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FDI can be administered as a single dose up to 1000\u00a0mg, whereas SFO has a maximum single dose of 120\u00a0mg. The primary endpoint, which was the maximum change in hemoglobin concentration from baseline, was noninferior for the FDI group compared with the SFO group. The incidence of treatment-emergent adverse events was lower in the FDI group (66.2%) than in the SFO group (90.8%). Notably, the incidence of serum phosphorus level\u2009&lt;\u20092.0\u00a0mg\/dL was significantly lower in the FDI group (8.4%) than in the SFO group (83.2%), and severe hypophosphatemia (\u2264\u20091.0\u00a0mg\/dL) occurred in 6.7% of SFO\u2011treated patients compared with none in the FDI group. The percentage of patients who achieved the cumulative total iron dose during the 8-week treatment period was higher in the FDI group (92.8%) than in the SFO group (43.2%). The study met its primary endpoint, and also demonstrated the tolerability of a high dose of FDI per infusion, with a lower incidence of hypophosphatemia.<\/jats:p>","DOI":"10.1007\/s12185-022-03401-0","type":"journal-article","created":{"date-parts":[[2022,7,5]],"date-time":"2022-07-05T23:22:32Z","timestamp":1657063352000},"page":"647-658","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["Intravenous ferric derisomaltose versus saccharated ferric oxide for iron deficiency anemia associated with menorrhagia: a randomized, open-label, active-controlled, noninferiority 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Dr. H. Kawabata reports honoraria for lectures and consulting fees associated with his role in the submitted study as a medical officer from Nippon Shinyaku Co., Ltd. He is also a board member of the Japanese BioIron Society. Dr. M. Sugimura reports consulting fees associated with his role in the submitted study as a coordinating investigator from Nippon Shinyaku Co., Ltd. T. Tamura, S. Tamai, and A. Fujibayashi are employees of Nippon Shinyaku Co., Ltd.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}