{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,6]],"date-time":"2026-06-06T04:33:45Z","timestamp":1780720425937,"version":"3.54.1"},"reference-count":33,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T00:00:00Z","timestamp":1753833600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Intl Journal of Cancer"],"published-print":{"date-parts":[[2025,12,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Severe cutaneous adverse reactions (SCARs) encompassing Stevens\u2010Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) are increasingly reported among patients treated with novel antiandrogens, but the signals of disproportionate reporting and clinical features remain inadequately defined. This study was an observational retrospective pharmacovigilance study using the publicly available FAERS\/EudraVigilance\/JADER databases. To explore the signals of disproportionate reporting, disproportionality analysis was conducted using information component (IC) and reporting odds ratio (ROR) methodologies. Descriptive statistics were calculated for baseline and demographic information, onset time, and reaction outcomes. There was no disproportional signal for SCARs in patients using abiraterone, enzalutamide, and darolutamide. Significant over\u2010reporting signals for apalutamide were observed in SJS (FAERS, ROR\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u20094.12, IC\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u20091.70,\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u200930; EudraVigilance, ROR\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u200911.54, IC\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u20092.84,\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u200955; JADER, ROR\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u20092.90, IC\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u20091.33,\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u200925), TEN (FAERS, ROR025\u2009=\u20094.40, IC025\u2009=\u20091.75,\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u200929, EudraVigilance, ROR\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u200930.96, IC\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u20093.74,\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u200958; JADER, ROR\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u20095.34, IC\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u20091.85,\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u200925), DRESS (FAERS, ROR025\u2009=\u20092.68, IC025\u2009=\u20091.33,\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u200938; EudraVigilance, ROR\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u200925.06, IC\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u20093.53,\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u200955; JADER, ROR\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u20090.62, IC\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u20090.19,\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u20096) and AGEP (FAERS, ROR025\u2009=\u20091.16, IC025\u2009=\u20090.55,\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u20097; EudraVigilance, ROR\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u20094.18, IC\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u20091.02,\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u20095; JADER, ROR\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u20091.05, IC\n                    <jats:sub>025<\/jats:sub>\n                    \u2009=\u20090.45,\n                    <jats:italic>N<\/jats:italic>\n                    \u2009=\u20094). Incorporated data from 3 databases, the lethal rates of apalutamide\u2010related SCARs were 24.4% for SJS, 51.1% for TEN, and 10.5% for DRESS. The median time to onset was 41\u2009days for SJS, 29\u2009days for TEN, and 40\u2009days for DRESS, respectively. The postmarketing pharmacovigilance study suggested an association between SCARs and apalutamide use, but not for other novel antiandrogens. As apalutamide gains greater clinical use, practitioners must be aware of apalutamide\u2010SCARs risk.\n                  <\/jats:p>","DOI":"10.1002\/ijc.70059","type":"journal-article","created":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T13:34:02Z","timestamp":1753882442000},"page":"2589-2602","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Severe cutaneous adverse reactions associated with novel antiandrogens: A disproportionality analysis of three databases"],"prefix":"10.1002","volume":"157","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8320-891X","authenticated-orcid":false,"given":"Jianhong","family":"Zhu","sequence":"first","affiliation":[{"name":"College of Pharmacy Jinan University  Guangzhou China"},{"name":"Department of Pharmacy, Sun\u2010Yat\u2010Sen Memorial Hospital Sun Yat\u2010Sen University  Guangzhou China"},{"name":"Shenshan Medical Center Memorial Hospital of Sun Yat\u2010Sen University  Shanwei Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaotong","family":"Huo","sequence":"additional","affiliation":[{"name":"College of Pharmacy Jinan University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xinyu","family":"Li","sequence":"additional","affiliation":[{"name":"College of Pharmacy Jinan University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ziwen","family":"Yang","sequence":"additional","affiliation":[{"name":"College of Pharmacy Jinan University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhaohui","family":"Huang","sequence":"additional","affiliation":[{"name":"College of Pharmacy Jinan University  Guangzhou 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