Trial Outcomes & Findings for Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease (NCT NCT03395639)
NCT ID: NCT03395639
Last Updated: 2022-07-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
168 participants
Primary outcome timeframe
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
Results posted on
2022-07-26
Participant Flow
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.
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.
Participant milestones
| Measure |
Main Treatment Period: 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.
|
Main Treatment Period: 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.
|
Extension Period: Edoxaban Only
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.
|
|---|---|---|---|
|
Main Treatment Period (0 to 4 Months)
STARTED
|
110
|
58
|
0
|
|
Main Treatment Period (0 to 4 Months)
Modified Intent to Treat Population
|
109
|
58
|
0
|
|
Main Treatment Period (0 to 4 Months)
COMPLETED
|
107
|
55
|
0
|
|
Main Treatment Period (0 to 4 Months)
NOT COMPLETED
|
3
|
3
|
0
|
|
Extension Period (4-13 Months)
STARTED
|
0
|
0
|
147
|
|
Extension Period (4-13 Months)
COMPLETED
|
0
|
0
|
144
|
|
Extension Period (4-13 Months)
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Main Treatment Period: 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.
|
Main Treatment Period: 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.
|
Extension Period: Edoxaban Only
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.
|
|---|---|---|---|
|
Main Treatment Period (0 to 4 Months)
Withdrawal by Subject
|
2
|
2
|
0
|
|
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
|
|
Extension Period (4-13 Months)
Adverse Event
|
0
|
0
|
2
|
|
Extension Period (4-13 Months)
Subject discontinued at PI discretion
|
0
|
0
|
1
|
Baseline Characteristics
Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease
Baseline characteristics by cohort
| Measure |
Edoxaban
n=110 Participants
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.
|
Standard of Care (SOC)
n=58 Participants
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
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.7 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
7.3 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
7.6 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Age, Customized
0 to 6 months
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Customized
6 months to <2 years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Customized
2 to <6 years
|
33 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Customized
6 to <12 years
|
41 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Age, Customized
12 to <18 years
|
28 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
80 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 earlierPopulation: Adjudicated bleeding events were assessed in participants in the Safety Analysis Set 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.
Outcome measures
| Measure |
Edoxaban
n=109 Participants
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.
|
Standard of Care (SOC)
n=58 Participants
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.
|
|---|---|---|
|
Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period
Major or CRNM bleeding events
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period
Major bleeding events
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period
All bleeding events (Major, CRNM, minor)
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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 earlierPopulation: Symptomatic thromboembolic events were assessed in participants in the Safety Analysis Set 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).
Outcome measures
| Measure |
Edoxaban
n=109 Participants
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.
|
Standard of Care (SOC)
n=58 Participants
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.
|
|---|---|---|
|
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
|
0 Participants
|
|
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
|
1 Participants
|
|
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
|
1 Participants
|
|
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period
Pulmonary embolism
|
0 Participants
|
1 Participants
|
|
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period
Stroke
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
|
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period
Intracardiac thrombus
|
0 Participants
|
0 Participants
|
|
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period
Myocardial infarction
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
SECONDARY outcome
Timeframe: 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 earlierPopulation: Death was assessed in participants in the modified Intent to Treat Population 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).
Outcome measures
| Measure |
Edoxaban
n=109 Participants
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.
|
Standard of Care (SOC)
n=58 Participants
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.
|
|---|---|---|
|
Number of Participants Who Died as a Result of Thromboembolic Event Within the Main Treatment Period
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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 earlierPopulation: Death was assessed in participants in the modified Intent to Treat Population within the Main Treatment Period.
Death due to any cause (all-cause mortality) was assessed.
Outcome measures
| Measure |
Edoxaban
n=109 Participants
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.
|
Standard of Care (SOC)
n=58 Participants
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.
|
|---|---|---|
|
Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) Within the Main Treatment Period
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 4 up to Month 13Population: Adjudicated bleeding events were assessed in participants with available data in the Safety Analysis Set within 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.
Outcome measures
| Measure |
Edoxaban
n=144 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants With Adjudicated Bleeding Events During the Extension Period
Major or CRNM bleeding events
|
1 Participants
|
—
|
|
Number of Participants With Adjudicated Bleeding Events During the Extension Period
Major bleeding events
|
1 Participants
|
—
|
|
Number of Participants With Adjudicated Bleeding Events During the Extension Period
All bleeding events (Major, CRNM, minor)
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Month 4 up to Month 13Population: Symptomatic thromboembolic events were assessed in participants with available data in the Safety Analysis Set within 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).
Outcome measures
| Measure |
Edoxaban
n=144 Participants
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.
|
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.
|
|---|---|---|
|
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
|
—
|
|
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period
Deep vein thrombosis
|
0 Participants
|
—
|
|
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period
Pulmonary embolism
|
0 Participants
|
—
|
|
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period
Stroke
|
2 Participants
|
—
|
|
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period
Systemic embolic event
|
0 Participants
|
—
|
|
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period
Intracardiac thrombus
|
0 Participants
|
—
|
|
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period
Myocardial infarction
|
2 Participants
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: Month 4 up to Month 13Population: Death was assessed in participants with available data in the modified Intent to Treat Population within 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).
Outcome measures
| Measure |
Edoxaban
n=144 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants Who Died as a Result of Thromboembolic Event During the Extension Period
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Month 4 up to Month 13Population: Death was assessed in participants with available data in the modified Intent to Treat Population within the Extension Period.
Death due to any cause (all-cause mortality) was assessed.
Outcome measures
| Measure |
Edoxaban
n=144 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) During the Extension Period
|
2 Participants
|
—
|
Adverse Events
Main Treatment Period: Edoxaban
Serious events: 5 serious events
Other events: 51 other events
Deaths: 0 deaths
Main Treatment Period: Standard of Care (SOC)
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Extension Period: Edoxaban Only
Serious events: 19 serious events
Other events: 69 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Main Treatment Period: Edoxaban
n=109 participants at risk
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.
|
Main Treatment Period: Standard of Care (SOC)
n=58 participants at risk
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.
|
Extension Period: Edoxaban Only
n=144 participants at risk
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.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
1.8%
2/109 • 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 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.
|
1.7%
1/58 • 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 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.
|
0.00%
0/144 • 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 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.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.92%
1/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.00%
0/144 • 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 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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/109 • 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 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.
|
1.7%
1/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/109 • 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 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.
|
1.7%
1/58 • 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 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.
|
0.00%
0/144 • 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 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
2/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.00%
0/144 • 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 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/109 • 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 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.
|
1.7%
1/58 • 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 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.
|
0.00%
0/144 • 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 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.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Congenital, familial and genetic disorders
Coarctation of the aorta
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
General disorders
Pyrexia
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
1.4%
2/144 • 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 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.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Investigations
Pulmonary arterial pressure increased
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Nervous system disorders
Syncope
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery stenosis
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Vascular disorders
Haematoma
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
Other adverse events
| Measure |
Main Treatment Period: Edoxaban
n=109 participants at risk
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.
|
Main Treatment Period: Standard of Care (SOC)
n=58 participants at risk
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.
|
Extension Period: Edoxaban Only
n=144 participants at risk
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.
|
|---|---|---|---|
|
Infections and infestations
Bronchitis
|
2.8%
3/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
2.1%
3/144 • 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 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.
|
|
General disorders
Pyrexia
|
4.6%
5/109 • 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 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.
|
1.7%
1/58 • 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 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.
|
9.0%
13/144 • 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 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
4/109 • 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 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.
|
3.4%
2/58 • 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 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.
|
6.2%
9/144 • 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 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.
|
|
Nervous system disorders
Headache
|
4.6%
5/109 • 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 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.
|
3.4%
2/58 • 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 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.
|
6.2%
9/144 • 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 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.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/109 • 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 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.
|
3.4%
2/58 • 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 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.
|
0.00%
0/144 • 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 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.
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/109 • 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 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.
|
3.4%
2/58 • 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 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.
|
0.00%
0/144 • 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 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
2/109 • 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 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.
|
3.4%
2/58 • 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 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.
|
4.9%
7/144 • 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 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.
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
4/109 • 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 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.
|
5.2%
3/58 • 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 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.
|
2.8%
4/144 • 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 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
3/109 • 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 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.
|
1.7%
1/58 • 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 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.
|
0.69%
1/144 • 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 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.
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
3/109 • 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 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.
|
3.4%
2/58 • 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 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.
|
4.2%
6/144 • 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 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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.8%
3/109 • 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 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.
|
3.4%
2/58 • 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 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.
|
4.2%
6/144 • 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 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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.7%
4/109 • 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 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.
|
1.7%
1/58 • 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 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.
|
2.1%
3/144 • 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 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.
|
|
Infections and infestations
Influenza
|
0.92%
1/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
3.5%
5/144 • 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 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.
|
|
Infections and infestations
Tonsillitis
|
1.8%
2/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
2.1%
3/144 • 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 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.
|
|
Infections and infestations
Viral infection
|
0.00%
0/109 • 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 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.
|
1.7%
1/58 • 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 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.
|
2.1%
3/144 • 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 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.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
2.1%
3/144 • 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 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.
|
|
Vascular disorders
Haematoma
|
0.00%
0/109 • 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 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.
|
0.00%
0/58 • 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 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.
|
3.5%
5/144 • 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 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.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/109 • 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 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.
|
3.4%
2/58 • 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 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.
|
0.00%
0/144 • 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 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place