Child With Adverse Drug Reactions
Conditions
Keywords
Pediatry; Adverse drug reactions; Pharmacovigilance
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.
Interventions
OTHERAdverse drug reaction
description of the adverse drug reactions (ADR) and the drugs involved in pediatrics
Sponsors
CHU de Reims
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the different type of ADR | 30 years |
Outcome results
None listed