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

Child With Adverse Drug Reactions Clinical Trial

— Pediatry ADR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03316014
• Other study ID #: 2016Ao003
• Status: Completed
• Phase: N/A
• First received: October 17, 2017
• Last updated: October 19, 2017
• Start date: January 1985
• Est. completion date: December 2014

Study information

• Verified date: October 2017
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 632
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Child With Adverse Drug Reactions
• Drug-Related Side Effects and Adverse Reactions

Intervention

Other:
• Adverse drug reaction
description of the adverse drug reactions (ADR) and the drugs involved in pediatrics

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the different type of ADR		30 years