{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T16:17:03Z","timestamp":1790957823449,"version":"4.1.0"},"reference-count":42,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2025,5,8]],"date-time":"2025-05-08T00:00:00Z","timestamp":1746662400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,5,8]],"date-time":"2025-05-08T00:00:00Z","timestamp":1746662400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Pertuzumab is used in combination with trastuzumab\u2010based therapy for HER2\u2010positive breast cancer. However, real\u2010world safety information on pertuzumab remains limited. This study assessed the safety of adding pertuzumab to trastuzumab\u2010based therapy for HER2\u2010positive breast cancer using real\u2010world data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>VigiBase, the World Health Organization's global database of adverse events (AEs), containing reports from November 1967 to December 2023, was used. Signals for pertuzumab\u2010associated AEs in breast cancer cases were detected using the reporting odds ratio (ROR).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Signals of trastuzumab plus pertuzumab relative to trastuzumab alone were detected in gastrointestinal disorders (ROR: 1.45, 95% confidence interval: 1.26\u20131.67), including diarrhoea (3.49, 2.83\u20134.30); infections and infestations (1.54, 1.24\u20131.91); and skin and subcutaneous tissue disorders (ROR: 1.63, 1.40\u20131.90), including pruritus (1.96, 1.51\u20132.55) and rash (1.63, 1.20\u20132.23). Further, signals of trastuzumab plus docetaxel plus pertuzumab relative to those of trastuzumab plus docetaxel were detected in gastrointestinal disorders (1.63, 1.38\u20131.93), including nausea (1.72, 1.24\u20132.39) and vomiting (1.48, 1.01\u20132.17), and in nervous system disorders (1.50, 1.20\u20131.87), including paraesthesia (2.60, 1.33\u20135.08) and peripheral sensory neuropathy (5.94, 1.79\u201319.71). The frequency of AEs causing or prolonging hospitalization was increased with trastuzumab plus pertuzumab compared to that with trastuzumab alone (1.18, 1.00\u20131.38).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>AE profiles after the addition of pertuzumab to trastuzumab\u2010based therapy were comprehensively identified. The findings in this study highlight the importance of considering these AEs when selecting pertuzumab combination therapy to ensure the safety of patients with breast cancer.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70094","type":"journal-article","created":{"date-parts":[[2025,5,9]],"date-time":"2025-05-09T00:49:22Z","timestamp":1746751762000},"page":"2659-2671","source":"Crossref","is-referenced-by-count":2,"title":["Comprehensive analysis of adverse event profile changes with pertuzumab addition to trastuzumab\u2010based breast cancer therapy: Disproportionality analysis using VigiBase"],"prefix":"10.1002","volume":"91","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9872-2559","authenticated-orcid":false,"given":"Tatsuaki","family":"Takeda","sequence":"first","affiliation":[{"name":"Department of Education and Research Center for Clinical Pharmacy, Faculty of Pharmaceutical Sciences Okayama University  Okayama Japan"},{"name":"Department of Pharmacy 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