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

NCT03316014 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 632

Last updated 2017-10-20

No results posted yet for this study

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

Conditions

  • Child With Adverse Drug Reactions

Interventions

OTHER

Adverse drug reaction

description of the adverse drug reactions (ADR) and the drugs involved in pediatrics

Sponsors & Collaborators

  • CHU de Reims

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1985-01-31
Primary Completion
2014-12-31
Completion
2014-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03316014 on ClinicalTrials.gov