0 Ratings
ID

4437

Description

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).

Keywords

Versions (1)
  1. 12/9/13 12/9/13 - Martin Dugas
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December 9, 2013

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

    German English

    Eligibility

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Description

    Einschlusskriterien

    Age
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI
    C0001779
    SNOMED CT 2010_0731
    424144002
    LNC
    MTHU010047
    Symptomatic Pulmonary Embolism or Deep Vein Thrombosis treated with Vitamin-K-Antagonists or Rivaroxaban
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI
    C0034065
    ICD10CM
    I26.99
    MDR
    10037377
    SNOMED CT 2010_0731
    59282003
    UMLS CUI
    C0149871
    ICD10CM
    I82.40
    LNC
    MTHU020788
    MDR
    10051055
    SNOMED CT 2010_0731
    128053003
    UMLS CUI
    C1096489
    MDR
    10053755
    UMLS CUI
    C1739768
    SNOMED CT 2010_0731
    442031002
    Ausschlusskriterien
    Description

    Ausschlusskriterien

    Legal lower age limitations (country specific)
    Description

    Legal lower age limitations (country specific)

    Data type

    boolean

    Alias
    UMLS CUI
    C0680135
    UMLS CUI
    C0682055
    Other indication for Vitamin-K-Antagonist-treatment than Pulmonary Embolism or Deep Vein Thrombosis
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI
    C0034065
    ICD10CM
    I26.99
    MDR
    10037377
    SNOMED CT 2010_0731
    59282003
    UMLS CUI
    C0149871
    ICD10CM
    I82.40
    LNC
    MTHU020788
    MDR
    10051055
    SNOMED CT 2010_0731
    128053003
    UMLS CUI
    C1096489
    MDR
    10053755
    Anticoagulation treatment should be continued
    Description

    Anticoagulation treatment should be continued

    Data type

    boolean

    Alias
    UMLS CUI
    C0150457
    MDR
    10053468
    SNOMED CT 2010_0731
    182764009
    UMLS CUI
    C0034065
    ICD10CM
    I26.99
    MDR
    10037377
    SNOMED CT 2010_0731
    59282003
    UMLS CUI
    C0149871
    ICD10CM
    I82.40
    LNC
    MTHU020788
    MDR
    10051055
    SNOMED CT 2010_0731
    128053003
    No contraception, No pregnancy or breast feeding
    Description

    No contraception, No pregnancy or breast feeding

    Data type

    boolean

    Alias
    UMLS CUI
    C0700589
    LNC
    MTHU024530
    MDR
    10010808
    SNOMED CT 2010_0731
    13197004
    UMLS CUI
    C0549206
    MDR
    10036586
    SNOMED CT 2010_0731
    77386006
    UMLS CUI
    C0006147
    MDR
    10006247
    SNOMED CT 2010_0731
    169741004
    Medizinische Konzepte
    Description

    Medizinische Konzepte

    Age
    Description

    Age

    Data type

    string

    Alias
    UMLS CUI
    C0001779
    SNOMED CT 2010_0731
    424144002
    LNC
    MTHU010047
    Pulmonary Embolism
    Description

    Pulmonary Embolism

    Data type

    string

    Alias
    UMLS CUI
    C0034065
    ICD10CM
    I26.99
    MDR
    10037377
    SNOMED CT 2010_0731
    59282003
    Deep Vein Thrombosis
    Description

    Deep Vein Thrombosis

    Data type

    string

    Alias
    UMLS CUI
    C0149871
    ICD10CM
    I82.40
    LNC
    MTHU020788
    MDR
    10051055
    SNOMED CT 2010_0731
    128053003
    Vitamin K antagonist
    Description

    Vitamin K antagonist

    Data type

    string

    Alias
    UMLS CUI
    C1096489
    MDR
    10053755
    Rivaroxaban
    Description

    Rivaroxaban

    Data type

    string

    Alias
    UMLS CUI
    C1739768
    SNOMED CT 2010_0731
    442031002
    age restriction in context
    Description

    age restriction in context

    Data type

    string

    Alias
    UMLS CUI
    C0680135
    age subdivision of legal significance
    Description

    age subdivision of legal significance

    Data type

    string

    Alias
    UMLS CUI
    C0682055
    Anticoagulant therapy
    Description

    Anticoagulant therapy

    Data type

    string

    Alias
    UMLS CUI
    C0150457
    MDR
    10053468
    SNOMED CT 2010_0731
    182764009
    Contraceptive methods
    Description

    Contraceptive methods

    Data type

    string

    Alias
    UMLS CUI
    C0700589
    LNC
    MTHU024530
    MDR
    10010808
    SNOMED CT 2010_0731
    13197004
    Patient currently pregnant
    Description

    Patient currently pregnant

    Data type

    string

    Alias
    UMLS CUI
    C0549206
    MDR
    10036586
    SNOMED CT 2010_0731
    77386006
    Breast Feeding
    Description

    Breast Feeding

    Data type

    string

    Alias
    UMLS CUI
    C0006147
    MDR
    10006247
    SNOMED CT 2010_0731
    169741004
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    Similar models

    Eligibility

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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