{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T04:22:04Z","timestamp":1792297324503,"version":"4.4.0"},"reference-count":32,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2020,6,24]],"date-time":"2020-06-24T00:00:00Z","timestamp":1592956800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100008272","name":"Novartis Pharmaceuticals Corporation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008272","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>Primary objective of this non\u2010interventional, post\u2010authorisation safety study was to provide real\u2010world safety data [incidence of adverse drug reactions (ADRs)\/serious adverse events (SAEs)] on adult patients with myelofibrosis exposed\/or not exposed to ruxolitinib. Key secondary objectives included the incidence\/outcome of events of special interest (bleeding events, serious\/opportunistic infections, second primary malignancies, and deaths). Overall, 462 patients were included [prevalent users\u00a0=\u00a0260, new users\u00a0=\u00a032, non\u2010exposed\u00a0=\u00a0170 (inclusive of ruxolitinib\u2010switch, <jats:italic>n<\/jats:italic>\u00a0=\u00a057)]. The exposure\u2010adjusted incidence rates (per 100 patient\u2010years) of ADRs (19\u00b73 vs. 19\u00b76) and SAEs (25\u00b72 vs. 25\u00b70) were comparable amongst new\u2010users <jats:italic>versus<\/jats:italic> prevalent\u2010users cohorts, respectively; most frequent ADRs across all cohorts included thrombocytopenia, anaemia, epistaxis, urinary tract infection, and herpes zoster. Anaemia, pneumonia, general physical health deterioration, sepsis, and death were the most frequent SAEs across all cohorts. Incidence rates of bleeding events (21\u00b76) and serious\/opportunistic infections (34\u00b75) were higher in ruxolitinib\u2010switch cohort <jats:italic>versus<\/jats:italic> other cohorts. The incidence rate of second primary malignancies was higher in the prevalent\u2010users cohort (10\u00b71) <jats:italic>versus<\/jats:italic> other cohorts. The observed safety profile of ruxolitinib in the present study along with the safety findings from the COMFORT\/JUMP\/EXPAND studies support the use of ruxolitinib for long\u2010term treatment of patients with myelofibrosis.<\/jats:p>","DOI":"10.1111\/bjh.16729","type":"journal-article","created":{"date-parts":[[2020,6,25]],"date-time":"2020-06-25T05:29:26Z","timestamp":1593062966000},"page":"764-774","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":31,"title":["Real\u2010world non\u2010interventional long\u2010term post\u2010authorisation safety study of ruxolitinib in myelofibrosis"],"prefix":"10.1111","volume":"191","author":[{"given":"Fiorenza","family":"Barraco","sequence":"first","affiliation":[{"name":"Centre Hospitalier Lyon Sud Pierre\u2010B\u00e9nite 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