| Autor: |
Zwang Julien, Dorsey Grant, Djimdé Abdoulaye, Karema Corine, Mårtensson Andreas, Ndiaye Jean-Louis, Sirima Sodiomon B, Olliaro Piero |
| Jazyk: |
angličtina |
| Rok vydání: |
2012 |
| Předmět: |
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| Zdroj: |
Malaria Journal, Vol 11, Iss 1, p 260 (2012) |
| Druh dokumentu: |
article |
| ISSN: |
1475-2875 |
| DOI: |
10.1186/1475-2875-11-260 |
| Popis: |
Abstract Background The widespread use of artesunate-amodiaquine (ASAQ) for treating uncomplicated malaria makes it important to gather and analyse information on its tolerability. Methods An individual-patient tolerability analysis was conducted using data from eight randomized controlled clinical trials conducted at 17 sites in nine sub-Saharan countries comparing ASAQ to other anti-malarial treatments. All patients who received at least one dose of the study drug were included in the analysis. Differences in adverse event (AE) and treatment emergent adverse event (TEAE) were analysed by Day 28. Results Of the 6,179 patients enrolled (74% Conclusion ASAQ was comparatively well-tolerated. Safety information is important, and must be collected and analysed in a standardized way. TEAEs are a more objective measure of treatment-induced toxicity. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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