Cardiac Disease
Conditions
Keywords
Children, Pediatrics, Cardiac disease with potential for thromboembolic complications, Prophylactic treatment, Anticoagulant drugs
Brief summary
A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care). All children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots. The study will find out if edoxaban is safer and more effective than the standard of care.
Detailed description
The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in pediatric subjects with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis with regard to the combination of major and clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and Haemostasis \[ISTH\] definition. The key secondary objective is to compare the efficacy of edoxaban against SOC with regard to the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by cardiac imaging.
Interventions
DRUGEdoxaban
Edoxaban 15 mg or 30 mg tablets for participants 12 to \<18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration
DRUGStandard of Care (SOC)
Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 17 Years
Healthy volunteers
No
Inclusion criteria
* Is a child with cardiac disease who is at risk for thromboembolic complications and requires at least 3 months antithrombotic anticoagulant prophylaxis Either one of the following: 1. a child with cardiac disease who has a history of cardiac shunt occlusion/thrombosis, with shunt still in place (secondary prevention). OR 2. a child with cardiac disease who requires (including those already taking, and those not yet taking) anticoagulation for primary prevention of TE. Cardiac conditions known to significantly increase the risk of thrombosis (hence, indications for primary TE prevention) are defined in Antithrombotic Therapy and Prevention of Thrombosis. Some examples of cardiac conditions at risk of thrombosis are Fontan surgery, heart failure, Kawasaki disease, and Blalock-Taussig and Glenn surgery. * Is a male or female child between 1 and \<18 years of age (children between 38 weeks gestational age and 1 year of age will be included in the study, however, only after the safety and efficacy data of 50 subjects between 1 and \<18 years of age in the edoxaban arm have been evaluated at the end of the 3-month treatment period) * Has parent(s)/legal guardian(s) or legally acceptable representative who is informed and provides signed consent for the child, to participate in the study with edoxaban treatment. Pediatric participants with appropriate intellectual maturity will be required to sign an assent form in addition to the signed informed consent from the parent(s)/legal guardian(s) or any legally acceptable representative. * If a female subject of childbearing potential, tests negative for pregnancy at Screening and consents to avoid becoming pregnant by using a locally approved contraception method throughout the study
Exclusion criteria
* Has evidence of symptomatic venous or arterial thrombosis and/or asymptomatic intracardiac thrombosis confirmed by a transthoracic echocardiogram during study screening period * Has mechanical heart valve(s) * Has active bleeding or high risk of bleeding contraindicating treatment with anticoagulant * Takes antithrombotic therapy (other than low-dose aspirin) that is not protocol-related * Administration of rifampin is prohibited during the study and subjects on concomitant use of rifampin are excluded * Has any hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk * Has estimated glomerular filtration rate (eGFR) \<30% of normal for age and size * Has stage 2 hypertension defined as blood pressure systolic and/or diastolic confirmed \>99th percentile plus 5 mmHg * Has thrombocytopenia or life expectancy less than three months * Has had Fontan procedure with a history of or signs/symptoms suggestive of protein-losing enteropathy * Is pregnant or breastfeeding * Has a contraindication to the use of heparin and/or vitamin K antagonist (VKA) * Has any condition that, as judged by the Investigator, would place the participant at increased risk of harm if he/she participated in the study, including contraindicated medications identified in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period | Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier | Adjudicated bleeding events included major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period. Based on modified ISTH recommendations, major bleeding is defined as a composite (ie, any) of the following: fatal bleeding; and/or symptomatic bleeding in a critical area or organ; and/or bleeding causing a decrease in hemoglobin level of \>2 g/dL, or leading to transfusion of the equivalent of ≥2 units of whole blood or red cells. A CRNM bleed is an 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, or a physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. Minor bleeding is any other overt bleeding event that does not meet criteria for either major or CRNM bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier | Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus, and myocardial infarction (MI). |
| Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) Within the Main Treatment Period | Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier | Death due to any cause (all-cause mortality) was assessed. |
| Number of Participants With Adjudicated Bleeding Events During the Extension Period | Month 4 up to Month 13 | Adjudicated bleeding events included major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period. Based on modified ISTH recommendations, major bleeding is defined as a composite (ie, any) of the following: fatal bleeding; and/or symptomatic bleeding in a critical area or organ; and/or bleeding causing a decrease in hemoglobin level of \>2 g/dL, or leading to transfusion of the equivalent of ≥2 units of whole blood or red cells. A CRNM bleed is an 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, or a physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. Minor bleeding is any other overt bleeding event that does not meet criteria for either major or CRNM bleeding. |
| Number of Participants Who Died as a Result of Thromboembolic Event Within the Main Treatment Period | Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier | Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus, and myocardial infarction (MI). |
| Number of Participants Who Died as a Result of Thromboembolic Event During the Extension Period | Month 4 up to Month 13 | Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus, and myocardial infarction (MI). |
| Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) During the Extension Period | Month 4 up to Month 13 | Death due to any cause (all-cause mortality) was assessed. |
| Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period | Month 4 up to Month 13 | Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus, and myocardial infarction (MI). |
Countries
Austria, Canada, Croatia, Egypt, France, Hungary, India, Israel, Lebanon, Spain, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Recruitment details
A total of 168 participants who met all inclusion criteria and no exclusion criteria were randomized to treatment; 167 participants received treatment and were included in the modified Intent to Treat and Safety Populations.
Pre-assignment details
All subjects at the Screening Visit were assessed for international normalized ratio (INR) and activated partial thromboplastin time (aPTT) and evaluated at the local laboratory.
Participants by arm
| Arm | Count |
|---|---|
| Edoxaban Participants who were randomized to edoxaban solution or tablets orally once a day. Participants 12 to \<18 years of age were administered 30 mg, 45 mg, or 60 mg edoxaban tablets or offered granules for oral suspension if they did not have the capacity to swallow. Participants under 12 years of age were administered edoxaban granules (dosed as mg/kg), with maximum dose of 45 mg for 6 months to \<12 years, maximum dose of 12 mg for \>28 days to \<6 months, and maximum dose of 6 mg for 38 weeks gestation to ≤28 days. | 110 |
| Standard of Care (SOC) Participants who were randomized to SOC regimen which may have included low molecular weight heparin (LMWH) and/or Vitamin K antagonist (VKA) according to the clinical site's SOC treatment regimen. | 58 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Extension Period (4-13 Months) | Adverse Event | 0 | 0 | 2 |
| Extension Period (4-13 Months) | Subject discontinued at PI discretion | 0 | 0 | 1 |
| Main Treatment Period (0 to 4 Months) | Adverse Event | 1 | 0 | 0 |
| Main Treatment Period (0 to 4 Months) | Participant discontinued at Principal Investigator discretion | 0 | 1 | 0 |
| Main Treatment Period (0 to 4 Months) | Withdrawal by Subject | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | Standard of Care (SOC) | Edoxaban | Total |
|---|---|---|---|
| Age, Continuous | 7.3 years STANDARD_DEVIATION 5.1 | 7.7 years STANDARD_DEVIATION 4.8 | 7.6 years STANDARD_DEVIATION 4.9 |
| Age, Customized 0 to 6 months | 3 Participants | 1 Participants | 4 Participants |
| Age, Customized 12 to <18 years | 16 Participants | 28 Participants | 44 Participants |
| Age, Customized 2 to <6 years | 17 Participants | 33 Participants | 50 Participants |
| Age, Customized 6 months to <2 years | 5 Participants | 7 Participants | 12 Participants |
| Age, Customized 6 to <12 years | 17 Participants | 41 Participants | 58 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 10 Participants | 17 Participants |
| Race/Ethnicity, Customized Unknown | 5 Participants | 8 Participants | 13 Participants |
| Race/Ethnicity, Customized White | 39 Participants | 80 Participants | 119 Participants |
| Sex: Female, Male Female | 21 Participants | 38 Participants | 59 Participants |
| Sex: Female, Male Male | 37 Participants | 72 Participants | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 109 | 0 / 58 | 2 / 144 |
| other Total, other adverse events | 51 / 109 | 24 / 58 | 69 / 144 |
| serious Total, serious adverse events | 5 / 109 | 3 / 58 | 19 / 144 |
Outcome results
Primary
Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period
Adjudicated bleeding events included major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period. Based on modified ISTH recommendations, major bleeding is defined as a composite (ie, any) of the following: fatal bleeding; and/or symptomatic bleeding in a critical area or organ; and/or bleeding causing a decrease in hemoglobin level of \>2 g/dL, or leading to transfusion of the equivalent of ≥2 units of whole blood or red cells. A CRNM bleed is an 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, or a physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. Minor bleeding is any other overt bleeding event that does not meet criteria for either major or CRNM bleeding.
Time frame: Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier
Population: Adjudicated bleeding events were assessed in participants in the Safety Analysis Set within the Main Treatment Period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Edoxaban | Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period | Major or CRNM bleeding events | 1 Participants |
| Edoxaban | Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period | Major bleeding events | 0 Participants |
| Edoxaban | Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period | All bleeding events (Major, CRNM, minor) | 4 Participants |
| Standard of Care (SOC) | Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period | Major or CRNM bleeding events | 1 Participants |
| Standard of Care (SOC) | Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period | Major bleeding events | 0 Participants |
| Standard of Care (SOC) | Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period | All bleeding events (Major, CRNM, minor) | 2 Participants |
95% CI: [-0.18, 0.12]
95% CI: [0, 0]
95% CI: [-0.24, 0.25]
Secondary
Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) During the Extension Period
Death due to any cause (all-cause mortality) was assessed.
Time frame: Month 4 up to Month 13
Population: Death was assessed in participants with available data in the modified Intent to Treat Population within the Extension Period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edoxaban | Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) During the Extension Period | 2 Participants |
Secondary
Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) Within the Main Treatment Period
Death due to any cause (all-cause mortality) was assessed.
Time frame: Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier
Population: Death was assessed in participants in the modified Intent to Treat Population within the Main Treatment Period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edoxaban | Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) Within the Main Treatment Period | 0 Participants |
| Standard of Care (SOC) | Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) Within the Main Treatment Period | 0 Participants |
Secondary
Number of Participants Who Died as a Result of Thromboembolic Event During the Extension Period
Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus, and myocardial infarction (MI).
Time frame: Month 4 up to Month 13
Population: Death was assessed in participants with available data in the modified Intent to Treat Population within the Extension Period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edoxaban | Number of Participants Who Died as a Result of Thromboembolic Event During the Extension Period | 0 Participants |
Secondary
Number of Participants Who Died as a Result of Thromboembolic Event Within the Main Treatment Period
Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus, and myocardial infarction (MI).
Time frame: Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier
Population: Death was assessed in participants in the modified Intent to Treat Population within the Main Treatment Period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Edoxaban | Number of Participants Who Died as a Result of Thromboembolic Event Within the Main Treatment Period | 0 Participants |
| Standard of Care (SOC) | Number of Participants Who Died as a Result of Thromboembolic Event Within the Main Treatment Period | 0 Participants |
Secondary
Number of Participants With Adjudicated Bleeding Events During the Extension Period
Adjudicated bleeding events included major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period. Based on modified ISTH recommendations, major bleeding is defined as a composite (ie, any) of the following: fatal bleeding; and/or symptomatic bleeding in a critical area or organ; and/or bleeding causing a decrease in hemoglobin level of \>2 g/dL, or leading to transfusion of the equivalent of ≥2 units of whole blood or red cells. A CRNM bleed is an 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, or a physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. Minor bleeding is any other overt bleeding event that does not meet criteria for either major or CRNM bleeding.
Time frame: Month 4 up to Month 13
Population: Adjudicated bleeding events were assessed in participants with available data in the Safety Analysis Set within the Extension Period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Edoxaban | Number of Participants With Adjudicated Bleeding Events During the Extension Period | Major or CRNM bleeding events | 1 Participants |
| Edoxaban | Number of Participants With Adjudicated Bleeding Events During the Extension Period | Major bleeding events | 1 Participants |
| Edoxaban | Number of Participants With Adjudicated Bleeding Events During the Extension Period | All bleeding events (Major, CRNM, minor) | 4 Participants |
Secondary
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period
Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus, and myocardial infarction (MI).
Time frame: Month 4 up to Month 13
Population: Symptomatic thromboembolic events were assessed in participants with available data in the Safety Analysis Set within the Extension Period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period | Thromboembolic event, Any Event | 4 Participants |
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period | Deep vein thrombosis | 0 Participants |
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period | Pulmonary embolism | 0 Participants |
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period | Stroke | 2 Participants |
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period | Systemic embolic event | 0 Participants |
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period | Intracardiac thrombus | 0 Participants |
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period | Myocardial infarction | 2 Participants |
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period | Asymptomatic intracardiac thrombus identified by cardiac imaging | 0 Participants |
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period | Death as a result of TE | 0 Participants |
Secondary
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period
Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus, and myocardial infarction (MI).
Time frame: Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier
Population: Symptomatic thromboembolic events were assessed in participants in the Safety Analysis Set within the Main Treatment Period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Deep vein thrombosis | 0 Participants |
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Intracardiac thrombus | 0 Participants |
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Stroke | 0 Participants |
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Myocardial infarction | 0 Participants |
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Pulmonary embolism | 0 Participants |
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Asymptomatic intracardiac thrombus identified by cardiac imaging | 0 Participants |
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Systemic embolic event | 0 Participants |
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Death as a result of TE | 0 Participants |
| Edoxaban | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Thromboembolic event, Any Event | 0 Participants |
| Standard of Care (SOC) | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Death as a result of TE | 0 Participants |
| Standard of Care (SOC) | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Thromboembolic event, Any Event | 1 Participants |
| Standard of Care (SOC) | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Deep vein thrombosis | 1 Participants |
| Standard of Care (SOC) | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Pulmonary embolism | 1 Participants |
| Standard of Care (SOC) | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Stroke | 0 Participants |
| Standard of Care (SOC) | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Systemic embolic event | 0 Participants |
| Standard of Care (SOC) | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Intracardiac thrombus | 0 Participants |
| Standard of Care (SOC) | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Myocardial infarction | 0 Participants |
| Standard of Care (SOC) | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period | Asymptomatic intracardiac thrombus identified by cardiac imaging | 0 Participants |