0 Bedömningar
ID

4437

Beskrivning

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).

Nyckelord

Versioner (1)
  1. 2013-12-09 2013-12-09 - Martin Dugas
Uppladdad den

9 december 2013

DOI

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Licens

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

    Tysk Engelsk

    Eligibility

    1 Formulär  
    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion criteria
    Beskrivning

    Inclusion criteria

    18 Years and older
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI
    C0001779
    SNOMED CT 2010_0731
    424144002
    LNC
    MTHU010047
    Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban
    Beskrivning

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

    Datatyp

    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
    Exclusion criteria
    Beskrivning

    Exclusion criteria

    Legal lower age limitations (country specific)
    Beskrivning

    Legal lower age limitations (country specific)

    Datatyp

    boolean

    Alias
    UMLS CUI
    C0680135
    UMLS CUI
    C0682055
    Indication for VKA other than DVT and/or PE
    Beskrivning

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

    Datatyp

    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
    Patients in whom anticoagulant treatment for their index PE or DVT should be continued
    Beskrivning

    Anticoagulation treatment should be continued

    Datatyp

    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
    Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
    Beskrivning

    No contraception, No pregnancy or breast feeding

    Datatyp

    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
    Medical Concepts
    Beskrivning

    Medical Concepts

    Age
    Beskrivning

    Age

    Datatyp

    string

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

    Pulmonary Embolism

    Datatyp

    string

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

    Deep Vein Thrombosis

    Datatyp

    string

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

    Vitamin K antagonist

    Datatyp

    string

    Alias
    UMLS CUI
    C1096489
    MDR
    10053755
    Rivaroxaban
    Beskrivning

    Rivaroxaban

    Datatyp

    string

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

    age restriction in context

    Datatyp

    string

    Alias
    UMLS CUI
    C0680135
    age subdivision of legal significance
    Beskrivning

    age subdivision of legal significance

    Datatyp

    string

    Alias
    UMLS CUI
    C0682055
    Anticoagulant therapy
    Beskrivning

    Anticoagulant therapy

    Datatyp

    string

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

    Contraceptive methods

    Datatyp

    string

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

    Patient currently pregnant

    Datatyp

    string

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

    Breast Feeding

    Datatyp

    string

    Alias
    UMLS CUI
    C0006147
    MDR
    10006247
    SNOMED CT 2010_0731
    169741004
    Tillbaka till toppen

    Similar models

    Eligibility

    1 Formulär
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Inclusion criteria
    Age
    Item
    18 Years and older
    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
    Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban
    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
    Exclusion criteria
    Legal lower age limitations (country specific)
    Item
    Legal lower age limitations (country specific)
    boolean
    C0680135 (UMLS CUI)
    C0682055 (UMLS CUI)
    Other indication for Vitamin-K-Antagonist-treatment than Pulmonary Embolism or Deep Vein Thrombosis
    Item
    Indication for VKA other than DVT and/or PE
    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
    Patients in whom anticoagulant treatment for their index PE or DVT should be continued
    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
    Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
    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
    Medical Concepts
    Age
    Item
    Age
    string
    C0001779 (UMLS CUI)
    424144002 (SNOMED CT 2010_0731)
    MTHU010047 (LNC)
    Pulmonary Embolism
    Item
    Pulmonary Embolism
    string
    C0034065 (UMLS CUI)
    I26.99 (ICD10CM)
    10037377 (MDR)
    59282003 (SNOMED CT 2010_0731)
    Deep Vein Thrombosis
    Item
    Deep Vein Thrombosis
    string
    C0149871 (UMLS CUI)
    I82.40 (ICD10CM)
    MTHU020788 (LNC)
    10051055 (MDR)
    128053003 (SNOMED CT 2010_0731)
    Vitamin K antagonist
    Item
    Vitamin K antagonist
    string
    C1096489 (UMLS CUI)
    10053755 (MDR)
    Rivaroxaban
    Item
    Rivaroxaban
    string
    C1739768 (UMLS CUI)
    442031002 (SNOMED CT 2010_0731)
    age restriction in context
    Item
    age restriction in context
    string
    C0680135 (UMLS CUI)
    age subdivision of legal significance
    Item
    age subdivision of legal significance
    string
    C0682055 (UMLS CUI)
    Anticoagulant therapy
    Item
    Anticoagulant therapy
    string
    C0150457 (UMLS CUI)
    10053468 (MDR)
    182764009 (SNOMED CT 2010_0731)
    Contraceptive methods
    Item
    Contraceptive methods
    string
    C0700589 (UMLS CUI)
    MTHU024530 (LNC)
    10010808 (MDR)
    13197004 (SNOMED CT 2010_0731)
    Patient currently pregnant
    Item
    Patient currently pregnant
    string
    C0549206 (UMLS CUI)
    10036586 (MDR)
    77386006 (SNOMED CT 2010_0731)
    Breast Feeding
    Item
    Breast Feeding
    string
    C0006147 (UMLS CUI)
    10006247 (MDR)
    169741004 (SNOMED CT 2010_0731)
    Tillbaka till toppen 

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