{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T21:50:10Z","timestamp":1790027410667,"version":"4.0.1"},"reference-count":0,"publisher":"Georg Thieme Verlag KG","issue":"02","license":[{"start":{"date-parts":[[2020,5,23]],"date-time":"2020-05-23T00:00:00Z","timestamp":1590192000000},"content-version":"vor","delay-in-days":52,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Janssen and Bayer","award":["NCT02555878"],"award-info":[{"award-number":["NCT02555878"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["TH Open"],"published-print":{"date-parts":[[2020,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>\n          Introduction\u2003In the CASSINI study, rivaroxaban thromboprophylaxis significantly reduced primary venous thromboembolism (VTE) endpoints during the intervention period, but several thromboembolic events designated as secondary efficacy endpoints were not included in the primary analysis. This study was aimed to evaluate the full impact of rivaroxaban thromboprophylaxis on all prespecified thromboembolic endpoints occurring on study.<\/jats:p><jats:p>\n          Methods\u2003CASSINI was a double-blind, randomized, placebo-controlled study in adult ambulatory patients with cancer at risk for VTE (Khorana score \u22652). Patients were screened at baseline for deep-vein thrombosis (DVT) and randomized if none was found. The primary efficacy endpoint was a composite of lower extremity proximal DVT, symptomatic upper extremity, or lower extremity distal DVT, any pulmonary embolism, and VTE-related death. This analysis evaluated all prespecified thromboembolic endpoints occurring on study to determine the full benefit of rivaroxaban prophylaxis. All endpoints were independently adjudicated.<\/jats:p><jats:p>\n          Results\u2003Total thromboembolic events occurred in fewer patients randomized to rivaroxaban during the full study period (29\/420 [6.9%] and 49\/421 [11.6%] patients in rivaroxaban and placebo groups, respectively [hazard ratio (HR)\u2009=\u20090.57; 95% confidence interval (CI): 0.36\u20130.90; p\u2009=\u20090.01]; number needed to treat [NNT]\u2009=\u200921). Similarly, fewer patients randomized to rivaroxaban experienced thromboembolism during the intervention period (13\/420 [3.1%] patients) versus placebo (38\/421 [9.0%] patients; HR\u2009=\u20090.33; 95% CI: 0.18\u20130.62; p &lt; 0.001; NNT\u2009=\u200917).<\/jats:p><jats:p>\n          Conclusion\u2003Our findings confirm the substantial benefit of rivaroxaban thromboprophylaxis when considering all prespecified thromboembolic events, even after excluding baseline screen-detected DVT. The low NNT, coupled with prior data demonstrating a high number needed to harm, should assist clinicians in determining the risk\/benefit of thromboprophylaxis in high-risk patients with cancer.<\/jats:p>","DOI":"10.1055\/s-0040-1712143","type":"journal-article","created":{"date-parts":[[2020,5,23]],"date-time":"2020-05-23T22:33:43Z","timestamp":1590273223000},"page":"e107-e112","source":"Crossref","is-referenced-by-count":19,"title":["Assessing Full Benefit of Rivaroxaban Prophylaxis in High-Risk Ambulatory Patients with Cancer: Thromboembolic Events in the Randomized CASSINI Trial"],"prefix":"10.1055","volume":"04","author":[{"given":"Alok A.","family":"Khorana","sequence":"additional","affiliation":[{"name":"Department of Hematology and Medical Oncology, Cleveland Clinic, Cleveland, Ohio, United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mair\u00e9ad G.","family":"McNamara","sequence":"additional","affiliation":[{"name":"Division of Cancer Sciences, Department of Medical Oncology, University of Manchester, The Christie NHS Foundation Trust, Manchester, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ajay K.","family":"Kakkar","sequence":"additional","affiliation":[{"name":"Thrombosis Research Institute and University College London, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael B.","family":"Streiff","sequence":"additional","affiliation":[{"name":"Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanno","family":"Riess","sequence":"additional","affiliation":[{"name":"Department of Medicine, Charit\u00e9 Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ujjwala","family":"Vijapurkar","sequence":"additional","affiliation":[{"name":"Clinical Biostatistics, Janssen Research & Development, LLC, Raritan, New Jersey, United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simrati","family":"Kaul","sequence":"additional","affiliation":[{"name":"Medical Affairs Internal Medicine, Janssen Scientific Affairs, LLC, Titusville, New Jersey, United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Wildgoose","sequence":"additional","affiliation":[{"name":"Medical Affairs Internal Medicine, Janssen Scientific Affairs, LLC, Titusville, New Jersey, United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerald A.","family":"Soff","sequence":"additional","affiliation":[{"name":"Hematology Service, Memorial Sloan Kettering Cancer Center, New York, New York, United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the CASSINI Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2020,5,23]]},"container-title":["TH Open"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/s-0040-1712143.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,5,23]],"date-time":"2020-05-23T22:33:45Z","timestamp":1590273225000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1055\/s-0040-1712143"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,4]]},"references-count":0,"journal-issue":{"issue":"02","published-online":{"date-parts":[[2020,4,16]]},"published-print":{"date-parts":[[2020,4]]}},"URL":"https:\/\/doi.org\/10.1055\/s-0040-1712143","relation":{},"ISSN":["2512-9465"],"issn-type":[{"value":"2512-9465","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,4]]}}}