Adverse Drug Reactions in Pediatrics: Experience of a Regional Pharmacovigilance Center
- Conditions
- Child With Adverse Drug Reactions
- Interventions
- Other: Adverse drug reaction
- Registration Number
- NCT03316014
- Lead Sponsor
- CHU de Reims
- 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 by the Regional Pharmacovigilance Center of Champagne-Ardenne between 1 January 1985 and 31 December 2014 involving children from 0 to 17 years inclusive was performed. For all notifications, we studied the patient and the ADR characteristics
- 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 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 by the Regional Pharmacovigilance Center of Champagne-Ardenne between 1 January 1985 and 31 December 2014 involving children from 0 to 17 years inclusive was performed. For all notifications, we studied the patient and the ADR characteristics.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 632
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adverse drug reaction Adverse drug reaction Children from 0 to 17 years inclusive with ADR notifications recorded in the French pharmaco-vigilance database by the Regional Pharmacovigilance Center of Champagne-Ardenne between 1 January 1985 and 31 December 2014
- Primary Outcome Measures
Name Time Method the different type of ADR 30 years
- Secondary Outcome Measures
Name Time Method