Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive and Psychomotor Side Effects (ERoADS)
试验速览
- 阶段
- 不适用
- 入组人数
- 500,000
- 试验地点
- 1
- 主要终点
- Association between drugs responsible for cognitive and psychomotor side effects and road traffic accidents cases
研究概览
简要总结
Drugs responsible for cognitive and psychomotor side effects may lead to impaired driving skills and road traffic accidents. This study investigates reports of road traffic accident for different class of drugs responsible for cognitive and psychomotor sides effects (pyschotropic agents, neurotropic agents, antineoplasic agents) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).
详细描述
Some medications are responsible of a wide range of cognitive and psychomotor side effects that may make it unsafe to drive and lead to risks of road accidents .The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of road traffic accidents following treatment with different class of drugs responsible for pyschomotor sides effects.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/03/2020
- •Adverse events reported were including the MedDRA terms: Road Traffic Accident (SMQ)
- •Patients treated with at least one liable nervous system drugs (ATC class N) or that can induce cognitive and pyschomotor undesirable effects by crossing the blood-brain barrier (ATC class A04, C02A, L)
排除标准
- •Chronology not compatible between the drug and the road traffic accident
研究组 & 干预措施
Road traffic accidents with medicines
Road traffic accidents cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by Drugs Responsible for Cognitive and Psychomotor Side Effects
干预措施: Drugs Responsible for Cognitive Side Effects (Drug)
结局指标
主要结局
Association between drugs responsible for cognitive and psychomotor side effects and road traffic accidents cases
时间窗: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020
Identification of cases with association between each individual of different class of drugs responsible for cognitive ans psychomotor side effects and road traffic accidents cases
次要结局
- Association between two drugs of the same class, leading to an over-reporting of road traffic accidents(Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020)
- Description of the population of patients having a road traffic accident related to taking medication(Case reported in the World Health Organization (WHO) of individual safety case reports to March 2020)