RT Journal Article T1 Surveillance of adverse events in the treatment of drug-resistant tuberculosis: A global feasibility study. A1 Akkerman, Onno A1 Aleksa, Alena A1 Alffenaar, Jan-Willem A1 Al-Marzouqi, Nada Hassan A1 Arias-Guillén, Miguel A1 Belilovski, Evgeny A1 Bernal, Enrique A1 Boeree, Martin J A1 Borisov, Sergey E A1 Bruchfeld, Judith A1 Cadiñanos Loidi, Julen A1 Cai, Qingshan A1 Caminero, Jose A A1 Cebrian Gallardo, Jose Joaquín A1 Centis, Rosella A1 Codecasa, Luigi Ruffo A1 D'Ambrosio, Lia A1 Dalcolmo, Margareth A1 Danila, Edvardas A1 Dara, Masoud A1 Davidavičienė, Edita A1 Davies Forsman, Lina A1 De Los Rios Jefe, Jorge A1 Denholm, Justin A1 Duarte, Raquel A1 Elamin, Seifeldin Eltaeb A1 Ferrarese, Maurizio A1 Filippov, Alexey A1 Ganatra, Shashank A1 Garcia, Ana A1 García-García, José-María A1 Gayoso, Regina A1 Giraldo Montoya, Angela Maria A1 Gomez Rosso, Roscio Gomez A1 Gualano, Gina A1 Hoefsloot, Wouter A1 Ilievska-Poposka, Biljana A1 Jonsson, Jerker A1 Khimova, Elena A1 Kuksa, Liga A1 Kunst, Heinke A1 Laniado-Laborín, Rafael A1 Li, Yang A1 Magis-Escurra, Cecile A1 Manfrin, Vinicio A1 Manga, Selene A1 Marchese, Valentina A1 Martínez Robles, Elena A1 Maryandyshev, Andrei A1 Matteelli, Alberto A1 Migliori, Giovanni Battista A1 Mullerpattan, Jai B A1 Munoz-Torrico, Marcela A1 Mustafa Hamdan, Hamdan A1 Nieto Marcos, Magnolia A1 Noordin, Noorliza Mohamad A1 Palmero, Domingo Juan A1 Palmieri, Fabrizio A1 Payen, Marie-Christine A1 Piubello, Alberto A1 Pontali, Emanuele A1 Pontarelli, Agostina A1 Quirós, Sarai A1 Rendon, Adrian A1 Skrahina, Alena A1 Šmite, Agnese A1 Solovic, Ivan A1 Sotgiu, Giovanni A1 Souleymane, Mahamadou Bassirou A1 Spanevello, Antonio A1 Stošić, Maja A1 Tadolini, Marina A1 Tiberi, Simon A1 Udwadia, Zarir Farokh A1 van den Boom, Martin A1 Vescovo, Marisa A1 Viggiani, Pietro A1 Visca, Dina A1 Zhurkin, Dmitry A1 Zignol, Matteo A1 members of the International Study Group on new anti-tuberculosis drugs and adverse events monitoring, K1 Adverse events K1 Bedaquiline K1 Delamanid K1 MDR-TB K1 Monitoring K1 Tuberculosis 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. YR 2019 FD 2019-04-03 LK https://hdl.handle.net/10668/26651 UL https://hdl.handle.net/10668/26651 LA en DS RISalud RD Apr 14, 2025