Evidence map›Paper›PMID 35790696›Full record

Trial reportInternational journal of hematology2022

Intravenous ferric derisomaltose versus saccharated ferric oxide for iron deficiency anemia associated with menorrhagia: a randomized, open-label, active-controlled, noninferiority study.

Hiroshi Kawabata, Takeshi Tamura, Soichiro Tamai, Akiko Fujibayashi, Motoi Sugimura, Study Group

Erratum issuedOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of hematology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.6field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 18 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Hiroshi KawabataDepartment of Hematology, National Hospital Organization Kyoto Medical Center, Kyoto, Japan. hkawabat@kuhp.kyoto-u.ac.jp.ORCID http://orcid.org/0000-0002-1918-8635
Takeshi TamuraClinical Development Department, Nippon Shinyaku Co., Ltd, Kyoto, Japan.
Soichiro TamaiData Science Department, Nippon Shinyaku Co., Ltd, Kyoto, Japan.
Akiko FujibayashiClinical Development Department, Nippon Shinyaku Co., Ltd, Kyoto, Japan.
Motoi SugimuraDepartment of Obstetrics, Gynecology and Family Medicine, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.
Study Group
Nippon Shinyaku (Japan) · JPKyoto Medical Center · JPHamamatsu University School of Medicine · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A multicenter, randomized, open-label, phase III study was conducted to compare the efficacy and safety of intravenous ferric derisomaltose (FDI) versus saccharated ferric oxide (SFO) in Japanese patients with iron deficiency anemia associated with menorrhagia. FDI can be administered as a single dose up to 1000 mg, whereas SFO has a maximum single dose of 120 mg. 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 < 2.0 mg/dL was significantly lower in the FDI group (8.4%) than in the SFO group (83.2%), and severe hypophosphatemia (≤ 1.0 mg/dL) occurred in 6.7% of SFO‑treated 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.

Indexed as

Anemia, Iron-DeficiencyFerric CompoundsHypophosphatemiaIron DeficienciesMenorrhagiaDisaccharidesFemaleFerric Oxide, SaccharatedHemoglobinsHumansIronPhosphorusDisaccharidesFerric Compoundsferric derisomaltoseFerric Oxide, SaccharatedHemoglobinsIronPhosphorusFerric derisomaltoseHypophosphatemiaIntravenous iron preparationIron deficiency anemia

Identifiers

PMID35790696
PMCPMC9588477
OpenAlexW4284687718

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.