Evidence map›Paper›PMID 34455706›Full record

Trial reportJournal of thrombosis and haemostasis : JTH2021

Risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer using edoxaban.

Floris T M Bosch, Frits I Mulder, Menno V Huisman, Jeffrey I Zwicker, Marcello Di Nisio, Marc Carrier, Annelise Segers, Peter Verhamme, Saskia Middeldorp, Jeffrey I Weitz and 8 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of thrombosis and haemostasis : JTH, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.4field-weighted citation impact, top 15% 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

14 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Prediction model for major bleeding in anticoagulated patients with cancer-associated venous thromboembolism using machine learning and natural language processing.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Observational
  6. Article
  7. Review
  8. Review
  9. Article
  10. Non-Invasive Cancer Detection Using Blood Test and Predictive Modeling Approach.Advances and applications in bioinformatics and chemistry : AABC · 2024
    Article
  11. Review
  12. Article
  13. Review
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 12 institutions in 5 countries.

Floris T M BoschDepartment of Internal Medicine, Tergooi Hospital, Hilversum, The Netherlands.ORCID 0000-0002-1286-5402
Frits I MulderDepartment of Internal Medicine, Tergooi Hospital, Hilversum, The Netherlands.ORCID 0000-0002-6902-3425
Menno V HuismanDepartment of Medicine-Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.
Jeffrey I ZwickerDivision of Hemostasis and Thrombosis, Division of Hematology and Oncology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, USA.ORCID 0000-0001-5810-6893
Marcello Di NisioDepartment of Medicine and Ageing Sciences, University G. D'Annunzio, Chieti, Italy.ORCID 0000-0001-5930-7304
Marc CarrierDepartment of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, ON, Canada.
Annelise SegersITREAS, Academic Research Organization, Amsterdam, the Netherlands.
Peter VerhammeDepartment of Vascular Medicine and Hemostasis, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0001-8698-2858
Saskia MiddeldorpDepartment of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0002-1006-6420
Jeffrey I WeitzMcMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, ON, Canada.
Michael A GrossoDaiichi Sankyo Pharma Development, Basking Ridge, NJ, USA.
Anil DuggalDaiichi Sankyo Pharma Development, Basking Ridge, NJ, USA.
Harry R BüllerDepartment of Vascular Medicine, Amsterdam Cardiovascular Science, Medical Centers, Amsterdam University, University of Amsterdam, Amsterdam, The Netherlands.
Tzu-Fei WangDepartment of Medicine, Ottawa Hospital Research Institute at the University of Ottawa, Ottawa, ON, Canada.ORCID 0000-0003-2407-9000
David GarciaDivision of Hematology, Department of Medicine, University of Washington, Seattle, WA, USA.
Pieter Willem KamphuisenDepartment of Internal Medicine, Tergooi Hospital, Hilversum, The Netherlands.
Gary E RaskobCollege of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
Nick van EsDepartment of Vascular Medicine, Amsterdam Cardiovascular Science, Medical Centers, Amsterdam University, University of Amsterdam, Amsterdam, The Netherlands.
Tergooi · NLAmsterdam University Medical Centers · NLDaiichi Sankyo (United States) · USUniversity of Ottawa · CABeth Israel Deaconess Medical Center · USKU Leuven · BELeiden University Medical Center · NLRadboud University Nijmegen · NLThrombosis and Atherosclerosis Research Institute · CAUniversity of Chieti-Pescara · ITUniversity of Oklahoma Health Sciences Center · USUniversity of Washington · US

Funding

Daiichi Sankyo Company
6 · The paper itself

Abstract

backgroundIn the Hokusai VTE Cancer study, the risk of major bleeding was 2.9% higher in the edoxaban group compared with the dalteparin group, mainly due to more gastrointestinal bleedings in patients with gastrointestinal cancer. The identification of risk factors for gastrointestinal bleeding may help to guide the use of DOACs in these patients.

objectivesTo evaluate risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban. PATIENTS/

methodsIn this nested case-control study in patients with gastrointestinal cancer randomized to edoxaban in the Hokusai VTE Cancer study, cases (patients with clinically relevant gastrointestinal bleeding during treatment) were randomly matched to three controls (patients who had no gastrointestinal bleeding). Data for the 4-week period prior to bleeding were retrospectively collected. Odds ratios (ORs) were calculated in a crude conditional logistic regression model and a multivariable model adjusted for age, sex, and cancer type.

resultsTwenty-four cases and 64 matched controls were included. In the multivariable analysis, advanced cancer, defined as regionally advanced or metastatic cancer (OR 3.6, 95% CI 1.01-12.6) and low hemoglobin levels (OR 4.8, 95% CI 1.5-16.0) were significantly associated with bleeding. There was no significant difference in patients with resected tumors (OR 0.4, 95% CI 0.1-1.4), or in patients on chemotherapy (OR 1.3, 95% CI 0.5-3.5).

conclusionAdvanced cancer and low hemoglobin levels were associated with an increased risk of gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban. We were unable to identify other risk factors, mainly due to limited statistical power.

Indexed as

Gastrointestinal NeoplasmsVenous ThromboembolismAnticoagulantsCase-Control StudiesFactor Xa InhibitorsGastrointestinal HemorrhageHumansPyridinesRetrospective StudiesRisk FactorsThiazolesAnticoagulantsedoxabanFactor Xa InhibitorsPyridinesThiazolesfactor Xa Inhibitorsgastrointestinal neoplasmshemorrhagerisk factorsvenous thrombosis

Identifiers

PMID34455706
PMCPMC9292167
OpenAlexW3197343960

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.