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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2023-06-01

Brief Summary

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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).

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Detailed Description

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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

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Accident, Traffic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Drugs Responsible for Cognitive Side Effects

Intervention Type DRUG

identification of road traffic accidents associated with drugs responsible for psychomotor side effects

Interventions

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Drugs Responsible for Cognitive Side Effects

identification of road traffic accidents associated with drugs responsible for psychomotor side effects

Intervention Type DRUG

Other Intervention Names

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Drugs Responsible for Pyschomotor Side Effects

Eligibility Criteria

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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)