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Journal Article > Research

Paediatric pharmacovigilance: use of pharmacovigilance data mining algorithms for signal detection in a safety dataset of a paediatric clinical study conducted in seven african countries

Kajungu DK, Erhart A, Talisuna AO, Bassat Q, Karema C, Nabasumba C, Nambozi M, Tinto H, Kremsner PG, Meremikwu M, D'Alessandro U, Speybroeck N
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Abstract
Pharmacovigilance programmes monitor and help ensuring the safe use of medicines which is critical to the success of public health programmes. The commonest method used for discovering previously unknown safety risks is spontaneous notifications. In this study we examine the use of data mining algorithms to identify signals from adverse events reported in a phase IIIb/IV clinical trial evaluating the efficacy and safety of several Artemisinin-based combination therapies (ACTs) for treatment of uncomplicated malaria in African children.
Countries
Burkina FasoGabonMozambiqueNigeriaRwandaUgandaZambia
Subject Area
pediatricsmalariafilovirus
DOI
10.1371/journal.pone.0096388
Published Date
01-May-2014
PubMed ID
24787710
Languages
English
Journal
PLOS One
Volume / Issue / Pages
Volume 9, Issue 5
Issue Date
01-May-2014
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