{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T18:29:16Z","timestamp":1791570556739,"version":"4.3.4"},"reference-count":42,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2022,1,13]],"date-time":"2022-01-13T00:00:00Z","timestamp":1642032000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,9,29]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Safety of treatment for multidrug-resistant tuberculosis (MDR\/RR-TB) can be an obstacle to treatment completion. Evaluate safety of longer MDR\/RR-TB regimens containing bedaquiline and\/or delamanid.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Multicentre (16 countries), prospective, observational study reporting incidence and frequency of clinically relevant adverse events of special interest (AESIs) among patients who received MDR\/RR-TB treatment containing bedaquiline and\/or delamanid. The AESIs were defined a priori as important events caused by bedaquiline, delamanid, linezolid, injectables, and other commonly used drugs. Occurrence of these events was also reported by exposure to the likely causative agent.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 2296 patients, the most common clinically relevant AESIs were peripheral neuropathy (26.4%), electrolyte depletion (26.0%), and hearing loss (13.2%) with an incidence per 1000 person months of treatment, 1000 person-months of treatment 21.5 (95% confidence interval [CI]: 19.8\u201323.2), 20.7 (95% CI: 19.1\u201322.4), and 9.7 (95% CI: 8.6\u201310.8), respectively. QT interval was prolonged in 2.7% or 1.8 (95% CI: 1.4\u20132.3)\/1000 person-months of treatment. Patients receiving injectables (N\u2005=\u2005925) and linezolid (N\u2005=\u20051826) were most likely to experience events during exposure. Hearing loss, acute renal failure, or electrolyte depletion occurred in 36.8% or 72.8 (95% CI: 66.0\u201380.0) times\/1000 person-months of injectable drug exposure. Peripheral neuropathy, optic neuritis, and\/or myelosuppression occurred in 27.8% or 22.8 (95% CI: 20.9\u201324.8) times\/1000 patient-months of linezolid exposure.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>AEs often related to linezolid and injectable drugs were more common than those frequently attributed to bedaquiline and delamanid. MDR-TB treatment monitoring and drug durations should reflect expected safety profiles of drug combinations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trials Registration<\/jats:title>\n                    <jats:p>NCT03259269.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciac019","type":"journal-article","created":{"date-parts":[[2022,1,12]],"date-time":"2022-01-12T15:11:37Z","timestamp":1642000297000},"page":"1006-1013","source":"Crossref","is-referenced-by-count":54,"title":["Safety of Treatment Regimens Containing Bedaquiline and Delamanid in the endTB Cohort"],"prefix":"10.1093","volume":"75","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0363-1479","authenticated-orcid":false,"given":"Catherine","family":"Hewison","sequence":"first","affiliation":[{"name":"Medical Department, M\u00e9decins Sans Fronti\u00e8res , Paris , 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