PDF(Pubmed)
Abstract：
UNASSIGNED: The primary aim of this study was to closely monitor and identify adverse events (AEs) linked to lenvatinib, a pharmacotherapeutic agent employed for the management of renal cell carcinoma, thyroid cancer, and hepatocellular carcinoma. The ultimate goal was to optimize patient safety and provide evidence-based guidance for the appropriate utilization of this medication.
UNASSIGNED: A comprehensive collection and analysis of reports from the FDA Adverse Event Reporting System (FAERS) database was conducted, encompassing the period from the first quarter of 2015 to the first quarter of 2023. Disproportionality analysis, employing robust algorithms including ROR, PRR, BCPNN, and EBGM was employed for effective data mining to quantify signals associated with lenvatinib-related AEs.
UNASSIGNED: Among the collected reports, a total of 15,193 cases were identified where lenvatinib was the \"primary suspected (PS)\" drug, resulting in 50,508 lenvatinib-induced AEs. An analysis was conducted to examine the occurrence of lenvatinib-induced adverse drug reactions (ADRs) across 26 organ systems. The findings revealed the presence of expected ADRs, including diarrhea, vomiting, stomatitis, hepatic encephalopathy, decreased appetite, dehydration, decreased weight, and electrolyte imbalances, which were consistent with the information provided in the drug labels. Furthermore, unexpected significant ADRs were observed at the preferred terms (PT) level, such as interstitial lung disease, pneumothorax, hypophysitis, failure to thrive, polycythemia, hypopituitarism, spontaneous pneumothorax, pulmonary cavitation, and limbic encephalitis. These findings indicated the potential occurrence of adverse effects that are currently not documented in the drug instructions.
UNASSIGNED: This study has successfully detected novel and unforeseen signals pertaining to ADRs associated with the administration of lenvatinib, thereby contributing significant insights into the intricate correlation between ADRs and the utilization of lenvatinib. The outcomes of this investigation underscore the utmost significance of continuous monitoring and vigilant surveillance in order to promptly identify and effectively manage AEs, consequently enhancing overall patient safety and well-being in the context of lenvatinib therapy.
UNASSIGNED: A comprehensive collection and analysis of reports from the FDA Adverse Event Reporting System (FAERS) database was conducted, encompassing the period from the first quarter of 2015 to the first quarter of 2023. Disproportionality analysis, employing robust algorithms including ROR, PRR, BCPNN, and EBGM was employed for effective data mining to quantify signals associated with lenvatinib-related AEs.
UNASSIGNED: Among the collected reports, a total of 15,193 cases were identified where lenvatinib was the \"primary suspected (PS)\" drug, resulting in 50,508 lenvatinib-induced AEs. An analysis was conducted to examine the occurrence of lenvatinib-induced adverse drug reactions (ADRs) across 26 organ systems. The findings revealed the presence of expected ADRs, including diarrhea, vomiting, stomatitis, hepatic encephalopathy, decreased appetite, dehydration, decreased weight, and electrolyte imbalances, which were consistent with the information provided in the drug labels. Furthermore, unexpected significant ADRs were observed at the preferred terms (PT) level, such as interstitial lung disease, pneumothorax, hypophysitis, failure to thrive, polycythemia, hypopituitarism, spontaneous pneumothorax, pulmonary cavitation, and limbic encephalitis. These findings indicated the potential occurrence of adverse effects that are currently not documented in the drug instructions.
UNASSIGNED: This study has successfully detected novel and unforeseen signals pertaining to ADRs associated with the administration of lenvatinib, thereby contributing significant insights into the intricate correlation between ADRs and the utilization of lenvatinib. The outcomes of this investigation underscore the utmost significance of continuous monitoring and vigilant surveillance in order to promptly identify and effectively manage AEs, consequently enhancing overall patient safety and well-being in the context of lenvatinib therapy.
摘要：
■本研究的主要目的是密切监测和识别与lenvatinib相关的不良事件（AE），用于治疗肾细胞癌的药物治疗剂，甲状腺癌,和肝细胞癌。最终目标是优化患者安全性，并为适当使用该药物提供循证指导。
■对来自FDA不良事件报告系统（FAERS）数据库的报告进行了全面收集和分析，涵盖从2015年第一季度到2023年第一季度的时期。不相称性分析,采用包括ROR在内的鲁棒算法，PRR,BCPNN,EBGM用于有效的数据挖掘，以量化与lenvatinib相关的AE相关的信号。
■在收集的报告中，总共15,193例被确定为“主要可疑（PS）”药物，导致50,508名伐替尼诱导的AE。进行了一项分析，以检查26个器官系统中lenvatinib引起的药物不良反应（ADR）的发生情况。研究结果表明，存在预期的ADR，包括腹泻,呕吐,口腔炎,肝性脑病,食欲下降,脱水,体重下降,和电解质失衡，这与药物标签中提供的信息一致。此外，在首选术语(PT)水平观察到意想不到的显著ADR，比如间质性肺病，气胸,垂体炎,未能茁壮成长，红细胞增多症,垂体功能减退,自发性气胸,肺空洞,和边缘叶脑炎.这些发现表明了目前未在药物说明书中记录的不良反应的潜在发生。
■本研究成功检测到与来伐替尼给药相关的新的和不可预见的ADR信号，从而对ADR与乐伐替尼的利用之间的复杂相关性做出了重要的见解。这项调查的结果强调了持续监测和警惕监测的最大意义，以便及时识别和有效管理不良事件。因此，在lenvatinib治疗的背景下，提高患者的整体安全性和幸福感。
■对来自FDA不良事件报告系统（FAERS）数据库的报告进行了全面收集和分析，涵盖从2015年第一季度到2023年第一季度的时期。不相称性分析,采用包括ROR在内的鲁棒算法，PRR,BCPNN,EBGM用于有效的数据挖掘，以量化与lenvatinib相关的AE相关的信号。
■在收集的报告中，总共15,193例被确定为“主要可疑（PS）”药物，导致50,508名伐替尼诱导的AE。进行了一项分析，以检查26个器官系统中lenvatinib引起的药物不良反应（ADR）的发生情况。研究结果表明，存在预期的ADR，包括腹泻,呕吐,口腔炎,肝性脑病,食欲下降,脱水,体重下降,和电解质失衡，这与药物标签中提供的信息一致。此外，在首选术语(PT)水平观察到意想不到的显著ADR，比如间质性肺病，气胸,垂体炎,未能茁壮成长，红细胞增多症,垂体功能减退,自发性气胸,肺空洞,和边缘叶脑炎.这些发现表明了目前未在药物说明书中记录的不良反应的潜在发生。
■本研究成功检测到与来伐替尼给药相关的新的和不可预见的ADR信号，从而对ADR与乐伐替尼的利用之间的复杂相关性做出了重要的见解。这项调查的结果强调了持续监测和警惕监测的最大意义，以便及时识别和有效管理不良事件。因此，在lenvatinib治疗的背景下，提高患者的整体安全性和幸福感。
