Trial Condition(s):
Venous Thromboembolism
EINSTEIN Junior: oral rivaroxaban in children with venous thrombosis (EINSTEIN Jr)
Bayer Identifier:
14372
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.
Inclusion Criteria
- Children aged birth to < 18 years with confirmed venous thromboembolism who receive initial treatment with therapeutic dosages of UFH (unfractionated heparin), LMWH (low molecular weight heparin) or fondaparinux and require anticoagulant therapy for at least 90 days. However, children aged birth to < 2 years with catheter-related thrombosis require anticoagulant therapy for at least 30 days. - For children younger than 6 months: -- Gestational age at birth of at least 37 weeks. -- Oral feeding/nasogastric/gastric feeding for at least 10 days. -- Body weight ≥2600 g
Exclusion Criteria
- Active bleeding or bleeding risk contraindicating anticoagulant therapy - An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m*2 (in children younger than 1 year, serum creatinine results above 97.5th percentile excludes participation) - Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or ALT> 5x upper level of normal (ULN) or total bilirubin > 2x ULN with direct bilirubin > 20% of the total - Platelet count < 50 x 109/L - Sustained uncontrolled hypertension defined as > 95th age percentile - Life expectancy < 3 months - Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), including but not limited to all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically - Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine - Childbearing potential without proper contraceptive measures, pregnancy or breast feeding
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Little Rock, United States, 72202-3500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90095 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chicago, United States, 60611 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43205-2696 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90027-6089 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bern, Switzerland, 3010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Luzern, Switzerland, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 197022 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sankt-Peterburg, Russia, 197110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 119049 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nizhny Novgorod, Russia, 603136 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krasnodar, Russia, 350013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yekaterinburg, Russia, 620028 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Volgograd, Russia, 400138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 117997 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guadalajara, Mexico | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durham, United States, 27710 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gainesville, United States, 32610 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kansas City, United States, 64108-9898 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Indianapolis, United States, 46202 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fort Worth, United States, 76104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cleveland, United States, 44106-2602 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, United States, 33701 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Atlanta, United States, 30322 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miami, United States, 33155 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lansing, United States, 48912 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newcastle Upon Tyne, United Kingdom, NE1 4LP | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Glasgow, United Kingdom, G51 4TF | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site AMSTERDAM, Netherlands, 1105 AZ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site UTRECHT, Netherlands, 3584 CX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GRONINGEN, Netherlands, 9713 GZ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ROTTERDAM, Netherlands, 3015 CE | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sao Paulo, Brazil, 04023-061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Campinas, Brazil, 13083-970 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site São Paulo, Brazil, 01227-200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United Kingdom, B4 6NH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Manchester, United Kingdom, M13 9WL | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cardiff, United Kingdom, CF14 4XW | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sheffield, United Kingdom, S10 2TH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Esplugues de LLobregat, Spain, 08950 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site A Coruña, Spain, 15006 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Padova, Italy, 35128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torino, Italy, 10126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Parkville, Australia, 3052 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MONTPELLIER, France, 34059 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PARIS, France, 75015 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site TOULOUSE Cedex 9, France, 31059 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01307 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Halle, Germany, 06120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Erlangen, Germany, 91054 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Innsbruck, Austria, 6020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linz, Austria, 4020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cincinnati, United States, 45229-3039 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Phoenix, United States, 85016 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Diego, United States, 92123 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jacksonville, United States, 32207 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site EDEGEM, Belgium, 2650 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ramat Gan, Israel, 5262000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 9112001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petach Tikva, Israel, 4920235 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Crumlin, Ireland, 12 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamilton, Canada, L8N 3Z5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5G 1X8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NIJMEGEN, Netherlands, 6525 GA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Afula, Israel, 1834111 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ottawa, Canada, K1H 8L1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Calgary, Canada, T3B 6A8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1097 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dallas, United States, 75235 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hong Kong, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Turku, Finland, 20520 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leeds, United Kingdom, LS1 3EX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H4A 3J1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sao Paulo, Brazil, 05403-000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100034 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hangzhou, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pensacola, United States, 32504 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Solna, Sweden, 171 64 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ciudad de México, Mexico, 06720 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site South Brisbane, Australia, 4101 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Obu, Japan, 474-8710 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bunkyo-ku, Japan, 113-8655 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Azumino, Japan, 399-8288 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Edinburgh, United Kingdom, EH9 1LF | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kemerovo, Russia, 650002 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kazan, Russia, 420138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Miguel de Tucumán, Argentina, 4000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Konya, Turkey, 42080 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Istanbul, Turkey, 34093 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adana, Turkey, 01130 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bratislava, Slovakia, 833 41 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Edmonton, Canada, T6G 2B7 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oxford, United Kingdom, OX3 9DU | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Carnaxide, Portugal, 2795-53 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 119228 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Singapore, Singapore, 229 899 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zürich, Switzerland, 8032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, SW3 6NP | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Multicenter, open-label, active-controlled, randomized study to evaluate the efficacy and safety of an age-and body weight-adjusted rivaroxaban regimen compared to standard of care in children with acute venous thromboembolism
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Incidence rates of all symptomatic recurrent venous thromboembolism during the main treatment periodThe Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference populationTimeframe: During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)
- Incidence rates of all symptomatic recurrent venous thromboembolism during extended treatment periodIncidence rates for all children except those aged < 2 years with catheter-related thrombosis. The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference Population. 'NA' denotes data that cannot be calculated.Timeframe: During extended treatment period: up to month 12.
- Number of subjects with the composite of all symptomatic recurrent venous thromboembolism during the 30 days post-study treatment period (i.e. >2 and ≤ 30 days after stop of study medication)The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Age group with primary efficacy outcome was reported.Timeframe: More than 2 and up to 30 days after stop of study medication
- Incidence rates of the composite of treatment emergent overt major bleeding and clinically relevant non-major (CRNM) bleeding during main treatment periodThe Central independent adjudication committee (CIAC) classified bleeding as: Major bleeding defined as overt bleeding and: · associated with a fall in hemoglobin of 2 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, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteriafor major bleeding, but associated with: medical intervention, or unscheduled contact (visit or telephone call) with a physician, or (temporary) cessation 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).Timeframe: During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)
- Incidence rates of the composite of treatment emergent overt major bleeding and clinically relevant non-major (CRNM) bleeding during extended treatment periodIncidence rates for all children except those aged < 2 years with catheter-related thrombosis. The CIAC classified bleeding as: Major bleeding defined as overt bleeding and: associated with a fall in hemoglobin of 2 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, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteriafor major bleeding, but associated with: medical intervention, or unscheduled contact (visit or telephone call) with a physician, or (temporary) cessation 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). 'NA' denotes data that cannot be calculated.Timeframe: During extended treatment period: up to month 12.
Secondary Outcome
- Incidence rates of the composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration in thrombotic burden on repeat imaging during the main treatment periodThe secondary efficacy outcome defined as the composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging as assessed by central independent adjudication committee. (CIAC) Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference populationTimeframe: During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)
- AUC(0-24)ss in plasmaAUC(0-24)ss: Area under the concentration vs. time curve from time 0 to 24 hours at steady state.Timeframe: over 24 hours
- Cmax,ss in plasmaMaximum drug concentration in measured matrix at steady state during a dosage intervalTimeframe: 0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours (one dosing interval in steady state)
- Ctrough,ss in plasmaCtrough,ss refers to the drug concentration at the end of the dosage interval at steady stateTimeframe: 0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours(one sampling interval in steady state)
- Prothrombin time (PT) ratios to baseline: Rivaroxaban administered once daily (suspension and tablet) in the age group 12-<18 yearsProthrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.Timeframe: Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
- Prothrombin time (PT) ratios to baseline: Rivaroxaban administered once daily (suspension and tablet) in the age group 6-<12 yearsProthrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.Timeframe: Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
- Prothrombin time (PT) ratios to baseline: Rivaroxaban administered twice daily (suspension and tablet) in the age group 6-<12 yearsProthrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.Timeframe: Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
- Prothrombin time (PT) ratios to baseline: Rivaroxaban administered twice daily (suspension) in the age group 2-<6 yearsProthrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.Timeframe: Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
- Prothrombin time (PT) ratios to baseline: Rivaroxaban administered twice daily (suspension) in the age group 0.5-<2 yearsProthrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.Timeframe: Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
- Prothrombin time (PT) ratios to baseline: Rivaroxaban administered three times daily (suspension) in the age group 2-<6 yearsProthrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.Timeframe: Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60
- Prothrombin time (PT) ratios to baseline: Rivaroxaban administered three times daily (suspension) in the age group 0.5-<2 yearsProthrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.Timeframe: Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60
- Prothrombin time (PT) ratios to baseline: Rivaroxaban administered three times daily (suspension) in the age group birth-<0.5 yearsProthrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.Timeframe: Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60
- Activated partial thromboplastin time (aPTT) ratios to baseline: Rivaroxaban administered once daily (suspension and tablet) in the age group 12-<18 yearsThe 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. The initial read-out is in seconds.Timeframe: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
- Activated partial thromboplastin time (aPTT) ratios to baseline: Rivaroxaban administered once daily (suspension and tablet) in the age group 6-<12 yearsThe 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. The initial read-out is in seconds.Timeframe: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
- Activated partial thromboplastin time (aPTT) ratios to baseline: Rivaroxaban administered twice daily (suspension and tablet) in the age group 6-<12 yearsThe 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. The initial read-out is in seconds.Timeframe: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
- Activated partial thromboplastin time (aPTT) ratios to baseline: Rivaroxaban administered twice daily (suspension) in the age group 2-<6 yearsThe 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. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.Timeframe: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
- Activated partial thromboplastin time (aPTT) ratios to baseline: Rivaroxaban administered twice daily (suspension) in the age group 0.5-<2 yearsThe 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. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.Timeframe: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
- Activated partial thromboplastin time (aPTT) ratios to baseline: Rivaroxaban administered three times daily (suspension) in the age group 2-<6 yearsThe 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. The initial read-out is in seconds.Timeframe: Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60
- Activated partial thromboplastin time (aPTT) ratios to baseline: Rivaroxaban administered three times daily (suspension) in the age group 0.5-<2 yearsThe 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. The initial read-out is in seconds.Timeframe: Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60
- Activated partial thromboplastin time (aPTT) ratios to baseline: Rivaroxaban administered three times daily (suspension) in the age group birth-<0.5 yearsThe 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. The initial read-out is in seconds.Timeframe: Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60
- Anti-Xa values: Rivaroxaban administered once daily (suspension and tablet) in the age group 12-<18 yearsThis is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.Timeframe: Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90
- Anti-Xa values: Rivaroxaban administered once daily (suspension and tablet) in the age group 6-<12 yearsThis is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.Timeframe: Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90
- Anti-Xa values: Rivaroxaban administered twice daily (suspension and tablet) in the age group 6-<12 yearsThis is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.Timeframe: Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90
- Anti-Xa values: Rivaroxaban administered twice daily (suspension) in the age group 2-<6 yearsThis is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.Timeframe: Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90
- Anti-Xa values: Rivaroxaban administered twice daily (suspension) in the age group 0.5-<2 yearsThis is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.Timeframe: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
- Anti-Xa values: Rivaroxaban administered three times daily (suspension) in the age group 2-<6 yearsThis is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.Timeframe: Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, and up to 16 hours on Day 90
- Anti-Xa values: Rivaroxaban administered three times daily (suspension) in the age group 0.5-<2 yearsThis is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.Timeframe: Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, and up to 16 hours on Day 90
- Anti-Xa values: Rivaroxaban administered three times daily (suspension) in the age group birth-<0.5 yearsThis is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.Timeframe: Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60
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