373","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/clc.22373","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/clc.22373","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,3]],"date-time":"2023-10-03T03:26:43Z","timestamp":1696303603000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/clc.22373"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,1,14]]},"references-count":14,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2015,2]]}},"alternative-id":["10.1002\/clc.22373"],"URL":"https:\/\/doi.org\/10.1002\/clc.22373","archive":["Portico"],"relation":{},"ISSN":["0160-9289","1932-8737"],"issn-type":[{"value":"0160-9289","type":"print"},{"value":"1932-8737","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,1,14]]}}}