Adverse Drug Reactions in Pediatrics: Experience of a Regional Pharmacovigilance Center
Launched by CHU DE REIMS · Oct 19, 2017
Trial Information
Current as of June 24, 2025
Completed
Keywords
ClinConnect Summary
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 th...
Gender
ALL
Eligibility criteria
- 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
About Chu De Reims
Chu de Reims, or the University Hospital of Reims, is a leading healthcare institution in France dedicated to advancing medical research and improving patient care through innovative clinical trials. As a prominent clinical trial sponsor, Chu de Reims focuses on a wide range of therapeutic areas, fostering collaboration between multidisciplinary teams of healthcare professionals and researchers. The hospital is committed to adhering to the highest ethical standards and regulatory guidelines, ensuring that all trials are designed to deliver reliable data while prioritizing patient safety and well-being. Through its robust research infrastructure, Chu de Reims aims to contribute significantly to the advancement of medical knowledge and the development of new treatment options.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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