NCT04480996

Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive Side Effects (ERoADS)

Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive and Psychomotor Side Effects (ERoADS)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500,000 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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).

Detailed description

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.

Conditions

• Accident, Traffic

Interventions

Type	Name	Description
DRUG	Drugs Responsible for Cognitive Side Effects	identification of road traffic accidents associated with drugs responsible for psychomotor side effects

Timeline

• Start date: 2020-03-01
• Primary completion: 2022-12-01
• Completion: 2023-06-01
• First posted: 2020-07-22
• Last updated: 2020-07-22

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study