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
AuthorsKajungu, D K
Talisuna, A O
MetadataShow full item record
AbstractPharmacovigilance 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.
PublisherPublic Library of Science
- Randomized, multicentre assessment of the efficacy and safety of ASAQ--a fixed-dose artesunate-amodiaquine combination therapy in the treatment of uncomplicated Plasmodium falciparum malaria.
- Authors: Ndiaye JL, Randrianarivelojosia M, Sagara I, Brasseur P, Ndiaye I, Faye B, Randrianasolo L, Ratsimbasoa A, Forlemu D, Moor VA, Traore A, Dicko Y, Dara N, Lameyre V, Diallo M, Djimde A, Same-Ekobo A, Gaye O
- Issue date: 2009 Jun 8
- A head-to-head comparison of four artemisinin-based combinations for treating uncomplicated malaria in African children: a randomized trial.
- Authors: Four Artemisinin-Based Combinations (4ABC) Study Group.
- Issue date: 2011 Nov
- Optimal Approach and Strategies to Strengthen Pharmacovigilance in Sub-Saharan Africa: A Cohort Study of Patients Treated with First-Line Artemisinin-Based Combination Therapies in the Nanoro Health and Demographic Surveillance System, Burkina Faso.
- Authors: Rouamba T, Sondo P, Derra K, Nakanabo-Diallo S, Bihoun B, Rouamba E, Tarnagda Z, Kazienga A, Valea I, Sorgho H, Pagnoni F, Samadoulougou-Kirakoya F, Tinto H
- Issue date: 2020
- Monitoring antimalarial safety and tolerability in clinical trials: a case study from Uganda.
- Authors: Staedke SG, Jagannathan P, Yeka A, Bukirwa H, Banek K, Maiteki-Sebuguzi C, Clark TD, Nzarubara B, Njama-Meya D, Mpimbaza A, Rosenthal PJ, Kamya MR, Wabwire-Mangen F, Dorsey G, Talisuna AO
- Issue date: 2008 Jun 11
- [Evaluation of the efficacy and safety of three 2-drug combinations for the treatment of uncomplicated Plasmodium falciparum malaria in Senegal: artesunate-amodiaquine, dihydroartemisinin-piperaquine, and artemether-lumefantrine].
- Authors: Sow D, Ndiaye JL, Sylla K, Ba MS, Tine RC, Faye B, Pene M, Ndiaye M, Seck A, Lo AC, Abiola A, Dieng Y, Gaye O
- Issue date: 2016 Jan-Mar