Trial reportBJOG : an international journal of obstetrics and gynaecology2018
Abnormal vaginal bleeding in women of reproductive age treated with edoxaban or warfarin for venous thromboembolism: a post hoc analysis of the Hokusai-VTE study.
Trial report in BJOG : an international journal of obstetrics and gynaecology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.
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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.
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.
Who cites it
22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 65 citations in OpenAlex.
- Oral direct thrombin inhibitors or oral factor Xa inhibitors versus conventional anticoagulants for the treatment of pulmonary embolism.The Cochrane database of systematic reviews · 2023Pooled it
- Oral direct thrombin inhibitors or oral factor Xa inhibitors versus conventional anticoagulants for the treatment of deep vein thrombosis.The Cochrane database of systematic reviews · 2023Pooled it
- Heavy Menstrual Bleeding in Women Treated with Direct Oral Anticoagulants: Results of the Prospective HEMBLED Registry.Thrombosis and haemostasis · 2026Trial
- Abnormal vaginal bleeding in women of reproductive age treated with edoxaban or warfarin for venous thromboembolism: a post hoc analysis of the Hokusai-VTE study.BJOG : an international journal of obstetrics and gynaecology · 2018Trial
- Real-world use of rivaroxaban for primary thromboprophylaxis and cardiac thrombosis treatment in congenital and acquired heart disease: a prospective cohort study.Scientific reports · 2026Article
- Sex Differences in Cancer-Associated Thrombosis.International journal of molecular sciences · 2026Review
- Cancer-related thrombosis: impact of biological sex on the risk of rethrombosis and bleeding.Haematologica · 2025Article
- Hormone-related thrombosis: duration of anticoagulation, risk of recurrence, and the role of hypercoagulability testing.Hematology. American Society of Hematology. Education Program · 2024Review
- Effects of antiplatelet therapy on menstrual blood loss in reproductive-aged women: a systematic review.Research and practice in thrombosis and haemostasis · 2024Article
- How do anticoagulants impact menstrual bleeding and quality of life? - The PERIOD study.Research and practice in thrombosis and haemostasis · 2023Article
- Anticoagulant therapy for women: implications for menstruation, pregnancy, and lactation.Hematology. American Society of Hematology. Education Program · 2022Article
- Article
- Reproductive issues in women on direct oral anticoagulants.Research and practice in thrombosis and haemostasis · 2021Article
- Do women with venous thromboembolism bleed more than men during anticoagulation? Data from the real-life, prospective START-Register.Therapeutic advances in drug safety · 2021Article
- Heavy menstrual bleeding on direct factor Xa inhibitors: Rationale and design of the MEDEA study.Research and practice in thrombosis and haemostasis · 2021Article
- Management of heavy menstrual bleeding on anticoagulation.Hematology. American Society of Hematology. Education Program · 2020Review
- Increasing use of anticoagulants in Germany and its impact on hospitalization rates for genitourinary bleeding.Journal of thrombosis and thrombolysis · 2020Article
- Effectiveness and Safety of Apixaban for Treatment of Venous Thromboembolism in Daily Practice.TH open : companion journal to thrombosis and haemostasis · 2020Article
- Susceptibility to adverse drug reactions.British journal of clinical pharmacology · 2019Review
- Sex matters: Practice 5P's when treating young women with venous thromboembolism.Journal of thrombosis and haemostasis : JTH · 2019Review
Corrections and comments
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Authors and funding
13 authors at 8 institutions in 9 countries.
Funding
Abstract
objectiveTo investigate the characteristics and outcome of abnormal vaginal bleeding in women receiving edoxaban or warfarin for treatment of venous thromboembolism (VTE). DESIGN AND
settingPost hoc analysis of the Hokusai-VTE study, a multicentre, randomised, double-blind trial comparing edoxaban with warfarin for acute symptomatic VTE. POPULATION: Women below 50 years receiving edoxaban or warfarin for treatment of VTE.
methodsWe collected data on diagnostic measures, treatment, and clinical outcome of abnormal vaginal bleeding events.
main outcome measuresOccurrence of major and clinically relevant nonmajor (CRNM) abnormal vaginal bleeding events.
resultsIn all, 628 women aged under 50 years were treated with edoxaban and 665 with warfarin. The rate of abnormal vaginal bleeding was 15/100 person-years (py) (95% CI 11-19) in women receiving edoxaban and 9/100 py (95% CI 6-12) in the warfarin group (hazard ratio: 1.7, 95% CI 1.1-2.5). Major abnormal vaginal bleeding occurred in eight (1.3%) women on edoxaban and in three (0.9%) women receiving warfarin [odds ratio (OR) 2.8; 95% CI 0.8-10.8], and CRNM abnormal vaginal bleeding occurred in 53 (8.4%) women treated with edoxaban and in 37 (5.6%) on warfarin therapy (OR 1.6, 95% CI 1.0-2.4). Over 85% of all vaginal bleeds were characterised by heavy menstrual bleeding. Major bleeds frequently required treatment, and in more than 75% of patients anticoagulant therapy was adjusted. The severity of clinical presentation and course of major and CRNM bleeds was mild in most patients.
conclusionsAbnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin. Reassuringly, most events could be managed conservatively and had a mild outcome. TWEETABLE ABSTRACT: Abnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin.
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Registered trials
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.