A Pharmacovigilance Study of Brain Oedema 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
- 9,524
- 试验地点
- 1
- 主要终点
- Identification of drugs associated with Brain Oedema
研究概览
简要总结
Literature reports the development of brain oedema following the use of certain drugs. Therefore, this study aims to present a comprehensive disproportionality analysis of brain oedema cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS).
详细描述
Brain oedema is a serious neurological condition, as it possesses a significant impact on the functional abilities of an individual by causing irreversible brain damage and potentiates the risk of mortality. Apart from a number of medical conditions causing brain oedema, evidence suggests the association of various drugs with brain oedema. Therefore, this study aims to provide a comprehensive disproportionality analysis of the drug-induced brain oedema reports 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
- •Brain Oedema cases reported in the FAERS database till 31/03/2019
- •Adverse event reported was included using the MedDRA term: Brain Oedema
排除标准
- •Drugs with less than 19 brain oedema reports
研究组 & 干预措施
Group/Cohort
Brain Oedema induced by drugs reported to the FAERS database from inception till first quarter of 2019
干预措施: Drugs, Generic (Drug)
结局指标
主要结局
Identification of drugs associated with Brain Oedema
时间窗: Cases reported to the FAERS database since inception till 31/03/2019
The search includes MedDRA (v-22) Preferred Term, "Brain Oedema (MedDRA code: 10048962) for the identification of all Brain Oedema case reports and drugs.
Detection of signals of Brain Oedema
时间窗: Cases reported to the FAERS database since inception till 31/03/2019
Signal detection using disproportionality analysis
次要结局
- Stratification of new signals with respect to gender(Cases reported to the FAERS database since inception till 31/03/2019)
- Trends of Brain Oedema reports in FAERS database(Cases reported to the FAERS database since inception till 31/03/2019)
- Description of the population of patients having Brain Oedema(Cases reported to the FAERS database since inception till 31/03/2019)
- Stratification of new signals with respect to age(Cases reported to the FAERS database since inception till 31/03/2019)
- Trends of Brain Oedema reports in Google searches(Cases reported to the FAERS database since inception till 31/03/2019)
研究者
Mohammad Ismail
Assistant Professor, Department of Pharmacy
University of Peshawar