Abstract：
UNASSIGNED: Daratumumab, a first-in-class humanized IgG1κ monoclonal antibody that targets the CD38 epitope, has been approved for treatment of multiple myeloma by FDA. The current study was to evaluate daratumumab-related adverse events (AEs) through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS).
UNASSIGNED: Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN) and the multi-item gamma Poisson shrinker (MGPS) algorithms were employed to quantify the signals of daratumumab-associated AEs.
UNASSIGNED: Out of 10,378,816 reports collected from the FAERS database, 8727 reports of daratumumab-associated AEs were identified. A total of 183 significant disproportionality preferred terms (PTs) were retained. Unexpected significant AEs such as meningitis aseptic, leukoencephalopathy, tumor lysis syndrome, disseminated intravascular coagulation, hyperviscosity syndrome, sudden hearing loss, ileus and diverticular perforation were also detected. The median onset time of daratumumab-related AEs was 11 days (interquartile range [IQR] 0-76 days), and most of the cases occurred within 30 days.
UNASSIGNED: Our study found potential new and unexpected AEs signals for daratumumab, suggesting prospective clinical studies are needed to confirm these results and illustrate their relationship.
UNASSIGNED: Disproportionality analyses, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN) and the multi-item gamma Poisson shrinker (MGPS) algorithms were employed to quantify the signals of daratumumab-associated AEs.
UNASSIGNED: Out of 10,378,816 reports collected from the FAERS database, 8727 reports of daratumumab-associated AEs were identified. A total of 183 significant disproportionality preferred terms (PTs) were retained. Unexpected significant AEs such as meningitis aseptic, leukoencephalopathy, tumor lysis syndrome, disseminated intravascular coagulation, hyperviscosity syndrome, sudden hearing loss, ileus and diverticular perforation were also detected. The median onset time of daratumumab-related AEs was 11 days (interquartile range [IQR] 0-76 days), and most of the cases occurred within 30 days.
UNASSIGNED: Our study found potential new and unexpected AEs signals for daratumumab, suggesting prospective clinical studies are needed to confirm these results and illustrate their relationship.
摘要：
■达拉图单抗，一类针对CD38表位的人源化IgG1κ单克隆抗体，已被FDA批准用于多发性骨髓瘤的治疗。目前的研究是通过美国食品和药物管理局不良事件报告系统（FAERS）的数据挖掘来评估达雷妥单抗相关的不良事件（AE）。
■不相称性分析，包括报告赔率比(ROR)，比例报告比率(PRR)，采用贝叶斯置信传播神经网络(BCPNN)和多项目伽玛泊松收缩(MGPS)算法量化达雷妥单抗相关AE的信号.
■在从FAERS数据库收集的10,378,816个报告中，确定了8727份达雷妥单抗相关的AE报告。总共保留了183个显着的不成比例的首选术语（PT）。意外的严重不良事件，如脑膜炎无菌，白质脑病,肿瘤溶解综合征,弥散性血管内凝血,高粘度综合征,突发性听力损失,肠梗阻和憩室穿孔也被发现。达雷妥单抗相关AE的中位发病时间为11天（四分位距[IQR]0-76天），大多数病例发生在30天内。
■我们的研究发现了达拉图单抗的潜在新的和意外的不良事件信号，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.
■不相称性分析，包括报告赔率比(ROR)，比例报告比率(PRR)，采用贝叶斯置信传播神经网络(BCPNN)和多项目伽玛泊松收缩(MGPS)算法量化达雷妥单抗相关AE的信号.
■在从FAERS数据库收集的10,378,816个报告中，确定了8727份达雷妥单抗相关的AE报告。总共保留了183个显着的不成比例的首选术语（PT）。意外的严重不良事件，如脑膜炎无菌，白质脑病,肿瘤溶解综合征,弥散性血管内凝血,高粘度综合征,突发性听力损失,肠梗阻和憩室穿孔也被发现。达雷妥单抗相关AE的中位发病时间为11天（四分位距[IQR]0-76天），大多数病例发生在30天内。
■我们的研究发现了达拉图单抗的潜在新的和意外的不良事件信号，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.
