Neoplasms

Symptoms and General Pathology

All Conditions

Heart and Blood Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasm Metastasis

Thrombosis

Pulmonary Embolism

Embolism

Thromboembolism

Venous Thromboembolism

Venous Thrombosis

Embolism and Thrombosis

Vascular Diseases

Lung Diseases

Respiratory Tract Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Fibrinolytic Agents

Anticoagulants

Anti-Infective Agents

Amino Acids

Heparin

Edoxaban

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Factor Xa Inhibitors

Antithrombins

Antithrombin III

Protease Inhibitors

Serine Proteinase Inhibitors

HIV Protease Inhibitors

Enzyme Inhibitors

Serine

After 5 days of low molecular weight heparin (LMWH), patients receive edoxaban treatment daily - tablet for oral use

Participants receive Dalteparin treatment daily -solution for subcutaneous injection

After the 5 day treatment with LMWH, patients receive edoxaban 60 mg once daily (QD) as 2 × 30 mg tablets (or 1 x 30 mg tablet QD for patients requiring dose adjustment) for the remainder of the treatment period.

Dalteparin was administered via subcutaneous injection at a dose of 200 IU/kg (maximum daily dose 18,000 IU) for 30 days, and at a dose of 150 IU/kg from Day 31 to the end of treatment.

Therapeutic doses of subcutaneous LMWH were administered for at least 5 days (to patients in the edoxaban group); this 5-day period may have included the pre-randomization LMWH (if applicable). The choice of parenteral LMWH was up to the treating physician.

Low molecular weight heparin

Global Clinical Leader

The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH) compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will be compared with dalteparin for superiority.

Cancer Venous Thromboembolism (VTE)

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

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

The primary safety endpoint was major bleeding events during the On-Treatment Study Period (defined as on-study drug or up to 3 days after the last dose of study drug).

Daiichi Sankyo

After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily

Edoxaban Group

Dalteparin Group

Total

Age, Continuous

18-64 Years

65-84 Years

85 years and over

Age, Customized

Sex: Female, Male

White

Black or African American

Asian

Native Hawaiian/Pacific Islander

Other

The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.

Race/Ethnicity, Customized

Netherlands

Belgium

Hungary

United States

Italy

France

Austria

Germany

Czechia

Spain

Australia

New Zealand

Canada

Region of Enrollment

Solid Tumor

Haematological Malignancy

Solid Tumor and Haematological Malignancy

Type of Cancer

Daiichi Sankyo US Contact for Clinical Trial Results

modified Intent to Treat (mITT), equating to the Safety Analysis Set

Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event

The HR, 2-sided CI and p-value are based on the Cox regression model with counting process approach for on-treatment including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.

Number of Participants With Adjudicated Major Bleeding Events While on Treatment

The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.

Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period

Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period

Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period

Number of Participants With VTE-Related Death

Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death

Overall Study

Spots Global Cancer Trial Database for active cancer with metastasis