{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T18:45:20Z","timestamp":1785782720776,"version":"3.56.0"},"reference-count":18,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T00:00:00Z","timestamp":1785456000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Oncol Pharm Pract"],"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Antibody-drug conjugates (ADCs) are cancer therapies that deliver cytotoxic agents to tumor cells. Despite their specificity, toxicity remains a concern. Cardiac adverse events (CAEs) have not been studied in prospective trials, and guidance remains limited. We conducted a pharmacovigilance analysis using the FDA Adverse Event Reporting System (FAERS) to identify CAEs associated with ADCs for hematologic malignancies and assess high-risk subpopulations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We analyzed five ADCs: gemtuzumab ozogamicin, inotuzumab ozogamicin, polatuzumab vedotin, loncastuximab tesirine, and belantamab mafodotin. CAEs were extracted from FAERS from each drug's approval through 2023. Disproportionality analysis used four metrics: reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), and Empirical Bayes Geometric Mean (EBGM), with signals defined as significant across all.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>CAEs represented 3.2% of adverse events (AEs) for gemtuzumab, 2.0% for polatuzumab, 0.96% for inotuzumab, and 1.3% for belantamab. Polatuzumab showed signals for atrial tachycardia (ROR 30.96) and ventricular failure (ROR 10.42). Gemtuzumab showed signals for ventricular dysfunction (ROR 78.42) and myocardial ischemia (ROR 19.39). Inotuzumab indicated a significant signal in cardiotoxicity (ROR 5.43). Belantamab had no significant signals, and loncastuximab was excluded due to limited reports. Subgroup analysis showed increased CAEs among belantamab's approved indications (p\u2009&lt;\u20090.01) and polatuzumab-associated hospitalizations (p\u2009=\u20090.01).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Our study is the first to identify subpopulations disproportionately affected by ADC-associated CAEs. These results support the need for drug labeling and cardiac monitoring in high-risk groups. Prospective studies should inform evidence-based recommendations regarding ADC administration and cardiotoxicity risk.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10781552261470082","type":"journal-article","created":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T15:12:51Z","timestamp":1785510771000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["A real-world pharmacovigilance analysis of cardiac adverse events associated with newer antibody-drug conjugates for hematological malignancies in adults: A disproportionality analysis from FDA adverse event reporting system database"],"prefix":"10.1177","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4961-1481","authenticated-orcid":false,"given":"Deepika","family":"Dilip","sequence":"first","affiliation":[{"name":"New York Medical College"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pritika","family":"Sharma","sequence":"additional","affiliation":[{"name":"Westchester Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Drugge","sequence":"additional","affiliation":[{"name":"New York Medical College"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arpita","family":"Pawa","sequence":"additional","affiliation":[{"name":"Ochsner Clinic Foundation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amir","family":"Steinberg","sequence":"additional","affiliation":[{"name":"Westchester Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,7,31]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12943-024-01963-7"},{"key":"e_1_3_3_3_2","unstructured":"Center for Drug Evaluation and Research. FDA approves Gemtuzumab Ozogamicin for CD33-positive AML. FDA https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-gemtuzumab-ozogamicin-cd33-positive-aml (2019 February 9 [cited 2025 May 15])."},{"key":"e_1_3_3_4_2","unstructured":"Zheng X Song Y Cao Y et al. Cardiac disorders associated with antibody-drug conjugate: a pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database. Rochester NY: Social Science Research Network. [cited 2025 May 21] https:\/\/papers.ssrn.com\/sol3\/papers.cfm?abstract_id=4981088."},{"key":"e_1_3_3_5_2","unstructured":"Long P Li S Pan L et al. Frontiers | Cardiovascular adverse events associated with antibody-drug conjugates (ADCs): a pharmacovigilance study based on the FAERS database. [cited 2025 May 21] https:\/\/www.frontiersin.org\/journals\/pharmacology\/articles\/10.3389\/fphar.2024.1378010\/full."},{"key":"e_1_3_3_6_2","unstructured":"Center for Drug Evaluation and Research. FDA\u2019s Adverse Event Reporting System (FAERS). FDA https:\/\/www.fda.gov\/drugs\/surveillance\/fdas-adverse-event-reporting-system-faers (2024 [cited 2025 May 27])."},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00210-024-02955-6"},{"key":"e_1_3_3_8_2","doi-asserted-by":"crossref","unstructured":"Shu Y He X Liu Y et al. A real-world disproportionality analysis of Olaparib: data mining of the public version of FDA adverse event reporting system. PubMed https:\/\/pubmed.ncbi.nlm.nih.gov\/35789689\/ (2022 [cited 2025 May 21]).","DOI":"10.2147\/CLEP.S365513"},{"key":"e_1_3_3_9_2","unstructured":"Peng Y Song Y Qin C et al. faers: R interface for FDA Adverse Event Reporting System https:\/\/bioconductor.org\/packages\/faers (2025)."},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1093\/ehjcvp\/pvaf027"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1097\/MPH.0000000000002325"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1038\/sj.leu.2404434"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1097\/CAD.0000000000001191"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13832"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1093\/oncolo\/oyaf298"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(21)00139-X"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-025-03824-8"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1093\/toxsci\/kfq189"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2017.1323867"}],"container-title":["Journal of Oncology Pharmacy Practice"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10781552261470082","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/10781552261470082","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10781552261470082","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T18:01:42Z","timestamp":1785780102000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/10781552261470082"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,31]]},"references-count":18,"alternative-id":["10.1177\/10781552261470082"],"URL":"https:\/\/doi.org\/10.1177\/10781552261470082","relation":{},"ISSN":["1078-1552","1477-092X"],"issn-type":[{"value":"1078-1552","type":"print"},{"value":"1477-092X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,31]]},"article-number":"10781552261470082"}}