{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T10:01:38Z","timestamp":1775728898256,"version":"3.50.1"},"reference-count":9,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2026,2,12]],"date-time":"2026-02-12T00:00:00Z","timestamp":1770854400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2026,2,12]],"date-time":"2026-02-12T00:00:00Z","timestamp":1770854400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Adv Ther"],"published-print":{"date-parts":[[2026,4]]},"DOI":"10.1007\/s12325-026-03504-8","type":"journal-article","created":{"date-parts":[[2026,2,12]],"date-time":"2026-02-12T07:04:23Z","timestamp":1770879863000},"page":"1552-1561","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Comprehensive Approach to Selection of Adverse Drug Reactions for a Drug with Conditional Marketing Authorisation in the European Union"],"prefix":"10.1007","volume":"43","author":[{"given":"Norbert","family":"Hittel","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natasa","family":"Lazarevic","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexandra","family":"Martin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Britta","family":"Schorn","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Axel","family":"Leporowski","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vivian","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vinu","family":"George","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emiel","family":"van Heumen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2026,2,12]]},"reference":[{"key":"3504_CR1","unstructured":"European Medicines Agency. Deltyba (delamanid): authorisation details. 2014. https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/deltyba#authorisation-details. Accessed 20 Aug 2024."},{"issue":"6","key":"3504_CR2","first-page":"274","volume":"1","author":"N Schoenfeld","year":"2024","unstructured":"Schoenfeld N, Barkane L, Davoliene I, et al. Real-life use of delamanid: results from the European post-authorisation safety study. IJTLD. 2024;1(6):274\u20138.","journal-title":"IJTLD"},{"key":"3504_CR3","doi-asserted-by":"publisher","first-page":"2151","DOI":"10.1056\/NEJMoa1112433","volume":"366","author":"MT Gler","year":"2012","unstructured":"Gler MT, Skripconoka V, Sanchez-Garavito E, et al. Delamanid for multidrug-resistant pulmonary tuberculosis. N Engl J Med. 2012;366:2151\u201360.","journal-title":"N Engl J Med"},{"key":"3504_CR4","unstructured":"WHO consolidated guidelines on drug-resistant tuberculosis treatment. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO."},{"key":"3504_CR5","unstructured":"European Medicines Agency. A GUIDELINE ON SUMMARY OF PRODUCT CHARACTERISTIC. 2009. https:\/\/health.ec.europa.eu\/system\/files\/2016-11\/smpc_guideline_rev2_en_0.pdf\u00a0. Accessed 20 Aug 2024."},{"key":"3504_CR6","unstructured":"CIOMS Working Groups III and V. Guidelines for Preparing Core Clinical-Safety Information on Drugs. 1999. https:\/\/cioms.ch\/publications\/product\/guidelines-preparing-core-clinical-safety-information-drugs-second-edition-report-cioms-working-groups-iii-v\/#description. Accessed 20 Aug 2024."},{"issue":"3","key":"3504_CR7","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0050067","volume":"5","author":"JP Vandenbroucke","year":"2008","unstructured":"Vandenbroucke JP. Observational research, randomised trials, and two views of medical science. PLoS Med. 2008;5(3):e67.","journal-title":"PLoS Med"},{"key":"3504_CR8","unstructured":"European Medicines Agency. Section 4.8: Undesirable effects Rev. 1 SmPC training presentation. https:\/\/www.ema.europa.eu\/en\/documents\/presentation\/presentation-section-48-undesirable-effects_en.pdf. Accessed 20 Aug 2024."},{"issue":"Suppl 1","key":"3504_CR9","doi-asserted-by":"publisher","first-page":"S90","DOI":"10.1016\/j.ijid.2022.02.043","volume":"124","author":"MJ Nasiri","year":"2022","unstructured":"Nasiri MJ, Zangiabadian M, Arabpour E, et al. Delamanid-containing regimens and multidrug-resistant tuberculosis: a systematic review and meta-analysis. Int J Infect Dis. 2022;124(Suppl 1):S90\u2013103.","journal-title":"Int J Infect Dis"}],"container-title":["Advances in Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12325-026-03504-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s12325-026-03504-8","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12325-026-03504-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T09:14:17Z","timestamp":1775726057000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s12325-026-03504-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,12]]},"references-count":9,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,4]]}},"alternative-id":["3504"],"URL":"https:\/\/doi.org\/10.1007\/s12325-026-03504-8","relation":{},"ISSN":["0741-238X","1865-8652"],"issn-type":[{"value":"0741-238X","type":"print"},{"value":"1865-8652","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,12]]},"assertion":[{"value":"27 September 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"19 January 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 February 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors have no competing interests to declare that are relevant to the content of this article. Norbert Hittel, Natasa Lazarevic and Alexandra Martin are employees of Otsuka Novel Products GmbH (ONPG). Britta Schorn, Axel Leporowski and Emiel van Heumen. are employees of Otsuka Pharma GmbH, Frankfurt, Germany. Vivian Zhang and Vinu George are employees of Otsuka Pharmaceutical Development and Commercialization, Princeton, NJ, USA.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors. No identifiable information about individuals was disclosed in the manuscript and all findings are reported in aggregated form.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}