An observational study in Child With Adverse Drug Reactions, sponsored by CHU de Reims. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-20.
Sponsored by CHU de Reims · Observational
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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
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.
449 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.
This study's enrollment of 632 is above the median of 414 across 162 observational studies indexed under Drug-Related Side Effects and Adverse Reactions.
Browse Drug-Related Side Effects and Adverse Reactions studies →CHU de Reims is the lead sponsor of 276 studies on the registry; 50 are open to participants now.
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Children from 0 to 17 years inclusive who presented an adverse drug reaction notified to the Regional Pharmacovigilance Center of Champagne-Ardenne.
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exclusion criteria:
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
description of the adverse drug reactions (ADR) and the drugs involved in pediatrics
the different type of ADR
Time frame: 30 years
No study locations are listed for this record.
Ran from Jan 1985 to primary completion in Dec 2014, 359 months.
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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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