Adverse Drug Reactions in Pediatrics: Experience of a Reg... | NCT03316014

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

NCT03316014

Sponsor

CHU de Reims

Status

Completed

Last Update Posted

Oct 20, 2017Actual

Enrollment

632Actual

Phase

Not provided

Conditions

Child With Adverse Drug Reactions

Interventions

Adverse drug reaction

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1985Actual

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Oct 17, 2017

First Submission Date that Met QC Criteria

Oct 19, 2017

First Posted Date

Oct 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2017

Last Update Posted Date

Oct 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

632Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Adverse drug reaction	Other	description of the adverse drug reactions (ADR) and the drugs involved in pediatrics	Adverse drug reaction

Measure	Description	Time Frame
the different type of ADR		30 years

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27203165	Background	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.

ID	Term
D011358	Product Surveillance, Postmarketing
D005069	Evaluation Studies as Topic
D008919	Investigative Techniques
D004346	Drug Information Services