Trial Outcomes & Findings for Safety of Dabigatran Etexilate in Blood Clot Prevention in Children (NCT NCT02197416)
NCT ID: NCT02197416
Last Updated: 2020-06-04
Results Overview
The event-free probability of first recurrence of VTE were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience recurrent VTE at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-VTE related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
214 participants
Primary outcome timeframe
At month 6 (Week 26) and 12 (Week 52) of on treatment period
Results posted on
2020-06-04
Participant Flow
This open label, single arm prospective cohort study was designed to assess the safety of dabigatran etexilate (DE) for secondary prevention of paediatric venous thromboembolism (VTE) with 12-month (365 days) treatment period followed by 28 days end of treatment follow-up. Results of participants were reported via 3 mutually exclusive age groups.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. 1 enrolled subject was withdrawn before treated due to unable to swallow the capsules.
Participant milestones
| Measure |
Dabigatran Etexilate (0 to < 2 Years)
Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 0 to \<2 years.
|
Dabigatran Etexilate (2 to <12 Years)
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and \<12 years.
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 2 to \< 12 years.
|
Dabigatran Etexilate (12 to <18 Years)
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 12 to \<18 years.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
43
|
161
|
|
Overall Study
COMPLETED
|
8
|
39
|
153
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
8
|
Reasons for withdrawal
| Measure |
Dabigatran Etexilate (0 to < 2 Years)
Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 0 to \<2 years.
|
Dabigatran Etexilate (2 to <12 Years)
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and \<12 years.
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 2 to \< 12 years.
|
Dabigatran Etexilate (12 to <18 Years)
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 12 to \<18 years.
|
|---|---|---|---|
|
Overall Study
Other reasons
|
0
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
Baseline characteristics by cohort
| Measure |
Dabigatran Etexilate (0 to < 2 Years)
n=9 Participants
Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 0 to \<2 years.
|
Dabigatran Etexilate (2 to <12 Years)
n=43 Participants
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and \<12 years.
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 2 to \< 12 years.
|
Dabigatran Etexilate (12 to <18 Years)
n=161 Participants
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 12 to \<18 years.
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
0.6 Years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
6.8 Years
STANDARD_DEVIATION 3.1 • n=7 Participants
|
15.1 Years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
12.8 Years
STANDARD_DEVIATION 4.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
203 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
194 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At month 6 (Week 26) and 12 (Week 52) of on treatment periodPopulation: The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints, demographics and baseline characteristics.
The event-free probability of first recurrence of VTE were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience recurrent VTE at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-VTE related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Outcome measures
| Measure |
Dabigatran Etexilate (0 to < 2 Years)
n=9 Participants
Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 0 to \<2 years.
|
Dabigatran Etexilate (2 to <12 Years)
n=43 Participants
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and \<12 years.
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 2 to \< 12 years.
|
Dabigatran Etexilate (12 to <18 Years)
n=161 Participants
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 12 to \<18 years.
|
|---|---|---|---|
|
Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 Months
6 months
|
1.000 Probability
Interval 1.0 to 1.0
|
1.000 Probability
Interval 1.0 to 1.0
|
0.979 Probability
Interval 0.937 to 0.993
|
|
Event-free Probability of Recurrence of Venous Thromboembolism (VTE) at 6 and 12 Months
12 months
|
1.000 Probability
Interval 1.0 to 1.0
|
1.000 Probability
Interval 1.0 to 1.0
|
0.979 Probability
Interval 0.937 to 0.993
|
PRIMARY outcome
Timeframe: At month 6 (Week 26) and month 12 (Week 52) of on treatment periodPopulation: The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints, demographics and baseline characteristics.
The event-free probability of major or minor (including CRNM) bleeding event were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience major or minor (including CRNM) bleeding event at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-bleeding related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Outcome measures
| Measure |
Dabigatran Etexilate (0 to < 2 Years)
n=9 Participants
Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 0 to \<2 years.
|
Dabigatran Etexilate (2 to <12 Years)
n=43 Participants
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and \<12 years.
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 2 to \< 12 years.
|
Dabigatran Etexilate (12 to <18 Years)
n=161 Participants
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 12 to \<18 years.
|
|---|---|---|---|
|
Event-free Probability of Major or Minor (Including Clinically Relevant Non-major (CRNM)) Bleeding Events at 6 and 12 Months
6 months
|
0.889 Probability
Interval 0.433 to 0.984
|
0.894 Probability
Interval 0.706 to 0.965
|
0.753 Probability
Interval 0.675 to 0.815
|
|
Event-free Probability of Major or Minor (Including Clinically Relevant Non-major (CRNM)) Bleeding Events at 6 and 12 Months
12 months
|
0.889 Probability
Interval 0.433 to 0.984
|
0.831 Probability
Interval 0.592 to 0.936
|
0.691 Probability
Interval 0.603 to 0.763
|
PRIMARY outcome
Timeframe: At month 6 (Week 26) and 12 (Week 52) of on treatment periodPopulation: The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints, demographics and baseline characteristics.
The event-free probability of mortality overall and related to thrombotic or thromboembolic events were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience mortality overall and related to thrombotic or thromboembolic events at the time of analysis, dropped out from the trial early, were lost to follow-up, were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Outcome measures
| Measure |
Dabigatran Etexilate (0 to < 2 Years)
n=9 Participants
Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 0 to \<2 years.
|
Dabigatran Etexilate (2 to <12 Years)
n=43 Participants
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and \<12 years.
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 2 to \< 12 years.
|
Dabigatran Etexilate (12 to <18 Years)
n=161 Participants
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 12 to \<18 years.
|
|---|---|---|---|
|
Event-free Probability of Mortality Overall and Related to Thrombotic or Thromboembolic Events at 6 and 12 Months
6 months
|
1.000 Probability
Interval 1.0 to 1.0
|
1.000 Probability
Interval 1.0 to 1.0
|
1.000 Probability
Interval 1.0 to 1.0
|
|
Event-free Probability of Mortality Overall and Related to Thrombotic or Thromboembolic Events at 6 and 12 Months
12 months
|
1.000 Probability
Interval 1.0 to 1.0
|
1.000 Probability
Interval 1.0 to 1.0
|
1.000 Probability
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: At month 6 (Week 26) and 12 (Week 52) of on treatment periodPopulation: The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints, demographics and baseline characteristics.
The event-free probability of PTS were provided by Kaplan-Meier estimation with its 95% confidence intervals (CIs) at 6 and 12 months. Patients who did not experience PTS at the time of analysis, dropped out from the trial early, were lost to follow-up, or had died from non-PTS related cause were considered as non-events and censored. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Outcome measures
| Measure |
Dabigatran Etexilate (0 to < 2 Years)
n=9 Participants
Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 0 to \<2 years.
|
Dabigatran Etexilate (2 to <12 Years)
n=43 Participants
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and \<12 years.
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 2 to \< 12 years.
|
Dabigatran Etexilate (12 to <18 Years)
n=161 Participants
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 12 to \<18 years.
|
|---|---|---|---|
|
Event-free Probability of Occurrence of Post-thrombotic Syndrome (PTS) at 6 and 12 Months
6 months
|
1.000 Probability
Interval 1.0 to 1.0
|
1.000 Probability
Interval 1.0 to 1.0
|
0.979 Probability
Interval 0.935 to 0.993
|
|
Event-free Probability of Occurrence of Post-thrombotic Syndrome (PTS) at 6 and 12 Months
12 months
|
1.000 Probability
Interval 1.0 to 1.0
|
1.000 Probability
Interval 1.0 to 1.0
|
0.979 Probability
Interval 0.935 to 0.993
|
SECONDARY outcome
Timeframe: From first DE administration to 3 days of residual effect period after last DE administration, up to 52 weeks+ 3 daysPopulation: The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints, demographics and baseline characteristics.
Percentage of participants with dabigatran etexilate dose adjustments during on treatment period. On treatment period was from first DE administration to 3 days of residual effect period after last DE administration.
Outcome measures
| Measure |
Dabigatran Etexilate (0 to < 2 Years)
n=9 Participants
Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 0 to \<2 years.
|
Dabigatran Etexilate (2 to <12 Years)
n=43 Participants
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and \<12 years.
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 2 to \< 12 years.
|
Dabigatran Etexilate (12 to <18 Years)
n=161 Participants
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 12 to \<18 years.
|
|---|---|---|---|
|
Percentage of Participants With Dabigatran Etexilate (DE) Dose Adjustments During on Treatment Period
|
66.7 Percentage of participants
|
39.5 Percentage of participants
|
21.1 Percentage of participants
|
SECONDARY outcome
Timeframe: At Visit 3 (day 4 after first dose of trial medication)Population: The pharmacodynamics (PD) set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with non-missing endpoint values were included in this analysis.
Outcome measures
| Measure |
Dabigatran Etexilate (0 to < 2 Years)
n=8 Participants
Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 0 to \<2 years.
|
Dabigatran Etexilate (2 to <12 Years)
n=23 Participants
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and \<12 years.
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 2 to \< 12 years.
|
Dabigatran Etexilate (12 to <18 Years)
n=105 Participants
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 12 to \<18 years.
|
|---|---|---|---|
|
Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)
|
46.6 Second (s)
Standard Deviation 18.1
|
57.1 Second (s)
Standard Deviation 70.4
|
56.8 Second (s)
Standard Deviation 64.6
|
SECONDARY outcome
Timeframe: Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.Population: The PD set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with DE dose adjustment and non-missing endpoint values were included in this analysis.
Outcome measures
| Measure |
Dabigatran Etexilate (0 to < 2 Years)
n=6 Participants
Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 0 to \<2 years.
|
Dabigatran Etexilate (2 to <12 Years)
n=16 Participants
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and \<12 years.
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 2 to \< 12 years.
|
Dabigatran Etexilate (12 to <18 Years)
n=31 Participants
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 12 to \<18 years.
|
|---|---|---|---|
|
Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)
|
49.1 Second (s)
Standard Deviation 26.8
|
57.3 Second (s)
Standard Deviation 23.9
|
59.0 Second (s)
Standard Deviation 80.8
|
SECONDARY outcome
Timeframe: At Visit 3 (day 4 after first dose of trial medication)Population: The pharmacodynamics (PD) set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with DE dose adjustment and non-missing endpoint values were included in this analysis.
Outcome measures
| Measure |
Dabigatran Etexilate (0 to < 2 Years)
n=8 Participants
Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 0 to \<2 years.
|
Dabigatran Etexilate (2 to <12 Years)
n=24 Participants
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and \<12 years.
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 2 to \< 12 years.
|
Dabigatran Etexilate (12 to <18 Years)
n=105 Participants
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 12 to \<18 years.
|
|---|---|---|---|
|
Central Measurement of Ecarin Clotting Time (ECT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)
|
52.7 Second (s)
Standard Deviation 17.6
|
64.3 Second (s)
Standard Deviation 55.7
|
69.5 Second (s)
Standard Deviation 30.3
|
SECONDARY outcome
Timeframe: Pharmacodynamics (PD) samples were collected from first dose of trial medication at day 1 and day 4, 22, 43, 85, 127, 183, 239 and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.Population: The pharmacodynamics (PD) set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with DE dose adjustment and non-missing endpoint values were included in this analysis.
Outcome measures
| Measure |
Dabigatran Etexilate (0 to < 2 Years)
n=6 Participants
Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 0 to \<2 years.
|
Dabigatran Etexilate (2 to <12 Years)
n=16 Participants
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and \<12 years.
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 2 to \< 12 years.
|
Dabigatran Etexilate (12 to <18 Years)
n=32 Participants
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 12 to \<18 years.
|
|---|---|---|---|
|
Central Measurement of Ecarin Clotting Time (ECT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)
|
53.3 Second (s)
Standard Deviation 19.4
|
66.6 Second (s)
Standard Deviation 23.6
|
69.2 Second (s)
Standard Deviation 28.7
|
SECONDARY outcome
Timeframe: At Visit 3 (day 4 after first dose of trial medication)Population: The pharmacodynamics (PD) set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with DE dose adjustment and non-missing endpoint values were included in this analysis.
Outcome measures
| Measure |
Dabigatran Etexilate (0 to < 2 Years)
n=8 Participants
Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 0 to \<2 years.
|
Dabigatran Etexilate (2 to <12 Years)
n=17 Participants
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and \<12 years.
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 2 to \< 12 years.
|
Dabigatran Etexilate (12 to <18 Years)
n=64 Participants
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 12 to \<18 years.
|
|---|---|---|---|
|
Central Measurement of Diluted Thrombin Time (dTT) at Visit 3 (After at Least Six Consecutive Dabigatran Etexilate (DE) Doses)
|
37.9 Second (s)
Standard Deviation 19.5
|
40.5 Second (s)
Standard Deviation 14.6
|
45.3 Second (s)
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: dTT values were collected at day 4, 22, 43, 85, 127, 183, 239, and 295 until last dose at day 365 and at post-titration (at least 3 days after dose adjustment) if needed, up to 365 days.Population: The pharmacodynamics (PD) set (PDS) included all treated patients who provided at least one evaluable PD observation and had no protocol deviations relevant to the evaluation of PD endpoints. Only those with DE dose adjustment and non-missing endpoint values were included in this analysis.
Outcome measures
| Measure |
Dabigatran Etexilate (0 to < 2 Years)
n=6 Participants
Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 nanogram(ng)/ milliliter (mL). The DE dose limit was 22.2 mg/kilogram (kg)/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 0 to \<2 years.
|
Dabigatran Etexilate (2 to <12 Years)
n=12 Participants
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years and who cannot take capsules between 8 and \<12 years.
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 2 to \< 12 years.
|
Dabigatran Etexilate (12 to <18 Years)
n=26 Participants
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
This arm includes participants aged between 12 to \<18 years.
|
|---|---|---|---|
|
Central Measurement of Diluted Thrombin Time (dTT) at Post-titration (After at Least 3 Days Following Any Dabigatran Etexilate (DE) Dose Adjustment)
|
40.0 Second (s)
Standard Deviation 24.3
|
46.0 Second (s)
Standard Deviation 18.6
|
43.4 Second (s)
Standard Deviation 17.7
|
Adverse Events
Dabigatran Etexilate (Treated Set)
Serious events: 30 serious events
Other events: 113 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dabigatran Etexilate (Treated Set)
n=213 participants at risk
Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
|
|---|---|
|
Cardiac disorders
Atrial flutter
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Cardiac disorders
Cardiac failure
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Cardiac disorders
Myocarditis
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Cardiac disorders
Pericardial effusion
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Cardiac disorders
Ventricular pre-excitation
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Congenital, familial and genetic disorders
Congenital anomaly
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Gastrointestinal disorders
Gastritis
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
General disorders
Chest pain
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
General disorders
Oedema peripheral
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Hepatobiliary disorders
Hepatic vein stenosis
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Infections and infestations
Catheter site infection
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Infections and infestations
Cellulitis
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Infections and infestations
Encephalitis
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Infections and infestations
Gastroenteritis
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Infections and infestations
Pneumonia
|
0.94%
2/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Infections and infestations
Pulpitis dental
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Infections and infestations
Tonsillitis
|
0.94%
2/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Injury, poisoning and procedural complications
Fall
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Injury, poisoning and procedural complications
Metal poisoning
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Investigations
Alanine aminotransferase increased
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Investigations
Blood bilirubin increased
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Investigations
Hepatic enzyme increased
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ewing's sarcoma recurrent
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Nervous system disorders
Headache
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Nervous system disorders
Migraine
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Renal and urinary disorders
Lupus nephritis
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Vascular disorders
Bleeding varicose vein
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Vascular disorders
Deep vein thrombosis
|
0.94%
2/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Vascular disorders
Haematoma
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Vascular disorders
Lupus vasculitis
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Vascular disorders
Phlebitis superficial
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Vascular disorders
Thrombosis
|
0.47%
1/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
Other adverse events
| Measure |
Dabigatran Etexilate (Treated Set)
n=213 participants at risk
Single oral dose of dabigatran etexilate (DE) oral liquid formulation (OLF) ranging from 6.25 milligram(mg) to 143.75 mg was administrated twice daily in the morning and evening for participants aged less than 12 months.
Single oral dose of DE pellets ranging from 20mg to 330mg was administrated twice daily in the morning and evening for participants aged less than 8 years.
Single oral dose of DE capsule ranging from 50 mg to 330mg was administrated twice daily in the morning and evening for participants aged at least 8 years.
Dosage of DE was adjusted by age and weight of participants intending to achieve trough plasma dabigatran concentrations between 50 and \<250 ng/mL. The DE dose limit was 22.2 mg/kg/day.The maximal DE single dose was 330 mg.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.1%
13/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
15/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.0%
15/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Gastrointestinal disorders
Nausea
|
8.0%
17/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Gastrointestinal disorders
Vomiting
|
7.0%
15/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
General disorders
Pyrexia
|
7.0%
15/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Infections and infestations
Nasopharyngitis
|
16.0%
34/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.6%
14/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.2%
11/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.1%
13/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Nervous system disorders
Headache
|
16.0%
34/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.6%
14/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.6%
14/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.2%
11/213 • From first dose until last dose of study drug + 3 days of residual effect period, up to 52 weeks + 3 days.
The treated set (TS) included all patients who were dispensed trial medication and had taken at least 1 dose of investigational treatment, which was used to assess safety endpoints. The adverse events were reported with single arm align with the study design.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER