{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T16:42:31Z","timestamp":1792600951760,"version":"4.5.0"},"reference-count":16,"publisher":"S. Karger AG","license":[{"start":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T00:00:00Z","timestamp":1790035200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/karger.com\/pages\/terms-and-conditions"},{"start":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T00:00:00Z","timestamp":1790035200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/karger.com\/pages\/terms-and-conditions"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Gynecol Obstet Invest"],"abstract":"<jats:p>Objectives: Mirvetuximab soravtansine (MIRV) received FDA approval for folate receptor alpha-positive, platinum-resistant epithelial ovarian cancer. Its post-marketing safety profile outside the trial setting has not been systematically characterized. This study aimed to characterize real-world adverse event signals associated with MIRV. Design: A retrospective disproportionality analysis was performed using FDA Adverse Event Reporting System (FAERS). Participants\/Materials: All reported MIRV-adverse event pairs were evaluated using frequentist and Bayesian disproportionality metrics. Setting: The study used data from the FAERS. Methods: Frequentist metrics and Bayesian metrics were calculated for each MIRV-event pair to identify signals meeting pre-specified disproportionality thresholds. Results: Of 474 drug-event pairs evaluated, 56 (11.8%) met signal criteria. Ocular toxicity dominated, with 22 signals including keratopathy (proportional reporting ratio [PRR] = 1,306.90; n = 35) and corneal epithelial microcysts (PRR = 2,318.20; n = 5). Pneumonitis was the most clinically prominent non-ocular signal (PRR = 61.63; n = 57). Peripheral neuropathy had the highest absolute case count (n = 65; PRR = 19.41). Limitations: As a spontaneous reporting database analysis, FAERS is subject to reporting bias, under-reporting, and lack of a denominator for true incidence estimation; disproportionality signals reflect statistical association, not confirmed causality. Conclusions: Post-marketing FAERS data corroborate the established safety profile, with strong disproportionality signals for ocular toxicity, pneumonitis, and peripheral neuropathy. These findings underscore the need for prospective confirmation as MIRV exposure accumulates.<\/jats:p>","DOI":"10.1159\/goi\/aczag012","type":"journal-article","created":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T11:09:52Z","timestamp":1789988992000},"page":"1-1","source":"Crossref","is-referenced-by-count":0,"title":["Post-Market Safety Analysis of Mirvetuximab Soravtansine: A Pharmacovigilance Analysis from a Large, Real-World Database"],"prefix":"10.1159","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4080-3030","authenticated-orcid":false,"given":"Connor","family":"Frey","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"127","published-online":{"date-parts":[[2026,9,22]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.22.01900"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1136\/ijgc-2024-005401"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2023.0197"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-23-0991"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.16250"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2024.11.011"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2309169"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0325760"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1002\/pds.677"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(24)01295-9"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2026.14557"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-18-2474"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1097\/ICU.0000000000001063"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1016\/j.ygyno.2024.10.013"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1007\/s11096-023-01673-y"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1158\/1535-7163.MCT-10-0644"}],"container-title":["Gynecologic and Obstetric Investigation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/karger.com\/article-pdf\/doi\/10.1159\/goi\/aczag012","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T16:02:03Z","timestamp":1792598523000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/goi\/aczag012"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,22]]},"references-count":16,"URL":"https:\/\/doi.org\/10.1159\/goi\/aczag012","archive":["Portico"],"relation":{},"ISSN":["0378-7346","1423-002X"],"issn-type":[{"value":"0378-7346","type":"print"},{"value":"1423-002X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,22]]}}}