Trial Outcomes & Findings for Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE) (NCT NCT02798471)
NCT ID: NCT02798471
Last Updated: 2025-02-28
Results Overview
Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
290 participants
Primary outcome timeframe
Randomization to Month 3
Results posted on
2025-02-28
Participant Flow
A total of 290 participants who met all inclusion criteria and no exclusion criteria were randomized to receive either edoxaban or standard of care treatment; 286 patients received at least 1 dose of study drug (modified intent-to-treat population).
Participant milestones
| Measure |
Edoxaban
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Overall Study
STARTED
|
147
|
143
|
|
Overall Study
Modified Intent-to-Treat Population
|
145
|
141
|
|
Overall Study
COMPLETED
|
128
|
119
|
|
Overall Study
NOT COMPLETED
|
19
|
24
|
Reasons for withdrawal
| Measure |
Edoxaban
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
2
|
|
Overall Study
Physician Decision
|
3
|
7
|
|
Overall Study
Death
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Other
|
5
|
3
|
|
Overall Study
Subject withdrew consent
|
0
|
6
|
|
Overall Study
Data entry error (reported as study completion and study discontinuation)
|
2
|
0
|
|
Overall Study
Randomized, but not treated
|
0
|
2
|
Baseline Characteristics
Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
Baseline characteristics by cohort
| Measure |
Edoxaban
n=147 Participants
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
n=143 Participants
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
Total
n=290 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
147 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
10.9 years
STANDARD_DEVIATION 5.99 • n=5 Participants
|
11.1 years
STANDARD_DEVIATION 6.03 • n=7 Participants
|
11.0 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
93 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
17 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
El Salvador
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Panama
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Guatemala
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
India
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Lebanon
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
9 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
13 participants
n=5 Participants
|
17 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to Month 3Population: Symptomatic recurrent VTE was assessed in the modified intent-to-treat population (mITT).
Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis.
Outcome measures
| Measure |
Edoxaban
n=145 Participants
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
n=141 Participants
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
|
5 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Randomization to Month 3Population: Death was assessed in the modified intent-to-treat population (mITT).
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out.
Outcome measures
| Measure |
Edoxaban
n=145 Participants
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
n=141 Participants
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Pulmonary embolism (PE) with or without deep vein thrombosis (DVT)
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Fatal PE
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Non-fatal PE
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Deep vein thrombosis (DVT) only
|
5 Participants
|
1 Participants
|
|
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Fatal DVT
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Non-fatal DVT
|
4 Participants
|
0 Participants
|
|
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Unexplained death which VTE cannot be ruled out
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Randomization to Month 3Population: Change in thrombotic burden was assessed in the modified intent-to-treat population (mITT).
No change or extension of thrombotic burden as assessed by quantitative diagnostic imaging of the index qualifying VTE thrombus at baseline and at Month 3. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA).
Outcome measures
| Measure |
Edoxaban
n=145 Participants
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
n=141 Participants
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Number of Participants With No Change or Extension of Thrombotic Burden During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
|
21 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: From randomization up to Month 12Population: Symptomatic VTE was assessed in the modified intent-to-treat (mITT) population.
Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis.
Outcome measures
| Measure |
Edoxaban
n=145 Participants
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
n=141 Participants
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Randomization to Month 3Population: Symptomatic recurrent VTE was assessed in the modified intent-to-treat population (mITT).
Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis.
Outcome measures
| Measure |
Edoxaban
n=145 Participants
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
n=141 Participants
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Number of Participants With Symptomatic Recurrent VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint)
Symptomatic VTE
|
4 Participants
|
1 Participants
|
|
Number of Participants With Symptomatic Recurrent VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint)
Pulmonary embolism (PE) with or without deep vein thrombosis (DVT)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Symptomatic Recurrent VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint)
Deep vein thrombosis (DVT) only
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From randomization up to Month 12Population: Death was assessed in the modified intent-to-treat population (mITT).
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out.
Outcome measures
| Measure |
Edoxaban
n=145 Participants
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
n=141 Participants
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Number of Participants Who Died as a Result of VTE During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Non-fatal PE
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Died as a Result of VTE During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Unexplained death which VTE cannot be ruled out
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Died as a Result of VTE During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Pulmonary embolism (PE) with or without deep vein thrombosis (DVT)
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Died as a Result of VTE During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Fatal PE
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died as a Result of VTE During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Deep vein thrombosis (DVT) only
|
6 Participants
|
1 Participants
|
|
Number of Participants Who Died as a Result of VTE During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Fatal DVT
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died as a Result of VTE During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Non-fatal DVT
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Randomization to Month 3Population: Death was assessed in the modified intent-to-treat population (mITT).
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out.
Outcome measures
| Measure |
Edoxaban
n=145 Participants
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
n=141 Participants
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint)
Death as a result of VTE
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint)
Unexplained death which VTE cannot be ruled out
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From randomization up to Month 12Population: Change in thrombotic burden was assessed in the modified intent-to-treat population (mITT).
No change or extension of thrombotic burden as assessed by quantitative diagnostic imaging of the index qualifying VTE thrombus. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA).
Outcome measures
| Measure |
Edoxaban
n=145 Participants
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
n=141 Participants
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Number of Participants With No Change or Extension of Thrombotic Burden During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
|
35 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Randomization to Month 3Population: Change in thrombotic burden was assessed in the modified intent-to-treat population (mITT).
Diagnosis of recurrent VTE requires the confirmation imaging and ≥1 symptom of VTE. Death from VTE is based on diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. No change or extension of thrombotic burden (quantitative diagnostic imaging) of the index qualifying VTE thrombus. Imaging criteria for VTE: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA).
Outcome measures
| Measure |
Edoxaban
n=145 Participants
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
n=141 Participants
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Number of Participants With Adjudicated Individual Component of Primary Efficacy Endpoints During the Main Treatment Period Following Edoxaban or Standard of Care Treatment
DVT only
|
4 Participants
|
0 Participants
|
|
Number of Participants With Adjudicated Individual Component of Primary Efficacy Endpoints During the Main Treatment Period Following Edoxaban or Standard of Care Treatment
Symptomatic recurrent VTE
|
4 Participants
|
1 Participants
|
|
Number of Participants With Adjudicated Individual Component of Primary Efficacy Endpoints During the Main Treatment Period Following Edoxaban or Standard of Care Treatment
PE with or without DVT
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adjudicated Individual Component of Primary Efficacy Endpoints During the Main Treatment Period Following Edoxaban or Standard of Care Treatment
Death as a result of VTE
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adjudicated Individual Component of Primary Efficacy Endpoints During the Main Treatment Period Following Edoxaban or Standard of Care Treatment
Unexplained death which VTE cannot be ruled out
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adjudicated Individual Component of Primary Efficacy Endpoints During the Main Treatment Period Following Edoxaban or Standard of Care Treatment
No change or extension of thrombotic burden
|
21 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: From randomization up to Month 12Population: All-cause mortality was assessed in the modified intent-to-treat (mITT) population.
All-cause mortality is defined as death due to any cause. Adjudicated data are reported for overall all-cause mortality, all-cause mortality by the primary cause of death, and primary cause of death further described by additional specifications.
Outcome measures
| Measure |
Edoxaban
n=145 Participants
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
n=141 Participants
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Number of Participants Reporting Adjudicated All-Cause Mortality During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated)
Other known causes of death: Other
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Adjudicated All-Cause Mortality During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated)
Other known causes of death: Infectious disease
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Adjudicated All-Cause Mortality During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated)
Participants with adjudicated all-cause mortality during treatment period
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting Adjudicated All-Cause Mortality During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated)
Participants with adjudicated all-cause mortality occurring after treatment period
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Adjudicated All-Cause Mortality During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated)
Venous thromboembolism (VTE)-related death
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Adjudicated All-Cause Mortality During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated)
Venous thromboembolism (VTE)-related death: Unexplained death which VTE cannot be ruled out
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Adjudicated All-Cause Mortality During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated)
Other known causes of death
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Adjudicated All-Cause Mortality During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated)
Other known causes of death: Cancer
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From randomization up to Month 12Population: Deep vein thrombosis, catheter-related thrombosis, sino-venous thrombosis, and pulmonary embolism were assessed in the modified intent-to-treat (mITT) population.
Deep vein thrombosis was assessed by ultrasonography or magnetic resonance venography (MRV), catheter-related thrombosis was assessed by ultrasonography or echocardiography, sino-venous thrombosis was assessed by brain MRI, and pulmonary embolism was assessed by nuclear ventilation/perfusion (V/Q) scanning.
Outcome measures
| Measure |
Edoxaban
n=145 Participants
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
n=141 Participants
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment
Main Treatment: Participants with cerebral sino-venous DVT thrombosis
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment
Main Treatment: Participants with PE with or without DVT
|
0 Participants
|
1 Participants
|
|
Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment
Overall Treatment: Participants with PE
|
1 Participants
|
1 Participants
|
|
Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment
Main Treatment: Participants with catheter-related thrombosis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment
Main Treatment: Participants with DVT only
|
4 Participants
|
0 Participants
|
|
Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment
Extension Treatment: Participants with DVT
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment
Extension Treatment: Participants with catheter-related thrombosis
|
0 Participants
|
0 Participants
|
|
Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment
Extension Treatment: Participants with sino-venous DVT thrombosis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment
Extension Treatment: Participants with PE
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment
Overall Treatment: Participants with DVT
|
5 Participants
|
0 Participants
|
|
Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment
Overall Treatment: Participants with catheter-related thrombosis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment
Overall Treatment: Participants with sino-venous DVT thrombosis
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Randomization to Month 3Population: Major and clinically relevant non-major bleeding events were assessed in the Safety Analysis Set.
Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug).
Outcome measures
| Measure |
Edoxaban
n=145 Participants
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
n=141 Participants
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From randomization up to Month 12Population: All bleeding events were assessed in the Safety Analysis Set.
All bleeding events included major bleeding defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells (RBCs), clinically relevant non-major bleeding defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug), nuisance bleeding, or a combination of bleeding events.
Outcome measures
| Measure |
Edoxaban
n=145 Participants
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
n=141 Participants
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Number of Participants With All Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
|
25 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: From randomization up to Month 12Population: Major and clinically relevant non-major bleeding events were assessed in the Safety Analysis Set.
Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug).
Outcome measures
| Measure |
Edoxaban
n=145 Participants
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
n=141 Participants
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
|
8 Participants
|
5 Participants
|
Adverse Events
Edoxaban
Serious events: 44 serious events
Other events: 51 other events
Deaths: 3 deaths
Standard of Care
Serious events: 37 serious events
Other events: 46 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Edoxaban
n=145 participants at risk
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
n=141 participants at risk
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Blood and lymphatic system disorders
Hypereosinophilic syndrome
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Blood and lymphatic system disorders
Sickle cell anemia
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
2/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
2.1%
3/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.1%
6/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
4.3%
6/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Cardiac disorders
Cardiogenic shock
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Congenital, familial and genetic disorders
Chronic granulomatous disease
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Eye disorders
Eyelid ptosis
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Eye disorders
Papilloedema
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Gastrointestinal disorders
Gastritis
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
2/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
1.4%
2/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
General disorders
Asthenia
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
General disorders
Medical device site rash
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
General disorders
Non-cardiac chest pain
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
General disorders
Pyrexia
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Hepatobiliary disorders
Liver disorder
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Bronchiolitis
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Device related infection
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Endocarditis
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Gastritis viral
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Influenza
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Paronychia
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Sepsis
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Subcutaneous abscess
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Urosepsis
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
1.4%
2/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Gastroenteritis
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
1.4%
2/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
1.4%
2/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
3/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Pneumonia
|
2.8%
4/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Injury, poisoning and procedural complications
Stoma complication
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Investigations
Liver function test increased
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Investigations
Platelet count decreased
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Metabolism and nutrition disorders
Lipoedema
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
1.4%
2/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Musculoskeletal and connective tissue disorders
Chest wall haematoma
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic astrocytoma
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Nervous system disorders
Idiopathic intracranial hypertension
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Nervous system disorders
Intracranial pressure increased
|
1.4%
2/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Nervous system disorders
Seizure
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
1.4%
2/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Nervous system disorders
Headache
|
1.4%
2/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
2.1%
3/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Psychiatric disorders
Psychiatric decompensation
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Psychiatric disorders
Suicidal ideation
|
1.4%
2/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Renal and urinary disorders
Urinary retention
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchomalacia
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiogenic pulmonary oedema
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
2/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Vascular disorders
Deep vein thrombosis
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Vascular disorders
Embolism venous
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Vascular disorders
Hypertension
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Vascular disorders
Peripheral embolism
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Vascular disorders
Post thrombotic syndrome
|
0.00%
0/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.71%
1/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Vascular disorders
Superior vena cava occlusion
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Vascular disorders
Venoocclusive disease
|
0.69%
1/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
0.00%
0/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
Other adverse events
| Measure |
Edoxaban
n=145 participants at risk
Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to \<18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age.
|
Standard of Care
n=141 participants at risk
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
11.0%
16/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
6.4%
9/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
General disorders
Pyrexia
|
8.3%
12/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
7.8%
11/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Nasopharyngitis
|
5.5%
8/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
2.1%
3/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
9/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
5.7%
8/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Nervous system disorders
Headache
|
13.8%
20/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
9.9%
14/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
12/145 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
7.1%
10/141 • Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place