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OpenTrials
Completed

NCT Number: NCT03316014

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

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

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Key information

Conditions

Child With Adverse Drug Reactions Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adverse drug reaction

Other

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

Primary outcomes

  1. the different type of ADR

    Time frame: 30 years

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: Pediatry ADR

Important dates

Study start
1985
Primary completion
2014
Study completion
2014
First posted
Oct 20, 2017
Registry last updated
Oct 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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