{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T19:23:36Z","timestamp":1792783416449,"version":"4.5.0"},"reference-count":26,"publisher":"Springer Science and Business Media LLC","issue":"12","license":[{"start":{"date-parts":[[2024,10,28]],"date-time":"2024-10-28T00:00:00Z","timestamp":1730073600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2024,10,28]],"date-time":"2024-10-28T00:00:00Z","timestamp":1730073600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"name":"The clinical trials and pharmacovigilance programme described in this paper were supported by Boehringer Ingelheim."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Adv Ther"],"published-print":{"date-parts":[[2024,12]]},"DOI":"10.1007\/s12325-024-03023-4","type":"journal-article","created":{"date-parts":[[2024,10,28]],"date-time":"2024-10-28T05:46:16Z","timestamp":1730094376000},"page":"4581-4590","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Safety and Tolerability of Nintedanib in Patients with Fibrosing Interstitial Lung Diseases: Post-marketing Data"],"prefix":"10.1007","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3325-6996","authenticated-orcid":false,"given":"Nazia","family":"Chaudhuri","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arata","family":"Azuma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kamila","family":"Sroka-Saidi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elvira","family":"Erhardt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivana","family":"Ritter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergio","family":"Harari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,10,28]]},"reference":[{"key":"3023_CR1","doi-asserted-by":"publisher","first-page":"958","DOI":"10.1056\/NEJMra2005230","volume":"383","author":"M Wijsenbeek","year":"2020","unstructured":"Wijsenbeek M, Cottin V. Spectrum of fibrotic lung diseases. N Engl J Med. 2020;383:958\u201368.","journal-title":"N Engl J Med"},{"key":"3023_CR2","doi-asserted-by":"publisher","first-page":"e18","DOI":"10.1164\/rccm.202202-0399ST","volume":"205","author":"G Raghu","year":"2022","unstructured":"Raghu G, Remy-Jardin M, Richeldi L, et al. Idiopathic pulmonary fibrosis (an update) and progressive pulmonary fibrosis in adults: an official ATS\/ERS\/JRS\/ALAT clinical practice guideline. Am J Respir Crit Care Med. 2022;205:e18\u201347.","journal-title":"Am J Respir Crit Care Med"},{"key":"3023_CR3","doi-asserted-by":"publisher","first-page":"4774","DOI":"10.1158\/0008-5472.CAN-07-6307","volume":"68","author":"F Hilberg","year":"2008","unstructured":"Hilberg F, Roth GJ, Krssak M, et al. BIBF 1120: triple angiokinase inhibitor with sustained receptor blockade and good antitumor efficacy. Cancer Res. 2008;68:4774\u201382.","journal-title":"Cancer Res"},{"key":"3023_CR4","doi-asserted-by":"publisher","first-page":"494","DOI":"10.1124\/jpet.117.244129","volume":"364","author":"F Hilberg","year":"2018","unstructured":"Hilberg F, Tontsch-Grunt U, Baum A, et al. Triple angiokinase inhibitor nintedanib directly inhibits tumor cell growth and induces tumor shrinkage via blocking oncogenic receptor tyrosine kinases. J Pharmacol Exp Ther. 2018;364:494\u2013503.","journal-title":"J Pharmacol Exp Ther"},{"key":"3023_CR5","doi-asserted-by":"publisher","first-page":"2071","DOI":"10.1056\/NEJMoa1402584","volume":"370","author":"L Richeldi","year":"2014","unstructured":"Richeldi L, du Bois RM, Raghu G, et al. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014;370:2071\u201382.","journal-title":"N Engl J Med"},{"key":"3023_CR6","doi-asserted-by":"publisher","first-page":"2518","DOI":"10.1056\/NEJMoa1903076","volume":"380","author":"O Distler","year":"2019","unstructured":"Distler O, Highland KB, Gahlemann M, et al. Nintedanib for systemic sclerosis-associated interstitial lung disease. N Engl J Med. 2019;380:2518\u201328.","journal-title":"N Engl J Med"},{"key":"3023_CR7","doi-asserted-by":"publisher","first-page":"1718","DOI":"10.1056\/NEJMoa1908681","volume":"381","author":"KR Flaherty","year":"2019","unstructured":"Flaherty KR, Wells AU, Cottin V, et al. Nintedanib in progressive fibrosing interstitial lung diseases. N Engl J Med. 2019;381:1718\u201327.","journal-title":"N Engl J Med"},{"key":"3023_CR8","doi-asserted-by":"publisher","first-page":"116","DOI":"10.1186\/s12931-015-0276-5","volume":"16","author":"T Corte","year":"2015","unstructured":"Corte T, Bonella F, Crestani B, et al. Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis. Respir Res. 2015;16:116.","journal-title":"Respir Res"},{"key":"3023_CR9","doi-asserted-by":"publisher","first-page":"1478","DOI":"10.1136\/annrheumdis-2020-217331","volume":"79","author":"JR Seibold","year":"2020","unstructured":"Seibold JR, Maher TM, Highland KB, et al. Safety and tolerability of nintedanib in patients with systemic sclerosis-associated interstitial lung disease: data from the SENSCIS trial. Ann Rheum Dis. 2020;79:1478\u201384.","journal-title":"Ann Rheum Dis"},{"key":"3023_CR10","doi-asserted-by":"publisher","first-page":"85","DOI":"10.1186\/s12931-022-01974-2","volume":"23","author":"V Cottin","year":"2022","unstructured":"Cottin V, Martinez FJ, Jenkins RG, et al. Safety and tolerability of nintedanib in patients with progressive fibrosing interstitial lung diseases: data from the randomized controlled INBUILD trial. Respir Res. 2022;23:85.","journal-title":"Respir Res"},{"key":"3023_CR11","doi-asserted-by":"publisher","first-page":"60","DOI":"10.1016\/S2213-2600(18)30339-4","volume":"7","author":"B Crestani","year":"2019","unstructured":"Crestani B, Huggins JT, Kaye M, et al. Long-term safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis: results from the open-label extension study, INPULSIS-ON. Lancet Respir Med. 2019;7:60\u20138.","journal-title":"Lancet Respir Med"},{"key":"3023_CR12","unstructured":"Allanore Y, Vonk MC, Distler O, et al. Continued treatment with nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD): three-year data from SENSCIS-ON. Poster presented at American College of Rheumatology Convergence, 2022. https:\/\/www.globalmedcomms.com\/respiratory\/ACR2022\/Allanore. Accessed 31 July 2024."},{"key":"3023_CR13","doi-asserted-by":"crossref","unstructured":"Wuyts WA, Bonella F, Chaudhuri N, et al. Continued nintedanib treatment in patients with progressive pulmonary fibrosis: data from INBUILD-ON. Poster presented at the European Respiratory Society International Congress, 2023. https:\/\/www.globalmedcomms.com\/respiratory\/ERS2023\/Wuyts1. Accessed 31 July 2024.","DOI":"10.1183\/13993003.congress-2023.PA2874"},{"key":"3023_CR14","doi-asserted-by":"publisher","first-page":"4209","DOI":"10.1007\/s12325-020-01452-5","volume":"37","author":"JA Lasky","year":"2020","unstructured":"Lasky JA, Criner GJ, Lazarus HM, et al. Safety of nintedanib in patients with idiopathic pulmonary fibrosis: global pharmacovigilance data. Adv Ther. 2020;37:4209\u201319.","journal-title":"Adv Ther"},{"key":"3023_CR15","doi-asserted-by":"publisher","first-page":"1434","DOI":"10.1183\/09031936.00174914","volume":"45","author":"L Wollin","year":"2015","unstructured":"Wollin L, Wex E, Pautsch A, et al. Mode of action of nintedanib in the treatment of idiopathic pulmonary fibrosis. Eur Respir J. 2015;45:1434\u201345.","journal-title":"Eur Respir J"},{"key":"3023_CR16","doi-asserted-by":"publisher","first-page":"162","DOI":"10.1097\/SPC.0b013e32835ec861","volume":"7","author":"JM Bowen","year":"2013","unstructured":"Bowen JM. Mechanisms of TKI-induced diarrhea in cancer patients. Curr Opin Support Palliat Care. 2013;7:162\u20137.","journal-title":"Curr Opin Support Palliat Care"},{"key":"3023_CR17","doi-asserted-by":"publisher","first-page":"2038","DOI":"10.1007\/s12325-023-02454-9","volume":"40","author":"AJ Podolanczuk","year":"2023","unstructured":"Podolanczuk AJ, Cottin V. A narrative review of real-world data on the safety of nintedanib in patients with idiopathic pulmonary fibrosis. Adv Ther. 2023;40:2038\u201350.","journal-title":"Adv Ther"},{"key":"3023_CR18","doi-asserted-by":"publisher","first-page":"e679","DOI":"10.1016\/S2665-9913(22)00215-6","volume":"4","author":"AM Hoffmann-Vold","year":"2022","unstructured":"Hoffmann-Vold AM, Volkmann ER, Allanore Y, et al. Safety and tolerability of nintedanib in patients with interstitial lung diseases in subgroups by sex: a post-hoc analysis of pooled data from four randomised controlled trials. Lancet Rheumatol. 2022;4:e679\u201387.","journal-title":"Lancet Rheumatol"},{"key":"3023_CR19","doi-asserted-by":"publisher","DOI":"10.1016\/j.critrevonc.2020.103186","volume":"157","author":"A Das","year":"2021","unstructured":"Das A, Mahapatra S, Bandyopadhyay D, et al. Bleeding with vascular endothelial growth factor tyrosine kinase inhibitor: a network meta-analysis. Crit Rev Oncol Hematol. 2021;157:103186.","journal-title":"Crit Rev Oncol Hematol"},{"key":"3023_CR20","doi-asserted-by":"publisher","first-page":"172","DOI":"10.1016\/j.ejcsup.2013.07.016","volume":"11","author":"M Schmidinger","year":"2013","unstructured":"Schmidinger M. Understanding and managing toxicities of vascular endothelial growth factor (VEGF) inhibitors. EJC Suppl. 2013;11:172\u201391.","journal-title":"EJC Suppl"},{"key":"3023_CR21","doi-asserted-by":"publisher","first-page":"150","DOI":"10.1378\/chest.14-0041","volume":"147","author":"W Dalleywater","year":"2015","unstructured":"Dalleywater W, Powell HA, Hubbard RB, Navaratnam V. Risk factors for cardiovascular disease in people with idiopathic pulmonary fibrosis: a population-based study. Chest. 2015;147:150\u20136.","journal-title":"Chest"},{"key":"3023_CR22","doi-asserted-by":"publisher","first-page":"108","DOI":"10.1159\/000504630","volume":"99","author":"KM Mortimer","year":"2020","unstructured":"Mortimer KM, Bartels DB, Hartmann N, et al. Characterizing health outcomes in idiopathic pulmonary fibrosis using US health claims data. Respiration. 2020;99:108\u201318.","journal-title":"Respiration"},{"key":"3023_CR23","doi-asserted-by":"publisher","first-page":"1793","DOI":"10.1007\/s11739-021-02651-w","volume":"16","author":"A Caminati","year":"2021","unstructured":"Caminati A, Madotto F, Conti S, et al. The natural history of idiopathic pulmonary fibrosis in a large European population: the role of age, sex and comorbidities. Intern Emerg Med. 2021;16:1793\u2013802.","journal-title":"Intern Emerg Med"},{"key":"3023_CR24","doi-asserted-by":"publisher","first-page":"1801797","DOI":"10.1183\/13993003.01797-2018","volume":"54","author":"I Noth","year":"2019","unstructured":"Noth I, Wijsenbeek M, Kolb M, et al. Cardiovascular safety of nintedanib in subgroups by cardiovascular risk at baseline in the TOMORROW and INPULSIS trials. Eur Respir J. 2019;54:1801797.","journal-title":"Eur Respir J"},{"key":"3023_CR25","doi-asserted-by":"publisher","first-page":"427","DOI":"10.1046\/j.1365-2125.1998.00713.x","volume":"45","author":"JCC Talbot","year":"1998","unstructured":"Talbot JCC, Nilsson BS. Pharmacovigilance in the pharmaceutical industry. Br J Clin Pharmacol. 1998;45:427\u201331.","journal-title":"Br J Clin Pharmacol"},{"key":"3023_CR26","doi-asserted-by":"publisher","first-page":"979","DOI":"10.1111\/j.1365-2125.2012.04249.x","volume":"73","author":"IR Edwards","year":"2012","unstructured":"Edwards IR. Pharmacovigilance. Br J Clin Pharmacol. 2012;73:979\u201382.","journal-title":"Br J Clin Pharmacol"}],"container-title":["Advances in Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12325-024-03023-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s12325-024-03023-4\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12325-024-03023-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,9]],"date-time":"2024-11-09T03:12:36Z","timestamp":1731121956000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s12325-024-03023-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10,28]]},"references-count":26,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2024,12]]}},"alternative-id":["3023"],"URL":"https:\/\/doi.org\/10.1007\/s12325-024-03023-4","relation":{},"ISSN":["0741-238X","1865-8652"],"issn-type":[{"value":"0741-238X","type":"print"},{"value":"1865-8652","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,10,28]]},"assertion":[{"value":"31 July 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 October 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 October 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Nazia Chaudhuri reports consulting fees from Boehringer Ingelheim, Redx, Liminal BioSciences, Vicore Pharma AB, Bridge Biotherapeutics, tranScrip and speaker fees from Boehringer Ingelheim. Nazia Chaudhuri is an Editorial Board member of <i>Advances in Therapy<\/i>. Nazia Chaudhuri was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions Arata Azuma reports research support from Boehringer Ingelheim; consulting fees from Boehringer Ingelheim and Kyorin Pharma Co.; speaker fees from Boehringer Ingelheim and participation on a data safety monitoring board for Taiho Co. and Toray Co. Kamila Sroka-Saidi, Elvira Erhardt and Ivana Ritter are employees of Boehringer Ingelheim. Sergio Harari reports research support from Aerovate, AstraZeneca, and Boehringer Ingelheim and consulting fees from Roche.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of Interest"}},{"value":"This analysis did not require institutional review board (IRB) approval as it was based on aggregate patient de-identified data from a pharmacovigilance database.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}