Status:
COMPLETED
Adverse Drug Reactions in Pediatrics: Experience of a Regional Pharmacovigilance Center
Lead Sponsor:
CHU de Reims
Conditions:
Child With Adverse Drug Reactions
Eligibility:
All Genders
18+ years
Brief Summary
Aim. - To describe the adverse drug reactions (ADR) and the drugs involved in pediatrics. Methods. - An observational study on all ADR notifications recorded in the French pharmaco-vigilance database...
Detailed Description
Pediatry aged under 18 years accounted for around 22% of the French general population. Data regarding drug safety from clinical trials are insufficient in this population. Aim. - To describe the ad...
Eligibility Criteria
Inclusion
- inclusion criteria:
- Children from 0 to 17 years inclusive
- Who presented an adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne
- exclusion criteria:
- none
Exclusion
Key Trial Info
Start Date :
January 1 1985
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
632 Patients enrolled
Trial Details
Trial ID
NCT03316014
Start Date
January 1 1985
End Date
December 1 2014
Last Update
October 20 2017
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