Trial Outcomes & Findings for Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study (NCT NCT02303431)
NCT ID: NCT02303431
Last Updated: 2023-10-11
Results Overview
A model-based pooled population pharmacokinetic (PK) method was used to estimate systemic clearance (CL/F). As prespecified in the protocol, arms were pooled due to sparse PK samples being collected. the median PK estimate is reported in all participants at a total of 5 blood samplings.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
66 participants
Primary outcome timeframe
0.25 to 1 hours, 1.5 to 3 hours, 4 to 8 hours, 9 to 14 hours, and 24 to 36 hours post-dose
Results posted on
2023-10-11
Participant Flow
A total of 66 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study and received treatment at 32 clinical sites in the United States, Canada, France, India, Italy, Jordan, Lebanon, Spain, Turkey, and the United Kingdom.
Participants were asked to fast for at least 4 hours before dosing and for an additional 2 hours after dosing. If this was not feasible because of the participant's age or other needs, (unflavored) milk, or an equivalent substitute liquid (but not fruit juices), was allowed until 1 hour before and starting at 1 hour postdose (total volume of liquids not to exceed 240 mL).
Participant milestones
| Measure |
Cohort 1a: 30 mg Edoxaban
Participants who were 12 to \< 18 years of age and received a single-dose, oral tablet of 30 mg edoxaban.
|
Cohort 1b: 60 mg Edoxaban
Participants who were 12 to \< 18 years of age and received a single dose, oral tablet of 60 mg edoxaban.
|
Cohort 2a: 24 mg Edoxaban
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 24 mg edoxaban.
|
Cohort 2b: 45 mg Edoxaban
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 45 mg edoxaban.
|
Cohort 3a: 0.7 mg/kg Edoxaban
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 0.7 mg/kg (cap 24 mg) edoxaban.
|
Cohort 3b: 1.4 mg/kg Edoxaban
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 1.4 mg/kg (cap 45 mg) edoxaban.
|
Cohort 4a: 0.75 mg/kg Edoxaban
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 0.75 mg/kg edoxaban.
|
Cohort 4b: 1.5 mg/kg Edoxaban
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 1.5 mg/kg edoxaban.
|
Cohort 5a: 0.4 mg/kg Edoxaban
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.4 mg/kg edoxaban.
|
Cohort 5b: 0.8 mg/kg Edoxaban
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.8 mg/kg edoxaban.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
7
|
6
|
7
|
6
|
7
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
8
|
7
|
7
|
6
|
7
|
6
|
7
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study
Baseline characteristics by cohort
| Measure |
Cohort 1a: 30 mg Edoxaban
n=8 Participants
Participants who were 12 to \< 18 years of age and received a single-dose, oral tablet of 30 mg edoxaban.
|
Cohort 1b: 60 mg Edoxaban
n=7 Participants
Participants who were 12 to \< 18 years of age and received a single dose, oral tablet of 60 mg edoxaban.
|
Cohort 2a: 24 mg Edoxaban
n=7 Participants
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 24 mg edoxaban.
|
Cohort 2b: 45 mg Edoxaban
n=6 Participants
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 45 mg edoxaban.
|
Cohort 3a: 0.7 mg/kg Edoxaban
n=7 Participants
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 0.7 mg/kg (cap 24 mg) edoxaban.
|
Cohort 3b: 1.4 mg/kg Edoxaban
n=6 Participants
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 1.4 mg/kg (cap 45 mg) edoxaban.
|
Cohort 4a: 0.75 mg/kg Edoxaban
n=7 Participants
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 0.75 mg/kg edoxaban.
|
Cohort 4b: 1.5 mg/kg Edoxaban
n=6 Participants
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 1.5 mg/kg edoxaban.
|
Cohort 5a: 0.4 mg/kg Edoxaban
n=6 Participants
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.4 mg/kg edoxaban.
|
Cohort 5b: 0.8 mg/kg Edoxaban
n=6 Participants
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.8 mg/kg edoxaban.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Age, Continuous
|
15.9 years
STANDARD_DEVIATION 1.1 • n=93 Participants
|
15.3 years
STANDARD_DEVIATION 1.3 • n=4 Participants
|
9.6 years
STANDARD_DEVIATION 1.1 • n=27 Participants
|
9.5 years
STANDARD_DEVIATION 1.9 • n=483 Participants
|
4.3 years
STANDARD_DEVIATION 1.6 • n=36 Participants
|
4.3 years
STANDARD_DEVIATION 1.4 • n=10 Participants
|
1.2 years
STANDARD_DEVIATION 0.5 • n=115 Participants
|
1.0 years
STANDARD_DEVIATION 0.5 • n=40 Participants
|
0.2 years
STANDARD_DEVIATION 0.2 • n=8 Participants
|
0.3 years
STANDARD_DEVIATION 0.2 • n=62 Participants
|
6.5 years
STANDARD_DEVIATION 6.0 • n=95 Participants
|
|
Age, Categorical
<=18 years
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
6 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=62 Participants
|
66 Participants
n=95 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
31 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
35 Participants
n=95 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
11 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
10 Participants
n=95 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=62 Participants
|
43 Participants
n=95 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
PRIMARY outcome
Timeframe: 0.25 to 1 hours, 1.5 to 3 hours, 4 to 8 hours, 9 to 14 hours, and 24 to 36 hours post-dosePopulation: Pharmacokinetic parameters were assessed in the Population Pharmacokinetic (PopPK) Analysis Set. As prespecified in the study protocol, PK parameters were reported from the pooled PopPK dataset in order to support dose determination in the ongoing Phase 3 DU176b-A-U312. The current pooled PopPK dataset included participants who were newborn to \<18 years of age (Cohort 1 to 5) as reported in the table.
A model-based pooled population pharmacokinetic (PK) method was used to estimate systemic clearance (CL/F). As prespecified in the protocol, arms were pooled due to sparse PK samples being collected. the median PK estimate is reported in all participants at a total of 5 blood samplings.
Outcome measures
| Measure |
All Participants
n=64 Participants
All participants included in the study (Cohorts 1a, 1b, 2a, 2b, 3a, 3b, 4a, 4b, 5a, and 5b).
|
Cohort 1b: 60 mg Edoxaban
Participants who were 12 to \< 18 years of age and received a single dose, oral tablet of 60 mg edoxaban.
|
Cohort 2a: 24 mg Edoxaban
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 24 mg edoxaban.
|
Cohort 2b: 45 mg Edoxaban
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 45 mg edoxaban.
|
Cohort 3a: 0.7 mg/kg Edoxaban
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 0.7 mg/kg (cap 24 mg) edoxaban.
|
Cohort 3b: 1.4 mg/kg Edoxaban
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 1.4 mg/kg (cap 45 mg) edoxaban.
|
Cohort 4a: 0.75 mg/kg Edoxaban
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 0.75 mg/kg edoxaban.
|
Cohort 4b: 1.5 mg/kg Edoxaban
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 1.5 mg/kg edoxaban.
|
Cohort 5a: 0.4 mg/kg Edoxaban
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.4 mg/kg edoxaban.
|
Cohort 5b: 0.8 mg/kg Edoxaban
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.8 mg/kg edoxaban.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter of Apparent Systemic Clearance (CL/F)
|
42.9 L/h
Interval 40.3 to 45.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 0.25 to 1 hours, 1.5 to 3 hours, 4 to 8 hours, 9 to 14 hours, and 24 to 36 hours post-dosePopulation: Pharmacokinetic parameters were assessed in the Population Pharmacokinetic (PopPK) Analysis Set. As prespecified in the study protocol, PK parameters were reported from the pooled PopPK dataset in order to support dose determination in the ongoing Phase 3 DU176b-A-U312. The current pooled PopPK dataset included participants who were newborn to \<18 years of age (Cohort 1 to 5) as reported in the table.
A model-based pooled population pharmacokinetic (PK) method was used to estimate apparent volume of distribution (V/F). As prespecified in the protocol, arms were pooled due to sparse PK samples being collected. the median PK estimate is reported in all participants at a total of 5 blood samplings.
Outcome measures
| Measure |
All Participants
n=64 Participants
All participants included in the study (Cohorts 1a, 1b, 2a, 2b, 3a, 3b, 4a, 4b, 5a, and 5b).
|
Cohort 1b: 60 mg Edoxaban
Participants who were 12 to \< 18 years of age and received a single dose, oral tablet of 60 mg edoxaban.
|
Cohort 2a: 24 mg Edoxaban
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 24 mg edoxaban.
|
Cohort 2b: 45 mg Edoxaban
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 45 mg edoxaban.
|
Cohort 3a: 0.7 mg/kg Edoxaban
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 0.7 mg/kg (cap 24 mg) edoxaban.
|
Cohort 3b: 1.4 mg/kg Edoxaban
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 1.4 mg/kg (cap 45 mg) edoxaban.
|
Cohort 4a: 0.75 mg/kg Edoxaban
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 0.75 mg/kg edoxaban.
|
Cohort 4b: 1.5 mg/kg Edoxaban
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 1.5 mg/kg edoxaban.
|
Cohort 5a: 0.4 mg/kg Edoxaban
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.4 mg/kg edoxaban.
|
Cohort 5b: 0.8 mg/kg Edoxaban
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.8 mg/kg edoxaban.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameter of Apparent Volume of Distribution (V/F)
|
198 Liters
Interval 180.0 to 219.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25 to 1 hours (except for Cohorts 4a, 4b, 5a, and 5b, 0.5 to 2 hours), 1.5 to 3 hours, 4 to 8 hours, 9 to 14 hours, and 24 to 36 hours post-dosePopulation: Pharmacodynamic (PD) parameters were assessed in participants with available data in the Pharmacodynamic Analysis Set. PD data were not assessed at certain timepoints due to patients not being available for the analysis (ie, indicated by rows with 0 participants at certain timepoints). In addition, standard deviation was not calculated for rows with just 1 participant in the analysis; data are reported for the timepoints in which data were collected.
Descriptive statistics were used to assess Mean Prothrombin Time (PT) by cohort at a total of 6 blood samplings.
Outcome measures
| Measure |
All Participants
n=7 Participants
All participants included in the study (Cohorts 1a, 1b, 2a, 2b, 3a, 3b, 4a, 4b, 5a, and 5b).
|
Cohort 1b: 60 mg Edoxaban
n=7 Participants
Participants who were 12 to \< 18 years of age and received a single dose, oral tablet of 60 mg edoxaban.
|
Cohort 2a: 24 mg Edoxaban
n=6 Participants
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 24 mg edoxaban.
|
Cohort 2b: 45 mg Edoxaban
n=5 Participants
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 45 mg edoxaban.
|
Cohort 3a: 0.7 mg/kg Edoxaban
n=6 Participants
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 0.7 mg/kg (cap 24 mg) edoxaban.
|
Cohort 3b: 1.4 mg/kg Edoxaban
n=4 Participants
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 1.4 mg/kg (cap 45 mg) edoxaban.
|
Cohort 4a: 0.75 mg/kg Edoxaban
n=4 Participants
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 0.75 mg/kg edoxaban.
|
Cohort 4b: 1.5 mg/kg Edoxaban
n=4 Participants
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 1.5 mg/kg edoxaban.
|
Cohort 5a: 0.4 mg/kg Edoxaban
n=6 Participants
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.4 mg/kg edoxaban.
|
Cohort 5b: 0.8 mg/kg Edoxaban
n=5 Participants
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.8 mg/kg edoxaban.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic Parameter Mean Prothrombin Time (PT)
Pre-dose: 0.25 to 1 hours
|
13.3 seconds
Standard Deviation 1.1
|
13.5 seconds
Standard Deviation 0.5
|
14.0 seconds
Standard Deviation 0.4
|
13.9 seconds
Standard Deviation 0.5
|
14.6 seconds
Standard Deviation 1.3
|
13.7 seconds
Standard Deviation 0.5
|
13.6 seconds
Standard Deviation 0.7
|
13.8 seconds
Standard Deviation 1.6
|
16.3 seconds
Standard Deviation 4.0
|
15.3 seconds
Standard Deviation 1.8
|
|
Pharmacodynamic Parameter Mean Prothrombin Time (PT)
Post-dose: 0.25 to 1 hours
|
15.0 seconds
Standard Deviation 1.8
|
17.3 seconds
Standard Deviation 4.1
|
19.1 seconds
Standard Deviation 3.1
|
21.3 seconds
Standard Deviation 7.0
|
18.7 seconds
Standard Deviation 2.0
|
22.0 seconds
Standard Deviation 0.8
|
21.4 seconds
Standard Deviation 2.4
|
26.5 seconds
Standard Deviation 7.6
|
18.3 seconds
Standard Deviation 3.0
|
21.8 seconds
Standard Deviation 4.1
|
|
Pharmacodynamic Parameter Mean Prothrombin Time (PT)
Pre-dose: 1.5 to 3 hours
|
13.3 seconds
Standard Deviation 1.0
|
13.5 seconds
Standard Deviation 0.5
|
14.0 seconds
Standard Deviation 0.4
|
14.9 seconds
Standard Deviation 2.2
|
14.7 seconds
Standard Deviation 1.3
|
13.7 seconds
Standard Deviation 0.5
|
14.3 seconds
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Prothrombin Time (PT)
Post-dose: 1.5 to 3 hours
|
17.6 seconds
Standard Deviation 2.5
|
23.0 seconds
Standard Deviation 3.8
|
26.8 seconds
Standard Deviation 14.9
|
25.3 seconds
Standard Deviation 5.9
|
21.0 seconds
Standard Deviation 2.5
|
21.3 seconds
Standard Deviation 2.3
|
20.0 seconds
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Prothrombin Time (PT)
Pre-dose: 3.5 to 6 hours
|
13.4 seconds
Standard Deviation 1.1
|
13.6 seconds
Standard Deviation 0.6
|
13.4 seconds
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Prothrombin Time (PT)
Post-dose: 3.5 to 6 hours
|
17.9 seconds
Standard Deviation 4.6
|
20.1 seconds
Standard Deviation 2.0
|
16.5 seconds
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Prothrombin Time (PT)
Pre-dose: 4 to 8 hours
|
12.9 seconds
|
13.4 seconds
Standard Deviation 0.1
|
14.2 seconds
Standard Deviation 0.2
|
13.9 seconds
Standard Deviation 0.5
|
14.7 seconds
Standard Deviation 1.3
|
13.7 seconds
Standard Deviation 0.5
|
14.3 seconds
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Prothrombin Time (PT)
Post-dose: 4 to 8 hours
|
15.9 seconds
|
17.5 seconds
Standard Deviation 2.3
|
17.9 seconds
Standard Deviation 1.3
|
18.0 seconds
Standard Deviation 2.2
|
17.3 seconds
Standard Deviation 0.8
|
16.1 seconds
Standard Deviation 2.0
|
17.4 seconds
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Prothrombin Time (PT)
Pre-dose: 6.5 to 8 hours
|
13.4 seconds
Standard Deviation 1.1
|
13.6 seconds
Standard Deviation 0.7
|
13.7 seconds
Standard Deviation 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Prothrombin Time (PT)
Post-dose: 6.5 to 8 hours
|
14.7 seconds
Standard Deviation 1.4
|
16.7 seconds
Standard Deviation 1.5
|
15.8 seconds
Standard Deviation 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Prothrombin Time (PT)
Pre-dose: 9 to 14 hours
|
12.9 seconds
|
13.4 seconds
Standard Deviation 0.1
|
14.4 seconds
Standard Deviation 0.5
|
14.9 seconds
Standard Deviation 2.2
|
14.7 seconds
Standard Deviation 1.3
|
13.7 seconds
Standard Deviation 0.5
|
14.3 seconds
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Prothrombin Time (PT)
Post-dose: 9 to 14 hours
|
13.9 seconds
|
15.9 seconds
Standard Deviation 1.6
|
15.8 seconds
Standard Deviation 1.1
|
17.7 seconds
Standard Deviation 5.1
|
16.1 seconds
Standard Deviation 1.2
|
16.0 seconds
Standard Deviation 2.5
|
16.7 seconds
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Prothrombin Time (PT)
Pre-dose: 24 to 36 hours
|
13.4 seconds
Standard Deviation 1.1
|
13.5 seconds
Standard Deviation 0.5
|
14.2 seconds
Standard Deviation 0.5
|
13.9 seconds
Standard Deviation 0.5
|
14.7 seconds
Standard Deviation 1.3
|
13.7 seconds
Standard Deviation 0.5
|
14.3 seconds
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Prothrombin Time (PT)
Post-dose: 24 to 36 hours
|
13.1 seconds
Standard Deviation 1.0
|
13.8 seconds
Standard Deviation 0.7
|
14.5 seconds
Standard Deviation 0.6
|
14.5 seconds
Standard Deviation 0.9
|
15.5 seconds
Standard Deviation 0.9
|
14.9 seconds
Standard Deviation 1.1
|
14.1 seconds
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25 to 1 hours (except for Cohorts 4a, 4b, 5a, and 5b, 0.5 to 2 hours), 1.5 to 3 hours, 4 to 8 hours, 9 to 14 hours, and 24 to 36 hours post-dosePopulation: Pharmacodynamic (PD) parameters were assessed in participants with available data in the Pharmacodynamic Analysis Set. PD data were not assessed at certain timepoints due to patients not being available for the analysis (ie, indicated by rows with 0 participants at certain timepoints). In addition, standard deviation was not calculated for rows with just 1 participant in the analysis; data are reported for the timepoints in which data were collected.
Descriptive statistics were used to assess Mean Activated Partial Thromboplastin Time by cohort for a total of 6 blood samplings.
Outcome measures
| Measure |
All Participants
n=7 Participants
All participants included in the study (Cohorts 1a, 1b, 2a, 2b, 3a, 3b, 4a, 4b, 5a, and 5b).
|
Cohort 1b: 60 mg Edoxaban
n=7 Participants
Participants who were 12 to \< 18 years of age and received a single dose, oral tablet of 60 mg edoxaban.
|
Cohort 2a: 24 mg Edoxaban
n=5 Participants
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 24 mg edoxaban.
|
Cohort 2b: 45 mg Edoxaban
n=5 Participants
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 45 mg edoxaban.
|
Cohort 3a: 0.7 mg/kg Edoxaban
n=6 Participants
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 0.7 mg/kg (cap 24 mg) edoxaban.
|
Cohort 3b: 1.4 mg/kg Edoxaban
n=4 Participants
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 1.4 mg/kg (cap 45 mg) edoxaban.
|
Cohort 4a: 0.75 mg/kg Edoxaban
n=4 Participants
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 0.75 mg/kg edoxaban.
|
Cohort 4b: 1.5 mg/kg Edoxaban
n=4 Participants
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 1.5 mg/kg edoxaban.
|
Cohort 5a: 0.4 mg/kg Edoxaban
n=6 Participants
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.4 mg/kg edoxaban.
|
Cohort 5b: 0.8 mg/kg Edoxaban
n=5 Participants
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.8 mg/kg edoxaban.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic Parameter Mean Activated Partial Thromboplastin Time (aPTT)
Pre-dose: 0.25 to 1 hours
|
24.1 seconds
Standard Deviation 1.5
|
26.0 seconds
Standard Deviation 1.6
|
33.9 seconds
Standard Deviation 6.4
|
32.7 seconds
Standard Deviation 2.8
|
34.3 seconds
Standard Deviation 4.1
|
40.7 seconds
Standard Deviation 21.0
|
32.9 seconds
Standard Deviation 5.3
|
34.9 seconds
Standard Deviation 8.2
|
41.0 seconds
Standard Deviation 17.9
|
47.7 seconds
Standard Deviation 13.0
|
|
Pharmacodynamic Parameter Mean Activated Partial Thromboplastin Time (aPTT)
Post-dose: 0.25 to 1 hours
|
26.6 seconds
Standard Deviation 2.0
|
28.4 seconds
Standard Deviation 4.8
|
57.9 seconds
Standard Deviation 26.3
|
42.4 seconds
Standard Deviation 9.9
|
39.4 seconds
Standard Deviation 6.4
|
45.3 seconds
Standard Deviation 20.1
|
45.4 seconds
Standard Deviation 6.3
|
46.0 seconds
Standard Deviation 10.9
|
39.5 seconds
Standard Deviation 3.8
|
52.6 seconds
Standard Deviation 18.1
|
|
Pharmacodynamic Parameter Mean Activated Partial Thromboplastin Time (aPTT)
Pre-dose: 1.5 to 3 hours
|
24.1 seconds
Standard Deviation 1.4
|
26.0 seconds
Standard Deviation 1.6
|
34.6 seconds
Standard Deviation 5.8
|
32.7 seconds
Standard Deviation 2.8
|
30.10 seconds
Standard Deviation 7.2
|
40.7 seconds
Standard Deviation 21.0
|
37.4 seconds
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Activated Partial Thromboplastin Time (aPTT)
Post-dose: 1.5 to 3 hours
|
27.7 seconds
Standard Deviation 1.1
|
32.8 seconds
Standard Deviation 3.0
|
62.5 seconds
Standard Deviation 35.7
|
43.0 seconds
Standard Deviation 3.9
|
38.1 seconds
Standard Deviation 8.9
|
45.5 seconds
Standard Deviation 7.9
|
40.9 seconds
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Activated Partial Thromboplastin Time (aPTT)
Pre-dose: 3.5 to 6 hours
|
23.8 seconds
Standard Deviation 1.1
|
26.1 seconds
Standard Deviation 1.9
|
32.2 seconds
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Activated Partial Thromboplastin Time (aPTT)
Post-dose: 3.5 to 6 hours
|
26.9 seconds
Standard Deviation 1.4
|
30.8 seconds
Standard Deviation 1.5
|
39.0 seconds
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Activated Partial Thromboplastin Time (aPTT)
Pre-dose: 4 to 8 hours
|
26.2 seconds
|
25.5 seconds
Standard Deviation 0.7
|
33.9 seconds
Standard Deviation 6.4
|
32.8 seconds
Standard Deviation 3.2
|
30.1 seconds
Standard Deviation 7.2
|
40.7 seconds
Standard Deviation 21.0
|
37.4 seconds
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Activated Partial Thromboplastin Time (aPTT)
Post-dose: 4 to 8 hours
|
24.4 seconds
|
28.9 seconds
Standard Deviation 1.0
|
35.5 seconds
Standard Deviation 4.9
|
38.8 seconds
Standard Deviation 5.7
|
36.7 seconds
Standard Deviation 10.1
|
35.7 seconds
Standard Deviation 4.6
|
35.8 seconds
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Activated Partial Thromboplastin Time (aPTT)
Pre-dose: 6.5 to 8 hours
|
23.8 seconds
Standard Deviation 1.1
|
26.7 seconds
Standard Deviation 1.7
|
32.2 seconds
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Activated Partial Thromboplastin Time (aPTT)
Post-dose: 6.5 to 8 hours
|
26.4 seconds
Standard Deviation 1.2
|
30.2 seconds
Standard Deviation 2.3
|
34.5 seconds
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Activated Partial Thromboplastin Time (aPTT)
Pre-dose: 9 to 14 hours
|
26.2 seconds
|
25.5 seconds
Standard Deviation 0.7
|
35.8 seconds
Standard Deviation 7.6
|
32.7 seconds
Standard Deviation 2.8
|
30.1 seconds
Standard Deviation 7.2
|
40.7 seconds
Standard Deviation 21.0
|
37.4 seconds
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Activated Partial Thromboplastin Time (aPTT)
Post-dose: 9 to 14 hours
|
23.7 seconds
|
27.7 seconds
Standard Deviation 0.3
|
35.3 seconds
Standard Deviation 2.8
|
35.9 seconds
Standard Deviation 5.7
|
33.8 seconds
Standard Deviation 7.4
|
35.1 seconds
Standard Deviation 7.3
|
35.0 seconds
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Activated Partial Thromboplastin Time (aPTT)
Pre-dose: 24 to 36 hours
|
24.4 seconds
Standard Deviation 1.3
|
26.0 seconds
Standard Deviation 1.6
|
32.0 seconds
Standard Deviation 5.6
|
32.7 seconds
Standard Deviation 2.8
|
29.9 seconds
Standard Deviation 8.1
|
40.7 seconds
Standard Deviation 21.0
|
37.4 seconds
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Activated Partial Thromboplastin Time (aPTT)
Post-dose: 24 to 36 hours
|
24.8 seconds
Standard Deviation 0.9
|
25.8 seconds
Standard Deviation 1.9
|
29.0 seconds
Standard Deviation 2.2
|
38.2 seconds
Standard Deviation 10.7
|
32.9 seconds
Standard Deviation 5.2
|
86.1 seconds
Standard Deviation 112.6
|
32.5 seconds
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and 0.25 to 1 hours (except for Cohorts 4a, 4b, 5a, and 5b, 0.5 to 2 hours), 1.5 to 3 hours, 4 to 8 hours, 9 to 14 hours, and 24 to 36 hours post-dosePopulation: Pharmacodynamic (PD) parameters were assessed in participants with available data in the Pharmacodynamic Analysis Set. PD data were not assessed at certain timepoints due to patients not being available for the analysis (ie, indicated by rows with 0 participants at certain timepoints). In addition, standard deviation was not calculated for rows with just 1 participant in the analysis; data are reported for the timepoints in which data were collected.
Descriptive statistics were used to assess Mean Anti-Factor Xa (FXa) by cohort for a total of 6 blood samplings.
Outcome measures
| Measure |
All Participants
n=7 Participants
All participants included in the study (Cohorts 1a, 1b, 2a, 2b, 3a, 3b, 4a, 4b, 5a, and 5b).
|
Cohort 1b: 60 mg Edoxaban
n=7 Participants
Participants who were 12 to \< 18 years of age and received a single dose, oral tablet of 60 mg edoxaban.
|
Cohort 2a: 24 mg Edoxaban
n=5 Participants
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 24 mg edoxaban.
|
Cohort 2b: 45 mg Edoxaban
n=5 Participants
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 45 mg edoxaban.
|
Cohort 3a: 0.7 mg/kg Edoxaban
n=6 Participants
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 0.7 mg/kg (cap 24 mg) edoxaban.
|
Cohort 3b: 1.4 mg/kg Edoxaban
n=5 Participants
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 1.4 mg/kg (cap 45 mg) edoxaban.
|
Cohort 4a: 0.75 mg/kg Edoxaban
n=4 Participants
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 0.75 mg/kg edoxaban.
|
Cohort 4b: 1.5 mg/kg Edoxaban
n=4 Participants
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 1.5 mg/kg edoxaban.
|
Cohort 5a: 0.4 mg/kg Edoxaban
n=6 Participants
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.4 mg/kg edoxaban.
|
Cohort 5b: 0.8 mg/kg Edoxaban
n=5 Participants
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.8 mg/kg edoxaban.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamic Parameter Mean Anti-Factor Xa (FXa)
Pre-dose: 3.5 to 6 hours
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Anti-Factor Xa (FXa)
Post-dose: 3.5 to 6 hours
|
0.9 IU/mL
Standard Deviation 0.4
|
1.7 IU/mL
Standard Deviation 0.4
|
1.4 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Anti-Factor Xa (FXa)
Pre-dose: 24 to 36 hours
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.1
|
0.1 IU/mL
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Anti-Factor Xa (FXa)
Post-dose: 24 to 36 hours
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.1
|
0.1 IU/mL
Standard Deviation 0.0
|
0.2 IU/mL
Standard Deviation 0.1
|
0.3 IU/mL
Standard Deviation 0.5
|
0.4 IU/mL
Standard Deviation 0.7
|
0.1 IU/mL
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Anti-Factor Xa (FXa)
Pre-dose: 0.25 to 1 hours
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.1
|
0.1 IU/mL
Standard Deviation 0.0
|
0.5 IU/mL
Standard Deviation 0.3
|
0.1 IU/mL
Standard Deviation 0.1
|
0.4 IU/mL
Standard Deviation 0.4
|
|
Pharmacodynamic Parameter Mean Anti-Factor Xa (FXa)
Post-dose: 0.25 to 1 hours
|
0.5 IU/mL
Standard Deviation 0.4
|
1.0 IU/mL
Standard Deviation 1.0
|
1.8 IU/mL
Standard Deviation 0.3
|
1.6 IU/mL
Standard Deviation 0.8
|
1.2 IU/mL
Standard Deviation 0.6
|
1.9 IU/mL
Standard Deviation 0.2
|
2.0 IU/mL
Standard Deviation 0.0
|
2.0 IU/mL
Standard Deviation 0.0
|
1.1 IU/mL
Standard Deviation 0.8
|
1.7 IU/mL
Standard Deviation 0.7
|
|
Pharmacodynamic Parameter Mean Anti-Factor Xa (FXa)
Pre-dose: 1.5 to 3 hours
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.1
|
0.1 IU/mL
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Anti-Factor Xa (FXa)
Post-dose: 1.5 to 3 hours
|
1.3 IU/mL
Standard Deviation 0.4
|
2.6 IU/mL
Standard Deviation 1.0
|
1.3 IU/mL
Standard Deviation 0.7
|
1.9 IU/mL
Standard Deviation 0.1
|
1.7 IU/mL
Standard Deviation 0.3
|
1.9 IU/mL
Standard Deviation 0.2
|
2.0 IU/mL
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Anti-Factor Xa (FXa)
Pre-dose: 4 to 8 hours
|
0.1 IU/mL
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.1
|
0.1 IU/mL
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Anti-Factor Xa (FXa)
Post-dose: 4 to 8 hours
|
1.0 IU/mL
|
1.2 IU/mL
Standard Deviation 0.7
|
0.8 IU/mL
Standard Deviation 0.3
|
1.5 IU/mL
Standard Deviation 0.3
|
0.7 IU/mL
Standard Deviation 0.2
|
0.8 IU/mL
Standard Deviation 0.6
|
1.2 IU/mL
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Anti-Factor Xa (FXa)
Pre-dose: 6.5 to 8 hours
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Anti-Factor Xa (FXa)
Post-dose: 6.5 to 8 hours
|
0.4 IU/mL
Standard Deviation 0.1
|
0.9 IU/mL
Standard Deviation 0.4
|
0.8 IU/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Anti-Factor Xa (FXa)
Pre-dose: 9 to 14 hours
|
0.1 IU/mL
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.0
|
0.1 IU/mL
Standard Deviation 0.1
|
0.1 IU/mL
|
—
|
—
|
—
|
|
Pharmacodynamic Parameter Mean Anti-Factor Xa (FXa)
Post-dose: 9 to 14 hours
|
0.4 IU/mL
|
0.6 IU/mL
Standard Deviation 0.3
|
0.3 IU/mL
Standard Deviation 0.1
|
0.8 IU/mL
Standard Deviation 0.5
|
0.2 IU/mL
Standard Deviation 0.1
|
0.4 IU/mL
Standard Deviation 0.2
|
0.3 IU/mL
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 30 minutes post-dosePopulation: Palatability scores were assessed in patients who received an oral suspension of edoxaban.
Overall palatability, bitterness, sweetness, and overall taste or aroma were assessed by participants (or guardians) receiving the liquid oral suspension where each subscale used a 100 mm visual analog scale (VAS), where a 0 score corresponded to a sad face and indicated a low palatability, bitter (sharp, pungent taste or smell), not sweet, and no aroma score (eg, patients not pleased; worse outcome in terms of palatability) and a 100 score corresponded to a happy face and indicated a high palatability, not bitter, very sweet, very tasty, and high aroma score (eg, patients were pleased; best outcome in terms of palatability). Patients who were old enough scored the VAS themselves. For younger children, the parents provided this information, if possible. For the youngest children, there was free text input available to provide information on whether the patient spat it out or may not have liked the flavor, etc.
Outcome measures
| Measure |
All Participants
n=7 Participants
All participants included in the study (Cohorts 1a, 1b, 2a, 2b, 3a, 3b, 4a, 4b, 5a, and 5b).
|
Cohort 1b: 60 mg Edoxaban
n=6 Participants
Participants who were 12 to \< 18 years of age and received a single dose, oral tablet of 60 mg edoxaban.
|
Cohort 2a: 24 mg Edoxaban
n=7 Participants
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 24 mg edoxaban.
|
Cohort 2b: 45 mg Edoxaban
n=6 Participants
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 45 mg edoxaban.
|
Cohort 3a: 0.7 mg/kg Edoxaban
n=7 Participants
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 0.7 mg/kg (cap 24 mg) edoxaban.
|
Cohort 3b: 1.4 mg/kg Edoxaban
n=6 Participants
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 1.4 mg/kg (cap 45 mg) edoxaban.
|
Cohort 4a: 0.75 mg/kg Edoxaban
n=6 Participants
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 0.75 mg/kg edoxaban.
|
Cohort 4b: 1.5 mg/kg Edoxaban
n=6 Participants
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 1.5 mg/kg edoxaban.
|
Cohort 5a: 0.4 mg/kg Edoxaban
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.4 mg/kg edoxaban.
|
Cohort 5b: 0.8 mg/kg Edoxaban
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.8 mg/kg edoxaban.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Palatability Score for the Liquid Formulation on a 100 mm Visual Analog Scale (VAS)
Overall palatability
|
53.6 mm
Standard Deviation 35.8
|
63.2 mm
Standard Deviation 48.9
|
55.3 mm
Standard Deviation 40.6
|
83.3 mm
Standard Deviation 20.4
|
77.3 mm
Standard Deviation 27.7
|
73.0 mm
Standard Deviation 22.9
|
67.3 mm
Standard Deviation 18.4
|
83.2 mm
Standard Deviation 14.1
|
—
|
—
|
|
Mean Palatability Score for the Liquid Formulation on a 100 mm Visual Analog Scale (VAS)
Bitterness
|
66.1 mm
Standard Deviation 44.5
|
53.2 mm
Standard Deviation 46.3
|
40.6 mm
Standard Deviation 43.5
|
66.7 mm
Standard Deviation 37.6
|
77.5 mm
Standard Deviation 27.2
|
36.3 mm
Standard Deviation 41.2
|
47.0 mm
Standard Deviation 32.6
|
65.7 mm
Standard Deviation 36.8
|
—
|
—
|
|
Mean Palatability Score for the Liquid Formulation on a 100 mm Visual Analog Scale (VAS)
Sweetness
|
39.1 mm
Standard Deviation 34.9
|
54.3 mm
Standard Deviation 36.9
|
65.9 mm
Standard Deviation 42.1
|
81.7 mm
Standard Deviation 21.6
|
86.2 mm
Standard Deviation 26.1
|
76.2 mm
Standard Deviation 20.2
|
68.5 mm
Standard Deviation 19.0
|
86.0 mm
Standard Deviation 13.3
|
—
|
—
|
|
Mean Palatability Score for the Liquid Formulation on a 100 mm Visual Analog Scale (VAS)
Overall taste
|
57.9 mm
Standard Deviation 42.3
|
78.2 mm
Standard Deviation 43.2
|
62.6 mm
Standard Deviation 44.9
|
83.3 mm
Standard Deviation 25.8
|
82.8 mm
Standard Deviation 24.3
|
80.5 mm
Standard Deviation 10.0
|
70.8 mm
Standard Deviation 17.0
|
85.2 mm
Standard Deviation 11.2
|
—
|
—
|
|
Mean Palatability Score for the Liquid Formulation on a 100 mm Visual Analog Scale (VAS)
Aroma
|
53.4 mm
Standard Deviation 38.4
|
57.7 mm
Standard Deviation 34.00
|
58.7 mm
Standard Deviation 39.5
|
75.0 mm
Standard Deviation 27.4
|
84.5 mm
Standard Deviation 23.9
|
72.3 mm
Standard Deviation 19.7
|
73.2 mm
Standard Deviation 13.9
|
74.2 mm
Standard Deviation 23.3
|
—
|
—
|
Adverse Events
Cohort 1a: 30 mg Edoxaban
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 1b: 60 mg Edoxaban
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2a: 24 mg Edoxaban
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2b: 45 mg Edoxaban
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3a: 0.7 mg/kg Edoxaban
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3b: 1.4 mg/kg Edoxaban
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4a: 0.75 mg/kg Edoxaban
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4b: 1.5 mg/kg Edoxaban
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5a: 0.4 mg/kg Edoxaban
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5b: 0.8 mg/kg Edoxaban
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1a: 30 mg Edoxaban
n=8 participants at risk
Participants who were 12 to \< 18 years of age and received a single-dose, oral tablet of 30 mg edoxaban.
|
Cohort 1b: 60 mg Edoxaban
n=7 participants at risk
Participants who were 12 to \< 18 years of age and received a single dose, oral tablet of 60 mg edoxaban.
|
Cohort 2a: 24 mg Edoxaban
n=7 participants at risk
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 24 mg edoxaban.
|
Cohort 2b: 45 mg Edoxaban
n=6 participants at risk
Participants who were 6 to \< 12 years of age and received a single dose, oral suspension of 45 mg edoxaban.
|
Cohort 3a: 0.7 mg/kg Edoxaban
n=7 participants at risk
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 0.7 mg/kg (cap 24 mg) edoxaban.
|
Cohort 3b: 1.4 mg/kg Edoxaban
n=6 participants at risk
Participants who were 2 to \< 6 years of age and received a single dose, oral suspension of 1.4 mg/kg (cap 45 mg) edoxaban.
|
Cohort 4a: 0.75 mg/kg Edoxaban
n=7 participants at risk
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 0.75 mg/kg edoxaban.
|
Cohort 4b: 1.5 mg/kg Edoxaban
n=6 participants at risk
Participants who were 6 months to \<2 years of age and received a single dose, oral suspension of 1.5 mg/kg edoxaban.
|
Cohort 5a: 0.4 mg/kg Edoxaban
n=6 participants at risk
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.4 mg/kg edoxaban.
|
Cohort 5b: 0.8 mg/kg Edoxaban
n=6 participants at risk
Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.8 mg/kg edoxaban.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
28.6%
2/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
|
Congenital, familial and genetic disorders
Sickle cell anaemia with crisis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
16.7%
1/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
14.3%
1/7 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
|
Additional Information
Contact for Clinical Trial Information
Daiichi Sankyo, Inc.
Phone: 908-992-6400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place