{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,31]],"date-time":"2026-01-31T00:15:33Z","timestamp":1769818533929,"version":"3.49.0"},"reference-count":45,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2021,1,24]],"date-time":"2021-01-24T00:00:00Z","timestamp":1611446400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","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":[[2021,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>We examined safety outcomes of interest (SOI) and overall survival (OS) among lung cancer patients initiating crizotinib and erlotinib in routine clinical practice.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This descriptive cohort study used routinely collected health data in Denmark, Finland, Sweden, the Netherlands, and the United States (US) during 2011\u20132017, following crizotinib commercial availability in each country. Among crizotinib or erlotinib initiators, we reported baseline characteristics and incidence rates and cumulative incidences of the SOI \u2013 hepatotoxicity, pneumonitis\/interstitial lung disease, QT interval prolongation\u2010related events, bradycardia, vision disorders, renal cysts, edema, leukopenia, neuropathy, photosensitivity, malignant melanoma, gastrointestinal perforation, cardiac failure and OS. Results from the European Union (EU) countries were combined using meta\u2010analysis; results from the US were reported separately.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>There were 456 patients in the crizotinib cohort and 2957 patients in the erlotinib cohort. Rates of the SOI per 1000 person\u2010years in the crizotinib cohort ranged from 0 to 65 in the EU and from 0 to 374 in the US. Rates of the SOI per 1000 person\u2010years in the erlotinib cohort ranged from 0 to 91 in the EU and from 3 to 394 in the US. In the crizotinib cohort, 2\u2010year OS was ~50% in both EU and US. In the erlotinib cohort, 2\u2010year OS was 21% in the EU and 35% in the US.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This study describes clinical outcomes among lung cancer patients initiating crizotinib or erlotinib in routine clinical practice. Differences between SOI rates in EU and US may be partially attributable to differences in the underlying databases.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5193","type":"journal-article","created":{"date-parts":[[2021,1,15]],"date-time":"2021-01-15T05:59:04Z","timestamp":1610690344000},"page":"758-769","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Outcomes in patients with lung cancer treated with crizotinib and erlotinib in routine clinical practice: A post\u2010authorization safety cohort study conducted in Europe and in the United States"],"prefix":"10.1002","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3415-3254","authenticated-orcid":false,"given":"Vera","family":"Ehrenstein","sequence":"first","affiliation":[{"name":"Department of Clinical Epidemiology, Department of Clinical Medicine Aarhus University and Aarhus University Hospital  Aarhus N Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4643-5029","authenticated-orcid":false,"given":"Kui","family":"Huang","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Johnny","family":"Kahlert","sequence":"additional","affiliation":[{"name":"Department of Clinical Epidemiology, Department of Clinical Medicine Aarhus University and Aarhus University Hospital  Aarhus N Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shahram","family":"Bahmanyar","sequence":"additional","affiliation":[{"name":"Centre for Pharmacoepidemiology, Karolinska Institutet Karolinska University Hospital SE  Stockholm Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P\u00e4r","family":"Karlsson","sequence":"additional","affiliation":[{"name":"Centre for Pharmacoepidemiology, Karolinska Institutet Karolinska University Hospital SE  Stockholm Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2731-8532","authenticated-orcid":false,"given":"Lukas","family":"L\u00f6fling","sequence":"additional","affiliation":[{"name":"Centre for Pharmacoepidemiology, Karolinska Institutet Karolinska University Hospital SE  Stockholm Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anthony P.","family":"Nunes","sequence":"additional","affiliation":[{"name":"Optum  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheryl","family":"Enger","sequence":"additional","affiliation":[{"name":"Optum  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Irene D.","family":"Bezemer","sequence":"additional","affiliation":[{"name":"PHARMO Institute for Drug Outcomes Research  Utrecht the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4487-3546","authenticated-orcid":false,"given":"Josephina G.","family":"Kuiper","sequence":"additional","affiliation":[{"name":"PHARMO Institute for Drug Outcomes Research  Utrecht the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fabian","family":"Hoti","sequence":"additional","affiliation":[{"name":"EPID Research  Espoo Finland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rosa","family":"Juuti","sequence":"additional","affiliation":[{"name":"EPID Research  Espoo Finland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pasi","family":"Korhonen","sequence":"additional","affiliation":[{"name":"EPID Research  Espoo Finland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jingping","family":"Mo","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  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