Trial Outcomes & Findings for Oral Rivaroxaban in Children With Venous Thrombosis (NCT NCT01684423)
NCT ID: NCT01684423
Last Updated: 2017-09-21
Results Overview
Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and: * associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or * leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or * occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or * contributing to death. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with: * medical intervention, or * unscheduled contact (visit or telephone call) with a physician, or * cessation (temporary) of study treatment, or * discomfort for the child such as pain or * impairment of activities of daily life (such as loss of school days or hospitalization).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
From start of study drug administration until end of the 30-day treatment period
Results posted on
2017-09-21
Participant Flow
The study was conducted at multiple centers in 10 countries worldwide between 19 February 2013 (first subject first visit) and 01 September 2016 (last subject last visit).
A total of 68 subjects were screened, of these 4 subjects failed screening. The remaining 64 subjects were randomized, of whom 63 subjects were treated.
Participant milestones
| Measure |
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years
Subjects aged from 12 - \<18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram \[mg\] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
|
Comparator, Age: 12 - <18 Years
Subjects aged from 12 - \<18 years received comparator as per standard of care.
|
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
|
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
|
Comparator, Age: 6 - < 12 Years
Subjects aged from 6 - \< 12 years received comparator as per standard of care.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
13
|
13
|
19
|
7
|
|
Overall Study
COMPLETED
|
11
|
13
|
12
|
19
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years
Subjects aged from 12 - \<18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram \[mg\] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
|
Comparator, Age: 12 - <18 Years
Subjects aged from 12 - \<18 years received comparator as per standard of care.
|
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
|
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
|
Comparator, Age: 6 - < 12 Years
Subjects aged from 6 - \< 12 years received comparator as per standard of care.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Oral Rivaroxaban in Children With Venous Thrombosis
Baseline characteristics by cohort
| Measure |
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years
n=11 Participants
Subjects aged from 12 - \<18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram \[mg\] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
|
Comparator, Age: 12 - <18 Years
n=13 Participants
Subjects aged from 12 - \<18 years received comparator as per standard of care.
|
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years
n=13 Participants
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
|
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years
n=19 Participants
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
|
Comparator, Age: 6 - < 12 Years
n=7 Participants
Subjects aged from 6 - \< 12 years received comparator as per standard of care.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
15.5 Years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
14.8 Years
STANDARD_DEVIATION 1.0 • n=7 Participants
|
8.5 Years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
8.3 Years
STANDARD_DEVIATION 1.9 • n=4 Participants
|
9.0 Years
STANDARD_DEVIATION 2.0 • n=21 Participants
|
11.0 Years
STANDARD_DEVIATION 3.7 • n=10 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
29 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
34 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration until end of the 30-day treatment periodPopulation: Full analysis set. Data was evaluated only for subjects who received active study medication.
Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and: * associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or * leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or * occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or * contributing to death. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with: * medical intervention, or * unscheduled contact (visit or telephone call) with a physician, or * cessation (temporary) of study treatment, or * discomfort for the child such as pain or * impairment of activities of daily life (such as loss of school days or hospitalization).
Outcome measures
| Measure |
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years
n=11 Participants
Subjects aged from 12 - \<18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram \[mg\] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
|
Comparator, Age: 12 - <18 Years
n=13 Participants
Subjects aged from 12 - \<18 years received comparator as per standard of care.
|
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years
n=13 Participants
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
|
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years
n=19 Participants
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
|
Comparator, Age: 6 - < 12 Years
n=7 Participants
Subjects aged from 6 - \< 12 years received comparator as per standard of care.
|
|---|---|---|---|---|---|
|
Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events
Major bleeding events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events
Clinically relevant non-major bleeding events
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study drug administration until end of the 30-day treatment periodPopulation: Full analysis set
The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence of venous thrombosis was documented by the appropriate imaging test.
Outcome measures
| Measure |
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years
n=11 Participants
Subjects aged from 12 - \<18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram \[mg\] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
|
Comparator, Age: 12 - <18 Years
n=13 Participants
Subjects aged from 12 - \<18 years received comparator as per standard of care.
|
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years
n=13 Participants
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
|
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years
n=19 Participants
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
|
Comparator, Age: 6 - < 12 Years
n=7 Participants
Subjects aged from 6 - \< 12 years received comparator as per standard of care.
|
|---|---|---|---|---|---|
|
Number of Subjects With Symptomatic Recurrent Venous Thromboembolism
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Repeat imaging at the end of the 30 day treatment periodPopulation: Full analysis set
The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. Asymptomatic deterioration in thrombotic burden was documented by the appropriate imaging test and the results were classified as normalized, improved, no relevant change, deteriorated, not evaluable or not available.
Outcome measures
| Measure |
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years
n=11 Participants
Subjects aged from 12 - \<18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram \[mg\] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
|
Comparator, Age: 12 - <18 Years
n=13 Participants
Subjects aged from 12 - \<18 years received comparator as per standard of care.
|
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years
n=13 Participants
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
|
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years
n=19 Participants
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
|
Comparator, Age: 6 - < 12 Years
n=7 Participants
Subjects aged from 6 - \< 12 years received comparator as per standard of care.
|
|---|---|---|---|---|---|
|
Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden
Normalized
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden
Improved
|
4 Participants
|
0 Participants
|
8 Participants
|
9 Participants
|
4 Participants
|
|
Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden
No relevant change
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden
Deteriorated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden
Not evaluable
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden
Not available
|
4 Participants
|
9 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31Population: Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.
Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.
Outcome measures
| Measure |
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years
n=11 Participants
Subjects aged from 12 - \<18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram \[mg\] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
|
Comparator, Age: 12 - <18 Years
n=12 Participants
Subjects aged from 12 - \<18 years received comparator as per standard of care.
|
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years
n=19 Participants
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
|
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
|
Comparator, Age: 6 - < 12 Years
Subjects aged from 6 - \< 12 years received comparator as per standard of care.
|
|---|---|---|---|---|---|
|
Change From Baseline in Prothrombin Time at Specified Time Points
Day 15: 2 to 4 hours post-dose
|
8.964 seconds
Standard Deviation 3.822
|
9.083 seconds
Standard Deviation 2.513
|
3.147 seconds
Standard Deviation 2.099
|
—
|
—
|
|
Change From Baseline in Prothrombin Time at Specified Time Points
Day 15: 6 to 8 hours post-dose
|
4.218 seconds
Standard Deviation 2.977
|
2.817 seconds
Standard Deviation 1.628
|
1.984 seconds
Standard Deviation 1.341
|
—
|
—
|
|
Change From Baseline in Prothrombin Time at Specified Time Points
Day 31: 10 to 16 hours post-dose
|
NA seconds
Standard Deviation NA
Data is not available because no subjects were evaluated for the given time points.
|
NA seconds
Standard Deviation NA
Data is not available because no subjects were evaluated for the given time points.
|
0.156 seconds
Standard Deviation 1.155
|
—
|
—
|
|
Change From Baseline in Prothrombin Time at Specified Time Points
Day 31: 20 to 24 hours post-dose
|
-0.082 seconds
Standard Deviation 1.020
|
-0.327 seconds
Standard Deviation 1.332
|
NA seconds
Standard Deviation NA
Data is not available because no subjects were evaluated for the given time points.
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31Population: Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.
The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway.
Outcome measures
| Measure |
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years
n=11 Participants
Subjects aged from 12 - \<18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram \[mg\] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
|
Comparator, Age: 12 - <18 Years
n=12 Participants
Subjects aged from 12 - \<18 years received comparator as per standard of care.
|
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years
n=19 Participants
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
|
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
|
Comparator, Age: 6 - < 12 Years
Subjects aged from 6 - \< 12 years received comparator as per standard of care.
|
|---|---|---|---|---|---|
|
Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points
Day 15: 2 to 4 hours post-dose
|
10.982 seconds
Standard Deviation 4.470
|
12.818 seconds
Standard Deviation 5.210
|
2.995 seconds
Standard Deviation 5.616
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points
Day 15: 6 to 8 hours post-dose
|
6.136 seconds
Standard Deviation 2.641
|
5.900 seconds
Standard Deviation 4.942
|
1.858 seconds
Standard Deviation 4.774
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points
Day 31: 10 to 16 hours post-dose
|
NA seconds
Standard Deviation NA
Data is not available because no subjects were evaluated for the given time points.
|
NA seconds
Standard Deviation NA
Data is not available because no subjects were evaluated for the given time points.
|
-0.483 seconds
Standard Deviation 6.488
|
—
|
—
|
|
Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points
Day 31: 20 to 24 hours post-dose
|
1.345 seconds
Standard Deviation 3.190
|
1.240 seconds
Standard Deviation 4.992
|
NA seconds
Standard Deviation NA
Data is not available because no subjects were evaluated for the given time points.
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31Population: Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.
The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.
Outcome measures
| Measure |
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years
n=11 Participants
Subjects aged from 12 - \<18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram \[mg\] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
|
Comparator, Age: 12 - <18 Years
n=12 Participants
Subjects aged from 12 - \<18 years received comparator as per standard of care.
|
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years
n=19 Participants
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
|
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
|
Comparator, Age: 6 - < 12 Years
Subjects aged from 6 - \< 12 years received comparator as per standard of care.
|
|---|---|---|---|---|---|
|
Anti-factor Xa Values at Specified Time Points
Day 15: pre-dose
|
16.081 microgram per liter (mcg/L)
Standard Deviation 6.136
|
8.136 microgram per liter (mcg/L)
Standard Deviation 3.069
|
31.553 microgram per liter (mcg/L)
Standard Deviation 25.416
|
—
|
—
|
|
Anti-factor Xa Values at Specified Time Points
Day 15: 2 to 4 hours post-dose
|
185.481 microgram per liter (mcg/L)
Standard Deviation 53.326
|
252.853 microgram per liter (mcg/L)
Standard Deviation 71.072
|
99.415 microgram per liter (mcg/L)
Standard Deviation 54.415
|
—
|
—
|
|
Anti-factor Xa Values at Specified Time Points
Day 15: 6 to 8 hours post-dose
|
105.223 microgram per liter (mcg/L)
Standard Deviation 54.339
|
68.670 microgram per liter (mcg/L)
Standard Deviation 32.845
|
77.929 microgram per liter (mcg/L)
Standard Deviation 50.074
|
—
|
—
|
|
Anti-factor Xa Values at Specified Time Points
Day 31: 10 to 16 hours post-dose
|
NA microgram per liter (mcg/L)
Standard Deviation NA
Data is not available because no subjects were evaluated for the given time points.
|
NA microgram per liter (mcg/L)
Standard Deviation NA
Data is not available because no subjects were evaluated for the given time points.
|
30.927 microgram per liter (mcg/L)
Standard Deviation 18.037
|
—
|
—
|
|
Anti-factor Xa Values at Specified Time Points
Day 31: 20 to 24 hours post-dose
|
16.038 microgram per liter (mcg/L)
Standard Deviation 7.653
|
8.409 microgram per liter (mcg/L)
Standard Deviation 3.664
|
NA microgram per liter (mcg/L)
Standard Deviation NA
Data is not available because no subjects were evaluated for the given time points.
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31Population: Pharmacokinetic analysis set (N= 42) included all subjects with at least one pharmacokinetic sample in accordance with the pharmacokinetic sampling strategy.
Geometric and percentage geometric coefficient of variation (%CV) were reported.
Outcome measures
| Measure |
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years
n=11 Participants
Subjects aged from 12 - \<18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram \[mg\] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
|
Comparator, Age: 12 - <18 Years
n=12 Participants
Subjects aged from 12 - \<18 years received comparator as per standard of care.
|
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years
n=19 Participants
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
|
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
|
Comparator, Age: 6 - < 12 Years
Subjects aged from 6 - \< 12 years received comparator as per standard of care.
|
|---|---|---|---|---|---|
|
Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points
Day 15: pre-dose
|
20.4822 microgram per liter (mcg/L)
Geometric Coefficient of Variation 40.6726
|
7.4367 microgram per liter (mcg/L)
Geometric Coefficient of Variation 152.9768
|
41.6025 microgram per liter (mcg/L)
Geometric Coefficient of Variation 183.6873
|
—
|
—
|
|
Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points
Day 15: 2 to 4 hours post-dose
|
219.6933 microgram per liter (mcg/L)
Geometric Coefficient of Variation 35.7518
|
240.6319 microgram per liter (mcg/L)
Geometric Coefficient of Variation 18.3387
|
119.2201 microgram per liter (mcg/L)
Geometric Coefficient of Variation 52.9889
|
—
|
—
|
|
Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points
Day 15: 6 to 8 hours post-dose
|
124.6723 microgram per liter (mcg/L)
Geometric Coefficient of Variation 49.1882
|
96.8051 microgram per liter (mcg/L)
Geometric Coefficient of Variation 41.8155
|
100.5992 microgram per liter (mcg/L)
Geometric Coefficient of Variation 52.6497
|
—
|
—
|
|
Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points
Day 31: 10 to 16 hours post-dose
|
NA microgram per liter (mcg/L)
Geometric Coefficient of Variation NA
Data is not available because no subjects were evaluated for the given time points.
|
NA microgram per liter (mcg/L)
Geometric Coefficient of Variation NA
Data is not available because no subjects were evaluated for the given time points.
|
43.5223 microgram per liter (mcg/L)
Geometric Coefficient of Variation 81.7283
|
—
|
—
|
|
Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points
Day 31: 20 to 24 hours post-dose
|
21.3252 microgram per liter (mcg/L)
Geometric Coefficient of Variation 43.1274
|
9.4654 microgram per liter (mcg/L)
Geometric Coefficient of Variation 167.7545
|
NA microgram per liter (mcg/L)
Geometric Coefficient of Variation NA
Data is not available because no subjects were evaluated for the given time points.
|
—
|
—
|
Adverse Events
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Comparator, Age: 12 - <18 Years
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Comparator, Age: 6 - < 12 Years
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years
n=11 participants at risk
Subjects aged from 12 - \<18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram \[mg\] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
|
Comparator, Age: 12 - <18 Years
n=13 participants at risk
Subjects aged from 12 - \<18 years received comparator as per standard of care.
|
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years
n=13 participants at risk
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
|
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years
n=19 participants at risk
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
|
Comparator, Age: 6 - < 12 Years
n=7 participants at risk
Subjects aged from 6 - \< 12 years received comparator as per standard of care.
|
|---|---|---|---|---|---|
|
Endocrine disorders
Hypothalamo-pituitary disorder
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 2 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Investigations
Influenza B virus test positive
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
Other adverse events
| Measure |
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years
n=11 participants at risk
Subjects aged from 12 - \<18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. Subjects with a body weight of 14 to less than 50 kilogram (kg) received a dose (equivalent to 20 milligram \[mg\] in adults) ranging from 5 to 15 mg, and subjects with a body weight (comparable to adults) of greater than or equal to 50 kg received a dose of 20 mg.
|
Comparator, Age: 12 - <18 Years
n=13 participants at risk
Subjects aged from 12 - \<18 years received comparator as per standard of care.
|
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years
n=13 participants at risk
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
|
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years
n=19 participants at risk
Subjects aged from 6 - \<12 years were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. Subjects with a body weight of 9 to less than 50 kg received a total daily dose (equivalent to 20 mg in adults) ranging from 6.4 to 15 mg and subjects with a body weight of greater than or equal to 50 kg received a total daily dose of 20 mg.
|
Comparator, Age: 6 - < 12 Years
n=7 participants at risk
Subjects aged from 6 - \< 12 years received comparator as per standard of care.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 2 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Ear and labyrinth disorders
Vertigo
|
9.1%
1/11 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Eye disorders
Eye pain
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
15.4%
2/13 • Number of events 3 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
14.3%
1/7 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
14.3%
1/7 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 2 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 2 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
10.5%
2/19 • Number of events 2 • From start of study drug administration until 30 day post study treatment
|
14.3%
1/7 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
9.1%
1/11 • Number of events 2 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
General disorders
Chest discomfort
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
General disorders
Chest pain
|
9.1%
1/11 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
14.3%
1/7 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
|
General disorders
Fatigue
|
9.1%
1/11 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
10.5%
2/19 • Number of events 2 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
General disorders
Pyrexia
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
10.5%
2/19 • Number of events 3 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
General disorders
Peripheral swelling
|
9.1%
1/11 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
General disorders
Localised oedema
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 2 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Infections and infestations
Nasopharyngitis
|
9.1%
1/11 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Infections and infestations
Rhinitis
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
1/11 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
14.3%
1/7 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
|
Injury, poisoning and procedural complications
Contusion
|
9.1%
1/11 • Number of events 2 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 2 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Investigations
Platelet count decreased
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
9.1%
1/11 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.1%
1/11 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Number of events 2 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
15.4%
2/13 • Number of events 2 • From start of study drug administration until 30 day post study treatment
|
15.8%
3/19 • Number of events 3 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
14.3%
1/7 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 2 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Psychiatric disorders
Suicidal ideation
|
9.1%
1/11 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Reproductive system and breast disorders
Menorrhagia
|
36.4%
4/11 • Number of events 8 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
1/11 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • Number of events 2 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 2 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.1%
1/11 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
1/11 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 3 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
|
Vascular disorders
Post thrombotic syndrome
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/19 • From start of study drug administration until 30 day post study treatment
|
14.3%
1/7 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
|
Vascular disorders
Hot flush
|
0.00%
0/11 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/13 • From start of study drug administration until 30 day post study treatment
|
5.3%
1/19 • Number of events 1 • From start of study drug administration until 30 day post study treatment
|
0.00%
0/7 • From start of study drug administration until 30 day post study treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60