PDF(Pubmed)
Abstract：
UNASSIGNED: Sotorasib has been approved for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Due to the limitations of clinical trials, potential adverse events (AEs) and long-term safety issues cannot be detected. The presented study aimed to evaluate sotorasib-associated AEs using the FDA Adverse Event Reporting System (FAERS) database.
UNASSIGNED: Post-marketing AE reports of sotorasib in the database were collected for analysis. Disproportionality analyses, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC) and empirical bayes geometric mean (EBGM) algorithms, were performed to mine the signals of sotorasib-associated AEs. The median duration, quartiles and the Weibull shape parameter (WSP) test were used to assess the onset time data.
UNASSIGNED: The database contained 1538 cases of sotorasib as primary suspect (PS), with 27 signals detected, scattering in 5 SOCs. The SOC of hepatobiliary disorders (182, ROR 4.48, PRR 4.07, IC 2.02, EBGM 4.07) met the four methodological thresholds. The median onset time of sotorasib-associated AEs was 42 days (interquartile range [IQR] 14-86.75 days). Different SOCs had different types of risk over time.
UNASSIGNED: After obtaining marketing authorization, the study identified all potentially relevant adverse event (AE) signals expected to have a reporting frequency higher than anticipated and characterized them during sotorasib treatment.
UNASSIGNED: Post-marketing AE reports of sotorasib in the database were collected for analysis. Disproportionality analyses, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC) and empirical bayes geometric mean (EBGM) algorithms, were performed to mine the signals of sotorasib-associated AEs. The median duration, quartiles and the Weibull shape parameter (WSP) test were used to assess the onset time data.
UNASSIGNED: The database contained 1538 cases of sotorasib as primary suspect (PS), with 27 signals detected, scattering in 5 SOCs. The SOC of hepatobiliary disorders (182, ROR 4.48, PRR 4.07, IC 2.02, EBGM 4.07) met the four methodological thresholds. The median onset time of sotorasib-associated AEs was 42 days (interquartile range [IQR] 14-86.75 days). Different SOCs had different types of risk over time.
UNASSIGNED: After obtaining marketing authorization, the study identified all potentially relevant adverse event (AE) signals expected to have a reporting frequency higher than anticipated and characterized them during sotorasib treatment.
摘要：
■Sotorasib已被批准用于治疗KRASG12C突变的局部晚期或转移性非小细胞肺癌（NSCLC）的成年患者。由于临床试验的局限性,无法检测到潜在不良事件（AE）和长期安全性问题。本研究旨在使用FDA不良事件报告系统（FAERS）数据库评估索托拉西布相关的AE。
■收集数据库中索托拉西的上市后AE报告进行分析。不相称性分析，包括报告赔率比(ROR)，比例报告比率(PRR)，信息分量(IC)和经验贝叶斯几何平均(EBGM)算法，进行以挖掘索托拉西布相关AE的信号。中位持续时间，使用四分位数和Weibull形状参数（WSP）检验来评估起效时间数据。
■该数据库包含1538例主要嫌疑人（PS），检测到27个信号，在5个SOC中散射。肝胆疾病的SOC（182，ROR4.48，PRR4.07，IC2.02，EBGM4.07）符合四个方法学阈值。索托拉西相关AE的中位发病时间为42天(四分位距[IQR]14-86.75天)。随着时间的推移，不同的SOC具有不同类型的风险。
■获得营销授权后，该研究确定了所有预期报告频率高于预期的潜在相关不良事件(AE)信号,并在索托拉西治疗期间对其进行了表征.
■收集数据库中索托拉西的上市后AE报告进行分析。不相称性分析，包括报告赔率比(ROR)，比例报告比率(PRR)，信息分量(IC)和经验贝叶斯几何平均(EBGM)算法，进行以挖掘索托拉西布相关AE的信号。中位持续时间，使用四分位数和Weibull形状参数（WSP）检验来评估起效时间数据。
■该数据库包含1538例主要嫌疑人（PS），检测到27个信号，在5个SOC中散射。肝胆疾病的SOC（182，ROR4.48，PRR4.07，IC2.02，EBGM4.07）符合四个方法学阈值。索托拉西相关AE的中位发病时间为42天(四分位距[IQR]14-86.75天)。随着时间的推移，不同的SOC具有不同类型的风险。
■获得营销授权后，该研究确定了所有预期报告频率高于预期的潜在相关不良事件(AE)信号,并在索托拉西治疗期间对其进行了表征.
