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A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer

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Trial Profile

A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Feb 2024

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At a glance

  • Drugs Edoxaban (Primary) ; Low molecular weight heparins (Primary) ; Dalteparin sodium
  • Indications Deep vein thrombosis; Pulmonary embolism; Venous thromboembolism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms Hokusai-VTE Cancer
  • Sponsors Daiichi Sankyo Inc

Most Recent Events

  • 13 Dec 2022 Results of post hoc analysis investigating the impact of platelet count on bleeding and recurrent thrombosis, presented at the 64th American Society of Hematology Annual Meeting and Exposition
  • 29 Aug 2021 Results of nested case-control study assessing risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban and identify patients with gastrointestinal cancer at low risk of bleeding in whom edoxaban can be safely prescribed, published in the Journal of Thrombosis and Haemostasis.
  • 04 Jul 2019 Post hoc analysis results (n=1046) were published in the Journal of Thrombosis and Haemostasis.

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