Trial Outcomes & Findings for Rivaroxaban for Treatment in Venous or Arterial Thrombosis in Neonates (NCT NCT02564718)
NCT ID: NCT02564718
Last Updated: 2018-07-10
Results Overview
Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated.
COMPLETED
PHASE1/PHASE2
10 participants
30 minutes to 1.5 hours post-dose; 2 to 4 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 1 (tid dosing)
2018-07-10
Participant Flow
Study was conducted at 9 study centers in 7 countries between 19 November 2015 (first participant first visit) and 18 December 2017 (last participant last visit).
Overall, 11 participants were screened, of these 1 participant was not included in the study due to withdrawal by parent. A total of 10 participants were assigned to treatment.
Participant milestones
| Measure |
Rivaroxaban (BAY59-7939) Suspension Bid
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
|
Rivaroxaban (BAY59-7939) Suspension Tid
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Rivaroxaban (BAY59-7939) Suspension Bid
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
|
Rivaroxaban (BAY59-7939) Suspension Tid
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
|
|---|---|---|
|
Overall Study
Withdrew from treatment
|
0
|
1
|
Baseline Characteristics
SAF included all participants who received at least one dose of rivaroxaban.
Baseline characteristics by cohort
| Measure |
Rivaroxaban (BAY59-7939) Suspension Bid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
|
Rivaroxaban (BAY59-7939) Suspension Tid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
1.81 Months
STANDARD_DEVIATION 2.24 • n=5 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
1.12 Months
STANDARD_DEVIATION 0.60 • n=5 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
1.47 Months
STANDARD_DEVIATION 1.59 • n=10 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
4 Participants
n=5 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
5 Participants
n=10 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
1 Participants
n=5 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
5 Participants
n=10 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
0 Participants
n=5 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
1 Participants
n=10 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
5 Participants
n=5 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
8 Participants
n=10 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 Participants
n=5 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
0 Participants
n=5 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
1 Participants
n=10 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
|
Weight
|
4.33 Kilogram (kg)
STANDARD_DEVIATION 2.19 • n=5 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
3.70 Kilogram (kg)
STANDARD_DEVIATION 0.85 • n=5 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
4.02 Kilogram (kg)
STANDARD_DEVIATION 1.60 • n=10 Participants • SAF included all participants who received at least one dose of rivaroxaban.
|
|
Prothrombin Time
|
13.3 Seconds (sec)
STANDARD_DEVIATION 0.378 • n=5 Participants • PD analysis set (PDS) included all participants with at least one blood sample for clotting parameters in accordance with the PD sampling strategy.
|
13.9 Seconds (sec)
STANDARD_DEVIATION 1.31 • n=4 Participants • PD analysis set (PDS) included all participants with at least one blood sample for clotting parameters in accordance with the PD sampling strategy.
|
NA Seconds (sec)
STANDARD_DEVIATION NA • n=9 Participants • PD analysis set (PDS) included all participants with at least one blood sample for clotting parameters in accordance with the PD sampling strategy.
|
|
Activated Partial Thromboplastin Time (aPTT)
|
34.0 Seconds (sec)
STANDARD_DEVIATION 4.05 • n=5 Participants • PDS included all participants with at least one blood sample for clotting parameters in accordance with the PD sampling strategy.
|
34.9 Seconds (sec)
STANDARD_DEVIATION 2.62 • n=4 Participants • PDS included all participants with at least one blood sample for clotting parameters in accordance with the PD sampling strategy.
|
NA Seconds (sec)
STANDARD_DEVIATION NA • n=9 Participants • PDS included all participants with at least one blood sample for clotting parameters in accordance with the PD sampling strategy.
|
PRIMARY outcome
Timeframe: 30 minutes to 1.5 hours post-dose; 2 to 4 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 1 (tid dosing)Population: Pharmacokinetic (PK) analysis set (PKS) included all participants with at least one PK sample in accordance with the PK sampling strategy.
Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated.
Outcome measures
| Measure |
Rivaroxaban (BAY59-7939) Suspension Bid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
|
Rivaroxaban (BAY59-7939) Suspension Tid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
|
|---|---|---|
|
Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1
30 minutes to 1.5 hours post-dose
|
85.2001 microgram per liter (mcg/L)
Geometric Coefficient of Variation 37.72
|
—
|
|
Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1
30 minutes to 3 hours post-dose
|
—
|
42.6837 microgram per liter (mcg/L)
Geometric Coefficient of Variation 39.35
|
|
Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1
2 to 4 hours post-dose
|
73.7641 microgram per liter (mcg/L)
Geometric Coefficient of Variation 64.38
|
—
|
|
Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1
7 to 8 hours post-dose
|
—
|
12.1027 microgram per liter (mcg/L)
Geometric Coefficient of Variation 130.13
|
PRIMARY outcome
Timeframe: 2 to 8 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 3 (tid dosing)Population: PKS included all participants with at least one PK sample in accordance with the PK sampling strategy.
Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated.
Outcome measures
| Measure |
Rivaroxaban (BAY59-7939) Suspension Bid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
|
Rivaroxaban (BAY59-7939) Suspension Tid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
|
|---|---|---|
|
Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 3
30 minutes to 3 hours post-dose
|
—
|
32.2879 microgram per liter (mcg/L)
Geometric Coefficient of Variation 267.05
|
|
Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 3
2 to 8 hours post-dose
|
102.3285 microgram per liter (mcg/L)
Geometric Coefficient of Variation 40.36
|
—
|
|
Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 3
7 to 8 hours post-dose
|
—
|
9.1716 microgram per liter (mcg/L)
Geometric Coefficient of Variation 160.52
|
PRIMARY outcome
Timeframe: 10 to 16 hours post-dose on Day 8 (bid dosing)Population: PKS included all participants with at least one PK sample in accordance with the PK sampling strategy.
Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated.
Outcome measures
| Measure |
Rivaroxaban (BAY59-7939) Suspension Bid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
|
Rivaroxaban (BAY59-7939) Suspension Tid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
|
|---|---|---|
|
Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 8
|
2.5696 microgram per liter (mcg/L)
Geometric Coefficient of Variation 70.82
|
NA microgram per liter (mcg/L)
Geometric Coefficient of Variation NA
No participants were analyzed at this time points for tid dosing regimen.
|
PRIMARY outcome
Timeframe: 10-16 hours post-dose on Day 8 (baseline), 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing)Population: Pharmacodynamic (PD) analysis set (PDS) included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.
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) Suspension Bid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
|
Rivaroxaban (BAY59-7939) Suspension Tid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
|
|---|---|---|
|
Change From Baseline in Prothrombin Time at Day 1
|
11.6 seconds (sec)
Standard Deviation 17.3
|
0.025 seconds (sec)
Standard Deviation 0.714
|
PRIMARY outcome
Timeframe: 10-16 hours post-dose on Day 8 (baseline), 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing)Population: PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.
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) Suspension Bid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
|
Rivaroxaban (BAY59-7939) Suspension Tid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
|
|---|---|---|
|
Change From Baseline in Prothrombin Time at Day 3
|
3.74 seconds (sec)
Standard Deviation 2.84
|
1.13 seconds (sec)
Standard Deviation 2.10
|
PRIMARY outcome
Timeframe: 10-16 hours post-dose on Day 8 (baseline), 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing)Population: PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.
The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway and is sensitive for deficiencies of factors I, II, V, VIII, IX, X, XI and XII.
Outcome measures
| Measure |
Rivaroxaban (BAY59-7939) Suspension Bid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
|
Rivaroxaban (BAY59-7939) Suspension Tid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
|
|---|---|---|
|
Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 1
|
13.6 seconds (sec)
Standard Deviation 12.4
|
2.33 seconds (sec)
Standard Deviation 5.53
|
PRIMARY outcome
Timeframe: 10-16 hours post-dose on Day 8 (baseline), 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing)Population: PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.
The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway and is sensitive for deficiencies of factors I, II, V, VIII, IX, X, XI and XII.
Outcome measures
| Measure |
Rivaroxaban (BAY59-7939) Suspension Bid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
|
Rivaroxaban (BAY59-7939) Suspension Tid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
|
|---|---|---|
|
Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 3
|
7.02 seconds (sec)
Standard Deviation 5.08
|
3.47 seconds (sec)
Standard Deviation 7.59
|
PRIMARY outcome
Timeframe: 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing)Population: PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.
The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.
Outcome measures
| Measure |
Rivaroxaban (BAY59-7939) Suspension Bid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
|
Rivaroxaban (BAY59-7939) Suspension Tid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
|
|---|---|---|
|
Anti-factor Xa Activity (Anti-Xa) Values at Day 1
|
63.3 microgram per liter (mcg/L)
Standard Deviation 60.8
|
18.0 microgram per liter (mcg/L)
Standard Deviation 8.37
|
PRIMARY outcome
Timeframe: 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing)Population: PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.
The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.
Outcome measures
| Measure |
Rivaroxaban (BAY59-7939) Suspension Bid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
|
Rivaroxaban (BAY59-7939) Suspension Tid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
|
|---|---|---|
|
Anti-factor Xa Activity (Anti-Xa) Values at Day 3
|
67.3 microgram per liter (mcg/L)
Standard Deviation 48.7
|
59.8 microgram per liter (mcg/L)
Standard Deviation 46.8
|
PRIMARY outcome
Timeframe: 10-16 hours post-dose on Day 8 (both bid and tid dosing)Population: PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.
The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.
Outcome measures
| Measure |
Rivaroxaban (BAY59-7939) Suspension Bid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
|
Rivaroxaban (BAY59-7939) Suspension Tid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
|
|---|---|---|
|
Anti-factor Xa Activity (Anti-Xa) Values at Day 8
|
7.25 microgram per liter (mcg/L)
Standard Deviation 0.00
|
9.92 microgram per liter (mcg/L)
Standard Deviation 5.35
|
SECONDARY outcome
Timeframe: From start of study drug administration until 30-day post study treatment periodPopulation: Safety analysis set (SAF) included all participants who received at least one dose of rivaroxaban.
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/deciliter (g/dL) or more, •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, example: 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
Outcome measures
| Measure |
Rivaroxaban (BAY59-7939) Suspension Bid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
|
Rivaroxaban (BAY59-7939) Suspension Tid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
|
|---|---|---|
|
Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events
Major bleeding events
|
0 count of participants
|
0 count of participants
|
|
Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events
Clinically relevant non-major bleeding events
|
0 count of participants
|
0 count of participants
|
SECONDARY outcome
Timeframe: From start of study drug administration until 30-day post study treatment periodPopulation: Full analysis set (FAS) included all participants from whom informed consent was obtained and who contributed any data thereafter.
Symptomatic recurrence of thromboembolism and asymptomatic deterioration was documented using the appropriate imaging test and confirmed by CIAC which was unaware of treatment assignment. Asymptomatic deterioration in thrombotic burden on repeat imaging, as assessed by the CIAC. Adjudication results were the basis for the final analyses.
Outcome measures
| Measure |
Rivaroxaban (BAY59-7939) Suspension Bid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
|
Rivaroxaban (BAY59-7939) Suspension Tid
n=5 Participants
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
|
|---|---|---|
|
Number of Participants With Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging
Symptomatic recurrent venous thromboembolism
|
0 count of participants
|
0 count of participants
|
|
Number of Participants With Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging
Asymptomatic deterioration in thrombotic burden
|
0 count of participants
|
0 count of participants
|
Adverse Events
Rivaroxaban (BAY59-7939) Suspension Bid
Rivaroxaban (BAY59-7939) Suspension Tid
Serious adverse events
| Measure |
Rivaroxaban (BAY59-7939) Suspension Bid
n=5 participants at risk
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
|
Rivaroxaban (BAY59-7939) Suspension Tid
n=5 participants at risk
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
|
|---|---|---|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/5 • From start of study treatment up to 30 days after the last administration of study drug
|
20.0%
1/5 • Number of events 1 • From start of study treatment up to 30 days after the last administration of study drug
|
Other adverse events
| Measure |
Rivaroxaban (BAY59-7939) Suspension Bid
n=5 participants at risk
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 3.2 milligram (mg) oral dose of rivaroxaban oral suspension twice daily (bid) for 7 days.
|
Rivaroxaban (BAY59-7939) Suspension Tid
n=5 participants at risk
Participants aged less than 6 months were administered with age- and body weight-adjusted 0.5 to 2.9 mg oral dose of rivaroxaban oral suspension thrice daily (tid) for 7 days.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • From start of study treatment up to 30 days after the last administration of study drug
|
0.00%
0/5 • From start of study treatment up to 30 days after the last administration of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bayer shall own the exclusive rights to all results, data, findings, radiological \& diagnostic images, discoveries, inventions \& specifications, whether patentable or not, that are originated, conceived, derived, produced, discovered, invented or otherwise made by Center, PI and/or Study Team Physicians and/or Members in connection with the performance of the Study (i.e. Results). Contract Partners hereby assign their rights to the Results to Bayer in advance and Bayer accepts such assignment.
- Publication restrictions are in place
Restriction type: OTHER