Song Meijuan, Xie Jian, Yang Liyuan, Liu Zhen
Department of Oncology, The First Affiliated Hospital of Shandong First Medical University and Shandong Provincial Qianfoshan Hospital, Shandong Lung Cancer Institute, Jinan, Shandong, China.
J Cancer Res Ther. 2025 Sep 1;21(4):917-923. doi: 10.4103/jcrt.jcrt_129_25. Epub 2025 Sep 4.
This study analyzes adverse event (AE) signals associated with ramucirumab using data from the FDA Adverse Event Reporting System (FAERS) to provide evidence supporting the safety of the drug for clinical use.
Data were extracted from the FAERS database using Open Vigil 2.1. Signal detection was performed using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN) methods. AEs were categorized and described using the Preferred Terms (PTs) and System Organ Class (SOC) classifications from the Medical Dictionary for Regulatory Activities.
A total of 1,701 AE reports related to ramucirumab were retrieved. Most reported cases involved male patients (59.79%), most aged 65-74 years (25.57%), with Asia being the primary region of report origin (59.08%). Based on the screening criteria, 130 PT signals across 18 SOC categories were identified, of which 72 PTs were not listed in the drug label. Frequently reported and strongly signaled AEs included hypertension, ascites, proteinuria, edema, and neutropenia-events already noted in the prescribing information of the drug. However, additional AEs, such as pyogenic granuloma, brainstem hemorrhage, interstitial lung disease, and peritonitis, which were not included in the labeling, also showed strong signals and warrant further exploration.
The commonly reported AEs of ramucirumab observed in real-world data are consistent with those listed on the drug label. Nevertheless, new suspicious AEs were identified. Enhanced clinical vigilance, through pretreatment risk assessment and ongoing posttreatment monitoring, is recommended to ensure patient safety.
本研究使用美国食品药品监督管理局不良事件报告系统（FAERS）的数据，分析与雷莫西尤单抗相关的不良事件（AE）信号，以提供支持该药物临床使用安全性的证据。
使用Open Vigil 2.1从FAERS数据库中提取数据。采用报告比值比（ROR）、比例报告比值比（PRR）和贝叶斯置信传播神经网络（BCPNN）方法进行信号检测。使用《监管活动医学词典》中的首选术语（PTs）和系统器官分类（SOC）对AE进行分类和描述。
共检索到1701份与雷莫西尤单抗相关的AE报告。大多数报告病例涉及男性患者（59.79%），大多数年龄在65 - 74岁（25.57%），报告来源的主要地区为亚洲（59.08%）。根据筛选标准，在18个SOC类别中识别出130个PT信号，其中72个PT未列在药品标签中。频繁报告且信号强烈的AE包括高血压、腹水、蛋白尿、水肿和中性粒细胞减少——这些事件已在该药物的处方信息中提及。然而，标签中未包含的其他AE，如化脓性肉芽肿、脑干出血、间质性肺病和腹膜炎，也显示出强烈信号，值得进一步探索。
在真实世界数据中观察到的雷莫西尤单抗常见报告AE与药品标签上列出的一致。尽管如此，仍识别出了新的可疑AE。建议通过治疗前风险评估和持续的治疗后监测加强临床警惕，以确保患者安全。
