A Phase 3 interventional study of Edoxaban and Standard of Care in Venous Thromboembolism (VTE), Pulmonary Embolism and Deep Vein Thrombosis (DVT), sponsored by Daiichi Sankyo. Completed at 140 sites in 34 countries. Open to participants aged 1 Day to 17 Years. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Daiichi Sankyo · Phase 3, Interventional, and Treatment
This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to compare the efficacy and safety of edoxaban against standard of care in pediatric subjects with confirmed VTE.
The objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC; including low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors) in the treatment and secondary prevention of VTE in pediatric subjects with regard to the composite efficacy endpoint (ie, symptomatic recurrent VTE, death as result of VTE, and no change or extension of thrombotic burden) during the first 3-month treatment period.
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's enrollment of 290 is above the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Edoxaban treatment will be dispensed to the participant on a monthly visit schedule. Edoxaban will be started orally at the age/weight/renal function appropriate dose, depending on the results of the ongoing U157 study (NCT02303431) for the Treatment Period.
Drug: Edoxaban
Standard of Care (SOC) treatment will be dispensed to the participant on a monthly visit schedule.
Drug: Standard of Care
15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age
Standard of care could include low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
Also known as: Warfarin/heparin, Enoxaparin, Fondaparinux
Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis.
Time frame: Randomization to Month 3
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out.
Time frame: Randomization to Month 3
Number of Participants With No Change or Extension of Thrombotic Burden During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
No change or extension of thrombotic burden as assessed by quantitative diagnostic imaging of the index qualifying VTE thrombus at baseline and at Month 3. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA).
Time frame: Randomization to Month 3
Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis.
Time frame: From randomization up to Month 12
Number of Participants With Symptomatic Recurrent VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint)
Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis.
Time frame: Randomization to Month 3
Number of Participants Who Died as a Result of VTE During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out.
Time frame: From randomization up to Month 12
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint)
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out.
Time frame: Randomization to Month 3
Number of Participants With No Change or Extension of Thrombotic Burden During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
No change or extension of thrombotic burden as assessed by quantitative diagnostic imaging of the index qualifying VTE thrombus. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA).
Time frame: From randomization up to Month 12
Number of Participants With Adjudicated Individual Component of Primary Efficacy Endpoints During the Main Treatment Period Following Edoxaban or Standard of Care Treatment
Diagnosis of recurrent VTE requires the confirmation imaging and ≥1 symptom of VTE. Death from VTE is based on diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. No change or extension of thrombotic burden (quantitative diagnostic imaging) of the index qualifying VTE thrombus. Imaging criteria for VTE: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA).
Time frame: Randomization to Month 3
Number of Participants Reporting Adjudicated All-Cause Mortality During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated)
All-cause mortality is defined as death due to any cause. Adjudicated data are reported for overall all-cause mortality, all-cause mortality by the primary cause of death, and primary cause of death further described by additional specifications.
Time frame: From randomization up to Month 12
Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment
Deep vein thrombosis was assessed by ultrasonography or magnetic resonance venography (MRV), catheter-related thrombosis was assessed by ultrasonography or echocardiography, sino-venous thrombosis was assessed by brain MRI, and pulmonary embolism was assessed by nuclear ventilation/perfusion (V/Q) scanning.
Time frame: From randomization up to Month 12
Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug).
Time frame: Randomization to Month 3
Number of Participants With All Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
All bleeding events included major bleeding defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells (RBCs), clinically relevant non-major bleeding defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug), nuisance bleeding, or a combination of bleeding events.
Time frame: From randomization up to Month 12
Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug).
Time frame: From randomization up to Month 12
A total of 290 participants who met all inclusion criteria and no exclusion criteria were randomized to receive either edoxaban or standard of care treatment; 286 patients received at least 1 dose of study drug (modified intent-to-treat population).
| Milestone | Edoxaban | Standard of Care |
|---|---|---|
| Started | 147 | 143 |
| Modified intent-to-treat population | 145 | 141 |
| Completed | 128 | 119 |
| Not completed | 19 | 24 |
| Withdrew: Adverse event | 7 | 2 |
| Withdrew: Physician decision | 3 | 7 |
| Withdrew: Death | 2 | 3 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Other | 5 | 3 |
| Withdrew: Subject withdrew consent | 0 | 6 |
| Withdrew: Data entry error (reported as study completion and study discontinuation) | 2 | 0 |
| Withdrew: Randomized, but not treated | 0 | 2 |
Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis.
| Participants | Edoxaban | Standard of Care |
|---|---|---|
| Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | 5 | 2 |
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out.
| Participants | Edoxaban | Standard of Care |
|---|---|---|
| Pulmonary embolism (PE) with or without deep vein thrombosis (DVT) | 0 | 1 |
| Fatal PE | 0 | 0 |
| Non-fatal PE | 0 | 1 |
| Deep vein thrombosis (DVT) only | 5 | 1 |
| Fatal DVT | 0 | 0 |
| Non-fatal DVT | 4 | 0 |
| Unexplained death which VTE cannot be ruled out | 1 | 1 |
No change or extension of thrombotic burden as assessed by quantitative diagnostic imaging of the index qualifying VTE thrombus at baseline and at Month 3. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA).
| Participants | Edoxaban | Standard of Care |
|---|---|---|
| Number of Participants With No Change or Extension of Thrombotic Burden During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | 21 | 29 |
Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis.
| Participants | Edoxaban | Standard of Care |
|---|---|---|
| Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | 7 | 2 |
Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis.
| Participants | Edoxaban | Standard of Care |
|---|---|---|
| Symptomatic VTE | 4 | 1 |
| Pulmonary embolism (PE) with or without deep vein thrombosis (DVT) | 0 | 1 |
| Deep vein thrombosis (DVT) only | 4 | 0 |
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out.
| Participants | Edoxaban | Standard of Care |
|---|---|---|
| Pulmonary embolism (PE) with or without deep vein thrombosis (DVT) | 1 | 1 |
| Fatal PE | 0 | 0 |
| Non-fatal PE | 1 | 1 |
| Deep vein thrombosis (DVT) only | 6 | 1 |
| Fatal DVT | 0 | 0 |
| Non-fatal DVT | 5 | 0 |
| Unexplained death which VTE cannot be ruled out | 1 | 1 |
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out.
| Participants | Edoxaban | Standard of Care |
|---|---|---|
| Death as a result of VTE | 1 | 1 |
| Unexplained death which VTE cannot be ruled out | 1 | 1 |
No change or extension of thrombotic burden as assessed by quantitative diagnostic imaging of the index qualifying VTE thrombus. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA).
| Participants | Edoxaban | Standard of Care |
|---|---|---|
| Number of Participants With No Change or Extension of Thrombotic Burden During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | 35 | 47 |
Diagnosis of recurrent VTE requires the confirmation imaging and ≥1 symptom of VTE. Death from VTE is based on diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. No change or extension of thrombotic burden (quantitative diagnostic imaging) of the index qualifying VTE thrombus. Imaging criteria for VTE: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA).
| Participants | Edoxaban | Standard of Care |
|---|---|---|
| Symptomatic recurrent VTE | 4 | 1 |
| PE with or without DVT | 0 | 1 |
| DVT only | 4 | 0 |
| Death as a result of VTE | 1 | 1 |
| Unexplained death which VTE cannot be ruled out | 1 | 1 |
| No change or extension of thrombotic burden | 21 | 29 |
All-cause mortality is defined as death due to any cause. Adjudicated data are reported for overall all-cause mortality, all-cause mortality by the primary cause of death, and primary cause of death further described by additional specifications.
| Participants | Edoxaban | Standard of Care |
|---|---|---|
| Participants with adjudicated all-cause mortality during treatment period | 2 | 3 |
| Participants with adjudicated all-cause mortality occurring after treatment period | 1 | 0 |
| Venous thromboembolism (VTE)-related death | 1 | 1 |
| Venous thromboembolism (VTE)-related death: Unexplained death which VTE cannot be ruled out | 1 | 1 |
| Other known causes of death | 1 | 2 |
| Other known causes of death: Cancer | 0 | 1 |
| Other known causes of death: Infectious disease | 0 | 1 |
| Other known causes of death: Other | 1 | 0 |
Deep vein thrombosis was assessed by ultrasonography or magnetic resonance venography (MRV), catheter-related thrombosis was assessed by ultrasonography or echocardiography, sino-venous thrombosis was assessed by brain MRI, and pulmonary embolism was assessed by nuclear ventilation/perfusion (V/Q) scanning.
| Participants | Edoxaban | Standard of Care |
|---|---|---|
| Main Treatment: Participants with DVT only | 4 | 0 |
| Main Treatment: Participants with catheter-related thrombosis | 1 | 0 |
| Main Treatment: Participants with cerebral sino-venous DVT thrombosis | 0 | 0 |
| Main Treatment: Participants with PE with or without DVT | 0 | 1 |
| Extension Treatment: Participants with DVT | 1 | 0 |
| Extension Treatment: Participants with catheter-related thrombosis | 0 | 0 |
| Extension Treatment: Participants with sino-venous DVT thrombosis | 1 | 0 |
| Extension Treatment: Participants with PE | 1 | 0 |
| Overall Treatment: Participants with DVT | 5 | 0 |
| Overall Treatment: Participants with catheter-related thrombosis | 1 | 0 |
| Overall Treatment: Participants with sino-venous DVT thrombosis | 1 | 0 |
| Overall Treatment: Participants with PE | 1 | 1 |
Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug).
| Participants | Edoxaban | Standard of Care |
|---|---|---|
| Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | 3 | 5 |
All bleeding events included major bleeding defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells (RBCs), clinically relevant non-major bleeding defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug), nuisance bleeding, or a combination of bleeding events.
| Participants | Edoxaban | Standard of Care |
|---|---|---|
| Number of Participants With All Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | 25 | 24 |
Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug).
| Participants | Edoxaban | Standard of Care |
|---|---|---|
| Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | 8 | 5 |
Collected over Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Edoxaban | 3/145 (2.1%) | 44/145 (30.3%) | 51/145 (35.2%) |
| Standard of Care | 3/141 (2.1%) | 37/141 (26.2%) | 46/141 (32.6%) |
| Event | Edoxaban | Standard of Care |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 6/145 | 6/141 |
| PneumoniaInfections and infestations | 4/145 | 0/141 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/145 | 3/141 |
| HeadacheNervous system disorders | 2/145 | 3/141 |
| Urinary tract infectionInfections and infestations | 3/145 | 0/141 |
| VomitingGastrointestinal disorders | 2/145 | 2/141 |
| CellulitisInfections and infestations | 0/145 | 2/141 |
| GastroenteritisInfections and infestations | 1/145 | 2/141 |
| Rhinovirus infectionInfections and infestations | 0/145 | 2/141 |
| DehydrationMetabolism and nutrition disorders | 1/145 | 2/141 |
| Event | Edoxaban | Standard of Care |
|---|---|---|
| HeadacheNervous system disorders | 20/145 | 14/141 |
| VomitingGastrointestinal disorders | 16/145 | 9/141 |
| PyrexiaGeneral disorders | 12/145 | 11/141 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 12/145 | 10/141 |
| Upper respiratory tract infectionInfections and infestations | 9/145 | 8/141 |
| NasopharyngitisInfections and infestations | 8/145 | 3/141 |
Baseline demographic characteristics were reported in the Randomized Analysis Set.
| Age, Categorical(Participants) | Edoxaban | Standard of Care | Total |
|---|---|---|---|
| <=18 years | 147 | 143 | 290 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Edoxaban | Standard of Care | Total |
|---|---|---|---|
| Mean | 10.9 ± 5.99 | 11.1 ± 6.03 | 11.0 ± 6.0 |
| Sex: Female, Male(Participants) | Edoxaban | Standard of Care | Total |
|---|---|---|---|
| Female | 70 | 70 | 140 |
| Male | 77 | 73 | 150 |
| Race (NIH/OMB)(Participants) | Edoxaban | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 24 | 26 | 50 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 9 | 10 | 19 |
| White | 93 | 87 | 180 |
| More than one race | 15 | 8 | 23 |
| Unknown or Not Reported | 5 | 11 | 16 |
| Region of Enrollment(participants) | Edoxaban | Standard of Care | Total |
|---|---|---|---|
| Singapore | 2 | 4 | 6 |
| United States | 24 | 17 | 41 |
| Czechia | 8 | 5 | 13 |
| Malaysia | 1 | 2 | 3 |
| Thailand | 7 | 8 | 15 |
| Portugal | 3 | 7 | 10 |
| Russia | 1 | 1 | 2 |
| Netherlands | 3 | 3 | 6 |
| South Korea | 6 | 3 | 9 |
| El Salvador | 5 | 0 | 5 |
| Panama | 1 | 0 | 1 |
| Brazil | 4 | 7 | 11 |
| Guatemala | 5 | 4 | 9 |
| Bulgaria | 3 | 1 | 4 |
| Chile | 1 | 1 | 2 |
| France | 1 | 4 | 5 |
| Croatia | 5 | 1 | 6 |
| Hungary | 12 | 11 | 23 |
| Ukraine | 4 | 0 | 4 |
| India | 3 | 5 | 8 |
| Spain | 4 | 6 | 10 |
| Lebanon | 4 | 5 | 9 |
| Canada | 4 | 9 | 13 |
| Turkey | 13 | 17 | 30 |
| Norway | 2 | 3 | 5 |
| Taiwan | 5 | 3 | 8 |
| Israel | 6 | 7 | 13 |
| Germany | 5 | 3 | 8 |
| Colombia | 5 | 6 | 11 |
Showing the first 100 of 140 sites across 34 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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/
Supporting information: Study protocol, Sap, Csr
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