NCT03316014

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
632

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1985

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1985

Completed
29.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

29.9 years

First QC Date

October 17, 2017

Last Update Submit

October 19, 2017

Conditions

Child With Adverse Drug Reactions

Keywords

Pediatry; Adverse drug reactions; Pharmacovigilance

Outcome Measures

Primary Outcomes (1)

  • the different type of ADR

    30 years

Study Arms (1)

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

Other: Adverse drug reaction

Interventions

Adverse drug reactionOTHER

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

Adverse drug reaction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children from 0 to 17 years inclusive who presented an adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne.

You may qualify if:

  • Children from 0 to 17 years inclusive
  • Who presented an adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27203165BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Adverse Drug Reaction Reporting Systems

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Product Surveillance, PostmarketingEvaluation Studies as TopicInvestigative TechniquesDrug Information ServicesPharmaceutical ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 20, 2017

Study Start

January 1, 1985

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 20, 2017

Record last verified: 2017-10