■塔拉佐帕尼被批准用于治疗乳腺癌。然而,在大量人群样本中,talazoparib长期的安全性仍不确定.这项研究的目的是为临床环境中安全使用他唑帕尼提供指导。方法:使用四种算法来量化他唑帕尼相关不良事件(AE)的信号,使用2018年第4季度至2023年第2季度的食品和药物管理局不良事件报告系统(FAERS)的数据.
■共报告了7,186,517条记录,737人表示他拉索莱布为主要可疑(PS)不良事件。同时保留了遵守四种算法的总共40个重要的优选术语(PT)。有可能经历不可预见和值得注意的AE,包括栓塞(0.46%),肺栓塞(1.06%),低钠血症(0.46%),低钾血症(0.40%),血尿(0.33%),心包积液(0.26%)。大多数与他唑帕尼相关的不良事件发生在开始用药的最初一个月内,中位发病时间为79天(IQR:22-207天)。
■我们的研究结果与临床观察结果一致,我们还发现了talazoparib潜在的新的和意想不到的AE信号,提示需要前瞻性临床研究来证实这些结果并说明它们之间的关系.我们的结果可能为进一步的talazoparib的安全性研究提供有价值的证据。
UNASSIGNED: Talazoparib was approved for the treatment of breast cancer. However, the safety of talazoparib in a large population sample over an extended period remained uncertain. The objective of this study is to offer guidance for the secure utilization of talazoparib in clinical settings.
UNASSIGNED: Four algorithms were used to quantify the
signals of talazoparib associated adverse events(AEs), using data from the food and drug administration adverse event reporting system(FAERS) between fourth quater of 2018 and second quater of 2023.
UNASSIGNED: A total of 7,186,517 records were reported, with 737 indicating talazoparib as the primary suspected (PS) AEs. A total of 40 significant preferred terms (PTs) that adhere to the four algorithms were simultaneously retained. There is a possibility of experiencing unforeseen and noteworthy AEs, including embolism(0.46%), pulmonary embolism(1.06%), hyponatremia(0.46%), hypokalemia(0.40%), hematuria(0.33%), and pericardial effusion(0.26%). Most of the AEs related to talazoparib occurred within the initial month of starting the medication, with a median onset time of 79 days (IQR: 22-207 days).
UNASSIGNED: Results of our study were consistent with clinical observations, and we also found potential new and unexpected AEs
signals for talazoparib, suggesting prospective clinical studies were needed to confirm these results and illustrate their relationship. Our results may provide valuable evidence for further safety studies of talazoparib.