UNASSIGNED: Data related to cenobamate-associated ADEs from the third quarter of 2020 to the second quarter of 2023 were collected. After standardizing the data, various signal quantification techniques, including ROR, MHRA, BCPNN, and MGPS, were employed for analysis.
UNASSIGNED: Among 2535 ADE reports where cenobamate was the primary suspected drug, 94 adverse reactions involving 11 different System Organ Class (SOC) categories were identified through the application of four signal quantification techniques. More specifically, neurological disorders and injuries resultant from complications are frequent adverse reactions associated with cenobamate.
UNASSIGNED: Our research findings align with established results, affirming the favorable safety profile of cenobamate. Effective prevention of adverse reactions induced by cenobamate can be achieved through the establishment of efficient blood concentration monitoring and dose adjustments.
■收集了从2020年第三季度到2023年第二季度与cinobamate相关的ADE相关的数据。标准化数据后,各种信号量化技术,包括ROR,MHRA,BCPNN,还有MGPS,被用于分析。
■在2535份ADE报告中,西尼obamate是主要的可疑药物,通过应用四种信号定量技术,确定了94种涉及11种不同系统器官类别(SOC)的不良反应。更具体地说,并发症引起的神经系统疾病和损伤是与西诺膦酸有关的常见不良反应。
■我们的研究结果与既定结果一致,肯定西尼obamate的良好安全性。通过建立有效的血药浓度监测和剂量调整,可以有效预防西诺膦酸引起的不良反应。