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

  • STATUS
    Recruiting
  • participants needed
    500000
  • sponsor
    University Hospital, Caen
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Updated on 19 February 2024
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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).

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.

Details
Condition Traffic Accident
Age 18years - 100years
Treatment Drugs Responsible for Cognitive Side Effects
Clinical Study IdentifierNCT04480996
SponsorUniversity Hospital, Caen
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

Chronology not compatible between the drug and the road traffic accident
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