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However, the safety and effectiveness of apixaban in clinical practice have not yet been elucidated thoroughly among Japanese <jats:styled-content style=\"fixed-case\">NVAF<\/jats:styled-content> patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A postmarketing surveillance study was conducted to determine the safety and effectiveness of apixaban. Patients were followed\u2010up for 104\u00a0weeks. Outcome events included adverse drug reactions (<jats:styled-content style=\"fixed-case\">ADR<\/jats:styled-content>s), hemorrhages, and thromboembolic events (ischemic stroke, systemic embolism [<jats:styled-content style=\"fixed-case\">SE<\/jats:styled-content>], and transient ischemic attack [<jats:styled-content style=\"fixed-case\">TIA<\/jats:styled-content>]).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 6306 <jats:styled-content style=\"fixed-case\">NVAF<\/jats:styled-content> patients in the safety analysis set (age, 74.5\u00a0\u00b1\u00a010.1\u00a0years; women, 41.1%; and <jats:styled-content style=\"fixed-case\">CHADS<\/jats:styled-content><jats:sub>2<\/jats:sub> score, 2.0\u00a0\u00b1\u00a01.4), 3600 patients (57.1%) received the standard dose (5\u00a0mg twice daily) and 2694 (42.7%) received a reduced dose (2.5\u00a0mg twice daily) of apixaban. <jats:styled-content style=\"fixed-case\">ADR<\/jats:styled-content>s occurred in 604 patients (9.58%), with the most common being epistaxis (0.86%), subcutaneous hemorrhage (0.67%), and hematuria (0.57%). Incidence rate of any hemorrhages and major hemorrhage was 5.52% per year and 2.36% per year, respectively. Incidence rate of ischemic stroke\/<jats:styled-content style=\"fixed-case\">SE<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">TIA<\/jats:styled-content> was 1.00% per year among 6286 patients in the effectiveness analysis set. Among three subgroups (3106 apixaban initiators, 2038 patients switched from warfarin, and 1118 patients switched from other <jats:styled-content style=\"fixed-case\">NOAC<\/jats:styled-content>s), incidence rates of major hemorrhage (<jats:italic>P<\/jats:italic>\u00a0=\u00a00.221 for trend) and ischemic stroke\/<jats:styled-content style=\"fixed-case\">SE<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">TIA<\/jats:styled-content> (<jats:italic>P<\/jats:italic>\u00a0=\u00a00.686 for trend) were comparable.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>No new safety signals of apixaban were identified in Japanese <jats:styled-content style=\"fixed-case\">NVAF<\/jats:styled-content> patients. Safety and effectiveness of apixaban were consistent with those in the <jats:styled-content style=\"fixed-case\">ARISTOTLE<\/jats:styled-content> study.<\/jats:p><\/jats:sec>","DOI":"10.1002\/joa3.12184","type":"journal-article","created":{"date-parts":[[2019,5,9]],"date-time":"2019-05-09T10:44:38Z","timestamp":1557398678000},"page":"506-514","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Safety and effectiveness of apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A regulatory postmarketing surveillance, the <scp>STANDARD<\/scp> study"],"prefix":"10.1002","volume":"35","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0775-8936","authenticated-orcid":false,"given":"Hiroshi","family":"Inoue","sequence":"first","affiliation":[{"name":"Saiseikai Toyama Hospital  Toyama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michiaki","family":"Umeyama","sequence":"additional","affiliation":[{"name":"Bristol\u2010Myers Squibb K.K.  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