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15 results on '"Mao, Wei"'

10. Bupi Yishen Formula Versus Losartan for Non-Diabetic Stage 4 Chronic Kidney Disease: A Randomized Controlled Trial

Author

Mao, Wei, primary, Yang, Nizhi, additional, Zhang, Lei, additional, Li, Chuang, additional, Wu, Yifan, additional, Ouyang, Wenwei, additional, Xu, Peng, additional, Zou, Chuan, additional, Pei, Chunpeng, additional, Shi, Wei, additional, Zhan, Jihong, additional, Yang, Hongtao, additional, Chen, Hongyu, additional, Wang, Xiaoqin, additional, Tian, Yun, additional, Yuan, Fang, additional, Sun, Wei, additional, Xiong, Guoliang, additional, Chen, Ming, additional, Guan, Jianguo, additional, Tang, Shuifu, additional, Zhang, Chunyan, additional, Liu, Yuning, additional, Deng, Yueyi, additional, Lin, Qizhan, additional, Lu, Fuhua, additional, Hong, Weihong, additional, Yang, Aicheng, additional, Fang, Jingai, additional, Rao, Jiazhen, additional, Wang, Lixin, additional, Bao, Kun, additional, Lin, Feng, additional, Xu, Yuan, additional, Lu, Zhaoyu, additional, Su, Guobin, additional, Zhang, La, additional, Johnson, David W, additional, Zhao, Daixin, additional, Hou, Haijing, additional, Fu, Lizhe, additional, Guo, Xinfeng, additional, Yang, Lihong, additional, Qin, Xindong, additional, Wen, Zehuai, additional, and Liu, Xusheng, additional

Published
2021
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15. A real-world pharmacovigilance study of polatuzumab vedotin based on the FDA adverse event reporting system (FAERS).

Author

Liu D, Mao W, Hu B, Li X, Zhao Q, Zhang L, and Hu J

Abstract

Background: Polatuzumab vedotin, the first FDA-approved antibody-drug conjugate (ADC) targeting CD79b, is utilized in the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL), as well as relapsed or refractory (R/R) DLBCL. Despite its approval, concerns persist regarding the long-term safety profile of polatuzumab vedotin. This study aims to evaluate the adverse events (AEs) associated with polatuzumab vedotin since its approval in 2019, utilizing data mining strategies applied to the FDA Adverse Event Reporting System (FAERS)., Methods: Signal detection employed four methodologies, including reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multi-item gamma poisson shrinker (MGPS), to evaluate and quantify the signals of polatuzumab vedotin-associated AEs. Additionally, subgroup analyses based on patients age, gender, and fatal cases were conducted to investigate AEs occurrences in specific subpopulations., Results: A total of 1,521 reports listing polatuzumab vedotin as a "principal suspect (PS)" drug were collected from the FAERS database. Through concurrent compliance with four algorithms, 19 significant Standardized MedDRA Query (SMQ) AEs and 92 significant Preferred Term (PT) AEs were detected. Subgroup analyses revealed a higher incidence of PTs in male patients compared to female patients, increased likelihood of polatuzumab vedotin-associated AEs in elder patients (>65 years), and AEs with a high risk of fatal cases include: blood lactate dehydrogenase increased, cytopenia, and hydronephrosis. The median time to AEs occurrence following polatuzumab vedotin initiation was 18.5 (5∼57.75) days, with 95% of AEs occurred within 162 days., Conclusion: This study identified various AEs associated with polatuzumab vedotin, offering critical insights for clinical monitoring and risk identification in patients receiving polatuzumab vedotin therapy., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Liu, Mao, Hu, Li, Zhao, Zhang and Hu.)

Published
2024
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