- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03316014
Adverse Drug Reactions in Pediatrics: Experience of a Regional Pharmacovigilance Center (Pediatry ADR)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
description of the adverse drug reactions (ADR) and the drugs involved in pediatrics
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the different type of ADR
Time Frame: 30 years
|
30 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016Ao003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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