PMID- 30953827 OWN - NLM STAT- MEDLINE DCOM- 20190808 LR - 20190808 IS - 1878-3511 (Electronic) IS - 1201-9712 (Linking) VI - 83 DP - 2019 Jun TI - Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study. PG - 72-76 LID - S1201-9712(19)30165-1 [pii] LID - 10.1016/j.ijid.2019.03.036 [doi] AB - The World Health Organization launched a global initiative, known as aDSM (active TB drug safety monitoring and management) to better describe the safety profile of new treatment regimens for drug-resistant tuberculosis (TB) in real-world settings. However, comprehensive surveillance is difficult to implement in several countries. The aim of the aDSM project is to demonstrate the feasibility of implementing national aDSM registers and to describe the type and the frequency of adverse events (AEs) associated with exposure to the new anti-TB drugs. Following a pilot study carried out in 2016, official involvement of TB reference centres/countries into the project was sought and cases treated with bedaquiline- and/or delamanid-containing regimens were consecutively recruited. AEs were prospectively collected ensuring potential attribution of the AE to a specific drug based on its known safety profile. A total of 309 cases were fully reported from 41 centres in 27 countries (65% males; 268 treated with bedaquiline, 20 with delamanid, and 21 with both drugs) out of an estimated 781 cases the participating countries had committed to report by the first quarter of 2019. CI - Copyright (c) 2019. Published by Elsevier Ltd. FAU - Akkerman, Onno AU - Akkerman O AD - University of Groningen, University Medical Center Groningen, Tuberculosis Center Beatrixoord, Haren, The Netherlands; University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases & Tuberculosis, Groningen, The Netherlands. Electronic address: o.w.akkerman@umcg.nl. FAU - Aleksa, Alena AU - Aleksa A AD - Department of Phthisiology, Grodno State Medical University, GRCC "Phthisiology", Grodno, Belarus. Electronic address: alex_helen2001@mail.ru. FAU - Alffenaar, Jan-Willem AU - Alffenaar JW AD - Sydney Pharmacy School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia; Westmead Hospital, Sydney, Australia; Dept. Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands. Electronic address: j.w.c.alffenaar@umcg.nl. FAU - Al-Marzouqi, Nada Hassan AU - Al-Marzouqi NH AD - Preventive Medicine Department, Ministry of Health and Prevention, Dubai, United Arab Emirates. Electronic address: nada.almarzouqi@moh.gov.ae. FAU - Arias-Guillen, Miguel AU - Arias-Guillen M AD - Servicio de Neumologia, Hospital Universitario Central de Asturias, Instituto de Investigacion Sanitaria del Principado de Asturias CIBER-Enfermedades Respiratorias. Instituto de Salud Carlos III, Oviedo Spain. Electronic address: miguelariasguillen@gmail.com. FAU - Belilovski, Evgeny AU - Belilovski E AD - Moscow Research and Clinical Center for TB Control, Moscow Government's Health Department, Moscow, Russian Federation. Electronic address: belilovsky@gmail.com. FAU - Bernal, Enrique AU - Bernal E AD - Unidad de Enfermedades Infecciosas, Hospital General Universitario Reina Sofia, Murcia, Spain. Electronic address: ebm.hgurs@gmail.com. FAU - Boeree, Martin J AU - Boeree MJ AD - Department of Pulmonary Diseases, Radboud Center of Infectious Diseases, Tuberculosis Center Dekkerswald Groesbeek, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: Martin.Boeree@radboudumc.nl. FAU - Borisov, Sergey E AU - Borisov SE AD - Moscow Research and Clinical Center for TB Control, Moscow Government's Health Department, Moscow, Russian Federation. Electronic address: sebarsik@gmail.com. FAU - Bruchfeld, Judith AU - Bruchfeld J AD - Division of Infectious Diseases, Department of Medicine, Solna, Karolinska Institute, Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden. Electronic address: judith.bruchfeld@ki.se. FAU - Cadinanos Loidi, Julen AU - Cadinanos Loidi J AD - Internal Medicine Department, Hospital General de Villalba, Collado Villalba, Spain. Electronic address: julen.cadinanos@hgvillalba.es. FAU - Cai, Qingshan AU - Cai Q AD - Zhejiang Integrated Traditional and Western Medicine Hospital, Hangzhou, China. Electronic address: caiqs66@163.com. FAU - Caminero, Jose A AU - Caminero JA AD - Pneumology Department, Hospital General de Gran Canaria "Dr. Negrin", Las Palmas de Gran Canaria, Spain; MDR-TB Unit, Tuberculosis Division, International Union against Tuberculosis and Lung Disease (The Union), Paris, France. Electronic address: jcamlun@gobiernodecanarias.org. FAU - Cebrian Gallardo, Jose Joaquin AU - Cebrian Gallardo JJ AD - Unidad de Neumologia, Agencia Sanitaria Costa del Sol, Marbella, Spain. Electronic address: jcebrian@hcs.es. FAU - Centis, Rosella AU - Centis R AD - Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy. Electronic address: rosella.centis@icsmaugeri.it. FAU - Codecasa, Luigi Ruffo AU - Codecasa LR AD - TB Reference Centre, Villa Marelli Institute/Niguarda Hospital, Milan, Italy. Electronic address: luigiruffo.codecasa@ospedaleniguarda.it. FAU - D'Ambrosio, Lia AU - D'Ambrosio L AD - Public Health Consulting Group, Lugano, Switzerland. Electronic address: liadambrosio59@gmail.com. FAU - Dalcolmo, Margareth AU - Dalcolmo M AD - Reference Center Helio Fraga, Fundacao Oswaldo Cruz (Fiocruz)/Ministry of Health, Rio de Janeiro, Brazil. Electronic address: margarethdalcolmo@gmail.com. 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FAU - Ferrarese, Maurizio AU - Ferrarese M AD - TB Reference Centre, Villa Marelli Institute/Niguarda Hospital, Milan, Italy. Electronic address: Maurizio.Ferrarese@ospedaleniguarda.it. FAU - Filippov, Alexey AU - Filippov A AD - Moscow Research and Clinical Center for TB Control, Moscow Government's Health Department, Moscow, Russian Federation. Electronic address: alex.phil.2010@yandex.ru. FAU - Ganatra, Shashank AU - Ganatra S AD - Department of Respiratory Medicine, P.D. Hinduja National Hospital and MRC, Mumbai, India. Electronic address: shashankganatra11@gmail.com. FAU - Garcia, Ana AU - Garcia A AD - Pulmonology Division, Municipal Hospital F.J. Muniz, Buenos Aires, Argentina. Electronic address: angarcia111@hotmail.com. FAU - Garcia-Garcia, Jose-Maria AU - Garcia-Garcia JM AD - Tuberculosis Research Programme, SEPAR, Barcelona, Spain. Electronic address: josemariagarciagarcia@gmail.com. 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FAU - Kunst, Heinke AU - Kunst H AD - Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom. Electronic address: h.kunst@qmul.ac.uk. FAU - Laniado-Laborin, Rafael AU - Laniado-Laborin R AD - Universidad Autonoma de Baja California, Baja California, Mexico; Clinica de Tuberculosis del Hospital General de Tijuana, Tijuana, Baja California, Mexico. Electronic address: rafaellaniado@gmail.com. FAU - Li, Yang AU - Li Y AD - Departments of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China. Electronic address: losty34217@gmail.com. FAU - Magis-Escurra, Cecile AU - Magis-Escurra C AD - Department of Pulmonary Diseases, Radboud Center of Infectious Diseases, Tuberculosis Center Dekkerswald Groesbeek, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: Cecile.Magis-Escurra@radboudumc.nl. FAU - Manfrin, Vinicio AU - Manfrin V AD - S. Bortolo Hospital, Vicenza, Italy. 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FAU - Mustafa Hamdan, Hamdan AU - Mustafa Hamdan H AD - MDR-TB Department, Abu anga Teaching Hospital, Khartoum, Sudan. Electronic address: drhamdanmh@gmail.com. FAU - Nieto Marcos, Magnolia AU - Nieto Marcos M AD - Hospital Doctor Moliner, Valencia, Spain. Electronic address: nmmagnolia@hotmail.com. FAU - Noordin, Noorliza Mohamad AU - Noordin NM AD - Disease Division, National Public Health Laboratory, Ministry of Health, Selangor, Malaysia. Electronic address: noorlizanoordin9@gmail.com. FAU - Palmero, Domingo Juan AU - Palmero DJ AD - Pulmonology Division, Municipal Hospital F.J. Muniz, Buenos Aires, Argentina. Electronic address: djpalmero@intramed.net. FAU - Palmieri, Fabrizio AU - Palmieri F AD - Respiratory Infectious Diseases Unit, National Institute for Infectious Diseases 'L. Spallanzani', IRCCS, Rome, Italy. Electronic address: fabrizio.palmieri@inmi.it. 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Electronic address: pietro.viggiani@asst-val.it. FAU - Visca, Dina AU - Visca D AD - Division of Pulmonary Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Tradate, Italy; Department of Medicine and Surgery, Respiratory Diseases, University of Insubria, Varese, Italy. Electronic address: dina.visca@icsmaugeri.it. FAU - Zhurkin, Dmitry AU - Zhurkin D AD - Republican Research and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus. Electronic address: dmitry_zhurkin@yahoo.com. FAU - Zignol, Matteo AU - Zignol M AD - Global Tuberculosis Programme, World Health Organization, Geneva, Switzerland. Electronic address: zignolm@who.int. CN - members of the International Study Group on new anti-tuberculosis drugs and adverse events monitoring LA - eng PT - Journal Article DEP - 20190403 PL - Canada TA - Int J Infect Dis JT - International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases JID - 9610933 RN - 0 (Antitubercular Agents) RN - 0 (Diarylquinolines) RN - 0 (Nitroimidazoles) RN - 0 (OPC-67683) RN - 0 (Oxazoles) RN - 78846I289Y (bedaquiline) CIN - Pulmonology. 2020 Jul - Aug;26(4):247-249. PMID: 31722846 MH - Antitubercular Agents/*adverse effects MH - Diarylquinolines/administration & dosage/*adverse effects MH - Drug Therapy, Combination MH - Feasibility Studies MH - Female MH - Humans MH - Male MH - Nitroimidazoles/administration & dosage/*adverse effects MH - Oxazoles/administration & dosage/*adverse effects MH - Pilot Projects MH - Tuberculosis/drug therapy MH - Tuberculosis, Multidrug-Resistant/*drug therapy MH - World Health Organization OTO - NOTNLM OT - Adverse events OT - Bedaquiline OT - Delamanid OT - MDR-TB OT - Monitoring OT - Tuberculosis EDAT- 2019/04/07 06:00 MHDA- 2019/08/09 06:00 CRDT- 2019/04/07 06:00 PHST- 2019/03/22 00:00 [received] PHST- 2019/03/29 00:00 [revised] PHST- 2019/03/29 00:00 [accepted] PHST- 2019/04/07 06:00 [pubmed] PHST- 2019/08/09 06:00 [medline] PHST- 2019/04/07 06:00 [entrez] AID - S1201-9712(19)30165-1 [pii] AID - 10.1016/j.ijid.2019.03.036 [doi] PST - ppublish SO - Int J Infect Dis. 2019 Jun;83:72-76. doi: 10.1016/j.ijid.2019.03.036. Epub 2019 Apr 3.