Status:
UNKNOWN
Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive Side Effects (ERoADS)
Lead Sponsor:
University Hospital, Caen
Conditions:
Accident, Traffic
Eligibility:
All Genders
18+ years
Brief 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 clas...
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 Wor...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- Chronology not compatible between the drug and the road traffic accident
Key Trial Info
Start Date :
March 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
500000 Patients enrolled
Trial Details
Trial ID
NCT04480996
Start Date
March 1 2020
End Date
June 1 2023
Last Update
July 22 2020
Active Locations (1)
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1
Caen University Hospital, Department of Pharmacology
Caen, Normandy, France, 14033