{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,20]],"date-time":"2026-02-20T07:35:38Z","timestamp":1771572938456,"version":"3.50.1"},"reference-count":46,"publisher":"Public Library of Science (PLoS)","issue":"2","license":[{"start":{"date-parts":[[2026,2,2]],"date-time":"2026-02-02T00:00:00Z","timestamp":1769990400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Bethune Charitable Foundation 2024 'Radiant China' Pharmaceutical Research Capacity Building Grant","award":["YLSY-ZH-QT-202410(019)"],"award-info":[{"award-number":["YLSY-ZH-QT-202410(019)"]}]},{"name":"Guangxi Science and Technology Major Project","award":["GuikeAA22096030"],"award-info":[{"award-number":["GuikeAA22096030"]}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To detect and quantify adverse drug event (ADE) signals linked to 120\u2009mg denosumab in the real world.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We queried the US Food and Drug Administration Adverse Event Reporting System (FAERS) for reports on 120\u2009mg denosumab, standardized, and categorized these events with Preferred Terms (PT) and System Organ Classes (SOC) from MedDRA version 27.1. Disproportionality analysis was performed using the reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We identified 10,963 ADE reports for 120\u2009mg of denosumab. Among 10 963 reports, 41.6% of patients were\u2009\u2265\u200965 years old, 37.1% were from the United States, and 17.7% were from Japan; 77.0% were serious. Data mining revealed 294 positive disproportionality signals across 27 SOCs. The highest signal proportions were for neoplasms (15.99%), musculoskeletal disorders (13.27%), infections (11.56%), gastrointestinal disorders (10.88%), and procedural complications (10.20%). The most frequent ADEs were osteonecrosis of the jaw (n\u2009=\u20093,082, 28.11%), death (n\u2009=\u2009803, 7.32%), hypocalcemia (n\u2009=\u2009799, 7.29%), and fatigue (n\u2009=\u2009282, 2.57%). The strongest signals by ROR were bone giant cell tumor (7888.08), bone giant cell tumor malignant (6502.96), osteonecrosis of the jaw (396.57), and bone giant cell tumor benign (312.37). Thirty-two unlisted events were identified, including exostosis of jaw, osteosarcoma, tooth fracture, and bone lesions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Clinicians should maintain vigilance for both established toxicities and these 32 emerging signals to ensure the safety of patients receiving 120\u2009mg of denosumab for oncological purposes.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pone.0342188","type":"journal-article","created":{"date-parts":[[2026,2,2]],"date-time":"2026-02-02T18:46:43Z","timestamp":1770058003000},"page":"e0342188","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":1,"title":["Mining the FAERS database reveals new safety signals for 120\u2009mg denosumab in oncology practice"],"prefix":"10.1371","volume":"21","author":[{"given":"Shaohuan","family":"Lu","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dongxiao","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Caiming","family":"Xiong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jialing","family":"Liang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yang","family":"Li","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Canhua","family":"Liang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qianxi","family":"Chen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-3240-5191","authenticated-orcid":true,"given":"Guangyi","family":"Meng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2026,2,2]]},"reference":[{"issue":"3","key":"pone.0342188.ref001","doi-asserted-by":"crossref","first-page":"195","DOI":"10.1358\/dot.2023.59.3.3453905","article-title":"Monoclonal 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