Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004539-30 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
Not provided
Not provided
Not provided
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The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. There will also be a check for bleeding and worsening of blood clots.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban (BAY59-7939) tablet, OD, Age: 12 - <18 | Experimental | Subjects aged from 12 - <18 years were administered with age and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR (immediate-release) tablet once daily (OD) 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 | Active Comparator | Subjects aged from 12 - <18 years received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist). |
|
| Rivaroxaban (BAY59-7939) tablet, OD, Age: 6 - <12 years | Experimental | 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. Subjects with a body weight of 14 to less than 50 kg received a dose (equivalent to 20 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. |
|
| Rivaroxaban (BAY59-7939) suspension, BID, Age: 6 - <12 years | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | Subjects were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events | Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and:
Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with:
| From start of study drug administration until end of the 30-day treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Symptomatic Recurrent Venous Thromboembolism | The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence of venous thrombosis was documented by the appropriate imaging test. | From start of study drug administration until end of the 30-day treatment period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72202-3500 | United States | |||
Not provided
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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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.
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).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 (BID). 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 | Active Comparator | Subjects aged from 6 - <12 years received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or INR-adjusted (vitamin K antagonist). |
|
| Active comparator | Drug | Subjects received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist). |
|
| Rivaroxaban (BAY59-7939) suspension | Drug | Subjects aged were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily. |
|
| Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden |
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. |
| Repeat imaging at the end of the 30 day treatment period |
| Change From Baseline in Prothrombin Time at Specified Time Points | Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade. | 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31 |
| Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points | The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway. | 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31 |
| Anti-factor Xa Values at Specified Time Points | The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. | 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31 |
| Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points | Geometric and percentage geometric coefficient of variation (%CV) were reported. | 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31 |
| Los Angeles |
| California |
| 90027-6089 |
| United States |
| Orange | California | 92868-3974 | United States |
| Chicago | Illinois | 60611 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Detroit | Michigan | 48201-2196 | United States |
| Minneapolis | Minnesota | 55404 | United States |
| New Hyde Park | New York | 11040 | United States |
| Cleveland | Ohio | 44106-2602 | United States |
| Columbus | Ohio | 43205-2696 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Houston | Texas | 77030 | United States |
| Richmond | Virginia | 23298 | United States |
| Westmead | New South Wales | 2145 | Australia |
| Parkville | Victoria | 3052 | Australia |
| South Brisbane | 4101 | Australia |
| Graz | Styria | 8036 | Austria |
| Innsbruck | Tyrol | 6020 | Austria |
| Linz | Upper Austria | 4020 | Austria |
| Vienna | 1090 | Austria |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Hamilton | Ontario | L8N 3Z5 | Canada |
| Ottawa | Ontario | K1H 8L1 | Canada |
| Toronto | Ontario | M5G 1X8 | Canada |
| Québec | G1V 4G2 | Canada |
| Bordeaux | 33076 | France |
| Montpellier | 34295 | France |
| Nantes | 44093 | France |
| Paris | 75015 | France |
| Paris | 75019 | France |
| Rennes | 35033 | France |
| Toulouse | 31059 | France |
| Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Erlangen | Bavaria | 91054 | Germany |
| Frankfurt am Main | Hesse | 60590 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Lübeck | Schleswig-Holstein | 23538 | Germany |
| Berlin | 13353 | Germany |
| Beersheba | 8410101 | Israel |
| Haifa | 3109601 | Israel |
| Jerusalem | 9112001 | Israel |
| Petah Tikva | 4920235 | Israel |
| Ramat Gan | 5262000 | Israel |
| Bari | Apulia | 70124 | Italy |
| Genoa | Liguria | 16147 | Italy |
| Milan | Lombardy | 20122 | Italy |
| Pavia | Lombardy | 27100 | Italy |
| Turin | Piedmont | 10126 | Italy |
| Padova | Veneto | 35128 | Italy |
| Amsterdam | 1081 HV | Netherlands |
| Amsterdam | Netherlands |
| Nijmegen | 6525 GA | Netherlands |
| Rotterdam | 3015 GJ | Netherlands |
| Utrecht | 3584 CX | Netherlands |
| Basel | Canton of Basel-City | 4056 | Switzerland |
| Sankt Gallen | Canton of St. Gallen | 9006 | Switzerland |
| Bern | 3010 | Switzerland |
| Lucerne | 6000 | Switzerland |
| Zurich | 8032 | Switzerland |
| FG001 | Comparator, Age: 12 - <18 Years | Subjects aged from 12 - <18 years received comparator as per standard of care. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | Comparator, Age: 6 - < 12 Years | Subjects aged from 6 - < 12 years received comparator as per standard of care. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Comparator, Age: 12 - <18 Years | Subjects aged from 12 - <18 years received comparator as per standard of care. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Comparator, Age: 6 - < 12 Years | Subjects aged from 6 - < 12 years received comparator as per standard of care. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events | Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and:
Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with:
| Full analysis set. Data was evaluated only for subjects who received active study medication. | Posted | Number | Participants | From start of study drug administration until end of the 30-day treatment period |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Symptomatic Recurrent Venous Thromboembolism | The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence of venous thrombosis was documented by the appropriate imaging test. | Full analysis set | Posted | Number | Participants | From start of study drug administration until end of the 30-day treatment period |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden | 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. | Full analysis set | Posted | Number | Participants | Repeat imaging at the end of the 30 day treatment period |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Prothrombin Time at Specified Time Points | Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade. | Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy. | Posted | Mean | Standard Deviation | seconds | 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points | The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway. | Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy. | Posted | Mean | Standard Deviation | seconds | 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-factor Xa Values at Specified Time Points | The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. | Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy. | Posted | Mean | Standard Deviation | microgram per liter (mcg/L) | 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points | Geometric and percentage geometric coefficient of variation (%CV) were reported. | Pharmacokinetic analysis set (N= 42) included all subjects with at least one pharmacokinetic sample in accordance with the pharmacokinetic sampling strategy. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per liter (mcg/L) | 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31 |
|
From start of study drug administration until 30 day post study treatment
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 11 | 9 | 11 | ||
| EG001 | Comparator, Age: 12 - <18 Years | Subjects aged from 12 - <18 years received comparator as per standard of care. | 1 | 13 | 8 | 13 | ||
| EG002 | 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. | 0 | 13 | 6 | 13 | ||
| EG003 | 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. | 2 | 19 | 12 | 19 | ||
| EG004 | Comparator, Age: 6 - < 12 Years | Subjects aged from 6 - < 12 years received comparator as per standard of care. | 0 | 7 | 2 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypothalamo-pituitary disorder | Endocrine disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Influenza B virus test positive | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Tooth loss | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vessel puncture site haematoma | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vessel puncture site swelling | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Post thrombotic syndrome | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayer.com |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Clinically relevant non-major bleeding events |
|
| OG003 | 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. |
| OG004 | Comparator, Age: 6 - < 12 Years | Subjects aged from 6 - < 12 years received comparator as per standard of care. |
|
|
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.
| OG003 | 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. |
| OG004 | Comparator, Age: 6 - < 12 Years | Subjects aged from 6 - < 12 years received comparator as per standard of care. |
|
|
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. |
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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. |
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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. |
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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. |
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