A Pharmacovigilance Study of Torsade de Pointes in the Food and Drug Administration Adverse Event Reporting System Using Data Mining Algorithms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,670
- 试验地点
- 1
- 主要终点
- Identification of drugs associated with TdP
研究概览
简要总结
Many cardiac and non-cardiac drugs are associated with TdP that may constitute a significant problem because of sudden cardiac death. This study aims to present a comprehensive overview and disproportionality analysis of TdP cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) in order to identify new signals of TdP.
详细描述
Drug-induced Torsade de Pointes (TdP) is a serious but an overlooked adverse drug reaction because a wide range of marketed drugs associated with TdP are commonly prescribed in routine practice. Owing to the heightened concern of a vast number of drug-TdP associations including newly approved drugs, the investigators, therefore, aims to investigate drug-TdP associations by performing disproportionality analysis in order to identify new signals of TdP utilizing the individual case reports of TdP in the FAERS database.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TdP cases reported in the FAERS database till 31/03/2019
- •Adverse event reported was including the MedDRA term: Torsade de Pointes
排除标准
- •Drugs with less than 10 TdP reports
研究组 & 干预措施
Group/Cohort
Torsade de Pointes induced by drugs reported to the FAERS database from inception till first quarter of 2019 (1990-2019)
干预措施: Drugs, Generic (Drug)
结局指标
主要结局
Identification of drugs associated with TdP
时间窗: Cases reported to the FAERS database till 31/03/2019
The search includes MedDRA (v-22) Preferred Term, "Torsade de Pointes (MedDRA code: 10044066) for the identification of all TdP case reports and drugs.
Identification of new signals of TdP
时间窗: Cases reported to the FAERS database till 31/03/2019
Signal detection using disproportionality analysis
次要结局
- Validation of already known drug-TdP associations(Cases reported to the FAERS database till 31/03/2019)
- Description of the population of patients having TdP(Cases reported to the FAERS database till 31/03/2019)
- Stratification of new signals with respect to age(Cases reported to the FAERS database till 31/03/2019)
- Stratification of new signals with respect to gender(Cases reported to the FAERS database till 31/03/2019)
- Trends of TdP reports in FAERS database(Cases reported to the FAERS database till 31/03/2019)
研究者
Mohammad Ismail
Assistant Professor, Department of Pharmacy
University of Peshawar