0 Avaliações
ID

4437

Descrição

This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT or PE who completed 6 or 12 months of treatment with rivaroxaban or VKA are eligible for this trial (Einstein-Extension study).

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Versões (1)
  1. 09/12/2013 09/12/2013 - Martin Dugas
Transferido a

9 de dezembro de 2013

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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    Eligibility NCT00439725 Deep Vein Thrombosis

    Alemão Inglês

    Eligibility

    1 Formulários  
    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Descrição

    Einschlusskriterien

    Age
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    SNOMED CT 2010_0731
    424144002 (undefined)
    LNC
    MTHU010047 (undefined)
    Symptomatic Pulmonary Embolism or Deep Vein Thrombosis treated with Vitamin-K-Antagonists or Rivaroxaban
    Descrição

    Symptomatic Pulmonary Embolism or Deep Vein Thrombosis treated with Vitamin-K-Antagonists or Rivaroxaban

    Tipo de dados

    boolean

    Alias
    UMLS CUI
    C0034065 (Pulmonary Embolism)
    SNOMED
    59282003
    LOINC
    LP90124-6
    ICD10CM
    I26.99 (undefined)
    MDR
    10037377 (undefined)
    SNOMED CT 2010_0731
    59282003 (undefined)
    UMLS CUI
    C0149871 (Deep Vein Thrombosis)
    SNOMED
    128053003
    ICD10CM
    I82.40 (undefined)
    LNC
    MTHU020788 (undefined)
    MDR
    10051055 (undefined)
    SNOMED CT 2010_0731
    128053003 (undefined)
    UMLS CUI
    C1096489 (Treatment with Vitamin K antagonist)
    MDR
    10053755 (undefined)
    UMLS CUI
    C1739768 (rivaroxaban)
    SNOMED
    442031002
    SNOMED CT 2010_0731
    442031002 (undefined)
    Ausschlusskriterien
    Descrição

    Ausschlusskriterien

    Legal lower age limitations (country specific)
    Descrição

    Legal lower age limitations (country specific)

    Tipo de dados

    boolean

    Alias
    UMLS CUI
    C0680135 (age restriction in context)
    UMLS CUI
    C0682055 (age subdivision of legal significance)
    Other indication for Vitamin-K-Antagonist-treatment than Pulmonary Embolism or Deep Vein Thrombosis
    Descrição

    Other indication for Vitamin-K-Antagonist-treatment than Pulmonary Embolism or Deep Vein Thrombosis

    Tipo de dados

    boolean

    Alias
    UMLS CUI
    C0034065 (Pulmonary Embolism)
    SNOMED
    59282003
    LOINC
    LP90124-6
    ICD10CM
    I26.99 (undefined)
    MDR
    10037377 (undefined)
    SNOMED CT 2010_0731
    59282003 (undefined)
    UMLS CUI
    C0149871 (Deep Vein Thrombosis)
    SNOMED
    128053003
    ICD10CM
    I82.40 (undefined)
    LNC
    MTHU020788 (undefined)
    MDR
    10051055 (undefined)
    SNOMED CT 2010_0731
    128053003 (undefined)
    UMLS CUI
    C1096489 (Treatment with Vitamin K antagonist)
    MDR
    10053755 (undefined)
    Anticoagulation treatment should be continued
    Descrição

    Anticoagulation treatment should be continued

    Tipo de dados

    boolean

    Alias
    UMLS CUI
    C0150457 (Anticoagulant therapy)
    SNOMED
    182764009
    LOINC
    LA28199-0
    MDR
    10053468 (undefined)
    SNOMED CT 2010_0731
    182764009 (undefined)
    UMLS CUI
    C0034065 (Pulmonary Embolism)
    SNOMED
    59282003
    LOINC
    LP90124-6
    ICD10CM
    I26.99 (undefined)
    MDR
    10037377 (undefined)
    SNOMED CT 2010_0731
    59282003 (undefined)
    UMLS CUI
    C0149871 (Deep Vein Thrombosis)
    SNOMED
    128053003
    ICD10CM
    I82.40 (undefined)
    LNC
    MTHU020788 (undefined)
    MDR
    10051055 (undefined)
    SNOMED CT 2010_0731
    128053003 (undefined)
    No contraception, No pregnancy or breast feeding
    Descrição

    No contraception, No pregnancy or breast feeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    LNC
    MTHU024530 (undefined)
    MDR
    10010808 (undefined)
    SNOMED CT 2010_0731
    13197004 (undefined)
    UMLS CUI
    C0549206 (Patient currently pregnant)
    SNOMED
    77386006
    LOINC
    LA14670-6
    MDR
    10036586 (undefined)
    SNOMED CT 2010_0731
    77386006 (undefined)
    UMLS CUI
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    MDR
    10006247 (undefined)
    SNOMED CT 2010_0731
    169741004 (undefined)
    Medizinische Konzepte
    Descrição

    Medizinische Konzepte

    Age
    Descrição

    Age

    Tipo de dados

    string

    Alias
    UMLS CUI
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    SNOMED CT 2010_0731
    424144002 (undefined)
    LNC
    MTHU010047 (undefined)
    Pulmonary Embolism
    Descrição

    Pulmonary Embolism

    Tipo de dados

    string

    Alias
    UMLS CUI
    C0034065 (Pulmonary Embolism)
    SNOMED
    59282003
    LOINC
    LP90124-6
    ICD10CM
    I26.99 (undefined)
    MDR
    10037377 (undefined)
    SNOMED CT 2010_0731
    59282003 (undefined)
    Deep Vein Thrombosis
    Descrição

    Deep Vein Thrombosis

    Tipo de dados

    string

    Alias
    UMLS CUI
    C0149871 (Deep Vein Thrombosis)
    SNOMED
    128053003
    ICD10CM
    I82.40 (undefined)
    LNC
    MTHU020788 (undefined)
    MDR
    10051055 (undefined)
    SNOMED CT 2010_0731
    128053003 (undefined)
    Vitamin K antagonist
    Descrição

    Vitamin K antagonist

    Tipo de dados

    string

    Alias
    UMLS CUI
    C1096489 (Treatment with Vitamin K antagonist)
    MDR
    10053755 (undefined)
    Rivaroxaban
    Descrição

    Rivaroxaban

    Tipo de dados

    string

    Alias
    UMLS CUI
    C1739768 (rivaroxaban)
    SNOMED
    442031002
    SNOMED CT 2010_0731
    442031002 (undefined)
    age restriction in context
    Descrição

    age restriction in context

    Tipo de dados

    string

    Alias
    UMLS CUI
    C0680135 (age restriction in context)
    age subdivision of legal significance
    Descrição

    age subdivision of legal significance

    Tipo de dados

    string

    Alias
    UMLS CUI
    C0682055 (age subdivision of legal significance)
    Anticoagulant therapy
    Descrição

    Anticoagulant therapy

    Tipo de dados

    string

    Alias
    UMLS CUI
    C0150457 (Anticoagulant therapy)
    SNOMED
    182764009
    LOINC
    LA28199-0
    MDR
    10053468 (undefined)
    SNOMED CT 2010_0731
    182764009 (undefined)
    Contraceptive methods
    Descrição

    Contraceptive methods

    Tipo de dados

    string

    Alias
    UMLS CUI
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    LNC
    MTHU024530 (undefined)
    MDR
    10010808 (undefined)
    SNOMED CT 2010_0731
    13197004 (undefined)
    Patient currently pregnant
    Descrição

    Patient currently pregnant

    Tipo de dados

    string

    Alias
    UMLS CUI
    C0549206 (Patient currently pregnant)
    SNOMED
    77386006
    LOINC
    LA14670-6
    MDR
    10036586 (undefined)
    SNOMED CT 2010_0731
    77386006 (undefined)
    Breast Feeding
    Descrição

    Breast Feeding

    Tipo de dados

    string

    Alias
    UMLS CUI
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    MDR
    10006247 (undefined)
    SNOMED CT 2010_0731
    169741004 (undefined)
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    Similar models

    Eligibility

    1 Formulários
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Einschlusskriterien
    Age
    Item
    boolean
    C0001779 (UMLS CUI)
    424144002 (SNOMED CT 2010_0731)
    MTHU010047 (LNC)
    Symptomatic Pulmonary Embolism or Deep Vein Thrombosis treated with Vitamin-K-Antagonists or Rivaroxaban
    Item
    boolean
    C0034065 (UMLS CUI)
    I26.99 (ICD10CM)
    10037377 (MDR)
    59282003 (SNOMED CT 2010_0731)
    C0149871 (UMLS CUI)
    I82.40 (ICD10CM)
    MTHU020788 (LNC)
    10051055 (MDR)
    128053003 (SNOMED CT 2010_0731)
    C1096489 (UMLS CUI)
    10053755 (MDR)
    C1739768 (UMLS CUI)
    442031002 (SNOMED CT 2010_0731)
    Item Group
    Ausschlusskriterien
    Legal lower age limitations (country specific)
    Item
    boolean
    C0680135 (UMLS CUI)
    C0682055 (UMLS CUI)
    Other indication for Vitamin-K-Antagonist-treatment than Pulmonary Embolism or Deep Vein Thrombosis
    Item
    boolean
    C0034065 (UMLS CUI)
    I26.99 (ICD10CM)
    10037377 (MDR)
    59282003 (SNOMED CT 2010_0731)
    C0149871 (UMLS CUI)
    I82.40 (ICD10CM)
    MTHU020788 (LNC)
    10051055 (MDR)
    128053003 (SNOMED CT 2010_0731)
    C1096489 (UMLS CUI)
    10053755 (MDR)
    Anticoagulation treatment should be continued
    Item
    boolean
    C0150457 (UMLS CUI)
    10053468 (MDR)
    182764009 (SNOMED CT 2010_0731)
    C0034065 (UMLS CUI)
    I26.99 (ICD10CM)
    10037377 (MDR)
    59282003 (SNOMED CT 2010_0731)
    C0149871 (UMLS CUI)
    I82.40 (ICD10CM)
    MTHU020788 (LNC)
    10051055 (MDR)
    128053003 (SNOMED CT 2010_0731)
    No contraception, No pregnancy or breast feeding
    Item
    boolean
    C0700589 (UMLS CUI)
    MTHU024530 (LNC)
    10010808 (MDR)
    13197004 (SNOMED CT 2010_0731)
    C0549206 (UMLS CUI)
    10036586 (MDR)
    77386006 (SNOMED CT 2010_0731)
    C0006147 (UMLS CUI)
    10006247 (MDR)
    169741004 (SNOMED CT 2010_0731)
    Item Group
    Medizinische Konzepte
    Age
    Item
    string
    C0001779 (UMLS CUI)
    424144002 (SNOMED CT 2010_0731)
    MTHU010047 (LNC)
    Pulmonary Embolism
    Item
    string
    C0034065 (UMLS CUI)
    I26.99 (ICD10CM)
    10037377 (MDR)
    59282003 (SNOMED CT 2010_0731)
    Deep Vein Thrombosis
    Item
    string
    C0149871 (UMLS CUI)
    I82.40 (ICD10CM)
    MTHU020788 (LNC)
    10051055 (MDR)
    128053003 (SNOMED CT 2010_0731)
    Vitamin K antagonist
    Item
    string
    C1096489 (UMLS CUI)
    10053755 (MDR)
    Rivaroxaban
    Item
    string
    C1739768 (UMLS CUI)
    442031002 (SNOMED CT 2010_0731)
    age restriction in context
    Item
    string
    C0680135 (UMLS CUI)
    age subdivision of legal significance
    Item
    string
    C0682055 (UMLS CUI)
    Anticoagulant therapy
    Item
    string
    C0150457 (UMLS CUI)
    10053468 (MDR)
    182764009 (SNOMED CT 2010_0731)
    Contraceptive methods
    Item
    string
    C0700589 (UMLS CUI)
    MTHU024530 (LNC)
    10010808 (MDR)
    13197004 (SNOMED CT 2010_0731)
    Patient currently pregnant
    Item
    string
    C0549206 (UMLS CUI)
    10036586 (MDR)
    77386006 (SNOMED CT 2010_0731)
    Breast Feeding
    Item
    string
    C0006147 (UMLS CUI)
    10006247 (MDR)
    169741004 (SNOMED CT 2010_0731)
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