{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,23]],"date-time":"2026-03-23T04:48:32Z","timestamp":1774241312951,"version":"3.50.1"},"reference-count":40,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,8,18]],"date-time":"2025-08-18T00:00:00Z","timestamp":1755475200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"},{"start":{"date-parts":[[2025,8,18]],"date-time":"2025-08-18T00:00:00Z","timestamp":1755475200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Sci Rep"],"DOI":"10.1038\/s41598-025-14710-9","type":"journal-article","created":{"date-parts":[[2025,8,18]],"date-time":"2025-08-18T13:00:13Z","timestamp":1755522013000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Signal mining and risk analysis of tisotumab vedotin adverse events based on the FAERS database"],"prefix":"10.1038","volume":"15","author":[{"given":"JuanJuan","family":"Li","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yang","family":"Zhao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xueqin","family":"Yang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juan","family":"Zheng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ting","family":"Yuan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qian","family":"Tang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mei","family":"Guo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,8,18]]},"reference":[{"issue":"6","key":"14710_CR1","first-page":"394","volume":"68","author":"F Bray","year":"2018","unstructured":"Bray, F. et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J. Clin. 68(6), 394\u2013424 (2018).","journal-title":"CA Cancer J. Clin."},{"issue":"3","key":"14710_CR2","first-page":"209","volume":"71","author":"H Sung","year":"2021","unstructured":"Sung, H. et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 Countries. CA Cancer J. Clin. 71(3), 209\u2013249 (2021).","journal-title":"CA Cancer J. Clin."},{"key":"14710_CR3","doi-asserted-by":"publisher","first-page":"48","DOI":"10.1016\/j.gore.2017.09.003","volume":"22","author":"AS Zamorano","year":"2017","unstructured":"Zamorano, A. S. et al. Repeating platinum\/bevacizumab in recurrent or progressive cervical cancer yields marginal survival benefits. Gynecol. Oncol. Rep. 22, 48\u201351 (2017).","journal-title":"Gynecol. Oncol. Rep."},{"issue":"3","key":"14710_CR4","doi-asserted-by":"publisher","first-page":"153","DOI":"10.1016\/j.clon.2016.10.002","volume":"29","author":"J McLachlan","year":"2017","unstructured":"McLachlan, J. et al. The impact of systemic therapy beyond first-line treatment for advanced cervical cancer. Clin. Oncol. 29(3), 153\u2013160 (2017).","journal-title":"Clin. Oncol."},{"issue":"1","key":"14710_CR5","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1158\/1541-7786.MCR-19-0582","volume":"18","author":"P Khongorzul","year":"2020","unstructured":"Khongorzul, P. et al. Antibody-drug conjugates: A comprehensive review. Mol. Cancer Res. 18(1), 3\u201319 (2020).","journal-title":"Mol. Cancer Res."},{"issue":"2","key":"14710_CR6","doi-asserted-by":"publisher","first-page":"139","DOI":"10.6004\/jadpro.2023.14.2.4","volume":"14","author":"CR Arn","year":"2023","unstructured":"Arn, C. R., Halla, K. J. & Gill, S. Tisotumab vedotin safety and tolerability in clinical practice: Managing adverse events. J. Adv. Pract. Oncol. 14(2), 139\u2013152 (2023).","journal-title":"J. Adv. Pract. Oncol."},{"issue":"3","key":"14710_CR7","doi-asserted-by":"publisher","first-page":"383","DOI":"10.1016\/S1470-2045(18)30859-3","volume":"20","author":"JS de Bono","year":"2019","unstructured":"de Bono, J. S. et al. Tisotumab vedotin in patients with advanced or metastatic solid tumours (InnovaTV 201): A first-in-human, multicentre, phase 1\u20132 trial. Lancet Oncol. 20(3), 383\u2013393 (2019).","journal-title":"Lancet Oncol."},{"issue":"5","key":"14710_CR8","doi-asserted-by":"publisher","first-page":"609","DOI":"10.1016\/S1470-2045(21)00056-5","volume":"22","author":"RL Coleman","year":"2021","unstructured":"Coleman, R. L. et al. Efficacy and safety of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204\/GOG-3023\/ENGOT-cx6): A multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 22(5), 609\u2013619 (2021).","journal-title":"Lancet Oncol."},{"issue":"17","key":"14710_CR9","first-page":"63","volume":"8","author":"R Ando","year":"2011","unstructured":"Ando, R. et al. Tissue factor expression in human pterygium. Mol. Vis. 8(17), 63\u201369 (2011).","journal-title":"Mol. Vis."},{"issue":"4","key":"14710_CR10","doi-asserted-by":"publisher","first-page":"519","DOI":"10.1038\/labinvest.2010.184","volume":"91","author":"Y Cho","year":"2011","unstructured":"Cho, Y. et al. Evidence for enhanced tissue factor expression in age-related macular degeneration. Lab Invest. 91(4), 519\u2013526 (2011).","journal-title":"Lab Invest."},{"issue":"2","key":"14710_CR11","doi-asserted-by":"publisher","first-page":"283","DOI":"10.1002\/cncr.34507","volume":"129","author":"Y Zhu","year":"2023","unstructured":"Zhu, Y. et al. Treatment-related adverse events of antibody-drug conjugates in clinical trials: A systematic review and meta-analysis. Cancer 129(2), 283\u2013295 (2023).","journal-title":"Cancer"},{"issue":"6","key":"14710_CR12","doi-asserted-by":"publisher","first-page":"1220","DOI":"10.1158\/1078-0432.CCR-19-2962","volume":"26","author":"DS Hong","year":"2020","unstructured":"Hong, D. S. et al. Tisotumab vedotin in previously treated recurrent or metastatic cervical cancer. Clin. Cancer Res. 26(6), 1220\u20131228 (2020).","journal-title":"Clin. Cancer Res."},{"issue":"8","key":"14710_CR13","doi-asserted-by":"publisher","first-page":"2788","DOI":"10.1111\/cas.15443","volume":"113","author":"K Yonemori","year":"2022","unstructured":"Yonemori, K. et al. Tisotumab vedotin in Japanese patients with recurrent\/metastatic cervical cancer: Results from the innovaTV 206 study. Cancer Sci. 113(8), 2788\u20132797 (2022).","journal-title":"Cancer Sci."},{"issue":"36","key":"14710_CR14","doi-asserted-by":"publisher","first-page":"5536","DOI":"10.1200\/JCO.23.00720","volume":"41","author":"I Vergote","year":"2023","unstructured":"Vergote, I. et al. Tisotumab vedotin in combination with carboplatin, pembrolizumab, or bevacizumab in recurrent or metastatic cervical cancer: Results from the innovaTV 205\/GOG-3024\/ENGOT-cx8 study. J. Clin. Oncol. 41(36), 5536\u20135549 (2023).","journal-title":"J. Clin. Oncol."},{"key":"14710_CR15","doi-asserted-by":"publisher","first-page":"175883592412776","DOI":"10.1177\/17588359241277647","volume":"16","author":"F Camarda","year":"2024","unstructured":"Camarda, F. et al. Antibody drug conjugates in recurrent or metastatic cervical cancer: A focus on tisotumab vedotin state of art. Ther. Adv. Med. Oncol. 16, 17588359241277648 (2024).","journal-title":"Ther. Adv. Med. Oncol."},{"key":"14710_CR16","unstructured":"U.S. Food and Drug Administration. NDA\/BLA Multi-Disciplinary Review and Evaluation: BLA 761208; Tivdak, Tisotumab vedotin-tftv. Accessed Jul 2025. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2021\/761208Orig1s000MultidisciplineR.pdf."},{"issue":"18","key":"14710_CR17","doi-asserted-by":"publisher","first-page":"2141","DOI":"10.1007\/s40265-021-01633-8","volume":"81","author":"A Markham","year":"2021","unstructured":"Markham, A. Tisotumab vedotin: First approval. Drugs 81(18), 2141\u20132147 (2021).","journal-title":"Drugs"},{"issue":"8","key":"14710_CR18","doi-asserted-by":"publisher","first-page":"e556","DOI":"10.1016\/j.cllc.2022.08.014","volume":"23","author":"DA Kaland","year":"2022","unstructured":"Kaland, D. A. et al. U.S. food and drug administration analysis of newly identified adverse events with lurbinectedin: Extravasation, rhabdomyolysis, and tumor lysis syndrome. Clin. Lung Cancer 23(8), e556\u2013e562 (2022).","journal-title":"Clin. Lung Cancer"},{"issue":"12","key":"14710_CR19","doi-asserted-by":"publisher","first-page":"e0278725","DOI":"10.1371\/journal.pone.0278725","volume":"17","author":"Y Yang","year":"2022","unstructured":"Yang, Y. et al. A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for venetoclax. PLoS ONE 17(12), e0278725 (2022).","journal-title":"PLoS ONE"},{"issue":"4","key":"14710_CR20","doi-asserted-by":"publisher","first-page":"315","DOI":"10.1007\/s002280050466","volume":"54","author":"A Bate","year":"1998","unstructured":"Bate, A. et al. A Bayesian neural network method for adverse drug reaction signal generation. Eur. J. Clin. Pharmacol. 54(4), 315\u2013321 (1998).","journal-title":"Eur. J. Clin. Pharmacol."},{"issue":"6","key":"14710_CR21","doi-asserted-by":"publisher","first-page":"483","DOI":"10.1002\/pds.677","volume":"10","author":"SJ Evans","year":"2001","unstructured":"Evans, S. J., Waller, P. C. & Davis, S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol. Drug Saf. 10(6), 483\u2013486 (2001).","journal-title":"Pharmacoepidemiol. Drug Saf."},{"issue":"6","key":"14710_CR22","doi-asserted-by":"publisher","first-page":"381","DOI":"10.2165\/00002018-200225060-00001","volume":"25","author":"A Szarfman","year":"2002","unstructured":"Szarfman, A., Machado, S. G. & O\u2019Neill, R. T. Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA\u2019s spontaneous reports database. Drug Saf. 25(6), 381\u2013392 (2002).","journal-title":"Drug Saf."},{"issue":"1","key":"14710_CR23","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1002\/pds.668","volume":"11","author":"EP van Puijenbroek","year":"2002","unstructured":"van Puijenbroek, E. P. et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol. Drug Saf. 11(1), 3\u201310 (2002).","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"14710_CR24","doi-asserted-by":"publisher","first-page":"106601","DOI":"10.1016\/j.intimp.2020.106601","volume":"84","author":"Y Hu","year":"2020","unstructured":"Hu, Y. et al. Colitis following the use of immune checkpoint inhibitors: A real-world analysis of spontaneous reports submitted to the FDA adverse event reporting system. Int. Immunopharmacol. 84, 106601 (2020).","journal-title":"Int. Immunopharmacol."},{"key":"14710_CR25","doi-asserted-by":"publisher","first-page":"101535","DOI":"10.1016\/j.eclinm.2022.101535","volume":"50","author":"YD Yan","year":"2022","unstructured":"Yan, Y. D. et al. Toxicity spectrum of immunotherapy in advanced lung cancer: A safety analysis from clinical trials and a pharmacovigilance system. EClinicalMedicine 50, 101535 (2022).","journal-title":"EClinicalMedicine"},{"issue":"7","key":"14710_CR26","doi-asserted-by":"publisher","first-page":"796","DOI":"10.7150\/ijms.6048","volume":"10","author":"T Sakaeda","year":"2013","unstructured":"Sakaeda, T. et al. Data mining of the public version of the FDA adverse event reporting system. Int. J. Med. Sci. 10(7), 796\u2013803 (2013).","journal-title":"Int. J. Med. Sci."},{"key":"14710_CR27","doi-asserted-by":"publisher","first-page":"15","DOI":"10.1186\/s40780-018-0109-z","volume":"4","author":"Y Noguchi","year":"2018","unstructured":"Noguchi, Y. et al. Signals of gastroesophageal reflux disease caused by incretin-based drugs: A disproportionality analysis using the Japanese adverse drug event report database. J. Pharm. Health Care Sci. 4, 15 (2018).","journal-title":"J. Pharm. Health Care Sci."},{"key":"14710_CR28","doi-asserted-by":"publisher","first-page":"103828","DOI":"10.1016\/j.ajp.2023.103828","volume":"90","author":"Q Zhou","year":"2023","unstructured":"Zhou, Q. et al. Adverse events of epidiolex: A real-world drug safety surveillance study based on the FDA adverse event reporting system (FAERS) database. Asian J. Psychiatr. 90, 103828 (2023).","journal-title":"Asian J. Psychiatr."},{"key":"14710_CR29","doi-asserted-by":"publisher","first-page":"1495137","DOI":"10.3389\/fimmu.2024.1495137","volume":"15","author":"H Chen","year":"2024","unstructured":"Chen, H. et al. Ocular adverse events associated with antibody-drug conjugates: A comprehensive pharmacovigilance analysis. Front. Immunol. 15, 1495137 (2024).","journal-title":"Front. Immunol."},{"issue":"8","key":"14710_CR30","doi-asserted-by":"publisher","first-page":"734","DOI":"10.1056\/NEJMoa1309748","volume":"370","author":"KS Tewari","year":"2014","unstructured":"Tewari, K. S. et al. Improved survival with bevacizumab in advanced cervical cancer. N. Engl. J. Med. 370(8), 734\u2013743 (2014).","journal-title":"N. Engl. J. Med."},{"issue":"10103","key":"14710_CR31","doi-asserted-by":"publisher","first-page":"1654","DOI":"10.1016\/S0140-6736(17)31607-0","volume":"390","author":"KS Tewari","year":"2017","unstructured":"Tewari, K. S. et al. Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (gynecologic oncology group 240). Lancet 390(10103), 1654\u20131663 (2017).","journal-title":"Lancet"},{"issue":"1","key":"14710_CR32","doi-asserted-by":"publisher","first-page":"39","DOI":"10.1093\/jjco\/hyw143","volume":"47","author":"T Sugiyama","year":"2017","unstructured":"Sugiyama, T. et al. A single-arm study evaluating bevacizumab, cisplatin, and paclitaxel followed by single-agent bevacizumab in Japanese patients with advanced cervical cancer. Jpn. J. Clin. Oncol. 47(1), 39\u201346 (2017).","journal-title":"Jpn. J. Clin. Oncol."},{"issue":"4","key":"14710_CR33","doi-asserted-by":"publisher","first-page":"235","DOI":"10.2500\/ajra.2015.29.4183","volume":"29","author":"S Shimizu","year":"2015","unstructured":"Shimizu, S. et al. Tissue factor and tissue factor pathway inhibitor in nasal mucosa and nasal secretions of chronic rhinosinusitis with nasal polyp. Am. J. Rhinol. Allergy 29(4), 235\u2013242 (2015).","journal-title":"Am. J. Rhinol. Allergy"},{"issue":"7","key":"14710_CR34","doi-asserted-by":"publisher","first-page":"1","DOI":"10.12968\/hmed.2021.0071","volume":"82","author":"J Ahmed","year":"2021","unstructured":"Ahmed, J. et al. Management of epistaxis: A guide for junior doctors. Br. J. Hosp. Med. 82(7), 1\u20138 (2021).","journal-title":"Br. J. Hosp. Med."},{"issue":"9","key":"14710_CR35","doi-asserted-by":"publisher","first-page":"759","DOI":"10.1016\/S0002-9343(00)00437-X","volume":"108","author":"R Manfredini","year":"2000","unstructured":"Manfredini, R., Gallerani, M. & Portaluppi, F. Seasonal variation in the occurrence of epistaxis. Am. J. Med. 108(9), 759\u2013760 (2000).","journal-title":"Am. J. Med."},{"issue":"8","key":"14710_CR36","doi-asserted-by":"publisher","first-page":"641","DOI":"10.1038\/s41573-023-00709-2","volume":"22","author":"C Dumontet","year":"2023","unstructured":"Dumontet, C. et al. Antibody-drug conjugates come of age in oncology. Nat. Rev. Drug Discov. 22(8), 641\u2013661 (2023).","journal-title":"Nat. Rev. Drug Discov."},{"issue":"421","key":"14710_CR37","doi-asserted-by":"publisher","first-page":"115534","DOI":"10.1016\/j.taap.2021.115534","volume":"15","author":"RL Best","year":"2021","unstructured":"Best, R. L. et al. Microtubule and tubulin binding and regulation of microtubule dynamics by the antibody drug conjugate (ADC) payload, monomethyl auristatin E (MMAE): Mechanistic insights into MMAE ADC peripheral neuropathy. Toxicol. Appl. Pharmacol. 15(421), 115534 (2021).","journal-title":"Toxicol. Appl. Pharmacol."},{"issue":"19","key":"14710_CR38","doi-asserted-by":"publisher","first-page":"1812","DOI":"10.1056\/NEJMoa1002965","volume":"363","author":"A Younes","year":"2010","unstructured":"Younes, A. et al. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N. Engl. J. Med. 363(19), 1812\u20131821 (2010).","journal-title":"N. Engl. J. Med."},{"issue":"8","key":"14710_CR39","doi-asserted-by":"publisher","first-page":"e343","DOI":"10.1038\/bcj.2015.72","volume":"5","author":"S Mariotto","year":"2015","unstructured":"Mariotto, S. et al. Brentuximab vedotin: Axonal microtubule\u2019s Apollyon. Blood Cancer J. 5(8), e343 (2015).","journal-title":"Blood Cancer J."},{"issue":"4","key":"14710_CR40","doi-asserted-by":"publisher","first-page":"537","DOI":"10.1111\/jocd.12308","volume":"16","author":"A Rossi","year":"2017","unstructured":"Rossi, A. et al. Chemotherapy-induced alopecia management: Clinical experience and practical advice. J. Cosmet. Dermatol. 16(4), 537\u2013541 (2017).","journal-title":"J. Cosmet. Dermatol."}],"container-title":["Scientific Reports"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s41598-025-14710-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41598-025-14710-9","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41598-025-14710-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,10]],"date-time":"2025-09-10T01:52:43Z","timestamp":1757469163000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s41598-025-14710-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,18]]},"references-count":40,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2025,12]]}},"alternative-id":["14710"],"URL":"https:\/\/doi.org\/10.1038\/s41598-025-14710-9","relation":{},"ISSN":["2045-2322"],"issn-type":[{"value":"2045-2322","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,18]]},"assertion":[{"value":"9 April 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 August 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 August 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"30212"}}