| アブストラクト | BACKGROUND: Trastuzumab deruxtecan (T-DXd) is a novel generation antibody-drug conjugate. However, current evidence for the safety of T-DXd is mostly limited to clinical trials. Therefore, we mine and analyze adverse events (AEs) caused by T-DXd based on the FAERS database and to provide reference for the safe use of drug in clinical practice. RESEARCH DESIGN AND METHODS: AEs associated with T-DXd were analyzed in the FAERS database from December 2019 to December 2023, and four disproportionality methods were combined to identify and evaluate reports. RESULTS: A total of 4651 AE reports of T-DXd as the 'primary suspect' were collected. The median time to onset of T-DXd-related AEs was 25 days. The proportion of serious AEs was 69.40%. Death (24.19%) accounted for the highest occurrence frequency of clinical serious outcomes. The top three AEs in both frequency and signal intensity were interstitial lung disease. We also found 12 novel AEs not recorded in the drug label. CONCLUSION: This study indicate the importance of timely mining and updating information of adverse drug reactions. Drug evaluation should be performed well before using T-DXd, and timely intervention measures should be taken to avoid related injury caused by AEs. |
|---|
| ジャーナル名 | Expert opinion on drug safety |
|---|
| Pubmed追加日 | 2024/12/8 |
|---|
| 投稿者 | Li, Xiangyu; Yang, Fang; Zhou, Fuqun; Zhu, Shenghong; Yuan, Lingjing; Ma, Li |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39644486/ |
|---|
