Adverse Drug Reactions in Pediatrics: Experience of a Regional Pharmacovigilance Center
NCT ID: NCT03316014
Last Updated: 2017-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
632 participants
OBSERVATIONAL
1985-01-31
2014-12-31
Brief Summary
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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
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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
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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
Adverse drug reaction
description of the adverse drug reactions (ADR) and the drugs involved in pediatrics
Interventions
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Adverse drug reaction
description of the adverse drug reactions (ADR) and the drugs involved in pediatrics
Eligibility Criteria
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Inclusion Criteria
* Who presented an adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne
Exclusion Criteria
18 Years
ALL
No
Sponsors
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CHU de Reims
OTHER
Responsible Party
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References
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Saint-Martin C, Kanagaratnam L, de Boissieu P, Azzouz B, Abou Taam M, Trenque T. [Adverse drug reactions in pediatrics: Experience of a regional pharmacovigilance center]. Therapie. 2016 Oct;71(5):467-473. doi: 10.1016/j.therap.2016.04.001. Epub 2016 Apr 11. French.
Other Identifiers
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2016Ao003
Identifier Type: -
Identifier Source: org_study_id