{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,30]],"date-time":"2026-03-30T14:11:35Z","timestamp":1774879895171,"version":"3.50.1"},"reference-count":43,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2021,3,15]],"date-time":"2021-03-15T00:00:00Z","timestamp":1615766400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001713","name":"European and Developing Countries Clinical Trials Partnership","doi-asserted-by":"publisher","award":["CSA2016S-1618"],"award-info":[{"award-number":["CSA2016S-1618"]}],"id":[{"id":"10.13039\/501100001713","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004441","name":"Styrelsen f\u00f6r Internationellt Utvecklingssamarbete","doi-asserted-by":"publisher","award":["CSA2016S-1618"],"award-info":[{"award-number":["CSA2016S-1618"]}],"id":[{"id":"10.13039\/100004441","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Preventive chemotherapy with diethylcarbamazine citrate (DEC) and albendazole (ALB) is the core intervention strategy to eliminate lymphatic filariasis (LF). We conducted a large-scale prospective active safety surveillance study to identify the incidence, type, severity, and risk factors for adverse events (AEs) following mass drug administration (MDA) of single-dose DEC and ALB in 10,010 participants from Kilifi County, Kenya. AEs were actively monitored and graded at 24 h, 48 h, and on day 7 Post-MDA. Out of 10,010 enrolled study participants, 1621 participants reported a total of 3102 AEs during a seven-day follow-up. The cumulative incidence of AEs was 16.2% (95% CI, 15.5\u201316.9%). The proportion of participants who experienced one, two, or \u2265three types of AEs was 9.2%, 4.6%, 2.4%, respectively. AEs were mild (87.3%), moderate (12.4%), and severe (0.3%) and resolved within 72 h. The five most common AEs were dizziness (5.9%), headache (5.6%), loss of appetite (3.3%), fever (2.9%), and drowsiness (2.6%). Older age, taking concurrent medications, \u2265three tablets of DEC, and type of meal taken before MDA were significant predictors of AEs. One in six participants experienced systemic mild-to-moderate severity grading and transient AEs. DEC and ALB co-administration for the elimination of LF is generally safe and well-tolerated.<\/jats:p>","DOI":"10.3390\/ph14030264","type":"journal-article","created":{"date-parts":[[2021,3,15]],"date-time":"2021-03-15T11:38:58Z","timestamp":1615808338000},"page":"264","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Safety and Tolerability of Mass Diethylcarbamazine and Albendazole Administration for the Elimination of Lymphatic Filariasis in Kenya: An Active Surveillance Study"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0543-9920","authenticated-orcid":false,"given":"Christabel","family":"Khaemba","sequence":"first","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, 14186 Stockholm, Sweden"},{"name":"Pharmacy and Poisons Board, 27663-00506 Nairobi, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3859-3660","authenticated-orcid":false,"given":"Abbie","family":"Barry","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, 14186 Stockholm, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6011-2253","authenticated-orcid":false,"given":"Wyckliff P.","family":"Omondi","sequence":"additional","affiliation":[{"name":"Ministry of Health -National Neglected Tropical Diseases Program, 30016-00100 Nairobi, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kefa","family":"Bota","sequence":"additional","affiliation":[{"name":"Ministry of Health -National Neglected Tropical Diseases Program, 30016-00100 Nairobi, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sultani","family":"Matendechero","sequence":"additional","affiliation":[{"name":"Ministry of Health -National Neglected Tropical Diseases Program, 30016-00100 Nairobi, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cecilia","family":"Wandera","sequence":"additional","affiliation":[{"name":"Ministry of Health -National Neglected Tropical Diseases Program, 30016-00100 Nairobi, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fred","family":"Siyoi","sequence":"additional","affiliation":[{"name":"Pharmacy and Poisons Board, 27663-00506 Nairobi, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elvis","family":"Kirui","sequence":"additional","affiliation":[{"name":"Ministry of Health -National Public Health Laboratory, Kenyatta National Hospital Grounds, 20750-00202 Nairobi, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Margaret","family":"Oluka","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Pharmacognosy, School of Pharmacy, University of Nairobi, 19676-00202 Nairobi, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pamela","family":"Nambwa","sequence":"additional","affiliation":[{"name":"Pharmacy and Poisons Board, 27663-00506 Nairobi, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5997-1157","authenticated-orcid":false,"given":"Parthasarathi","family":"Gurumurthy","sequence":"additional","affiliation":[{"name":"Pharmacovigilance and Clinical Trials, Botswana Medicines Regulatory Authority, Gaborone 505155, Botswana"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6309-476X","authenticated-orcid":false,"given":"Sammy 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