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This study aimed to monitor and evaluate both clinical and biological safety of pyronaridine\u2010artesunate (PA) in real\u2010life conditions in Burkina Faso's health system. This was a single\u2010arm, open\u2010label study, where patients attending Nanoro health facilities with uncomplicated malaria were consented to be part of a cohort event monitoring (CEM). At inclusion (day\u20100), PA was administered orally once a day for 3\u2009days. Patients spontaneous reported any clinical adverse events (AEs) occurring within 28\u2009days following the treatment. Additionally, the study focused on AEs of special interest (AESI), namely clinical signs related to hepatotoxicity and increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST). A nested subset of patients with blood sample collection at day\u20100 and day\u20107 were monitored to investigate the effect of PA on biochemistry parameters. From September 2017 to October 2018, 2786 patients were treated with PA. About 97.8% (2720\/2786) of patients did not report any AE. The most commonly reported events were respiratory, thoracic, and mediastinal disorders (8.3 per 1000), infections and infestations (7.9 per 1000), and gastrointestinal disorders (7.2 per 1000). No clinical or biological hepatotoxicity event related to PA was reported during the follow\u2010up. Changes in biochemistry parameters remained within laboratory reference ranges. The study showed that PA is a well\u2010tolerated drug and should be considered as a good option by malaria control programs in countries where existing first\u2010line antimalarial drugs are continuously threatened by the emergence of drug resistance.<\/jats:p>","DOI":"10.1002\/prp2.987","type":"journal-article","created":{"date-parts":[[2022,7,20]],"date-time":"2022-07-20T06:49:18Z","timestamp":1658299758000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Prospective observational study to evaluate the clinical and biological safety profile of pyronaridine\u2013artesunate in a rural health district in Burkina Faso"],"prefix":"10.1002","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0594-3887","authenticated-orcid":false,"given":"Toussaint","family":"Rouamba","sequence":"first","affiliation":[{"name":"Clinical Research Unit of Nanoro, Institute for Research in Health Sciences National Center for Scientific and Technological Research  Ouagadougou Burkina Faso"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Sondo","sequence":"additional","affiliation":[{"name":"Clinical Research Unit of Nanoro, Institute for Research in Health Sciences National Center for Scientific and Technological Research  Ouagadougou Burkina Faso"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isidore W.","family":"Yerbanga","sequence":"additional","affiliation":[{"name":"Clinical Research Unit of Nanoro, Institute for Research in Health Sciences National Center for Scientific and Technological Research  Ouagadougou Burkina Faso"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adelaide","family":"Compaore","sequence":"additional","affiliation":[{"name":"Clinical Research Unit of Nanoro, Institute for Research in Health Sciences National Center for Scientific and Technological Research  Ouagadougou Burkina Faso"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maminata","family":"Traore\u2010Coulibaly","sequence":"additional","affiliation":[{"name":"Clinical Research Unit of Nanoro, Institute for Research in Health Sciences National Center for Scientific and Technological Research  Ouagadougou Burkina Faso"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franck S.","family":"Hien","sequence":"additional","affiliation":[{"name":"Clinical Research Unit of Nanoro, Institute for Research in Health Sciences National Center for Scientific and Technological Research  Ouagadougou Burkina Faso"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nassirou A.","family":"Diande","sequence":"additional","affiliation":[{"name":"Clinical Research Unit of Nanoro, Institute for Research in Health Sciences National Center for Scientific and Technological Research  Ouagadougou Burkina Faso"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Innocent","family":"Valea","sequence":"additional","affiliation":[{"name":"Clinical Research Unit of Nanoro, Institute for Research in Health Sciences National Center for Scientific and Technological Research  Ouagadougou Burkina Faso"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc Christian","family":"Tahita","sequence":"additional","affiliation":[{"name":"Clinical Research Unit of Nanoro, Institute for Research in Health Sciences National Center for Scientific and Technological Research  Ouagadougou Burkina Faso"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita","family":"Baiden","sequence":"additional","affiliation":[{"name":"INDEPTH\u2013Network  Accra Ghana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fred","family":"Binka","sequence":"additional","affiliation":[{"name":"INDEPTH\u2013Network  Accra Ghana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Halidou","family":"Tinto","sequence":"additional","affiliation":[{"name":"Clinical Research Unit of Nanoro, Institute for Research in Health Sciences National Center for Scientific and Technological Research  Ouagadougou Burkina Faso"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,7,19]]},"reference":[{"key":"e_1_2_14_2_1","volume-title":"Guidelines for the Treatment of Malaria","author":"World Health Organization","year":"2015"},{"key":"e_1_2_14_3_1","volume-title":"Global Technical Strategy for Malaria 2016\u20132030. 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