A pharmacovigilance study of adverse event profiles and haemorrhagic safety of bevacizumab based on the FAERS database

Bevacizumab is used for the treatment of advanced malignant tumors; it acts by inhibiting angiogenesis. This study aimed to examine adverse events (AEs) of bevacizumab, especially hemorrhage, using the Food and Drug Administration Adverse Event Reporting System (FAERS) database. The reporting odds ratio (ROR) and proportional reporting ratio (PRR) were used to analyze the AEs of bevacizumab using FAERS registration data from January 2004 to September 2022. Clinical information regarding hemorrhagic signals was further analyzed. The number of bevacizumab-associated AE reports was 96,477. Our study found that 892 significant preferred terms (PTs) were spread throughout 25 organ systems. The system organ classes (SOCs) focus on general disorders, administration site conditions, blood and lymphatic system disorders, injury, poisoning, and procedural complications. A total of 2,847 bevacizumab-related hemorrhage cases were reported, and 37 hemorrhagic signals were identified. Hemorrhagic signals were focused on SOC levels in vascular, gastrointestinal, and nervous system disorders. Colorectal, lung, and breast cancers are the three most common malignancies associated with BV-induced hemorrhage. The AE report from the present study confirms the majority of label information for bevacizumab, while also identifying new AEs. In addition, this was a large descriptive study of bevacizumab-induced hemorrhage.

贝伐珠单抗（Bevacizumab）可用于晚期恶性肿瘤的治疗，其通过抑制血管生成发挥作用。本研究依托美国食品药品监督管理局不良反应报告系统（Food and Drug Administration Adverse Event Reporting System, FAERS）数据库，旨在探析贝伐珠单抗的不良反应（adverse events, AEs），尤其是出血相关不良反应。研究纳入2004年1月至2022年9月的FAERS注册数据，采用报告比值比（reporting odds ratio, ROR）与比例报告比值比（proportional reporting ratio, PRR）对贝伐珠单抗相关不良反应进行分析，并进一步针对出血信号展开临床信息分析。本研究共收集到贝伐珠单抗相关不良反应报告96477例。结果显示，892个具有统计学意义的首选术语（preferred terms, PTs）分布于25个器官系统中，主要集中于全身性疾病、给药部位情况、血液及淋巴系统疾病、损伤、中毒与操作并发症等系统器官分类（system organ classes, SOCs）。共计报告贝伐珠单抗相关出血病例2847例，共识别出37个出血相关信号。出血信号主要集中于血管疾病、胃肠道疾病与神经系统疾病的系统器官分类范畴。结直肠癌、肺癌与乳腺癌是与贝伐珠单抗诱导出血相关的三大常见恶性肿瘤。本研究的不良反应报告验证了贝伐珠单抗现有药品说明书中的多数信息，同时也发现了新的不良反应类型。此外，本研究为一项针对贝伐珠单抗诱导出血的大规模描述性研究。