{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T03:30:38Z","timestamp":1786591838588,"version":"build-2736575974"},"reference-count":55,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,4,29]],"date-time":"2024-04-29T00:00:00Z","timestamp":1714348800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2024,4,29]],"date-time":"2024-04-29T00:00:00Z","timestamp":1714348800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Guidelines recommend low\u2010molecular\u2010weight heparins (LMWHs) for patients with cancer\u2010associated thrombosis. However, until recently, only dalteparin and tinzaparin were approved in the European Economic Area (EEA) for these patients. This study compares the benefit\u2013risk profile of enoxaparin with dalteparin and tinzaparin for the extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrence in adult patients with active cancer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A semi\u2010quantitative structured benefit\u2013risk assessment was conducted for the label\u2010extension application of enoxaparin based on the benefit\u2013risk action team descriptive framework: define decision context; determine key benefit and risk outcomes; identify data sources; extract data; interpret results.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The key benefits were defined as reduced all\u2010cause mortality and venous thromboembolism (VTE) recurrence (including symptomatic DVT, fatal PE or non\u2010fatal PE); the key risks were major and non\u2010major bleeding of clinical significance, and heparin\u2010induced thrombocytopenia (HIT). Enoxaparin demonstrated comparable effects for the reduction of VTE recurrence and all\u2010cause mortality versus other EEA\u2010approved LMWHs (dalteparin, tinzaparin). There was no evidence of a significant difference between enoxaparin and the comparator groups with regard to incidence of major and non\u2010major bleeding. The data on HIT were too limited to assess the difference between the two groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The assessment demonstrated a favourable benefit\u2013risk profile for enoxaparin similar to that of other EEA\u2010approved LMWHs for the treatment of DVT and PE and the prevention of recurrence in patients with active cancer and thus supported the label\u2010extension approval.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.5795","type":"journal-article","created":{"date-parts":[[2024,4,29]],"date-time":"2024-04-29T03:23:47Z","timestamp":1714361027000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Structured benefit\u2013risk assessment for enoxaparin, in the context of its label extension, for the extended treatment of deep vein thrombosis and pulmonary embolism, and prevention of its recurrence in patients with active cancer"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2606-776X","authenticated-orcid":false,"given":"Marie\u2010Laure","family":"K\u00fcrzinger","sequence":"first","affiliation":[{"name":"Sanofi, Global Epidemiology and Benefit\u2010Risk, PSPV  Gentilly France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chantal","family":"El\u2010Haddad","sequence":"additional","affiliation":[{"name":"Sanofi, Global Epidemiology and Benefit\u2010Risk, PSPV  Gentilly France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatiana","family":"Gouin\u2010Soboleva","sequence":"additional","affiliation":[{"name":"Sanofi, Global Patient Safety &amp; Pharmacovigilance  Gentilly France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zita","family":"Fazekas","sequence":"additional","affiliation":[{"name":"Sanofi, Global Regulatory Affairs\u2010EU\u2010GenMed  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9889-3358","authenticated-orcid":false,"given":"Denis","family":"Granados","sequence":"additional","affiliation":[{"name":"Sanofi, Global Epidemiology and Benefit\u2010Risk, PSPV  Gentilly France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Benito\u2010Garcia","sequence":"additional","affiliation":[{"name":"Sanofi, Global Medical Evidence Generation  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasmina","family":"Djoudi","sequence":"additional","affiliation":[{"name":"Sanofi, Global Medical Cardiovascular  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,4,29]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1182\/asheducation\u20102013.1.684"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.23062"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1182\/bloodadvances.2020003442"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1182\/hematology.2020002268"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chest.2015.11.026"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.2147\/VHRM.S83718"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.160.6.761"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1378\/chest.11\u20102301"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.19.01461"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdr392"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2000.18.17.3078"},{"key":"e_1_2_13_13_1","unstructured":"Clexane Forte Syringes SmPC.Accessed March 2024.https:\/\/www.medicines.org.uk\/emc\/product\/1695\/smpc#gref"},{"key":"e_1_2_13_14_1","unstructured":"PROTECT: BRAT framework.Accessed March 2024.https:\/\/imi-protect-eu.cc.ic.ac.uk\/BRAT.html"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/2042098620976951"},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3636"},{"key":"e_1_2_13_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3676"},{"key":"e_1_2_13_18_1","unstructured":"US Food and Drug Administration.Benefit\u2013risk Assessment for New Drug and Biological Products. 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