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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000991-49 | EudraCT Number | ||
| CTRI/2018/01/011249 | Registry Identifier | Clinical Trials Registry - India (CTRI) | |
| NCT02798471 | Registry Identifier | ClinicalTrials.gov |
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This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to compare the efficacy and safety of edoxaban against standard of care in pediatric subjects with confirmed VTE.
The objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC; including low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors) in the treatment and secondary prevention of VTE in pediatric subjects with regard to the composite efficacy endpoint (ie, symptomatic recurrent VTE, death as result of VTE, and no change or extension of thrombotic burden) during the first 3-month treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Edoxaban | Experimental | Edoxaban treatment will be dispensed to the participant on a monthly visit schedule. Edoxaban will be started orally at the age/weight/renal function appropriate dose, depending on the results of the ongoing U157 study (NCT02303431) for the Treatment Period. |
|
| Standard of Care | Experimental | Standard of Care (SOC) treatment will be dispensed to the participant on a monthly visit schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edoxaban | Drug | 15 or 30 mg tablets for participants 12 years of age to <18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis. | Randomization to Month 3 |
| Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. | Randomization to Month 3 |
| Number of Participants With No Change or Extension of Thrombotic Burden During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | No change or extension of thrombotic burden as assessed by quantitative diagnostic imaging of the index qualifying VTE thrombus at baseline and at Month 3. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA). | Randomization to Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Tucson | Arizona | 85724 | United States | ||
| Children's Hospital Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23991658 | Background | Hokusai-VTE Investigators; Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31. |
| Label | URL |
|---|---|
| Related Information | View source |
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De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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A total of 290 participants who met all inclusion criteria and no exclusion criteria were randomized to receive either edoxaban or standard of care treatment; 286 patients received at least 1 dose of study drug (modified intent-to-treat population).
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| ID | Title | Description |
|---|---|---|
| FG000 | Edoxaban | Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to <18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age. |
| FG001 | Standard of Care |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2021 |
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| Standard of Care | Drug | Standard of care could include low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors. |
|
|
| From randomization up to Month 12 |
| Number of Participants With Symptomatic Recurrent VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint) | Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis. | Randomization to Month 3 |
| Number of Participants Who Died as a Result of VTE During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. | From randomization up to Month 12 |
| Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint) | Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. | Randomization to Month 3 |
| Number of Participants With No Change or Extension of Thrombotic Burden During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | No change or extension of thrombotic burden as assessed by quantitative diagnostic imaging of the index qualifying VTE thrombus. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA). | From randomization up to Month 12 |
| Number of Participants With Adjudicated Individual Component of Primary Efficacy Endpoints During the Main Treatment Period Following Edoxaban or Standard of Care Treatment | Diagnosis of recurrent VTE requires the confirmation imaging and ≥1 symptom of VTE. Death from VTE is based on diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. No change or extension of thrombotic burden (quantitative diagnostic imaging) of the index qualifying VTE thrombus. Imaging criteria for VTE: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA). | Randomization to Month 3 |
| Number of Participants Reporting Adjudicated All-Cause Mortality During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated) | All-cause mortality is defined as death due to any cause. Adjudicated data are reported for overall all-cause mortality, all-cause mortality by the primary cause of death, and primary cause of death further described by additional specifications. | From randomization up to Month 12 |
| Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment | Deep vein thrombosis was assessed by ultrasonography or magnetic resonance venography (MRV), catheter-related thrombosis was assessed by ultrasonography or echocardiography, sino-venous thrombosis was assessed by brain MRI, and pulmonary embolism was assessed by nuclear ventilation/perfusion (V/Q) scanning. | From randomization up to Month 12 |
| Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug). | Randomization to Month 3 |
| Number of Participants With All Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | All bleeding events included major bleeding defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells (RBCs), clinically relevant non-major bleeding defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug), nuisance bleeding, or a combination of bleeding events. | From randomization up to Month 12 |
| Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug). | From randomization up to Month 12 |
| Los Angeles |
| California |
| 90027 |
| United States |
| UCLA Medical Center CAR | Los Angeles | California | 90095 | United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | 60453 | United States |
| Indiana Hemophilia and Thrombosis Center | Indianapolis | Indiana | 46260 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Spectrum Health Helen DeVos Children's Hospital Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| Children's Hospital & Clinics of Minnesota | Minneapolis | Minnesota | 55404 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University North Carolina- Chapel Hill | Chapel Hill | North Carolina | 27517 | United States |
| Levine Children's Hospital Charlotte | Charlotte | North Carolina | 28204 | United States |
| The Presbyterian Hospital | Charlotte | North Carolina | 28210 | United States |
| East Carolina University | Greenville | North Carolina | 27858 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Hasbro Children's Hospital | Providence | Rhode Island | 02903 | United States |
| Le Bonheur Childrens Hospital | Memphis | Tennessee | 38105 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Hospital Italiano Regional del Sur | Buenos Aires | B8001HXM | Argentina |
| Sanatorio Allende | Córdoba | X5000JHQ | Argentina |
| Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer | Curitiba | Paraná | 81520-060 | Brazil |
| IMIP - Instituto de Medicina Integral Professor Fernando Figueira | Pernambuco | Recife | 50070-550 | Brazil |
| Hospital São Vicente de Paulo | Passo Fundo | Rio Grande do Sul | 99010-080 | Brazil |
| Hospital da Cidade de Passo Fundo | Passo Fundo | Rio Grande do Sul | 99010-260 | Brazil |
| Instituto de Cardiologia do Rio Grande do Sul | Pôrto Alegre | Rio Grande do Sul | 90620-001 | Brazil |
| Hospital de Câncer de Barretos - Fundação Pio XII | Barretos | São Paulo | 14784-400 | Brazil |
| Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP | Campinas | São Paulo | 13083-878 | Brazil |
| Centro Multidisciplinar de Estudos Clínicos - CEMEC | Santo André | São Paulo | 09190-510 | Brazil |
| Santa Casa de Votuporanga | Votuporanga | São Paulo | 15500-003 | Brazil |
| Hospital Samaritano | São Paulo | 01232-010 | Brazil |
| Hospital da Luz Amico Saude LTDA | São Paulo | 04013-060 | Brazil |
| Hospital Infantil Pequeno Príncipe | São Paulo | 04013-060 | Brazil |
| GRAACC - Grupo de Apoio ao Adolescente e à Criança com Câncer | São Paulo | 04039-001 | Brazil |
| UNIFESP - Universidade Federal de São Paulo | São Paulo | 04039-032 | Brazil |
| Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | São Paulo | 05403-000 | Brazil |
| HMCG - Hospital e Maternidade Dr. Christovão da Gama | São Paulo | 09030-010 | Brazil |
| UMHAT "Sv. Georgi", EAD | Plovdiv | 4000 | Bulgaria |
| MHAT - "National Heart Hospital" EAD | Sofia | 1309 | Bulgaria |
| MHAT 'Tokuda Hospital Sofia', EAD | Sofia | 1407 | Bulgaria |
| Medical Center for Specialized Ambulatory Medical Assistance for Children's Diseases | Sofia | 1612 | Bulgaria |
| Edmonton Clinic Health Academy | Edmonton | Alberta | T6G 2B7 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| McMaster Children's Hospital | Hamilton | Ontario | L8N 3Z5 | Canada |
| Hospital El Carmen Dr. Luis Valentin Ferrada | Maipú | 9251521 | Chile |
| Clinica Las Condes | Santiago | 7591047 | Chile |
| Clinical Hospital Centre Rijeka | Rijeka | 51000 | Croatia |
| General Hospital Zadar | Zadar | 23000 | Croatia |
| Children's Hospital Zagreb | Zagreb | 10 000 | Croatia |
| University Hospital Centre Zagreb, University of Zagreb School of Medicine | Zagreb | 10000 | Croatia |
| Fakultni nemocnice Brno | Brno | 613 00 | Czechia |
| CTC Hodonin s.r.o. | Hodonín | 69501 | Czechia |
| Dětská klinika Fakultní nemocnice | Hradec Králové | 500 05 | Czechia |
| University Hospital Pilsen, CZ | Pilsen | 305 99 | Czechia |
| Ålborg Universitetshospital | Aalborg | 9000 | Denmark |
| Hospital Nacional de Niños Benjamín Bloom | San Salvador | Salvador | El Salvador |
| Clinical Hospital Centre Cavale Blanche BREST | Brest | Finistere | 29200 | France |
| Groupe Hospitalier Sud - Hôpital Haut-Lévêque | Pessac | Gironde | 33600 | France |
| Hôpital des enfants, CHU Toulouse | Toulouse | Haute Garonne | 31059 | France |
| CHU Rennes - Hopital Sud | Rennes | Ille Et Vilaine | 35203 | France |
| CHU Angers - Hôpital Hôtel Dieu | Angers | 49100 | France |
| CHU Clermont Ferrand - Hôpital d'Estaing | Clermont-Ferrand | 63003 | France |
| CHU Arnaud de Villeneuve | Montpellier | 34295 | France |
| Universitaetsklinikum Essen | Essen | North Rhine-Westphalia | 45122 | Germany |
| Charite - Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Unidad de Cirugía Cardiovascular de Guatemala (UNICAR) | Guatemala City | Guatemala |
| Unidad Nacional de Oncología Pediátrica (UNOP) | Guatemala City | Guatemala |
| Semmelweis University 2nd Department of Pediatrics | Budapest | 1094 | Hungary |
| Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases | Budapest | H-1097 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| University of Szeged, Department of Pediatrics | Szeged | 6720 | Hungary |
| Shree Krishna Hospital & Medical Research Centre, H M Patel Centre for Medical Care and Education | Karamsad | Gujarat | 388325 | India |
| Nirmal Hospital | Surat | Gujarat | 395002 | India |
| Jain Institute of Vascular Sciences | Bangalore | Karnataka | 560052 | India |
| M. S. Ramaiah Medical College and Hospital | Bangalore | Karnataka | 560054 | India |
| Government Medical College and Hospital | Nagpur | Maharashtra | 440003 | India |
| Sir Ganga Ram Hospital | New Delhi | National Capital Territory of Delhi | 110060 | India |
| Christian Medical College | Ludhiana | Punjab | 141008 | India |
| Institute of Child Health | Kolkata | West Bengal | 700017 | India |
| Indraprastha Apollo Hospitals | Delhi | 110076 | India |
| Rambam Medical Center | Haifa | 3109601 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Hadassah ein Kerem | Jerusalem | 91120 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Strathmore University Medical Centre | Nairobi | 59857-00200 | Kenya |
| American University of Beirut Medical Center | Beirut | 1107 2020 | Lebanon |
| Saint George University Hospital Medical Center | Beirut | 166378 | Lebanon |
| Hotel Dieu de France Hospital | Beirut | 166830 | Lebanon |
| Hospital Raja Perempuan Zainab II | Kota Bharu | Kelantan | 15586 | Malaysia |
| Erasmus MC Sophia | Rotterdam | 3000 CB | Netherlands |
| Oslo University Hospital | Oslo | 15-274 | Norway |
| INDICASAT AIP Site 7871 | Panama City | 0843-01103 | Panama |
| INDICASAT AIP Site 7872 | Panama City | 0843-01103 | Panama |
| Hospital de Braga | Braga | 4710-243 | Portugal |
| Hospital da Senhora da Oliveira | Guimarães | 4835-044 | Portugal |
| Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santa Marta | Lisbon | 1169-1024 | Portugal |
| Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| S.C Centrul Clinic Mediquest S.R.L | Sângeorgiu de Mureş | 547530 | Romania |
| FSBI of Science "Kirov Scientific and Research Institute of Hematology and Blood Transfusion, FMBA" | Kirov | 610027 | Russia |
| Russian Scientific Center of Radiology and Nuclear Medicine of Ministry of Health of Russian Federation, Department of Pediatric Oncology | Moscow | 117997 | Russia |
| Mother and Child Health Care Institute of Serbia "Dr. Vukan Cupic" | Belgrade | 11070 | Serbia |
| Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| National University Hospital | Singapore | 119074 | Singapore |
| KK Women's And Children's Hospital | Singapore | 229899 | Singapore |
| University Medical Centre Ljubljana | Ljubljana | 1000 | Slovenia |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 3080 | South Korea |
| Severance Hospital, Yonsei University | Seoul | 3722 | South Korea |
| Samsung Medical Center | Seoul | 6351 | South Korea |
| Hospital Universitari Vall d'Hebron | Barcelona | 8035 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario Araba | Vitoria-Gasteiz | Álava | 01009 | Spain |
| Buddhist Tzu Chi General Hospital | Hualien City | 970 | Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 81362 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| Taipei Medical University Hospital | Taipei | 11031 | Taiwan |
| Ramathibodi Hospital | Bangkok | 10300 | Thailand |
| King Chulalongkorn Memorial Hospital | Bangkok | 10330 | Thailand |
| Phramongkutklao Hospital | Bangkok | 10400 | Thailand |
| Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University | Chiang Mai | 50200 | Thailand |
| Srinagarind Hospital | Khon Kaen | 40002 | Thailand |
| Songklanagarind Hospital | Songkhla | 90110 | Thailand |
| Cukurova University Faculty of Medicine Balcali Hospital Pediatry Department | Adana | 1330 | Turkey (Türkiye) |
| Hacettepe University Medical Faculty | Ankara | 6100 | Turkey (Türkiye) |
| Ankara Çocuk Sağlığı Ve Hastalıkları Hematoloji Onkoloji Eğitim Araştırma Hastanesi | Ankara | 6110 | Turkey (Türkiye) |
| Istanbul University Istanbul Medical Faculty | Istanbul | 34093 | Turkey (Türkiye) |
| Yeditepe University Oncology Hospital | Istanbul | 34718 | Turkey (Türkiye) |
| Ege University Medical Faculty | Izmir | 35040 | Turkey (Türkiye) |
| Izmir Tepecik Training and Research Hospital | Izmir | 35170 | Turkey (Türkiye) |
| Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi | Izmir | 35210 | Turkey (Türkiye) |
| Erciyes University Medical Faculty | Kayseri | 38039 | Turkey (Türkiye) |
| Mersin University Health Research and Practice Hospital | Mersin | 33343 | Turkey (Türkiye) |
| Regional Children's Clinical Hospital | Dnipro | 49100 | Ukraine |
| CI of Healthcare Regional Children CH Gastroenterology Center Kharkiv NMU | Kharkiv | 61093 | Ukraine |
| Children City Clinical Hospital | Poltava | 36004 | Ukraine |
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors. |
| Modified Intent-to-Treat Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline demographic characteristics were reported in the Randomized Analysis Set.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Edoxaban | Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to <18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age. |
| BG001 | Standard of Care | Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors. |
| BG002 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis. | Symptomatic recurrent VTE was assessed in the modified intent-to-treat population (mITT). | Posted | Count of Participants | Participants | Randomization to Month 3 |
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| Primary | Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. | Death was assessed in the modified intent-to-treat population (mITT). | Posted | Count of Participants | Participants | Randomization to Month 3 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With No Change or Extension of Thrombotic Burden During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | No change or extension of thrombotic burden as assessed by quantitative diagnostic imaging of the index qualifying VTE thrombus at baseline and at Month 3. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA). | Change in thrombotic burden was assessed in the modified intent-to-treat population (mITT). | Posted | Count of Participants | Participants | Randomization to Month 3 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis. | Symptomatic VTE was assessed in the modified intent-to-treat (mITT) population. | Posted | Count of Participants | Participants | From randomization up to Month 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Symptomatic Recurrent VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint) | Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis. | Symptomatic recurrent VTE was assessed in the modified intent-to-treat population (mITT). | Posted | Count of Participants | Participants | Randomization to Month 3 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Died as a Result of VTE During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. | Death was assessed in the modified intent-to-treat population (mITT). | Posted | Count of Participants | Participants | From randomization up to Month 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint) | Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. | Death was assessed in the modified intent-to-treat population (mITT). | Posted | Count of Participants | Participants | Randomization to Month 3 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With No Change or Extension of Thrombotic Burden During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | No change or extension of thrombotic burden as assessed by quantitative diagnostic imaging of the index qualifying VTE thrombus. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA). | Change in thrombotic burden was assessed in the modified intent-to-treat population (mITT). | Posted | Count of Participants | Participants | From randomization up to Month 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adjudicated Individual Component of Primary Efficacy Endpoints During the Main Treatment Period Following Edoxaban or Standard of Care Treatment | Diagnosis of recurrent VTE requires the confirmation imaging and ≥1 symptom of VTE. Death from VTE is based on diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. No change or extension of thrombotic burden (quantitative diagnostic imaging) of the index qualifying VTE thrombus. Imaging criteria for VTE: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA). | Change in thrombotic burden was assessed in the modified intent-to-treat population (mITT). | Posted | Count of Participants | Participants | Randomization to Month 3 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting Adjudicated All-Cause Mortality During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated) | All-cause mortality is defined as death due to any cause. Adjudicated data are reported for overall all-cause mortality, all-cause mortality by the primary cause of death, and primary cause of death further described by additional specifications. | All-cause mortality was assessed in the modified intent-to-treat (mITT) population. | Posted | Count of Participants | Participants | From randomization up to Month 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment | Deep vein thrombosis was assessed by ultrasonography or magnetic resonance venography (MRV), catheter-related thrombosis was assessed by ultrasonography or echocardiography, sino-venous thrombosis was assessed by brain MRI, and pulmonary embolism was assessed by nuclear ventilation/perfusion (V/Q) scanning. | Deep vein thrombosis, catheter-related thrombosis, sino-venous thrombosis, and pulmonary embolism were assessed in the modified intent-to-treat (mITT) population. | Posted | Count of Participants | Participants | From randomization up to Month 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug). | Major and clinically relevant non-major bleeding events were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | Randomization to Month 3 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With All Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | All bleeding events included major bleeding defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells (RBCs), clinically relevant non-major bleeding defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug), nuisance bleeding, or a combination of bleeding events. | All bleeding events were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | From randomization up to Month 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) | Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug). | Major and clinically relevant non-major bleeding events were assessed in the Safety Analysis Set. | Posted | Count of Participants | Participants | From randomization up to Month 12 |
|
Treatment-emergent adverse events were collected from the date the Informed Consent Form was signed up to Month 12.
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 | Edoxaban | Pediatric patients who were randomized to edoxaban treatment. Edoxaban was administered as 15 or 30 mg tablets for participants 12 years of age to <18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age. | 3 | 145 | 44 | 145 | 51 | 145 |
| EG001 | Standard of Care | Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors. | 3 | 141 | 37 | 141 | 46 | 141 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypereosinophilic syndrome | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sickle cell anemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chronic granulomatous disease | Congenital, familial and genetic disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Papilloedema | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Medical device site rash | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Enterovirus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastritis viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Stoma complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Stoma site haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Lipoedema | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chest wall haematoma | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anaplastic astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Idiopathic intracranial hypertension | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cerebral venous sinus thrombosis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Psychiatric decompensation | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bronchomalacia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Non-cardiogenic pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Post thrombotic syndrome | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Superior vena cava occlusion | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Venoocclusive disease | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo | 908-992-6400 | CTRinfo@dsi.com |
| Oct 13, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D011655 | Pulmonary Embolism |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D013927 | Thrombosis |
Not provided
Not provided
| ID | Term |
|---|---|
| C552171 | edoxaban |
| D059039 | Standard of Care |
| D014859 | Warfarin |
| D006493 | Heparin |
| D017984 | Enoxaparin |
| D000077425 | Fondaparinux |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D006495 | Heparin, Low-Molecular-Weight |
| D009844 | Oligosaccharides |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Czechia |
|
| Malaysia |
|
| Thailand |
|
| Portugal |
|
| Russia |
|
| Netherlands |
|
| South Korea |
|
| El Salvador |
|
| Panama |
|
| Brazil |
|
| Guatemala |
|
| Bulgaria |
|
| Chile |
|
| France |
|
| Croatia |
|
| Hungary |
|
| Ukraine |
|
| India |
|
| Spain |
|
| Lebanon |
|
| Canada |
|
| Turkey |
|
| Norway |
|
| Taiwan |
|
| Israel |
|
| Germany |
|
| Colombia |
|
|
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
|
|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|
| OG001 |
| Standard of Care |
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors. |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 |
| Standard of Care |
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors. |
|
|
| Standard of Care |
Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors. |
|
|
| OG001 | Standard of Care | Pediatric patients who were randomized to standard of care (SOC) treatment. Standard of care may have included low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors. |
|
|