NCT03316014

Adverse Drug Reactions in Pediatrics: Experience of a Regional Pharmacovigilance Center

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 632 (actual)
• Sponsor: CHU de Reims · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Child With Adverse Drug Reactions

Interventions

Type	Name	Description
OTHER	Adverse drug reaction	description of the adverse drug reactions (ADR) and the drugs involved in pediatrics

Timeline

• Start date: 1985-01-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2017-10-20
• Last updated: 2017-10-20