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Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report

Sergey Borisov, Edvardas Danila, Andrei Maryandyshev, Margareth Dalcolmo, Skaidrius Miliauskas, Liga Kuksa, Selene Manga, Alena Skrahina, Saulius Diktanas, Luigi Ruffo Codecasa, Alena Aleksa, Judith Bruchfeld, Antoniya Koleva, Alberto Piubello, Zarir Farokh Udwadia, Onno W. Akkerman, Evgeny Belilovski, Enrique Bernal, Martin J. Boeree, Julen Cadiñanos Loidi, Qingshan Cai, Jose Joaquín Cebrian Gallardo, Masoud Dara, Edita Davidavičienė, Lina Davies Forsman, Jorge De Los Rios, Justin Denholm, Jacinta Drakšienė, Raquel Duarte, Seifeldin Eltaeb Elamin, Nadia Escobar Salinas, Maurizio Ferrarese, Alexey Filippov, Ana Garcia, José-María García-García, Ieva Gaudiesiute, Blagovesta Gavazova, Regina Gayoso, Roscio Gomez Rosso, Vygantas Gruslys, Gina Gualano, Wouter Hoefsloot, Jerker Jonsson, Elena Khimova, Heinke Kunst, Rafael Laniado-Laborín, Yang Li, Cecile Magis-Escurra, Vinicio Manfrin, Valentina Marchese, Elena Martínez Robles, Alberto Matteelli, Jesica Mazza-Stalder, Charalampos Moschos, Marcela Muñoz-Torrico, Hamdan Mustafa Hamdan, Birutė Nakčerienė, Laurent Nicod, Magnolia Nieto Marcos, Domingo Juan Palmero, Fabrizio Palmieri, Apostolos Papavasileiou, Marie-Christine Payen, Agostina Pontarelli, Sarai Quirós, Adrian Rendon, Laura Saderi, Agnese Šmite, Ivan Solovic, Mahamadou Bassirou Souleymane, Marina Tadolini, Martin van den Boom, Marisa Vescovo, Pietro Viggiani, Askar Yedilbayev, Rolandas Zablockis, Dmitry Zhurkin, Matteo Zignol, Dina Visca, Antonio Spanevello, José A. Caminero, Jan-Willem Alffenaar, Simon Tiberi, Rosella Centis, Lia D'Ambrosio, Emanuele Pontali, Giovanni Sotgiu, Giovanni Battista Migliori
European Respiratory Journal 2019 54: 1901522; DOI: 10.1183/13993003.01522-2019
Sergey Borisov
1Moscow Research and Clinical Center for TB Control, Moscow Government's Health Department, Moscow, Russian Federation
69These authors contributed equally
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Edvardas Danila
2Clinic of Chest Diseases, Immunology and Allergology, Vilnius University Medical Faculty, Centre of Pulmonology and Allergology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania
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Andrei Maryandyshev
3Northern State Medical University, Arkhangelsk, Russian Federation
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Margareth Dalcolmo
4Reference Center Hélio Fraga, Fundação Oswaldo Cruz (Fiocruz)/Ministry of Health, Rio de Janeiro, Brazil
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Skaidrius Miliauskas
5Dept of Pulmonology, Lithuanian University of Health Sciences, Kaunas, Lithuania
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Liga Kuksa
6MDR-TB Dept, Riga East University Hospital for TB and Lung Disease Centre, Riga, Latvia
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Selene Manga
7Dept of Infectious Diseases, University National San Antonio Abad Cusco, Cusco, Peru
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Alena Skrahina
8Republican Research and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus
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Saulius Diktanas
9Tuberculosis Dept, 3rd Tuberculosis Unit, Republican Klaipėda Hospital, Klaipėda, Lithuania
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Luigi Ruffo Codecasa
10TB Reference Centre, Villa Marelli Institute, Niguarda Hospital, Milan, Italy
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Alena Aleksa
11Dept of Phthisiology and Pulmonology, Grodno State Medical University, Grodno, Belarus
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Judith Bruchfeld
12Division of Infectious Diseases, Dept of Medicine, Karolinska Institute, Solna, Sweden
13Dept of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden
69These authors contributed equally
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Antoniya Koleva
14Pulmonology and Physiotherapy Dept, Gabrovo Lung Diseases Hospital, Gabrovo, Bulgaria
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Alberto Piubello
15Tuberculosis Division, International Union against Tuberculosis and Lung Disease (The Union), Paris, France
16Tuberculosis Division, Damien Foundation, Niamey, Niger
69These authors contributed equally
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Zarir Farokh Udwadia
17Dept of Respiratory Medicine, P.D. Hinduja National Hospital and MRC, Mumbai, India
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Onno W. Akkerman
18University of Groningen, University Medical Center Groningen, Dept of Pulmonary Diseases and Tuberculosis, Groningen, The Netherlands
19University of Groningen, University Medical Center Groningen, TB Center Beatrixoord, Haren, The Netherlands
69These authors contributed equally
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Evgeny Belilovski
1Moscow Research and Clinical Center for TB Control, Moscow Government's Health Department, Moscow, Russian Federation
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Enrique Bernal
20Unidad de Enfermedades Infecciosas, Hospital General Universitario Reina Sofia, Murcia, Spain
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Martin J. Boeree
21Radboud University Medical Center, Center Dekkerswald, Nijmegen, The Netherlands
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Julen Cadiñanos Loidi
22Internal Medicine Dept, Hospital General de Villalba, Collado Villalba, Spain
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Qingshan Cai
23Zhejiang Integrated Traditional and Western Medicine Hospital, Hangzhou, China
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Jose Joaquín Cebrian Gallardo
24Unidad de Neumología, Agencia Sanitaria Costa del Sol, Marbella, Spain
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Masoud Dara
25World Health Organization Regional Office for Europe, Copenhagen, Denmark
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Edita Davidavičienė
26National TB Registry, Public Health Dept, Ministry of Health, Vilnius, Lithuania
27Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania
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Lina Davies Forsman
12Division of Infectious Diseases, Dept of Medicine, Karolinska Institute, Solna, Sweden
13Dept of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden
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Jorge De Los Rios
28Centro de Excelencia de TB “Niño Jesus”, Servicio de Neumologia, Hospital Maria Auxiliadora, Lima, Peru
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Justin Denholm
29Victorian Tuberculosis Program, Melbourne Health, Melbourne, Australia
30Dept of Microbiology and Immunology, University of Melbourne, Melbourne, Australia
69These authors contributed equally
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Jacinta Drakšienė
9Tuberculosis Dept, 3rd Tuberculosis Unit, Republican Klaipėda Hospital, Klaipėda, Lithuania
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Raquel Duarte
31National Reference Centre for MDR-TB, Hospital Centre Vila Nova de Gaia, Dept of Pneumology, Public Health Science and Medical Education Dept, Faculty of Medicine, University of Porto, Porto, Portugal
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Seifeldin Eltaeb Elamin
32MDR-TB Department, Abu anga Teaching Hospital, Khartoum, Sudan
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Nadia Escobar Salinas
33Division of Disease Prevention and Control, Dept of Communicable Diseases, National Tuberculosis Control and Elimination Programme, Ministry of Health, Santiago, Chile
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Maurizio Ferrarese
10TB Reference Centre, Villa Marelli Institute, Niguarda Hospital, Milan, Italy
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Alexey Filippov
1Moscow Research and Clinical Center for TB Control, Moscow Government's Health Department, Moscow, Russian Federation
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Ana Garcia
34Pulmonology Division, Municipal Hospital F.J. Muñiz, Buenos Aires, Argentina
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José-María García-García
35Tuberculosis Research Programme, SEPAR, Barcelona, Spain
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Ieva Gaudiesiute
5Dept of Pulmonology, Lithuanian University of Health Sciences, Kaunas, Lithuania
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Blagovesta Gavazova
36“Improve the Sustainability of the National TB Programme”, Sofia, Bulgaria
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Regina Gayoso
4Reference Center Hélio Fraga, Fundação Oswaldo Cruz (Fiocruz)/Ministry of Health, Rio de Janeiro, Brazil
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Roscio Gomez Rosso
37National Institute of Respiratory and Environmental Diseases “Prof. Dr. Juan Max Boettner” Asunción, Paraguay
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Vygantas Gruslys
2Clinic of Chest Diseases, Immunology and Allergology, Vilnius University Medical Faculty, Centre of Pulmonology and Allergology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania
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Gina Gualano
38Respiratory Infectious Diseases Unit, National Institute for Infectious Diseases “L. Spallanzani”, IRCCS, Rome, Italy
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Wouter Hoefsloot
21Radboud University Medical Center, Center Dekkerswald, Nijmegen, The Netherlands
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Jerker Jonsson
39Dept of Public Health Analysis and Data Management, Public Health Agency of Sweden, Solna, Sweden
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Elena Khimova
3Northern State Medical University, Arkhangelsk, Russian Federation
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Heinke Kunst
40Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK
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Rafael Laniado-Laborín
41Universidad Autónoma de Baja California, Baja California, Mexico; Clínica de Tuberculosis del Hospital General de Tijuana, Tijuana, Mexico
69These authors contributed equally
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Yang Li
42Dept of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China
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Cecile Magis-Escurra
21Radboud University Medical Center, Center Dekkerswald, Nijmegen, The Netherlands
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Vinicio Manfrin
43S. Bortolo Hospital, Vicenza, Italy
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Valentina Marchese
44Clinic of Infectious and Tropical Diseases, WHO Collaborating Centre for TB elimination and TB/HIV co-infection, University of Brescia, Brescia, Italy
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Elena Martínez Robles
45Internal Medicine Dept, Tuberculosis Unit, Hospital de Cantoblanco – Hospital General Universitario La Paz, Madrid, Spain
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Alberto Matteelli
44Clinic of Infectious and Tropical Diseases, WHO Collaborating Centre for TB elimination and TB/HIV co-infection, University of Brescia, Brescia, Italy
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Jesica Mazza-Stalder
46Division of Pulmonary Medicine, University Hospital of Lausanne CHUV, Lausanne, Switzerland
69These authors contributed equally
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Charalampos Moschos
47Dept of Tuberculosis, Sotiria Athens Hospital of Chest Diseases, Athens, Greece
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Marcela Muñoz-Torrico
48Clínica de Tuberculosis, Instituto Nacional De Enfermedades Respiratorias Ismael Cosio Villegas, Ciudad De Mexico, Mexico
69These authors contributed equally
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Hamdan Mustafa Hamdan
32MDR-TB Department, Abu anga Teaching Hospital, Khartoum, Sudan
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Birutė Nakčerienė
26National TB Registry, Public Health Dept, Ministry of Health, Vilnius, Lithuania
27Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania
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Laurent Nicod
46Division of Pulmonary Medicine, University Hospital of Lausanne CHUV, Lausanne, Switzerland
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Magnolia Nieto Marcos
49Internal Medicine Dept, Hospital Doctor Moliner, Valencia, Spain
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Domingo Juan Palmero
34Pulmonology Division, Municipal Hospital F.J. Muñiz, Buenos Aires, Argentina
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Fabrizio Palmieri
38Respiratory Infectious Diseases Unit, National Institute for Infectious Diseases “L. Spallanzani”, IRCCS, Rome, Italy
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Apostolos Papavasileiou
47Dept of Tuberculosis, Sotiria Athens Hospital of Chest Diseases, Athens, Greece
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Marie-Christine Payen
50Division of Infectious Diseases, CHU Saint-Pierre, Université Libre de Bruxelles (ULB), Brussels, Belgium
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Agostina Pontarelli
51Reference Center for MDR-TB and HIV-TB, Eugenio Morelli Hospital, Sondalo, Italy
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Sarai Quirós
52Pneumology Dept, Tuberculosis Unit, Hospital de Cantoblanco – Hospital General Universitario La Paz, Madrid, Spain
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Adrian Rendon
53Centro de Investigación, Prevención y Tratamiento de Infecciones Respiratorias CIPTIR, University Hospital of Monterrey UANL (Universidad Autonoma de Nuevo Leon), Monterrey, Mexico
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Laura Saderi
54Clinical Epidemiology and Medical Statistics Unit, Dept of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy
69These authors contributed equally
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Agnese Šmite
6MDR-TB Dept, Riga East University Hospital for TB and Lung Disease Centre, Riga, Latvia
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Ivan Solovic
55National Institute for TB, Lung Diseases and Thoracic Surgery, Vysne Hagy, Catholic University Ruzomberok, Ruzomberok, Slovakia
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Mahamadou Bassirou Souleymane
16Tuberculosis Division, Damien Foundation, Niamey, Niger
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Marina Tadolini
56Unit of Infectious Diseases, Dept of Medical and Surgical Sciences Alma Mater Studiorum University of Bologna, Bologna, Italy
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Martin van den Boom
25World Health Organization Regional Office for Europe, Copenhagen, Denmark
69These authors contributed equally
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Marisa Vescovo
34Pulmonology Division, Municipal Hospital F.J. Muñiz, Buenos Aires, Argentina
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Pietro Viggiani
51Reference Center for MDR-TB and HIV-TB, Eugenio Morelli Hospital, Sondalo, Italy
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Askar Yedilbayev
25World Health Organization Regional Office for Europe, Copenhagen, Denmark
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Rolandas Zablockis
2Clinic of Chest Diseases, Immunology and Allergology, Vilnius University Medical Faculty, Centre of Pulmonology and Allergology, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania
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Dmitry Zhurkin
8Republican Research and Practical Centre for Pulmonology and Tuberculosis, Minsk, Belarus
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Matteo Zignol
57Global Tuberculosis Programme, World Health Organization, Geneva, Switzerland
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Dina Visca
58Division of Pulmonary Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Tradate, Italy
59Dept of Medicine and Surgery, Respiratory Diseases, University of Insubria, Tradate, Italy
69These authors contributed equally
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Antonio Spanevello
58Division of Pulmonary Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, Tradate, Italy
59Dept of Medicine and Surgery, Respiratory Diseases, University of Insubria, Tradate, Italy
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José A. Caminero
60Pneumology Dept, Hospital General de Gran Canaria “Dr. Negrin”, Las Palmas de Gran Canaria, Spain
61MDR-TB Unit, Tuberculosis Division, International Union against Tuberculosis and Lung Disease (The Union), Paris, France
69These authors contributed equally
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Jan-Willem Alffenaar
62University of Sydney, Faculty of Medicine and Health, School of Pharmacy, Sydney, Australia
63Westmead Hospital, Sydney, Australia
64University of Groningen, University Medical Center Groningen, Dept of Pharmacy and Pharmacology, Groningen, The Netherlands
69These authors contributed equally
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Simon Tiberi
40Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK
65Dept of Infection, Royal London and Newham Hospitals, Barts Health NHS Trust, London, UK
69These authors contributed equally
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Rosella Centis
66Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy
69These authors contributed equally
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Lia D'Ambrosio
67Public Health Consulting Group, Lugano, Switzerland
69These authors contributed equally
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Emanuele Pontali
68Dept of Infectious Diseases, Galliera Hospital, Genova, Italy
69These authors contributed equally
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Giovanni Sotgiu
54Clinical Epidemiology and Medical Statistics Unit, Dept of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy
69These authors contributed equally
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Giovanni Battista Migliori
66Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy
69These authors contributed equally
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  • For correspondence: giovannibattista.migliori@icsmaugeri.it
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Abstract

The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events.

The aim of this prospective study was to evaluate the frequency and severity of adverse events to anti-tuberculosis (TB) drugs in a cohort of consecutive TB patients treated with new (i.e. bedaquiline, delamanid) and repurposed (i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection.

Globally, 45 centres from 26 countries/regions reported 658 patients (68.7% male, 4.4% HIV co-infected) treated as follows: 87.7% with bedaquiline, 18.4% with delamanid (6.1% with both), 81.5% with linezolid and 32.4% with clofazimine. Overall, 504 adverse event episodes were reported: 447 (88.7%) were classified as minor (grade 1–2) and 57 (11.3%) as serious (grade 3–5). The majority of the 57 serious adverse events reported by 55 patients (51 out of 57, 89.5%) ultimately resolved. Among patients reporting serious adverse events, some drugs held responsible were discontinued: bedaquiline in 0.35% (two out of 577), delamanid in 0.8% (one out of 121), linezolid in 1.9% (10 out of 536) and clofazimine in 1.4% (three out of 213) of patients. Serious adverse events were reported in 6.9% (nine out of 131) of patients treated with amikacin, 0.4% (one out of 221) with ethionamide/prothionamide, 2.8% (15 out of 536) with linezolid and 1.8% (eight out of 498) with cycloserine/terizidone.

The aDSM study provided valuable information, but implementation needs scaling-up to support patient-centred care.

Abstract

Previous evidence on adverse events is available from single studies. This global project (658 patients from 26 countries) demonstrates aDSM is feasible and serious adverse events of recommended drugs are reasonably low (overall 57 out of 504, 11.3%). http://bit.ly/2kzvbqe

Footnotes

  • This article has supplementary material available from erj.ersjournals.com

  • Author contributions: The manuscript was conceived, planned, written, edited and approved using a collaborative approach, following the internal GTN (Global Tuberculosis Network) and internationally acknowledged rules on authorship, based on major intellectual contribution to the steps mentioned above. The study represents a global effort involving 26 countries in all continents. G. Sotgiu, S. Tiberi, R. Centis, L. D'Ambrosio and G.B. Migliori wrote the protocol. G. Sotgiu, L. Saderi and R. Duarte revised it for methodological content. G. Sotgiu, L. Saderi, R. Centis and L. D'Ambrosio performed the analysis. S. Tiberi, R. Centis, L. D'Ambrosio, E. Pontali, J-W. Alffenaar, J.A. Caminero, G. Sotgiu and G.B. Migliori wrote the first draft of the manuscript. S. Borisov, J. Bruchfeld, A. Piubello, O.W. Akkermann, J. Denholm, J-M. García-García, R. Laniado-Laborín, J. Mazza-Stalder, A. Matteelli, M. Muñoz-Torrico, M. van den Boom, D. Visca, J.A. Caminero and G. Sotgiu wrote the sections of the manuscript (second draft). A. Spanevello, J-M. García-García, Z.F. Udwadia, E. Danila, A. Maryandyshev and M. Dalcolmo provided comments to the second draft (third draft). A. Maryandyshev, S. Miliauskas, L. Kuksa, S. Manga, A. Skrahina, S. Diktanas, L.R. Codecasa, A. Aleksa, A. Koleva, E. Belilovski, E. Bernal, M.J. Boeree, J. Cadiñanos Loidi, Q. Cai, J.J. Cebrian Gallardo, M. Dara, E. Davidavičienė, L. Davies Forsman, J. De Los Rios, S.E. Elamin, N. Escobar Salinas, M. Ferrarese, A. Filippov, B. Gadzheva, A. Garcia, R. Gayoso, R. Gomez Rosso, V. Gruslys, G. Gualano, W. Hoefsloot, J. Jonsson, E. Khimova, H. Kunst, Y. Li, C. Magis-Escurra, V. Manfrin, V. Marchese, E. Martínez Robles, C. Moschos, H. Mustafa Hamdan, B. Nakčerienė, L. Nicod, M. Nieto Marcos, D.J. Palmero, F. Palmieri, A. Papavasileiou, M-C. Payen, A. Pontarelli, S. Quirós, A. Rendon, L. Saderi, A. Šmite, I. Solovic, M.B. Souleymane, M. Tadolini, M. Vescovo, P. Viggiani, A. Yedilbayev, R. Zablockis, D. Zhurkin and M. Zignol provided additions to the fourth draft. S. Tiberi and J. Denholm proofread the manuscript. All co-authors approved the final manuscript.

  • Conflict of interest: S. Borisov has nothing to disclose.

  • Conflict of interest: E. Danila has nothing to disclose.

  • Conflict of interest: A. Maryandyshev has nothing to disclose.

  • Conflict of interest: M. Dalcolmo has nothing to disclose.

  • Conflict of interest: S. Miliauskas has nothing to disclose.

  • Conflict of interest: L. Kuksa reports personal fees for trial participation from Otsuka and Tibotec, personal fees for lectures from Johnson and Johnson Services Inc., outside the submitted work.

  • Conflict of interest: S. Manga has nothing to disclose.

  • Conflict of interest: A. Skrahina has nothing to disclose.

  • Conflict of interest: S. Diktanas reports personal fees for trial participation from Otsuka, grants for meeting attendance from Janssen (Sirturo), outside the submitted work.

  • Conflict of interest: L.R. Codecasa has nothing to disclose.

  • Conflict of interest: A. Aleksa has nothing to disclose.

  • Conflict of interest: J. Bruchfeld has nothing to disclose.

  • Conflict of interest: A. Koleva has nothing to disclose.

  • Conflict of interest: A. Piubello has nothing to disclose.

  • Conflict of interest: Z.F. Udwadia has nothing to disclose.

  • Conflict of interest: O.W. Akkerman has nothing to disclose.

  • Conflict of interest: E. Belilovski has nothing to disclose.

  • Conflict of interest: E. Bernal has nothing to disclose.

  • Conflict of interest: M.J. Boeree has nothing to disclose.

  • Conflict of interest: J. Cadiñanos Loidi has nothing to disclose.

  • Conflict of interest: Q. Cai has nothing to disclose.

  • Conflict of interest: J.J. Cebrian Gallardo has nothing to disclose.

  • Conflict of interest: M. Dara has nothing to disclose.

  • Conflict of interest: E. Davidavičienė has nothing to disclose.

  • Conflict of interest: L. Davies Forsman has nothing to disclose.

  • Conflict of interest: J. De Los Rios has nothing to disclose.

  • Conflict of interest: J. Denholm has nothing to disclose.

  • Conflict of interest: J. Drakšienė has nothing to disclose.

  • Conflict of interest: R. Duarte has nothing to disclose.

  • Conflict of interest: S.E. Elamin has nothing to disclose.

  • Conflict of interest: N. Escobar Salinas has nothing to disclose.

  • Conflict of interest: M. Ferrarese has nothing to disclose.

  • Conflict of interest: A. Filippov has nothing to disclose.

  • Conflict of interest: A. Garcia has nothing to disclose.

  • Conflict of interest: J.M. García-García has nothing to disclose.

  • Conflict of interest: I. Gaudiesiute has nothing to disclose.

  • Conflict of interest: B. Gavazova has nothing to disclose.

  • Conflict of interest: R. Gayoso has nothing to disclose.

  • Conflict of interest: R. Gomez Rosso has nothing to disclose.

  • Conflict of interest: V. Gruslys has nothing to disclose.

  • Conflict of interest: G. Gualano has nothing to disclose.

  • Conflict of interest: W. Hoefsloot has nothing to disclose.

  • Conflict of interest: J. Jonsson has nothing to disclose.

  • Conflict of interest: E. Khimova has nothing to disclose.

  • Conflict of interest: H. Kunst has nothing to disclose.

  • Conflict of interest: R. Laniado-Laborín has nothing to disclose.

  • Conflict of interest: Y. Li has nothing to disclose.

  • Conflict of interest: C. Magis-Escurra has nothing to disclose.

  • Conflict of interest: V. Manfrin has nothing to disclose.

  • Conflict of interest: V. Marchese has nothing to disclose.

  • Conflict of interest: E. Martínez Robles has nothing to disclose.

  • Conflict of interest: A. Matteelli has nothing to disclose.

  • Conflict of interest: J. Mazza-Stalder has nothing to disclose.

  • Conflict of interest: C. Moschos has nothing to disclose.

  • Conflict of interest: M. Muñoz-Torrico has nothing to disclose.

  • Conflict of interest: H. Mustafa Hamdan has nothing to disclose.

  • Conflict of interest: B. Nakčerienė has nothing to disclose.

  • Conflict of interest: L. Nicod has nothing to disclose.

  • Conflict of interest: M. Nieto Marcos has nothing to disclose.

  • Conflict of interest: D.J. Palmero has nothing to disclose.

  • Conflict of interest: F. Palmieri has nothing to disclose.

  • Conflict of interest: A. Papavasileiou has nothing to disclose.

  • Conflict of interest: M-C. Payen has nothing to disclose.

  • Conflict of interest: A. Pontarelli has nothing to disclose.

  • Conflict of interest: S. Quirós has nothing to disclose.

  • Conflict of interest: A. Rendon has nothing to disclose.

  • Conflict of interest: L. Saderi has nothing to disclose.

  • Conflict of interest: A. Šmite has nothing to disclose.

  • Conflict of interest: I. Solovic has nothing to disclose.

  • Conflict of interest: M.B. Souleymane has nothing to disclose.

  • Conflict of interest: M. Tadolini has nothing to disclose.

  • Conflict of interest: M. van den Boom has nothing to disclose.

  • Conflict of interest: M. Vescovo has nothing to disclose.

  • Conflict of interest: P. Viggiani has nothing to disclose.

  • Conflict of interest: A. Yedilbayev has nothing to disclose.

  • Conflict of interest: R. Zablockis has nothing to disclose.

  • Conflict of interest: D. Zhurkin has nothing to disclose.

  • Conflict of interest: M. Zignol has nothing to disclose.

  • Conflict of interest: D. Visca has nothing to disclose.

  • Conflict of interest: A. Spanevello has nothing to disclose.

  • Conflict of interest: J.A. Caminero has nothing to disclose.

  • Conflict of interest: J-W. Alffenaar has nothing to disclose.

  • Conflict of interest: S. Tiberi has nothing to disclose.

  • Conflict of interest: R. Centis has nothing to disclose.

  • Conflict of interest: L. D'Ambrosio has nothing to disclose.

  • Conflict of interest: E. Pontali has nothing to disclose.

  • Conflict of interest: G. Sotgiu has nothing to disclose.

  • Conflict of interest: G.B. Migliori has nothing to disclose.

  • Support statement: The project is supported by the Global Tuberculosis Network (GTN; Committees on TB Treatment, Clinical Trials and Global TB Consilium) and was part of the European Respiratory Society Latin American project in collaboration with ALAT (Asociación Latino Americana de Torax – Latino American Thoracic Association) and SBPT (Brazilian Society of Pulmonology and Tuberculosis). This article belongs to the scientific activities of the WHO Collaborating Centre for Tuberculosis and Lung Diseases, Tradate, ITA-80, 2017–2020- GBM/RC/LDA.

  • Received August 1, 2019.
  • Accepted September 17, 2019.
  • Copyright ©ERS 2019
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Vol 54 Issue 6 Table of Contents
European Respiratory Journal: 54 (6)
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Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report
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Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report
Sergey Borisov, Edvardas Danila, Andrei Maryandyshev, Margareth Dalcolmo, Skaidrius Miliauskas, Liga Kuksa, Selene Manga, Alena Skrahina, Saulius Diktanas, Luigi Ruffo Codecasa, Alena Aleksa, Judith Bruchfeld, Antoniya Koleva, Alberto Piubello, Zarir Farokh Udwadia, Onno W. Akkerman, Evgeny Belilovski, Enrique Bernal, Martin J. Boeree, Julen Cadiñanos Loidi, Qingshan Cai, Jose Joaquín Cebrian Gallardo, Masoud Dara, Edita Davidavičienė, Lina Davies Forsman, Jorge De Los Rios, Justin Denholm, Jacinta Drakšienė, Raquel Duarte, Seifeldin Eltaeb Elamin, Nadia Escobar Salinas, Maurizio Ferrarese, Alexey Filippov, Ana Garcia, José-María García-García, Ieva Gaudiesiute, Blagovesta Gavazova, Regina Gayoso, Roscio Gomez Rosso, Vygantas Gruslys, Gina Gualano, Wouter Hoefsloot, Jerker Jonsson, Elena Khimova, Heinke Kunst, Rafael Laniado-Laborín, Yang Li, Cecile Magis-Escurra, Vinicio Manfrin, Valentina Marchese, Elena Martínez Robles, Alberto Matteelli, Jesica Mazza-Stalder, Charalampos Moschos, Marcela Muñoz-Torrico, Hamdan Mustafa Hamdan, Birutė Nakčerienė, Laurent Nicod, Magnolia Nieto Marcos, Domingo Juan Palmero, Fabrizio Palmieri, Apostolos Papavasileiou, Marie-Christine Payen, Agostina Pontarelli, Sarai Quirós, Adrian Rendon, Laura Saderi, Agnese Šmite, Ivan Solovic, Mahamadou Bassirou Souleymane, Marina Tadolini, Martin van den Boom, Marisa Vescovo, Pietro Viggiani, Askar Yedilbayev, Rolandas Zablockis, Dmitry Zhurkin, Matteo Zignol, Dina Visca, Antonio Spanevello, José A. Caminero, Jan-Willem Alffenaar, Simon Tiberi, Rosella Centis, Lia D'Ambrosio, Emanuele Pontali, Giovanni Sotgiu, Giovanni Battista Migliori
European Respiratory Journal Dec 2019, 54 (6) 1901522; DOI: 10.1183/13993003.01522-2019

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Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report
Sergey Borisov, Edvardas Danila, Andrei Maryandyshev, Margareth Dalcolmo, Skaidrius Miliauskas, Liga Kuksa, Selene Manga, Alena Skrahina, Saulius Diktanas, Luigi Ruffo Codecasa, Alena Aleksa, Judith Bruchfeld, Antoniya Koleva, Alberto Piubello, Zarir Farokh Udwadia, Onno W. Akkerman, Evgeny Belilovski, Enrique Bernal, Martin J. Boeree, Julen Cadiñanos Loidi, Qingshan Cai, Jose Joaquín Cebrian Gallardo, Masoud Dara, Edita Davidavičienė, Lina Davies Forsman, Jorge De Los Rios, Justin Denholm, Jacinta Drakšienė, Raquel Duarte, Seifeldin Eltaeb Elamin, Nadia Escobar Salinas, Maurizio Ferrarese, Alexey Filippov, Ana Garcia, José-María García-García, Ieva Gaudiesiute, Blagovesta Gavazova, Regina Gayoso, Roscio Gomez Rosso, Vygantas Gruslys, Gina Gualano, Wouter Hoefsloot, Jerker Jonsson, Elena Khimova, Heinke Kunst, Rafael Laniado-Laborín, Yang Li, Cecile Magis-Escurra, Vinicio Manfrin, Valentina Marchese, Elena Martínez Robles, Alberto Matteelli, Jesica Mazza-Stalder, Charalampos Moschos, Marcela Muñoz-Torrico, Hamdan Mustafa Hamdan, Birutė Nakčerienė, Laurent Nicod, Magnolia Nieto Marcos, Domingo Juan Palmero, Fabrizio Palmieri, Apostolos Papavasileiou, Marie-Christine Payen, Agostina Pontarelli, Sarai Quirós, Adrian Rendon, Laura Saderi, Agnese Šmite, Ivan Solovic, Mahamadou Bassirou Souleymane, Marina Tadolini, Martin van den Boom, Marisa Vescovo, Pietro Viggiani, Askar Yedilbayev, Rolandas Zablockis, Dmitry Zhurkin, Matteo Zignol, Dina Visca, Antonio Spanevello, José A. Caminero, Jan-Willem Alffenaar, Simon Tiberi, Rosella Centis, Lia D'Ambrosio, Emanuele Pontali, Giovanni Sotgiu, Giovanni Battista Migliori
European Respiratory Journal Dec 2019, 54 (6) 1901522; DOI: 10.1183/13993003.01522-2019
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