| アブストラクト | OBJECTIVE: This study aimed to comprehensively evaluate the post-market safety of the oncolytic virus Talimogene Laherparepvec (T-VEC) using Food and Drug Administration Adverse Event Reporting System (FAERS) database. METHODS: After data standardization, the reporting odds ratio (ROR) was used to calculate the correlation between various organ system levels and preferred terms. RESULTS: A total of 16,231,751 adverse event reports were retrieved from the FAERS database, of which 1211 were related to Talimogene Laherparepvec (T-VEC). Fifty-three positive safety signals related to T-VEC were identified. The median onset time of related adverse events (AEs) was 40 days. Chi-square analysis revealed age-related differences: patients aged>/=65 years were more prone to gastrointestinal adverse reactions, while those under 65 years were more susceptible to infections and infestations, as well as skin and subcutaneous tissue adverse reactions. CONCLUSION: This study provides a valuable evaluation of the post-market safety of T-VEC. Further research is needed to validate and confirm these findings. The study shows that T-VEC-related adverse reactions in real-world data are predominantly mild, but there is a correlation between age and adverse reactions at some System Organ Class (SOC) levels. Clinicians should be aware of the different adverse reaction profiles in patients of different ages during drug administration. |
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| ジャーナル名 | European journal of pharmacology |
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| Pubmed追加日 | 2025/8/11 |
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| 投稿者 | Cai, Rongbing; Zhao, Yuehan; Guo, Dandan; Wang, Ling |
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| 組織名 | Department of Oncology, First Affiliated Hospital of Dalian Medical University,;Dalian, 116011, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40784659/ |
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