{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T07:25:11Z","timestamp":1773300311517,"version":"3.50.1"},"reference-count":19,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2015,2,12]],"date-time":"2015-02-12T00:00:00Z","timestamp":1423699200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004328","name":"Genentech Inc","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004328","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2015,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>Using liver laboratory tests (LLTs), Hy's law is a method used to identify drug\u2010induced liver injury (DILI), after excluding other causes. Elevated LLTs in chemotherapy\u2010exposed patients may result from tumor effects or comorbidities. This study evaluated incidence of Hy's law in chemotherapy\u2010treated cancer patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We identified breast, colorectal, and lung cancer patients diagnosed in 1 January 2000 to 31 December 2007 at a Midwestern health system. Using automated data, potential Hy's law (PHL) cases were defined by patterns of elevated LLTs suggestive of DILI. Among those treated with chemotherapy, we excluded PHL patients with pre\u2010existing conditions that could cause liver injury, producing a cohort meeting Hy's law criteria, according to automated data. Medical record review, conducted among these automated data\u2010derived Hy's law patients, further excluded those with causes of liver injury other than chemotherapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Using automated data, among chemotherapy\u2010exposed patients (<jats:italic>N<\/jats:italic>\u2009=\u20092788), 91 (3.3%) met PHL criteria using LLTs and 64 (2.3%) met Hy's law after excluding underlying liver injury using the International Classification of Diseases, 9th Revision codes. After a medical record review, 62 of 64 patients qualifying as Hy's law through automated data had other potential causes, leaving two patients (0.07%; 95%CI: 0.01\u20130.24%) with chemotherapy as a likely alternative cause of liver injury.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Abnormal LLTs are common in chemotherapy\u2010treated patients. Medical record review showed that the incidence of Hy's law events is rare. These data provide context for evaluating DILI in clinical trials and postmarketing surveillance of anticancer therapies, understanding that automated data alone may substantially overestimate the number of Hy's law cases. Copyright \u00a9 2015 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.3757","type":"journal-article","created":{"date-parts":[[2015,2,13]],"date-time":"2015-02-13T10:25:08Z","timestamp":1423823108000},"page":"427-434","source":"Crossref","is-referenced-by-count":12,"title":["Incidence of liver injury among cancer patients receiving chemotherapy in an integrated health system"],"prefix":"10.1002","volume":"24","author":[{"given":"Marianne","family":"Ulcickas Yood","sequence":"first","affiliation":[{"name":"EpiSource LLC  Newton MA USA"},{"name":"Boston University School of Public Health  Boston MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michele","family":"Bortolini","sequence":"additional","affiliation":[{"name":"F. Hoffman\u2010La Roche AG  Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deborah","family":"Casso","sequence":"additional","affiliation":[{"name":"EpiSource LLC  Newton MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean G.","family":"Beck","sequence":"additional","affiliation":[{"name":"EpiSource LLC  Newton MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan A.","family":"Oliveria","sequence":"additional","affiliation":[{"name":"EpiSource LLC  Newton MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karen E.","family":"Wells","sequence":"additional","affiliation":[{"name":"Department of Public Health Sciences Henry Ford Hospital  Detroit MI USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kimberley J.","family":"Woodcroft","sequence":"additional","affiliation":[{"name":"Department of Public Health Sciences Henry Ford Hospital  Detroit MI USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisa I.","family":"Wang","sequence":"additional","affiliation":[{"name":"Genentech Inc.  South San Francisco CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,2,12]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"FDA Guidance for Industry. Drug Induced Liver Injury: Pre\u2010marketing Clinical Evaluation.FDACDER\/CBER Rockville:July 2009.http:\/\/www.fda.gov\/downloads\/Drugs\/..\/Guidances\/UCM174090.pdf[accessed 1 October 2012]."},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-137-12-200212170-00007"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra052270"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200730040-00001"},{"key":"e_1_2_9_6_1","volume-title":"Hepatotoxicity: the Adverse Effects of Drugs and Other Chemicals on the Liver","author":"Zimmerman H","year":"1978"},{"key":"e_1_2_9_7_1","volume-title":"Hepatotoxicity: the Adverse Effects of Drugs and Other Chemicals on the Liver","author":"Zimmerman H","year":"1999"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.20800"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.gastro.2005.05.006"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1209"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1211"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2008.262"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.22633"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3405"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yrtph.2008.06.001"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1053\/jhep.2002.34857"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.seminoncol.2005.11.002"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1177\/0192623309351719"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3435"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.3470"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.3757","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.3757","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,5]],"date-time":"2023-10-05T03:26:02Z","timestamp":1696476362000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.3757"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,2,12]]},"references-count":19,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2015,4]]}},"alternative-id":["10.1002\/pds.3757"],"URL":"https:\/\/doi.org\/10.1002\/pds.3757","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,2,12]]}}}