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Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395639
Recruitment Status : Completed
First Posted : January 10, 2018
Results First Posted : July 26, 2022
Last Update Posted : July 26, 2022
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Cardiac Disease
Interventions Drug: Edoxaban
Drug: Standard of Care (SOC)
Enrollment 168
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.
Arm/Group Title Main Treatment Period: Edoxaban Main Treatment Period: Standard of Care (SOC) Extension Period: Edoxaban Only
Hide Arm/Group Description 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. 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. 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.
Period Title: Main Treatment Period (0 to 4 Months)
Started 110 58 0
Modified Intent to Treat Population 109 58 0
Completed 107 55 0
Not Completed 3 3 0
Reason Not Completed
Withdrawal by Subject             2             2             0
Adverse Event             1             0             0
Participant discontinued at Principal Investigator discretion             0             1             0
Period Title: Extension Period (4-13 Months)
Started 0 0 147 [1]
Completed 0 0 144
Not Completed 0 0 3
Reason Not Completed
Adverse Event             0             0             2
Subject discontinued at PI discretion             0             0             1
[1]
15 participants who completed the Main Treatment Period did not participate in the Extension Period
Arm/Group Title Edoxaban Standard of Care (SOC) Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 110 58 168
Hide Baseline Analysis Population Description
Demographic and baseline characteristics were assessed in the Intent to Treat Population (ITT).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants 58 participants 168 participants
7.7  (4.8) 7.3  (5.1) 7.6  (4.9)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 58 participants 168 participants
0 to 6 months
1
   0.9%
3
   5.2%
4
   2.4%
6 months to <2 years
7
   6.4%
5
   8.6%
12
   7.1%
2 to <6 years
33
  30.0%
17
  29.3%
50
  29.8%
6 to <12 years
41
  37.3%
17
  29.3%
58
  34.5%
12 to <18 years
28
  25.5%
16
  27.6%
44
  26.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 58 participants 168 participants
Female
38
  34.5%
21
  36.2%
59
  35.1%
Male
72
  65.5%
37
  63.8%
109
  64.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 58 participants 168 participants
Asian
6
   5.5%
3
   5.2%
9
   5.4%
Black or African American
4
   3.6%
3
   5.2%
7
   4.2%
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian/Pacific Islander
2
   1.8%
1
   1.7%
3
   1.8%
White
80
  72.7%
39
  67.2%
119
  70.8%
Other
10
   9.1%
7
  12.1%
17
  10.1%
Unknown
8
   7.3%
5
   8.6%
13
   7.7%
1.Primary Outcome
Title Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Adjudicated bleeding events were assessed in participants in the Safety Analysis Set within the Main Treatment Period.
Arm/Group Title Edoxaban Standard of Care (SOC)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 109 58
Measure Type: Count of Participants
Unit of Measure: Participants
Major or CRNM bleeding events
1
   0.9%
1
   1.7%
Major bleeding events
0
   0.0%
0
   0.0%
All bleeding events (Major, CRNM, minor)
4
   3.7%
2
   3.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Edoxaban, Standard of Care (SOC)
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference in adjudicated major or CRNM bleeding rates were assessed.
Method of Estimation Estimation Parameter Annualized rate difference
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.18 to 0.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Edoxaban, Standard of Care (SOC)
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference in adjudicated major bleeding rates were assessed.
Method of Estimation Estimation Parameter Annualized rate difference
Estimated Value 0
Confidence Interval (2-Sided) 95%
0 to 0
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Edoxaban, Standard of Care (SOC)
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference in all adjudicated bleeding (major, CRNM, minor) rates were assessed.
Method of Estimation Estimation Parameter Annualized rate difference
Estimated Value 0
Confidence Interval (2-Sided) 95%
-0.24 to 0.25
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Symptomatic thromboembolic events were assessed in participants in the Safety Analysis Set within the Main Treatment Period.
Arm/Group Title Edoxaban Standard of Care (SOC)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 109 58
Measure Type: Count of Participants
Unit of Measure: Participants
Thromboembolic event, Any Event
0
   0.0%
1
   1.7%
Deep vein thrombosis
0
   0.0%
1
   1.7%
Pulmonary embolism
0
   0.0%
1
   1.7%
Stroke
0
   0.0%
0
   0.0%
Systemic embolic event
0
   0.0%
0
   0.0%
Intracardiac thrombus
0
   0.0%
0
   0.0%
Myocardial infarction
0
   0.0%
0
   0.0%
Asymptomatic intracardiac thrombus identified by cardiac imaging
0
   0.0%
0
   0.0%
Death as a result of TE
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Number of Participants Who Died as a Result of Thromboembolic Event Within the Main Treatment Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Death was assessed in participants in the modified Intent to Treat Population within the Main Treatment Period.
Arm/Group Title Edoxaban Standard of Care (SOC)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 109 58
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) Within the Main Treatment Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Death was assessed in participants in the modified Intent to Treat Population within the Main Treatment Period.
Arm/Group Title Edoxaban Standard of Care (SOC)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 109 58
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number of Participants With Adjudicated Bleeding Events During the Extension Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Adjudicated bleeding events were assessed in participants with available data in the Safety Analysis Set within the Extension Period.
Arm/Group Title Edoxaban
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 144
Measure Type: Count of Participants
Unit of Measure: Participants
Major or CRNM bleeding events
1
   0.7%
Major bleeding events
1
   0.7%
All bleeding events (Major, CRNM, minor)
4
   2.8%
6.Secondary Outcome
Title Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Symptomatic thromboembolic events were assessed in participants with available data in the Safety Analysis Set within the Extension Period.
Arm/Group Title Edoxaban
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 144
Measure Type: Count of Participants
Unit of Measure: Participants
Thromboembolic event, Any Event
4
   2.8%
Deep vein thrombosis
0
   0.0%
Pulmonary embolism
0
   0.0%
Stroke
2
   1.4%
Systemic embolic event
0
   0.0%
Intracardiac thrombus
0
   0.0%
Myocardial infarction
2
   1.4%
Asymptomatic intracardiac thrombus identified by cardiac imaging
0
   0.0%
Death as a result of TE
0
   0.0%
7.Secondary Outcome
Title Number of Participants Who Died as a Result of Thromboembolic Event During the Extension Period
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Death was assessed in participants with available data in the modified Intent to Treat Population within the Extension Period.
Arm/Group Title Edoxaban
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 144
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
8.Secondary Outcome
Title Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) During the Extension Period
Hide Description Death due to any cause (all-cause mortality) was assessed.
Time Frame Month 4 up to Month 13
Hide Outcome Measure Data
Hide Analysis Population Description
Death was assessed in participants with available data in the modified Intent to Treat Population within the Extension Period.
Arm/Group Title Edoxaban
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 144
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.4%
Time Frame Adverse events (AEs) were collected from the time of signing the informed consent form up to 30 days after the last dose of study drug, up to 13 months.
Adverse Event Reporting Description Adverse events (AEs) were defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
 
Arm/Group Title Main Treatment Period: Edoxaban Main Treatment Period: Standard of Care (SOC) Extension Period: Edoxaban Only
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Main Treatment Period: Edoxaban Main Treatment Period: Standard of Care (SOC) Extension Period: Edoxaban Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/109 (0.00%)   0/58 (0.00%)   2/144 (1.39%) 
Hide Serious Adverse Events
Main Treatment Period: Edoxaban Main Treatment Period: Standard of Care (SOC) Extension Period: Edoxaban Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/109 (4.59%)   3/58 (5.17%)   19/144 (13.19%) 
Blood and lymphatic system disorders       
Haemolysis  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Immune thrombocytopenia  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Cardiac disorders       
Cardiac failure  1  2/109 (1.83%)  1/58 (1.72%)  0/144 (0.00%) 
Coronary artery thrombosis  1  1/109 (0.92%)  0/58 (0.00%)  0/144 (0.00%) 
Atrial thrombosis  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Cardiac disorder  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Coronary artery occlusion  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Myocardial infarction  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Myocardial ischaemia  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Palpitations  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Congenital, familial and genetic disorders       
Coarctation of the aorta  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Gastrointestinal disorders       
Vomiting  1  0/109 (0.00%)  1/58 (1.72%)  1/144 (0.69%) 
Gingival bleeding  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Mucous stools  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
General disorders       
Non-cardiac chest pain  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Pyrexia  1  0/109 (0.00%)  0/58 (0.00%)  2/144 (1.39%) 
Infections and infestations       
Abscess limb  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Bronchitis  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Injury, poisoning and procedural complications       
Skin laceration  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Soft tissue injury  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Traumatic liver injury  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Investigations       
Pulmonary arterial pressure increased  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Metabolism and nutrition disorders       
Hyponatraemia  1  0/109 (0.00%)  1/58 (1.72%)  0/144 (0.00%) 
Nervous system disorders       
Cerebellar infarction  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Cerebral haematoma  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Paraesthesia  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Syncope  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Renal and urinary disorders       
Acute kidney injury  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Respiratory, thoracic and mediastinal disorders       
Pleural effusion  1  2/109 (1.83%)  0/58 (0.00%)  0/144 (0.00%) 
Pulmonary embolism  1  0/109 (0.00%)  1/58 (1.72%)  0/144 (0.00%) 
Dyspnoea  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Epistaxis  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Pulmonary artery stenosis  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Skin and subcutaneous tissue disorders       
Petechiae  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
Vascular disorders       
Haematoma  1  0/109 (0.00%)  0/58 (0.00%)  1/144 (0.69%) 
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Main Treatment Period: Edoxaban Main Treatment Period: Standard of Care (SOC) Extension Period: Edoxaban Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   51/109 (46.79%)   24/58 (41.38%)   69/144 (47.92%) 
Gastrointestinal disorders       
Diarrhoea  1  3/109 (2.75%)  1/58 (1.72%)  1/144 (0.69%) 
Vomiting  1  3/109 (2.75%)  2/58 (3.45%)  6/144 (4.17%) 
General disorders       
Pyrexia  1  5/109 (4.59%)  1/58 (1.72%)  13/144 (9.03%) 
Infections and infestations       
Bronchitis  1  3/109 (2.75%)  0/58 (0.00%)  3/144 (2.08%) 
Upper respiratory tract infection  1  2/109 (1.83%)  2/58 (3.45%)  7/144 (4.86%) 
Nasopharyngitis  1  4/109 (3.67%)  3/58 (5.17%)  4/144 (2.78%) 
Influenza  1  1/109 (0.92%)  0/58 (0.00%)  5/144 (3.47%) 
Tonsillitis  1  2/109 (1.83%)  0/58 (0.00%)  3/144 (2.08%) 
Viral infection  1  0/109 (0.00%)  1/58 (1.72%)  3/144 (2.08%) 
Laryngitis  1  0/109 (0.00%)  2/58 (3.45%)  0/144 (0.00%) 
Investigations       
Catheterisation cardiac  1  0/109 (0.00%)  2/58 (3.45%)  0/144 (0.00%) 
Metabolism and nutrition disorders       
Iron deficiency  1  0/109 (0.00%)  2/58 (3.45%)  0/144 (0.00%) 
Nervous system disorders       
Headache  1  5/109 (4.59%)  2/58 (3.45%)  9/144 (6.25%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  14/109 (12.84%)  2/58 (3.45%)  9/144 (6.25%) 
Cough  1  4/109 (3.67%)  2/58 (3.45%)  9/144 (6.25%) 
Epistaxis  1  3/109 (2.75%)  2/58 (3.45%)  6/144 (4.17%) 
Rhinorrhoea  1  4/109 (3.67%)  1/58 (1.72%)  3/144 (2.08%) 
Skin and subcutaneous tissue disorders       
Ecchymosis  1  0/109 (0.00%)  0/58 (0.00%)  3/144 (2.08%) 
Vascular disorders       
Haematoma  1  0/109 (0.00%)  0/58 (0.00%)  5/144 (3.47%) 
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Contact for Clinical Trial Information
Organization: Daiichi Sankyo
Phone: 908-992-6400
EMail: CTRinfo@dsi.com
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT03395639    
Other Study ID Numbers: DU176b-C-U313
2017-000475-90 ( EudraCT Number )
First Submitted: January 4, 2018
First Posted: January 10, 2018
Results First Submitted: June 2, 2022
Results First Posted: July 26, 2022
Last Update Posted: July 26, 2022