{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T12:13:38Z","timestamp":1791980018987,"version":"4.4.0"},"reference-count":28,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2024,9,14]],"date-time":"2024-09-14T00:00:00Z","timestamp":1726272000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,9,14]],"date-time":"2024-09-14T00:00:00Z","timestamp":1726272000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"BMS-Pfizer Alliance"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Transl Oncol"],"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Purpose<\/jats:title>\n            <jats:p>We developed a predictive model to assess the risk of major bleeding (MB) within 6 months of primary venous thromboembolism (VTE) in cancer patients receiving anticoagulant treatment. We also sought to describe the prevalence and incidence of VTE in cancer patients, and to describe clinical characteristics at baseline and bleeding events during follow-up in patients receiving anticoagulants.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>This observational, retrospective, and multicenter study used natural language processing and machine learning (ML), to analyze unstructured clinical data from electronic health records from nine Spanish hospitals between 2014 and 2018. All adult cancer patients with VTE receiving anticoagulants were included. Both clinically- and ML-driven feature selection was performed to identify MB predictors. Logistic regression (LR), decision tree (DT), and random forest (RF) algorithms were used to train predictive models, which were validated in a hold-out dataset and compared to the previously developed CAT-BLEED score.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>Of the 2,893,108 cancer patients screened, in-hospital VTE prevalence was 5.8% and the annual incidence ranged from 2.7 to 3.9%. We identified 21,227 patients with active cancer and VTE receiving anticoagulants (53.9% men, median age of 70\u00a0years). MB events after VTE diagnosis occurred in 10.9% of patients within the first six months. MB predictors included: hemoglobin, metastasis, age, platelets, leukocytes, and serum creatinine. The LR, DT, and RF models had AUC-ROC (95% confidence interval) values of 0.60 (0.55, 0.65), 0.60 (0.55, 0.65), and 0.61 (0.56, 0.66), respectively. These models outperformed the CAT-BLEED score with values of 0.53 (0.48, 0.59).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>Our study shows encouraging results in identifying anticoagulated patients with cancer-associated VTE who are at high risk of MB.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s12094-024-03586-2","type":"journal-article","created":{"date-parts":[[2024,9,14]],"date-time":"2024-09-14T11:01:51Z","timestamp":1726311711000},"page":"1816-1825","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Prediction model for major bleeding in anticoagulated patients with cancer-associated venous thromboembolism using machine learning and natural language processing"],"prefix":"10.1007","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6977-8249","authenticated-orcid":false,"given":"Andr\u00e9s J.","family":"Mu\u00f1oz Mart\u00edn","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8850-8866","authenticated-orcid":false,"given":"Ram\u00f3n","family":"Lecumberri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2092-5142","authenticated-orcid":false,"given":"Juan Carlos","family":"Souto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1214-6595","authenticated-orcid":false,"given":"Berta","family":"Obispo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6273-5078","authenticated-orcid":false,"given":"Antonio","family":"Sanchez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5527-0786","authenticated-orcid":false,"given":"Jorge","family":"Aparicio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4335-0313","authenticated-orcid":false,"given":"Cristina","family":"Aguayo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9593-4559","authenticated-orcid":false,"given":"David","family":"Gutierrez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9159-9025","authenticated-orcid":false,"given":"Andr\u00e9s","family":"Garc\u00eda Palomo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9119-5330","authenticated-orcid":false,"given":"Diego","family":"Benavent","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2446-186X","authenticated-orcid":false,"given":"Miren","family":"Taberna","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6984-0727","authenticated-orcid":false,"given":"Mar\u00eda Carmen","family":"Vi\u00f1uela-Ben\u00e9itez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6638-7485","authenticated-orcid":false,"given":"Daniel","family":"Arumi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-1657-1118","authenticated-orcid":false,"given":"Miguel \u00c1ngel","family":"Hern\u00e1ndez-Presa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,9,14]]},"reference":[{"key":"3586_CR1","doi-asserted-by":"publisher","first-page":"529","DOI":"10.1111\/j.1538-7836.2006.01804.x","volume":"4","author":"JW Blom","year":"2006","unstructured":"Blom JW, Vanderschoot JPM, Oostindi\u00ebr MJ, Osanto S, van der Meer FJM, Rosendaal FR. Incidence of venous thrombosis in a large cohort of 66,329 cancer patients: results of a record linkage study. J Thromb Haemost. 2006;4:529\u201335.","journal-title":"J Thromb Haemost"},{"key":"3586_CR2","doi-asserted-by":"publisher","first-page":"57","DOI":"10.1160\/TH15-08-0686","volume":"117","author":"AT Cohen","year":"2017","unstructured":"Cohen AT, Katholing A, Rietbrock S, Bamber L, Martinez C. Epidemiology of first and recurrent venous thromboembolism in patients with active cancer. A population-based cohort study. Thromb Haemost. 2017;117:57\u201365. https:\/\/doi.org\/10.1160\/TH15-08-0686.","journal-title":"Thromb Haemost"},{"key":"3586_CR3","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1001275","volume":"9","author":"F Horsted","year":"2012","unstructured":"Horsted F, West J, Grainge MJ. Risk of venous thromboembolism in patients with cancer: a systematic review and meta-analysis. PLoS Med. 2012;9: e1001275. https:\/\/doi.org\/10.1371\/journal.pmed.1001275.","journal-title":"PLoS Med"},{"key":"3586_CR4","doi-asserted-by":"publisher","first-page":"3972","DOI":"10.1182\/blood-2014-01-549733","volume":"123","author":"CE Chee","year":"2014","unstructured":"Chee CE, Ashrani AA, Marks RS, Petterson TM, Bailey KR, Melton LJ, et al. Predictors of venous thromboembolism recurrence and bleeding among active cancer patients: a population-based cohort study. Blood. 2014;123:3972\u20138. https:\/\/doi.org\/10.1182\/blood-2014-01-549733.","journal-title":"Blood"},{"issue":"Suppl 2","key":"3586_CR5","doi-asserted-by":"publisher","first-page":"S58","DOI":"10.1016\/S0049-3848(10)70015-3","volume":"125","author":"J Trujillo-Santos","year":"2010","unstructured":"Trujillo-Santos J, Nieto JA, Ru\u00edz-Gamietea A, L\u00f3pez-Jim\u00e9nez L, Garc\u00eda-Bragado F, Quintavalla R, et al. Bleeding complications associated with anticoagulant therapy in patients with cancer. Thromb Res. 2010;125(Suppl 2):S58-61. https:\/\/doi.org\/10.1016\/S0049-3848(10)70015-3.","journal-title":"Thromb Res"},{"key":"3586_CR6","doi-asserted-by":"publisher","first-page":"496","DOI":"10.1200\/JCO.2014.59.7351","volume":"38","author":"NS Key","year":"2020","unstructured":"Key NS, Khorana AA, Kuderer NM, Bohlke K, Lee AYY, Arcelus JI, et al. Venous thromboembolism prophylaxis and treatment in patients with cancer: ASCO clinical practice guideline update. J Clin Oncol. 2020;38:496\u2013520. https:\/\/doi.org\/10.1200\/JCO.2014.59.7351.","journal-title":"J Clin Oncol"},{"key":"3586_CR7","doi-asserted-by":"publisher","first-page":"664","DOI":"10.1002\/ajh.25059","volume":"93","author":"MB Streiff","year":"2018","unstructured":"Streiff MB, Milentijevic D, McCrae K, Yannicelli D, Fortier J, Nelson WW, et al. Effectiveness and safety of anticoagulants for the treatment of venous thromboembolism in patients with cancer. Am J Hematol. 2018;93:664\u201371. https:\/\/doi.org\/10.1002\/ajh.25059.","journal-title":"Am J Hematol"},{"key":"3586_CR8","doi-asserted-by":"publisher","first-page":"18","DOI":"10.1007\/s11912-019-0767-5","volume":"21","author":"HK Patel","year":"2019","unstructured":"Patel HK, Khorana AA. Anticoagulation in cancer patients: a summary of pitfalls to avoid. Curr Oncol Rep. 2019;21:18. https:\/\/doi.org\/10.1007\/s11912-019-0767-5.","journal-title":"Curr Oncol Rep"},{"key":"3586_CR9","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000001235","volume":"94","author":"D Farge","year":"2015","unstructured":"Farge D, Trujillo-Santos J, Debourdeau P, Bura-Riviere A, Rodriguez-Beltr\u00e1n EM, Nieto JA, et al. Fatal events in cancer patients receiving anticoagulant therapy for venous thromboembolism. Medicine (Baltimore). 2015;94: e1235. https:\/\/doi.org\/10.1097\/MD.0000000000001235.","journal-title":"Medicine (Baltimore)"},{"key":"3586_CR10","doi-asserted-by":"publisher","first-page":"1668","DOI":"10.1055\/s-0038-1668523","volume":"118","author":"G Agnelli","year":"2018","unstructured":"Agnelli G, Becattini C, Bauersachs R, Brenner B, Campanini M, Cohen A, et al. Apixaban versus dalteparin for the treatment of acute venous thromboembolism in patients with cancer: the caravaggio study. Thromb Haemost. 2018;118:1668\u201378. https:\/\/doi.org\/10.1055\/s-0038-1668523.","journal-title":"Thromb Haemost"},{"key":"3586_CR11","doi-asserted-by":"publisher","first-page":"582","DOI":"10.1016\/j.thromres.2015.07.011","volume":"136","author":"F Posch","year":"2015","unstructured":"Posch F, K\u00f6nigsbr\u00fcgge O, Zielinski C, Pabinger I, Ay C. Treatment of venous thromboembolism in patients with cancer: a network meta-analysis comparing efficacy and safety of anticoagulants. Thromb Res. 2015;136:582\u20139. https:\/\/doi.org\/10.1016\/j.thromres.2015.07.011.","journal-title":"Thromb Res"},{"key":"3586_CR12","doi-asserted-by":"publisher","first-page":"818","DOI":"10.1055\/s-0041-1735251","volume":"122","author":"MA de Winter","year":"2022","unstructured":"de Winter MA, Dorresteijn JAN, Ageno W, Ay C, Beyer-Westendorf J, Coppens M, et al. Estimating bleeding risk in patients with cancer-associated thrombosis: evaluation of existing risk scores and development of a new risk score. Thromb Haemost. 2022;122:818\u201329. https:\/\/doi.org\/10.1055\/s-0041-1735251.","journal-title":"Thromb Haemost"},{"key":"3586_CR13","doi-asserted-by":"publisher","first-page":"181","DOI":"10.1016\/j.thromres.2023.06.015","volume":"228","author":"AJ Mu\u00f1oz","year":"2023","unstructured":"Mu\u00f1oz AJ, Souto JC, Lecumberri R, Obispo B, Sanchez A, Aparicio J, et al. Development of a predictive model of venous thromboembolism recurrence in anticoagulated cancer patients using machine learning. Thromb Res. 2023;228:181\u20138. https:\/\/doi.org\/10.1016\/j.thromres.2023.06.015.","journal-title":"Thromb Res"},{"key":"3586_CR14","doi-asserted-by":"publisher","DOI":"10.2196\/20492","volume":"9","author":"L Canales","year":"2021","unstructured":"Canales L, Menke S, Marchesseau S, D\u2019Agostino A, Del Rio-Bermudez C, Taberna M, et al. Assessing the performance of clinical natural language processing systems: development of an evaluation methodology. JMIR Med Inform. 2021;9: e20492. https:\/\/doi.org\/10.2196\/20492.","journal-title":"JMIR Med Inform"},{"key":"3586_CR15","doi-asserted-by":"publisher","first-page":"2003142","DOI":"10.1183\/13993003.03142-2020","volume":"57","author":"JL Izquierdo","year":"2021","unstructured":"Izquierdo JL, Almonacid C, Gonz\u00e1lez Y, Del Rio-Bermudez C, Ancochea J, C\u00e1rdenas R, et al. The impact of COVID-19 on patients with asthma. Eur Respir J. 2021;57:2003142. https:\/\/doi.org\/10.1183\/13993003.03142-2020.","journal-title":"Eur Respir J"},{"key":"3586_CR16","doi-asserted-by":"publisher","first-page":"692","DOI":"10.1111\/j.1538","volume":"3","author":"S Schulman","year":"2005","unstructured":"Schulman S, Kearon C, Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005;3:692\u20134. https:\/\/doi.org\/10.1111\/j.1538.","journal-title":"J Thromb Haemost"},{"key":"3586_CR17","first-page":"23","volume":"57","author":"L Espinosa","year":"2016","unstructured":"Espinosa L, Tello J, Pardo A, Medrano I, Ure\u00f1a A, Salcedo I, et al. Savana: a global information extraction and terminology expansion framework in the medical domain. Procesamiento del Lenguaje Natural. 2016;57:23\u201330.","journal-title":"Procesamiento del Lenguaje Natural"},{"key":"3586_CR18","doi-asserted-by":"publisher","first-page":"1433","DOI":"10.1182\/blood.2020005819","volume":"136","author":"FI Mulder","year":"2020","unstructured":"Mulder FI, Bosch FTM, Young AM, Marshall A, McBane RD II, Zemla TJ, et al. Direct oral anticoagulants for cancer-associated venous thromboembolism: a systematic review and meta-analysis. Blood. 2020;136:1433\u201341. https:\/\/doi.org\/10.1182\/blood.2020005819.","journal-title":"Blood"},{"key":"3586_CR19","doi-asserted-by":"publisher","first-page":"1439","DOI":"10.1055\/s-0038-1667001","volume":"118","author":"N Kraaijpoel","year":"2018","unstructured":"Kraaijpoel N, Di Nisio M, Mulder FI, van Es N, Beyer-Westendorf J, Carrier M, et al. Clinical impact of bleeding in cancer-associated venous thromboembolism: results from the Hokusai VTE cancer study. Thromb Haemost. 2018;118:1439\u201349. https:\/\/doi.org\/10.1055\/s-0038-1667001.","journal-title":"Thromb Haemost"},{"key":"3586_CR20","doi-asserted-by":"publisher","first-page":"435","DOI":"10.1160\/TH08-02-0125","volume":"100","author":"J Trujillo-Santos","year":"2008","unstructured":"Trujillo-Santos J, Nieto JA, Tiberio G, Piccioli A, Di Micco P, Prandoni P, et al. Predicting recurrences or major bleeding in cancer patients with venous thromboembolism. Findings from the RIETE Registry. Thromb Haemost. 2008;100:435\u20139.","journal-title":"Thromb Haemost"},{"key":"3586_CR21","doi-asserted-by":"publisher","first-page":"4839","DOI":"10.1200\/JCO.2009.22.3271","volume":"27","author":"AA Khorana","year":"2009","unstructured":"Khorana AA, Connolly GC. Assessing risk of venous thromboembolism in the patient with cancer. JCO. 2009;27:4839\u201347. https:\/\/doi.org\/10.1200\/JCO.2009.22.3271.","journal-title":"JCO"},{"key":"3586_CR22","doi-asserted-by":"publisher","first-page":"1599","DOI":"10.1056\/NEJMoa1915103","volume":"382","author":"G Agnelli","year":"2020","unstructured":"Agnelli G, Becattini C, Meyer G, Mu\u00f1oz A, Huisman MV, Connors JM, et al. Apixaban for the treatment of venous thromboembolism associated with cancer. N Engl J Med. 2020;382:1599\u2013607. https:\/\/doi.org\/10.1056\/NEJMoa1915103.","journal-title":"N Engl J Med"},{"key":"3586_CR23","doi-asserted-by":"publisher","first-page":"41","DOI":"10.1016\/j.ejim.2020.05.031","volume":"78","author":"A Carmona-Bayonas","year":"2020","unstructured":"Carmona-Bayonas A, G\u00f3mez D, de Castro EM, P\u00e9rez Segura P, Mu\u00f1oz Langa J, Jimenez-Fonseca P, et al. A snapshot of cancer-associated thromboembolic disease in 2018\u20132019: first data from the TESEO prospective registry. Eur J Intern Med. 2020;78:41\u20139. https:\/\/doi.org\/10.1016\/j.ejim.2020.05.031.","journal-title":"Eur J Intern Med"},{"key":"3586_CR24","doi-asserted-by":"publisher","DOI":"10.1002\/rth2.12505","volume":"5","author":"JS Pedersen","year":"2021","unstructured":"Pedersen JS, Laursen MS, Rajeeth Savarimuthu T, Hansen RS, Alnor AB, Bjerre KV, et al. Deep learning detects and visualizes bleeding events in electronic health records. Res Pract Thromb Haemost. 2021;5: e12505. https:\/\/doi.org\/10.1002\/rth2.12505.","journal-title":"Res Pract Thromb Haemost"},{"key":"3586_CR25","doi-asserted-by":"publisher","first-page":"3484","DOI":"10.1182\/blood-2002-01-0108","volume":"100","author":"P Prandoni","year":"2002","unstructured":"Prandoni P, Lensing AWA, Piccioli A, Bernardi E, Simioni P, Girolami B, et al. Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis. Blood. 2002;100:3484\u20138. https:\/\/doi.org\/10.1182\/blood-2002-01-0108.","journal-title":"Blood"},{"key":"3586_CR26","doi-asserted-by":"publisher","first-page":"3008","DOI":"10.1111\/jth.15516","volume":"19","author":"FTM Bosch","year":"2021","unstructured":"Bosch FTM, Mulder FI, Huisman MV, Zwicker JI, Di Nisio M, Carrier M, et al. Risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer using edoxaban. J Thromb Haemost. 2021;19:3008\u201317. https:\/\/doi.org\/10.1111\/jth.15516.","journal-title":"J Thromb Haemost"},{"key":"3586_CR27","doi-asserted-by":"publisher","first-page":"1017","DOI":"10.1007\/s11239-020-02274-6","volume":"51","author":"C G\u00f3mez-Cuervo","year":"2021","unstructured":"G\u00f3mez-Cuervo C, Rivas A, Vison\u00e0 A, Ruiz-Gim\u00e9nez N, Blanco-Molina \u00c1, Ca\u00f1as I, et al. Predicting the risk for major bleeding in elderly patients with venous thromboembolism using the Charlson index. Findings from the RIETE. J Thromb Thrombolysis. 2021;51:1017\u201325. https:\/\/doi.org\/10.1007\/s11239-020-02274-6.","journal-title":"J Thromb Thrombolysis"},{"key":"3586_CR28","doi-asserted-by":"publisher","first-page":"85","DOI":"10.1016\/j.thromres.2020.12.031","volume":"199","author":"MA de Winter","year":"2021","unstructured":"de Winter MA, van Es N, B\u00fcller HR, Visseren FLJ, Nijkeuter M. Prediction models for recurrence and bleeding in patients with venous thromboembolism: a systematic review and critical appraisal. Thromb Res. 2021;199:85\u201396. https:\/\/doi.org\/10.1016\/j.thromres.2020.12.031.","journal-title":"Thromb Res"}],"updated-by":[{"DOI":"10.1007\/s12094-024-03780-2","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2024,11,19]],"date-time":"2024-11-19T00:00:00Z","timestamp":1731974400000}}],"container-title":["Clinical and Translational Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12094-024-03586-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s12094-024-03586-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12094-024-03586-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,15]],"date-time":"2025-04-15T21:02:10Z","timestamp":1744750930000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s12094-024-03586-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9,14]]},"references-count":28,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2025,4]]}},"alternative-id":["3586"],"URL":"https:\/\/doi.org\/10.1007\/s12094-024-03586-2","relation":{"correction":[{"id-type":"doi","id":"10.1007\/s12094-024-03780-2","asserted-by":"object"}]},"ISSN":["1699-3055"],"issn-type":[{"value":"1699-3055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,9,14]]},"assertion":[{"value":"24 April 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 June 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 September 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 November 2024","order":4,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Update","order":5,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The original online version of this article was revised to correct the affiliation for author Mar\u00eda Carmen Vi\u00f1uela Ben\u00e9itez.","order":6,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"19 November 2024","order":7,"name":"change_date","label":"Change Date","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Correction","order":8,"name":"change_type","label":"Change Type","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"A Correction to this paper has been published:","order":9,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"https:\/\/doi.org\/10.1007\/s12094-024-03780-2","URL":"https:\/\/doi.org\/10.1007\/s12094-024-03780-2","order":10,"name":"change_details","label":"Change Details","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"DB and MT are employees of Savana, which was a paid consultant to BMS-Pfizer Alliance. DA and MAHP are employees of Pfizer Company, one of the study sponsors.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Employment"}},{"value":"AM declares personal fees and non-financial support from Celgene, Sanofi, Pfizer-Bristol Myers Squibb (BMS), LEO Pharma, Daiichi Sankyo, Incyte, AstraZeneca, MSD Oncology, Lilly, Roche, Rovi, Bayer, Servier Menarini, Merk Serono and Amgen. RL declares personal fees from Rovi, LEO Pharma, Sanofi and Janssen. JS declares personal fees and non-financial support from Rovi, Stago Laboratories, Pfizer, LEO Pharma and Devicare. BO declares personal fees from Sanofi, Lilly, Angellini, LEO Pharma and Rovi. JA has received personal fees from Servier, Merk, Bayer, Amgen, Sirtex Medical, Sanofi, Roche and Celgene. CA declares non-financial support from GlaxoSmithKline, Pfizer, MSD Oncology, Novartis and Pierre Fabre. AG declares personal fees from Roche, Amgen, MSD Oncology, Eisai Europe, Novartis and Pierre Fabre. AM, RL, JS, BO, AS, JA, CA, DG, AG, MV declare honorarium from BMS-Pfizer Alliance in connection with the development of this manuscript. The remaining authors declare no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study was classified as a non-postauthorization study by the Spanish Agency of Medicines and Health Products and was approved by the corresponding Institutional Review Boards of the participating centers. Patient consent was waived because aggregated and anonymized data were analyzed from deidentified EHRs.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"This study was approved by the Ethics Committee of Research with Medicines (CEIm) of Fundaci\u00f3n Jim\u00e9nez D\u00edaz (CEIm: #EO094-19_FJD) and the institutional Review Board of each participating hospital after being classified as a \u2018other post-authorization study (EPA-OD)\u2019 by the Spanish Agency of Medicines and Health Products (AEMPS). All methods and analysis followed legal and regulatory requirements and followed generally accepted research practices described in the Helsinki Declaration in its latest edition. All data were collected from patients\u2019 EHRs, which were anonymized and aggregated in an irreversible, dissociated manner. Patient consent was therefore not required. Results are reported following the Transparent Reporting of a multivariate prediction model for Individual Prognosis or Diagnosis (TRIPOD) guidelines.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics statement"}}]}}