{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T08:54:59Z","timestamp":1781513699051,"version":"3.54.1"},"reference-count":36,"publisher":"Springer Science and Business Media LLC","issue":"8","license":[{"start":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T00:00:00Z","timestamp":1772150400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T00:00:00Z","timestamp":1772150400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Naunyn-Schmiedeberg's Arch Pharmacol"],"published-print":{"date-parts":[[2026,5]]},"DOI":"10.1007\/s00210-026-05148-5","type":"journal-article","created":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T04:11:50Z","timestamp":1772165510000},"page":"11993-12002","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Real-world disproportionality analysis of trabectedin using the United States food and drug administration adverse event reporting system"],"prefix":"10.1007","volume":"399","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1857-9180","authenticated-orcid":false,"given":"Xiaojuan","family":"Lin","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liwei","family":"Guo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaohong","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chen","family":"Yan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-3247-6904","authenticated-orcid":false,"given":"Li","family":"Lin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0812-2729","authenticated-orcid":false,"given":"Maohua","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,2,27]]},"reference":[{"issue":"4","key":"5148_CR1","doi-asserted-by":"publisher","first-page":"579","DOI":"10.1016\/j.ejca.2011.09.027","volume":"48","author":"S Baruchel","year":"2012","unstructured":"Baruchel S, Pappo A et al (2012) A phase 2 trial of trabectedin in children with recurrent rhabdomyosarcoma, Ewing sarcoma and non-rhabdomyosarcoma soft tissue sarcomas: a report from the Children\u2019s Oncology Group. Eur J Cancer 48(4):579\u2013585","journal-title":"Eur J Cancer"},{"issue":"8","key":"5148_CR2","doi-asserted-by":"publisher","first-page":"101015","DOI":"10.1016\/j.disamonth.2020.101015","volume":"66","author":"BMI Cabral","year":"2020","unstructured":"Cabral BMI, Edding SN et al (2020) Rhabdomyolysis. Dis Mon 66(8):101015","journal-title":"Dis Mon"},{"issue":"3","key":"5148_CR3","doi-asserted-by":"publisher","first-page":"476","DOI":"10.1007\/s10637-017-0546-9","volume":"36","author":"E Calvo","year":"2018","unstructured":"Calvo E, Azaro A et al (2018) Hepatic safety analysis of trabectedin: results of a pharmacokinetic study with trabectedin in patients with hepatic impairment and experience from a phase 3 clinical trial. Invest New Drugs 36(3):476\u2013486","journal-title":"Invest New Drugs"},{"key":"5148_CR4","doi-asserted-by":"publisher","first-page":"1116937","DOI":"10.3389\/fonc.2023.1116937","volume":"13","author":"SP Chawla","year":"2023","unstructured":"Chawla SP, Tellez WA et al (2023) Activity of TNT: a phase 2 study using talimogene laherparepvec, nivolumab and trabectedin for previously treated patients with advanced sarcomas (NCT# 03886311). Front Oncol 13:1116937","journal-title":"Front Oncol"},{"issue":"11","key":"5148_CR5","doi-asserted-by":"publisher","first-page":"957","DOI":"10.1080\/14737140.2020.1822744","volume":"20","author":"LM de San Gonz\u00e1lez","year":"2020","unstructured":"de San Gonz\u00e1lez LM, Martin-Broto J et al (2020) Real-world evidence of the efficacy and tolerability of trabectedin in patients with advanced soft-tissue sarcoma. Expert Rev Anticancer Ther 20(11):957\u2013963","journal-title":"Expert Rev Anticancer Ther"},{"issue":"25","key":"5148_CR6","doi-asserted-by":"publisher","first-page":"4188","DOI":"10.1200\/JCO.2008.21.0088","volume":"27","author":"GD Demetri","year":"2009","unstructured":"Demetri GD, Chawla SP et al (2009) Efficacy and safety of trabectedin in patients with advanced or metastatic liposarcoma or leiomyosarcoma after failure of prior anthracyclines and ifosfamide: results of a randomized phase II study of two different schedules. J Clin Oncol 27(25):4188\u20134196","journal-title":"J Clin Oncol"},{"issue":"8","key":"5148_CR7","doi-asserted-by":"publisher","first-page":"786","DOI":"10.1200\/JCO.2015.62.4734","volume":"34","author":"GD Demetri","year":"2016","unstructured":"Demetri GD, von Mehren M et al (2016) Efficacy and safety of trabectedin or dacarbazine for metastatic liposarcoma or leiomyosarcoma after failure of conventional chemotherapy: results of a phase III randomized multicenter clinical trial. J Clin Oncol 34(8):786\u2013793","journal-title":"J Clin Oncol"},{"issue":"10","key":"5148_CR8","doi-asserted-by":"publisher","first-page":"1360","DOI":"10.1016\/S1470-2045(18)30438-8","volume":"19","author":"G Grignani","year":"2018","unstructured":"Grignani G, D\u2019Ambrosio L et al (2018) Trabectedin and olaparib in patients with advanced and non-resectable bone and soft-tissue sarcomas (TOMAS): an open-label, phase 1b study from the Italian Sarcoma Group. Lancet Oncol 19(10):1360\u20131371","journal-title":"Lancet Oncol"},{"issue":"30s","key":"5148_CR9","doi-asserted-by":"publisher","first-page":"13","DOI":"10.2217\/fon-2022-0518","volume":"18","author":"G Grignani","year":"2022","unstructured":"Grignani G, Le Cesne A et al (2022) Trabectedin as second-line treatment in advanced soft tissue sarcoma: quality of life and safety outcomes. Future Oncology (London, England) 18(30s):13\u201322","journal-title":"Future Oncology (London, England)"},{"issue":"1","key":"5148_CR10","doi-asserted-by":"publisher","first-page":"130","DOI":"10.1038\/sj.clpt.6100259","volume":"83","author":"J Hing","year":"2008","unstructured":"Hing J, Perez-Ruixo JJ et al (2008) Mechanism-based pharmacokinetic\/pharmacodynamic meta-analysis of trabectedin (ET-743, Yondelis) induced neutropenia. Clin Pharmacol Ther 83(1):130\u2013143","journal-title":"Clin Pharmacol Ther"},{"issue":"3","key":"5148_CR11","doi-asserted-by":"publisher","first-page":"617","DOI":"10.1038\/s41375-023-01829-9","volume":"37","author":"A Hochhaus","year":"2023","unstructured":"Hochhaus A, R\u00e9a D et al (2023) Asciminib vs bosutinib in chronic-phase chronic myeloid leukemia previously treated with at least two tyrosine kinase inhibitors: longer-term follow-up of ASCEMBL. Leukemia 37(3):617\u2013626","journal-title":"Leukemia"},{"key":"5148_CR12","doi-asserted-by":"publisher","first-page":"106601","DOI":"10.1016\/j.intimp.2020.106601","volume":"84","author":"Y Hu","year":"2020","unstructured":"Hu Y, Gong J et al (2020) 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","journal-title":"Int Immunopharmacol"},{"issue":"1","key":"5148_CR13","doi-asserted-by":"publisher","first-page":"98","DOI":"10.1177\/2168479013514236","volume":"48","author":"L Huang","year":"2014","unstructured":"Huang L, Guo T et al (2014) A review of statistical methods for safety surveillance. Ther Innov Regul Sci 48(1):98\u2013108","journal-title":"Ther Innov Regul Sci"},{"issue":"11","key":"5148_CR14","doi-asserted-by":"publisher","first-page":"3565","DOI":"10.1002\/cam4.3903","volume":"10","author":"RL Jones","year":"2021","unstructured":"Jones RL, Herzog TJ et al (2021) Cardiac safety of trabectedin monotherapy or in combination with pegylated liposomal doxorubicin in patients with sarcomas and ovarian cancer. Cancer Med 10(11):3565\u20133574","journal-title":"Cancer Med"},{"issue":"3","key":"5148_CR15","doi-asserted-by":"publisher","first-page":"279","DOI":"10.1016\/j.critrevonc.2015.02.012","volume":"94","author":"K Jordan","year":"2015","unstructured":"Jordan K, Jahn F et al (2015) Trabectedin: supportive care strategies and safety profile. Crit Rev Oncol Hematol 94(3):279\u2013290","journal-title":"Crit Rev Oncol Hematol"},{"issue":"4","key":"5148_CR16","doi-asserted-by":"publisher","first-page":"R135","DOI":"10.1530\/EC-18-0109","volume":"7","author":"E Kardalas","year":"2018","unstructured":"Kardalas E, Paschou SA et al (2018) Hypokalemia: a clinical update. Endocr Connect 7(4):R135\u2013R146","journal-title":"Endocr Connect"},{"issue":"3","key":"5148_CR17","doi-asserted-by":"publisher","first-page":"420","DOI":"10.3390\/healthcare10030420","volume":"10","author":"MA Khaleel","year":"2022","unstructured":"Khaleel MA, Khan AH et al (2022) A standardized dataset of a spontaneous adverse event reporting system. Healthcare 10(3):420","journal-title":"Healthcare"},{"issue":"15","key":"5148_CR18","doi-asserted-by":"publisher","first-page":"1965","DOI":"10.3390\/cells12151965","volume":"12","author":"A Kr\u00fcger-Genge","year":"2023","unstructured":"Kr\u00fcger-Genge A, K\u00f6hler S et al (2023) Anti-cancer prodrug cyclophosphamide exerts thrombogenic effects on human venous endothelial cells independent of CYP450 activation-relevance to thrombosis. Cells 12(15):1965","journal-title":"Cells"},{"issue":"6","key":"5148_CR19","doi-asserted-by":"publisher","first-page":"499","DOI":"10.1007\/s40259-014-0100-7","volume":"28","author":"C Leporini","year":"2014","unstructured":"Leporini C, Patan\u00e8 M et al (2014) A comprehensive safety evaluation of trabectedin and drug-drug interactions of trabectedin-based combinations. BioDrugs\u202f: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy 28(6):499\u2013511","journal-title":"BioDrugs : Clin Immunother Biopharma Gene Ther"},{"issue":"6","key":"5148_CR20","doi-asserted-by":"publisher","first-page":"e27529","DOI":"10.1016\/j.heliyon.2024.e27529","volume":"10","author":"Y Lin","year":"2024","unstructured":"Lin Y, Zheng X et al (2024) A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for alpelisib. Heliyon 10(6):e27529","journal-title":"Heliyon"},{"issue":"13","key":"5148_CR21","doi-asserted-by":"publisher","first-page":"1488","DOI":"10.1200\/JCO.23.01225","volume":"42","author":"D Lorusso","year":"2024","unstructured":"Lorusso D, Raspagliesi F et al (2024) Single-agent trabectedin versus physician\u2019s choice chemotherapy in patients with recurrent ovarian cancer with BRCA-mutated and\/or BRCAness phenotype: a randomized phase III trial. Journal of Clinical Oncology\u202f: Official Journal of the American Society of Clinical Oncology 42(13):1488\u20131498","journal-title":"Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology"},{"issue":"12","key":"5148_CR22","doi-asserted-by":"publisher","first-page":"3647","DOI":"10.3390\/cancers12123647","volume":"12","author":"M Maillard","year":"2020","unstructured":"Maillard M, Chevreau C et al (2020) Pharmacogenetic study of trabectedin-induced severe hepatotoxicity in patients with advanced soft tissue sarcoma. Cancers 12(12):3647","journal-title":"Cancers"},{"issue":"8","key":"5148_CR23","doi-asserted-by":"publisher","first-page":"1044","DOI":"10.1016\/S1470-2045(22)00380-1","volume":"23","author":"P Pautier","year":"2022","unstructured":"Pautier P, Italiano A et al (2022) Doxorubicin alone versus doxorubicin with trabectedin followed by trabectedin alone as first-line therapy for metastatic or unresectable leiomyosarcoma (LMS-04): a randomised, multicentre, open-label phase 3 trial. Lancet Oncol 23(8):1044\u20131054","journal-title":"Lancet Oncol"},{"issue":"10","key":"5148_CR24","doi-asserted-by":"publisher","first-page":"867","DOI":"10.2165\/00003088-200746100-00005","volume":"46","author":"JJ Perez-Ruixo","year":"2007","unstructured":"Perez-Ruixo JJ, Zannikos P et al (2007) Population pharmacokinetic meta-analysis of trabectedin (ET-743, Yondelis) in cancer patients. Clin Pharmacokinet 46(10):867\u2013884","journal-title":"Clin Pharmacokinet"},{"issue":"2","key":"5148_CR25","doi-asserted-by":"publisher","first-page":"974","DOI":"10.3390\/md13020974","volume":"13","author":"BJ Petek","year":"2015","unstructured":"Petek BJ, Loggers ET et al (2015) Trabectedin in soft tissue sarcomas. Mar Drugs 13(2):974\u2013983","journal-title":"Mar Drugs"},{"issue":"1","key":"5148_CR26","doi-asserted-by":"publisher","first-page":"34","DOI":"10.3109\/0284186X.2014.958530","volume":"54","author":"LH Schack","year":"2015","unstructured":"Schack LH, Mouritsen LS et al (2015) The Danish experience with trabectedin treatment for metastatic sarcoma: Importance of hyponatremia. Acta Oncologica (Stockholm, Sweden) 54(1):34\u201340","journal-title":"Acta Oncologica (Stockholm, Sweden)"},{"key":"5148_CR27","doi-asserted-by":"publisher","first-page":"789","DOI":"10.2147\/CLEP.S365513","volume":"14","author":"Y Shu","year":"2022","unstructured":"Shu Y, He X et al (2022) A real-world disproportionality analysis of olaparib: data mining of the public version of FDA adverse event reporting system. Clin Epidemiol 14:789\u2013802","journal-title":"Clin Epidemiol"},{"issue":"1","key":"5148_CR28","doi-asserted-by":"publisher","first-page":"129","DOI":"10.2215\/CJN.0000000000000244","volume":"19","author":"RH Sterns","year":"2024","unstructured":"Sterns RH, Rondon-Berrios H et al (2024) Treatment Guidelines for Hyponatremia: Stay the Course. Clinical Journal of the American Society of Nephrology\u202f: CJASN 19(1):129\u2013135","journal-title":"Clinical Journal of the American Society of Nephrology : CJASN"},{"issue":"1","key":"5148_CR29","doi-asserted-by":"publisher","first-page":"21","DOI":"10.2174\/1574886313666181026100000","volume":"14","author":"V Subeesh","year":"2019","unstructured":"Subeesh V, Maheswari E et al (2019) Novel adverse events of iloperidone: a disproportionality analysis in US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Curr Drug Saf 14(1):21\u201326","journal-title":"Curr Drug Saf"},{"issue":"2","key":"5148_CR30","doi-asserted-by":"publisher","first-page":"112","DOI":"10.1053\/j.semdp.2019.02.006","volume":"36","author":"K Thway","year":"2019","unstructured":"Thway K (2019) Well-differentiated liposarcoma and dedifferentiated liposarcoma: an updated review. Semin Diagn Pathol 36(2):112\u2013121","journal-title":"Semin Diagn Pathol"},{"key":"5148_CR31","unstructured":"U.S. Food and Drug Administration (2026). Labels for NDA 207953. Revised December 23, 2025.\u00a0 https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2025\/207953s009lbl.pdf.\u00a0Accessed 24 Feb 2026"},{"key":"5148_CR32","doi-asserted-by":"publisher","first-page":"12077","DOI":"10.1038\/srep12077","volume":"5","author":"B Vincenzi","year":"2015","unstructured":"Vincenzi B, Stumbo L et al (2015) Lack of correlation between liver tests abnormalities and trabectedin efficacy in the treatment of soft tissue sarcoma: a retrospective study. Sci Rep 5:12077","journal-title":"Sci Rep"},{"issue":"7","key":"5148_CR33","doi-asserted-by":"publisher","first-page":"815","DOI":"10.6004\/jnccn.2022.0035","volume":"20","author":"M von Mehren","year":"2022","unstructured":"von Mehren M, Kane JM et al (2022) Soft Tissue Sarcoma, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw 20(7):815\u2013833","journal-title":"J Natl Compr Canc Netw"},{"issue":"3","key":"5148_CR34","doi-asserted-by":"publisher","first-page":"e0320585","DOI":"10.1371\/journal.pone.0320585","volume":"20","author":"Y Yu","year":"2025","unstructured":"Yu Y, Zhang K et al (2025) Safety assessment of sodium zirconium cyclosilicate: a FAERS-based disproportionality analysis. PLoS ONE 20(3):e0320585","journal-title":"PLoS ONE"},{"key":"5148_CR35","doi-asserted-by":"publisher","first-page":"1266890","DOI":"10.3389\/fphar.2023.1266890","volume":"14","author":"T Yuan","year":"2023","unstructured":"Yuan T, Li F et al (2023) Adverse events in patients with advanced urothelial carcinoma treated with erdafitinib: a retrospective pharmacovigilance study. Front Pharmacol 14:1266890","journal-title":"Front Pharmacol"},{"issue":"1","key":"5148_CR36","doi-asserted-by":"publisher","first-page":"745","DOI":"10.1186\/s12885-023-11201-w","volume":"23","author":"Q Zhang","year":"2023","unstructured":"Zhang Q, Ding Y et al (2023) A real-world disproportionality analysis of Rucaparib: post-marketing pharmacovigilance data. BMC Cancer 23(1):745","journal-title":"BMC Cancer"}],"container-title":["Naunyn-Schmiedeberg's Archives of Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00210-026-05148-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00210-026-05148-5","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00210-026-05148-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T08:18:41Z","timestamp":1781511521000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00210-026-05148-5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,27]]},"references-count":36,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2026,5]]}},"alternative-id":["5148"],"URL":"https:\/\/doi.org\/10.1007\/s00210-026-05148-5","relation":{},"ISSN":["0028-1298","1432-1912"],"issn-type":[{"value":"0028-1298","type":"print"},{"value":"1432-1912","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,27]]},"assertion":[{"value":"7 July 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 February 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"27 February 2026","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"}},{"value":"Our study is a secondary analysis of publicly available summary statistics and requires no specific ethical approval.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not commissioned, externally peer-reviewed.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Provenance and peer review"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Clinical trial number"}}]}}