{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T16:06:02Z","timestamp":1786982762634,"version":"build-2736575974"},"reference-count":49,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,11,25]],"date-time":"2020-11-25T00:00:00Z","timestamp":1606262400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2020,11,25]],"date-time":"2020-11-25T00:00:00Z","timestamp":1606262400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"DOI":"10.13039\/100016473","name":"American Regent, Inc.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100016473","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drug Saf"],"published-print":{"date-parts":[[2021,1]]},"DOI":"10.1007\/s40264-020-01022-2","type":"journal-article","created":{"date-parts":[[2020,11,25]],"date-time":"2020-11-25T07:09:44Z","timestamp":1606288184000},"page":"107-119","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using the US Food and Drug Administration Adverse Event Reporting System"],"prefix":"10.1007","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6793-9643","authenticated-orcid":false,"given":"Henry","family":"Trumbo","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karolina","family":"Kaluza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Syed","family":"Numan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence T.","family":"Goodnough","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,11,25]]},"reference":[{"issue":"5","key":"1022_CR1","doi-asserted-by":"publisher","first-page":"615","DOI":"10.1182\/blood-2013-06-508325","volume":"123","author":"NJ Kassebaum","year":"2014","unstructured":"Kassebaum NJ, Jasrasaria R, Naghavi M, Wulf SK, Johns N, Lozano R, et al. A systematic analysis of global anemia burden from 1990 to 2010. Blood. 2014;123(5):615\u201324.","journal-title":"Blood"},{"key":"1022_CR2","unstructured":"World Health Organization. Micronutrient deficiences: iron deficiency anemia. https:\/\/www.who.int\/health-topics\/anaemia. Accessed 20 Apr 2020."},{"issue":"2","key":"1022_CR3","first-page":"98","volume":"87","author":"MW Short","year":"2013","unstructured":"Short MW, Domagalski JE. Iron deficiency anemia: evaluation and management. Am Fam Physician. 2013;87(2):98\u2013104.","journal-title":"Am Fam Physician."},{"issue":"19","key":"1022_CR4","doi-asserted-by":"publisher","first-page":"2062","DOI":"10.1001\/jama.2015.15572","volume":"314","author":"C Wang","year":"2015","unstructured":"Wang C, Graham DJ, Kane RC, Xie D, Wernecke M, Levenson M, et al. Comparative risk of anaphylactic reactions associated with intravenous iron products. JAMA. 2015;314(19):2062.","journal-title":"JAMA"},{"key":"1022_CR5","doi-asserted-by":"publisher","first-page":"w14434","DOI":"10.4414\/smw.2017.14434","volume":"147","author":"GE Clenin","year":"2017","unstructured":"Clenin GE. The treatment of iron deficiency without anaemia (in otherwise healthy persons). Swiss Med Wkly. 2017;147:w14434. https:\/\/doi.org\/10.4414\/smw.2017.14434.","journal-title":"Swiss Med Wkly."},{"issue":"1","key":"1022_CR6","doi-asserted-by":"publisher","first-page":"338","DOI":"10.1182\/asheducation-2010.1.338","volume":"2010","author":"M Auerbach","year":"2010","unstructured":"Auerbach M, Ballard H. Clinical use of intravenous iron: administration, efficacy, and safety. Hematology. 2010;2010(1):338\u201347.","journal-title":"Hematology."},{"issue":"1","key":"1022_CR7","doi-asserted-by":"publisher","first-page":"16","DOI":"10.1007\/s12185-017-2373-3","volume":"107","author":"D Girelli","year":"2018","unstructured":"Girelli D, Ugolini S, Busti F, Marchi G, Castagna A. Modern iron replacement therapy: clinical and pathophysiological insights. Int J Hematol. 2018;107(1):16\u201330.","journal-title":"Int J Hematol."},{"issue":"2","key":"1022_CR8","doi-asserted-by":"publisher","first-page":"378","DOI":"10.1093\/ndt\/gfi253","volume":"21","author":"GM Chertow","year":"2006","unstructured":"Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmen J. Update on adverse drug events associated with parenteral iron. Nephrol Dial Transplant. 2006;21(2):378\u201382. https:\/\/doi.org\/10.1093\/ndt\/gfi253.","journal-title":"Nephrol Dial Transplant."},{"key":"1022_CR9","unstructured":"AMAG Pharmaceuticals Inc. Feraheme\u00ae (ferumoxytol injection), for intravenous use, prescribing information. Waltham, MA. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/022180s009lbl.pdf. Accessed 10 Dec 2019."},{"key":"1022_CR10","unstructured":"Patheon Italia S.p.A. InFeD\u00ae (iron dextran injection USP) prescribing information. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2009\/017441s171lbl.pdf. Accessed 20 Apr 2020."},{"issue":"12","key":"1022_CR11","doi-asserted-by":"publisher","first-page":"3646","DOI":"10.1111\/trf.15587","volume":"59","author":"J Abdulrehman","year":"2019","unstructured":"Abdulrehman J, Tang GH, Auerbach M, Santesso N, Sholzberg M. The safety and efficacy of ferumoxytol in the treatment of iron deficiency: a systematic review and meta-analysis. Transfusion. 2019;59(12):3646\u201356. https:\/\/doi.org\/10.1111\/trf.15587.","journal-title":"Transfusion."},{"issue":"5","key":"1022_CR12","doi-asserted-by":"publisher","first-page":"683","DOI":"10.1002\/ajh.25060","volume":"93","author":"NF Adkinson","year":"2018","unstructured":"Adkinson NF, Strauss WE, Macdougall IC, Bernard KE, Auerbach M, Kaper RF, et al. Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia: a randomized trial. Am J Hematol. 2018;93(5):683\u201390. https:\/\/doi.org\/10.1002\/ajh.25060.","journal-title":"Am J Hematol."},{"issue":"1","key":"1022_CR13","doi-asserted-by":"publisher","first-page":"12","DOI":"10.1016\/j.mayocp.2014.10.007","volume":"90","author":"T Avni","year":"2015","unstructured":"Avni T, Bieber A, Grossman A, Green H, Leibovici L, Gafter-Gvili A. The safety of intravenous iron preparations: systematic review and meta-analysis. Mayo Clin Proc. 2015;90(1):12\u201323. https:\/\/doi.org\/10.1016\/j.mayocp.2014.10.007.","journal-title":"Mayo Clin Proc."},{"issue":"1","key":"1022_CR14","doi-asserted-by":"publisher","first-page":"e0171098","DOI":"10.1371\/journal.pone.0171098","volume":"12","author":"JB Wetmore","year":"2017","unstructured":"Wetmore JB, Weinhandl ED, Zhou J, Gilbertson DT. Relative incidence of acute adverse events with ferumoxytol compared to other intravenous iron compounds: a matched cohort study. PLoS ONE. 2017;12(1):e0171098. https:\/\/doi.org\/10.1371\/journal.pone.0171098.","journal-title":"PLoS ONE"},{"issue":"7","key":"1022_CR15","doi-asserted-by":"publisher","first-page":"1443","DOI":"10.1093\/ndt\/gfh820","volume":"20","author":"GR Bailie","year":"2005","unstructured":"Bailie GR, Clark JA, Lane CE, Lane PL. Hypersensitivity reactions and deaths associated with intravenous iron preparations. Nephrol Dial Transplant. 2005;20(7):1443\u20139. https:\/\/doi.org\/10.1093\/ndt\/gfh820.","journal-title":"Nephrol Dial Transplant."},{"issue":"4","key":"1022_CR16","doi-asserted-by":"publisher","first-page":"310","DOI":"10.2146\/ajhp110262","volume":"69","author":"GR Bailie","year":"2012","unstructured":"Bailie GR. Comparison of rates of reported adverse events associated with i.v. iron products in the United States. Am J Health Syst Pharm. 2012;69(4):310\u201320. https:\/\/doi.org\/10.2146\/ajhp110262.","journal-title":"Am J Health Syst Pharm."},{"issue":"3","key":"1022_CR17","doi-asserted-by":"publisher","first-page":"463","DOI":"10.1007\/s40264-018-0769-5","volume":"42","author":"B Ehlken","year":"2019","unstructured":"Ehlken B, Nathell L, Gohlke A, Bocuk D, Toussi M, Wohlfeil S. Evaluation of the reported rates of severe hypersensitivity reactions associated with ferric carboxymaltose and iron (III) isomaltoside 1000 in Europe based on data from EudraVigilance and VigiBase between 2014 and 2017. Drug Saf. 2019a;42(3):463\u201371. https:\/\/doi.org\/10.1007\/s40264-018-0769-5.","journal-title":"Drug Saf."},{"issue":"1","key":"1022_CR18","doi-asserted-by":"publisher","first-page":"35","DOI":"10.1007\/s40264-019-00868-5","volume":"43","author":"L Nathell","year":"2020","unstructured":"Nathell L, Gohlke A, Wohlfeil S. Reported severe hypersensitivity reactions after intravenous iron administration in the European Economic Area (EEA) before and after implementation of risk minimization measures. Drug Saf. 2020;43(1):35\u201343. https:\/\/doi.org\/10.1007\/s40264-019-00868-5.","journal-title":"Drug Saf."},{"issue":"5","key":"1022_CR19","doi-asserted-by":"publisher","first-page":"451","DOI":"10.1002\/ajh.24326","volume":"91","author":"TG DeLoughery","year":"2016","unstructured":"DeLoughery TG, Auerbach M. Is low-molecular weight iron dextran really the most risky iron? Unconvincing data from an unconvincing study. Am J Hematol. 2016;91(5):451\u20132. https:\/\/doi.org\/10.1002\/ajh.24326.","journal-title":"Am J Hematol."},{"issue":"5","key":"1022_CR20","doi-asserted-by":"publisher","first-page":"693","DOI":"10.1007\/s40264-019-00815-4","volume":"42","author":"B Ehlken","year":"2019","unstructured":"Ehlken B, Nathell L, Gohlke A, Bocuk D, Toussi M, Wohlfeil S. Authors\u2019 reply to Schaffalitzky de Muckadell and colleague\u2019s comment on \u201cEvaluation of the Reported Rates of Severe Hypersensitivity Reactions Associated with Ferric Carboxymaltose and Iron (III) Isomaltoside 1000 in Europe Based on Data from EudraVigilance and VigiBase between 2014 and 2017.\u201d Drug Saf. 2019b;42(5):693\u20136. https:\/\/doi.org\/10.1007\/s40264-019-00815-4.","journal-title":"Drug Saf."},{"issue":"5","key":"1022_CR21","doi-asserted-by":"publisher","first-page":"689","DOI":"10.1007\/s40264-019-00814-5","volume":"42","author":"SP de Muckadell","year":"2019","unstructured":"Schaffalizky de Muckadell P, Strom CC. Comment on \u201cEvaluation of the Reported Rates of Severe Hypersensitivity Reactions Associated with Ferric Carboxymaltose and Iron(III) Isomaltoside 1000 in Europe Based on Data from EudraVigilance and VigiBase Between 2014 and 2017.\u201d Drug Saf. 2019;42(5):689\u201391. https:\/\/doi.org\/10.1007\/s40264-019-00814-5.","journal-title":"Drug Saf."},{"issue":"5","key":"1022_CR22","doi-asserted-by":"publisher","first-page":"503","DOI":"10.1007\/s40264-020-00929-0","volume":"43","author":"SP de Muckadell","year":"2020","unstructured":"Schaffalizky de Muckadell P, Strom CC. Comment on \u201cReported Severe Hypersensitivity Reactions after Intravenous Iron Administration in the European Economic Area (EEA) Before and After Implementation of Risk Minimization Measures.\u201d Drug Saf. 2020;43(5):503\u20135. https:\/\/doi.org\/10.1007\/s40264-020-00929-0.","journal-title":"Drug Saf."},{"issue":"9","key":"1022_CR23","doi-asserted-by":"publisher","first-page":"650","DOI":"10.1002\/ajh.21794","volume":"85","author":"DK Wysowski","year":"2010","unstructured":"Wysowski DK, Swartz L, Borders-Hemphill BV, Goulding MR, Dormitzer C. Use of parenteral iron products and serious anaphylactic-type reactions. Am J Hematol. 2010;85(9):650\u20134. https:\/\/doi.org\/10.1002\/ajh.21794.","journal-title":"Am J Hematol."},{"issue":"20","key":"1022_CR24","doi-asserted-by":"publisher","first-page":"30047","DOI":"10.1016\/j.therap.2020.02.022","volume":"S0040\u20135957","author":"K Bihan","year":"2020","unstructured":"Bihan K, Lebrun-Vignes B, Funck-Brentano C, Salem JE. Uses of pharmacovigilance databases: an overview. Therapie. 2020;S0040\u20135957(20):30047. https:\/\/doi.org\/10.1016\/j.therap.2020.02.022.","journal-title":"Therapie."},{"issue":"3","key":"1022_CR25","doi-asserted-by":"publisher","first-page":"201","DOI":"10.1080\/17512433.2020.1740086","volume":"13","author":"J Sultana","year":"2020","unstructured":"Sultana J, Trifiro G. The potential role of big data in the detection of adverse drug reactions. Expert Rev Clin Pharmacol. 2020;13(3):201\u20134. https:\/\/doi.org\/10.1080\/17512433.2020.1740086.","journal-title":"Expert Rev Clin Pharmacol."},{"key":"1022_CR26","unstructured":"US Food and Drug Administration. FDA Adverse Event Reporting System (FAERS) quarterly data extract files. https:\/\/fis.fda.gov\/extensions\/FPD-QDE-FAERS\/FPD-QDE-FAERS.html. Accessed 7 Apr 2020."},{"key":"1022_CR27","unstructured":"US Food and Drug Administration. Questions and answers on FDA's Adverse Event Reporting System (FAERS). 2019. https:\/\/www.fda.gov\/drugs\/surveillance\/questions-and-answers-fdas-adverse-event-reporting-system-faers. Accessed 7 Apr 2020."},{"key":"1022_CR28","unstructured":"Advera Health Analytics Inc. Evidex\u00ae. https:\/\/www.adverahealth.com\/solutions\/overview#software. Accessed 20 Apr 2020."},{"key":"1022_CR29","doi-asserted-by":"publisher","first-page":"160026","DOI":"10.1038\/sdata.2016.26","volume":"3","author":"JM Banda","year":"2016","unstructured":"Banda JM, Evans L, Vanguri RS, Tatonetti NP, Ryan PB, Shah NH. A curated and standardized adverse drug event resource to accelerate drug safety research. Sci Data. 2016;3:160026. https:\/\/doi.org\/10.1038\/sdata.2016.26.","journal-title":"Sci Data."},{"issue":"6","key":"1022_CR30","doi-asserted-by":"publisher","first-page":"561","DOI":"10.1007\/s40264-016-0409-x","volume":"39","author":"KB Hoffman","year":"2016","unstructured":"Hoffman KB, Dimbil M, Tatonetti NP, Kyle RF. A pharmacovigilance signaling system based on FDA regulatory action and post-marketing adverse event reports. Drug Saf. 2016;39(6):561\u201375.","journal-title":"Drug Saf."},{"issue":"8","key":"1022_CR31","doi-asserted-by":"publisher","first-page":"519","DOI":"10.1002\/pds.1001","volume":"13","author":"KJ Rothman","year":"2004","unstructured":"Rothman KJ, Lanes S, Sacks ST. The reporting odds ratio and its advantages over the proportional reporting ratio. Pharmacoepidemiol Drug Saf. 2004;13(8):519\u201323. https:\/\/doi.org\/10.1002\/pds.1001.","journal-title":"Pharmacoepidemiol Drug Saf."},{"key":"1022_CR32","unstructured":"Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project (HCUP). https:\/\/www.ahrq.gov\/data\/hcup\/index.html. Accessed 20 Apr 2020."},{"key":"1022_CR33","unstructured":"Healthcare Cost and Utilization Project (HCUP).https:\/\/www.hcup-us.ahrq.gov\/. Accessed 20 Apr 2020."},{"key":"1022_CR34","unstructured":"Medical Dictionary for Regulatory Activities. MedDRA version 22.0. https:\/\/www.meddra.org. Accessed 7 Apr 2020."},{"key":"1022_CR35","unstructured":"Medical Dictionary for Regulatory Activities. Standardised MedDRA queries (SMQs). https:\/\/www.meddra.org\/how-to-use\/tools\/smqs. Accessed 7 Apr 2020."},{"issue":"6","key":"1022_CR36","doi-asserted-by":"publisher","first-page":"427","DOI":"10.1002\/pds.1742","volume":"18","author":"A Bates","year":"2009","unstructured":"Bates A, Evans SJW. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf. 2009;18(6):427\u201336.","journal-title":"Pharmacoepidemiol Drug Saf."},{"key":"1022_CR37","unstructured":"B\u00f6hm R. Primer on disproportionality analysis. 2018. http:\/\/openvigil.sourceforge.net\/doc\/DPA.pdf. Accessed 7 Apr 2020."},{"issue":"1","key":"1022_CR38","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1002\/pds.668","volume":"11","author":"EP van Puijenbroek","year":"2002","unstructured":"van Puijenbroek EP, Bate A, Leufkens HGM, Lindquist M, Orre R, Egberts ACG. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf. 2002;11(1):3\u201310.","journal-title":"Pharmacoepidemiol Drug Saf."},{"issue":"6","key":"1022_CR39","doi-asserted-by":"publisher","first-page":"539","DOI":"10.1038\/clpt.2013.24","volume":"93","author":"R Harpaz","year":"2013","unstructured":"Harpaz R, DuMouchel W, LePendu P, Bauer-Mehren A, Ryan P, Shah NH. Performance of pharmacovigilance signal-detection algorithms for the FDA adverse event reporting system. Clin Pharmacol Ther. 2013;93(6):539\u201346. https:\/\/doi.org\/10.1038\/clpt.2013.24.","journal-title":"Clin Pharmacol Ther."},{"issue":"6","key":"1022_CR40","doi-asserted-by":"publisher","first-page":"577","DOI":"10.1007\/s40264-015-0289-5","volume":"38","author":"G Candore","year":"2015","unstructured":"Candore G, Juhlin K, Manlik K, Thakrar B, Quarcoo N, Seabroke S, et al. Comparison of statistical signal detection methods within and across spontaneous reporting databases. Drug Saf. 2015;38(6):577\u201387. https:\/\/doi.org\/10.1007\/s40264-015-0289-5.","journal-title":"Drug Saf."},{"issue":"2","key":"1022_CR41","doi-asserted-by":"publisher","first-page":"195","DOI":"10.1002\/pds.3529","volume":"23","author":"F Maignen","year":"2014","unstructured":"Maignen F, Hauben M, Hung E, Van Holle L, Dogne JM. Assessing the extent and impact of the masking effect of disproportionality analyses on two spontaneous reporting systems databases. Pharmacoepidemiol Drug Saf. 2014;23(2):195\u2013207. https:\/\/doi.org\/10.1002\/pds.3529.","journal-title":"Pharmacoepidemiol Drug Saf."},{"issue":"7","key":"1022_CR42","doi-asserted-by":"publisher","first-page":"231","DOI":"10.1177\/2042098617704143","volume":"8","author":"F Maignen","year":"2017","unstructured":"Maignen F, Hauben M, Dogne JM. A mathematical framework to quantify the masking effect associated with the confidence intervals of measures of disproportionality. Ther Adv Drug Saf. 2017;8(7):231\u201344. https:\/\/doi.org\/10.1177\/2042098617704143.","journal-title":"Ther Adv Drug Saf."},{"issue":"12","key":"1022_CR43","first-page":"1134","volume":"21","author":"KB Hoffman","year":"2015","unstructured":"Hoffman KB, Dimbil M, Kyle RF, Tatonetti NP, Erdman CB, Demakas A, et al. A drug safety rating system based on postmarketing costs associated with adverse events and patient outcomes. J Manag Care Spec Pharm. 2015;21(12):1134\u201343.","journal-title":"J Manag Care Spec Pharm."},{"key":"1022_CR44","unstructured":"Zhao Y, Encinosa W. The cost of end-of-life hospitalizations: Healthcare Cost and Utilization Project (HCUP) statistical brief. 2007. https:\/\/www.hcup-us.ahrq.gov\/reports\/statbriefs\/sb81.pdf. Accessed 20 Apr 2020."},{"key":"1022_CR45","unstructured":"BioPortal. Mappings. http:\/\/bioportal.bioontology.org\/mappings. Accessed 7 Apr 2020."},{"key":"1022_CR46","unstructured":"US Bureau of Labor Statistics. Consumer price index. 2020. https:\/\/www.bls.gov\/bls\/news-release\/cpi.htm. Accessed 13 Oct 2020."},{"issue":"4","key":"1022_CR47","doi-asserted-by":"publisher","first-page":"615","DOI":"10.1007\/s10534-015-9845-9","volume":"28","author":"S Neiser","year":"2015","unstructured":"Neiser S, Rentsch D, Dippon U, Kappler A, Weidler PG, G\u00f6ttlicher J, et al. Physico-chemical properties of the new generation IV iron preparations ferumoxytol, iron isomaltoside 1000 and ferric carboxymaltose. Biometals. 2015;28(4):615\u201335.","journal-title":"Biometals"},{"issue":"7","key":"1022_CR48","doi-asserted-by":"publisher","first-page":"761","DOI":"10.1080\/14740338.2017.1323867","volume":"16","author":"YM Alatawi","year":"2017","unstructured":"Alatawi YM, Hansen RA. Empirical estimation of under-reporting in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). Expert Opin Drug Saf. 2017;16(7):761\u20137. https:\/\/doi.org\/10.1080\/14740338.2017.1323867.","journal-title":"Expert Opin Drug Saf."},{"issue":"4","key":"1022_CR49","doi-asserted-by":"publisher","first-page":"271","DOI":"10.1002\/pds.848","volume":"12","author":"N Moore","year":"2003","unstructured":"Moore N, Hall G, Sturkenboom M, Mann R, Lagnaoui R, Begaud B. Biases affecting the proportional reporting ratio (PPR) in spontaneous reports pharmacovigilance databases: the example of sertindole. Pharmacoepidemiol Drug Saf. 2003;12(4):271\u201381. https:\/\/doi.org\/10.1002\/pds.848.","journal-title":"Pharmacoepidemiol Drug Saf."}],"container-title":["Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-020-01022-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40264-020-01022-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-020-01022-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,4,9]],"date-time":"2021-04-09T07:42:52Z","timestamp":1617954172000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40264-020-01022-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,11,25]]},"references-count":49,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,1]]}},"alternative-id":["1022"],"URL":"https:\/\/doi.org\/10.1007\/s40264-020-01022-2","relation":{},"ISSN":["0114-5916","1179-1942"],"issn-type":[{"value":"0114-5916","type":"print"},{"value":"1179-1942","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,11,25]]},"assertion":[{"value":"10 November 2020","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"25 November 2020","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study was supported by American Regent, USA, which holds the marketing rights for ferric carboxymaltose in the USA, and which provided funding to Advera Health Analytics, Inc. (Santa Rosa, CA, USA) to conduct the FAERS data extraction and analysis.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Henry Trumbo is a consultant for American Regent, Daiichi Sankyo, and Allergan. Lawrence T. Goodnough is a consultant for American Regent. Karolina Kaluza and Syed Numan are employees of American Regent, the manufacturers of ferric carboxymaltose.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest\/Competing interests"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The code used to conduct this analysis was provided by Evidex<sup>\u00ae<\/sup> (which is not publicly available), PostgreSQL (a free and open-source relational database), and Microsoft<sup>\u00ae<\/sup> Excel<sup>\u00ae<\/sup>.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"The source data and analytics for this study were provided by Evidex<sup>\u00ae<\/sup>, licensed by Advera Health Analytics, Inc., and are not publicly available. Healthcare Cost and Utilization Project data are made publicly available by the Agency for Healthcare Research and Quality.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"HT and LTG contributed to the interpretation of data, and to the reviewing and writing of the report. KK and SN contributed to the conception and design of the analysis, the interpretation of data, and to the reviewing and writing of the report. All authors read and approved the final version.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}