| アブストラクト | Zolbetuximab, a monoclonal antibody against claudin-18.2 (CLDN18.2), improves outcomes in CLDN18.2-positive gastric cancer, but gastrointestinal adverse events-especially nausea and vomiting-are frequently reported. Using PMDA-JADER (April 2004-March 2025), we identified individual case safety reports (ICSRs) listing zolbetuximab as a suspected drug and defined the outcome with MedDRA-concordant preferred terms (nausea, vomiting, nausea and vomiting, retching). Within zolbetuximab reports, binary logistic regression with sex (male reference) and age (<60 years reference) showed higher adjusted odds in females (aOR 3.07; 95% CI 1.45-6.51; p=0.003) and lower odds in patients >/=60 years (aOR 0.25; 95% CI 0.10-0.61; p=0.002); model calibration was acceptable (Hosmer-Lemeshow p=1.000). Disproportionality analysis yielded a markedly elevated reporting odds ratio (ROR) for zolbetuximab versus all other reports (ROR 85.40; 95% CI 62.58-116.53), whereas immune checkpoint inhibitors showed no signal. These measures reflect reporting disproportionality within a spontaneous-reporting system and should not be interpreted as incidence or causality. These exploratory findings support proactive, guideline-based antiemetic strategies-particularly for younger female patients-and warrant prospective confirmation. |
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| 組織名 | Department of Pharmacy, International University of Health and Welfare Narita;Hospital, 852, Hatakeda, Narita-shi, Chiba, 286-8520, Japan. |
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