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32156

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Study ID: 104619 Clinical Study ID: 63129 Study Title:A multinational, randomized, double-blind comparison of once daily subcutaneous fondaparinux sodium with placebo for the prevention of venous thromboembolic events in acutely ill medical patients (ARTEMIS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thrombosis, Venous

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  1. 2018-10-22 2018-10-22 -
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GlaxoSmithKline

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22 oktober 2018

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    Subcutaneous fondaparinux sodium for prevention of venous thromboembolic events; Study ID: 104619

    Engelsk

    Unscheduled Assessment of Symptomatic DVT

    1 Formulär  
    Unscheduled Assessment of Symptomatic DVT
    Beskrivning

    Unscheduled Assessment of Symptomatic DVT

    Alias
    UMLS CUI-1
    C0149871
    UMLS CUI-2
    C0220825
    Date of first clinical signs/symptoms of DVT
    Beskrivning

    Deep Vein Thrombosis; Date of onset

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0149871
    UMLS CUI [1,2]
    C0574845
    Side
    Beskrivning

    Deep Vein Thrombosis; Side

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0149871
    UMLS CUI [1,2]
    C0441987
    Ultrasonography
    Beskrivning

    Ultrasonography

    Alias
    UMLS CUI-1
    C0041618
    Not done
    Beskrivning

    Ultrasonography

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0041618
    Date performed
    Beskrivning

    Ultrasonography, Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0041618
    UMLS CUI [1,2]
    C0011008
    Result
    Beskrivning

    Ultrasonography, Result

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0041618
    UMLS CUI [1,2]
    C1274040
    left Leg, Common Femoral
    Beskrivning

    Ultrasonography, Common femoral vein, left

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0041618
    UMLS CUI [1,2]
    C1275667
    UMLS CUI [1,3]
    C0205091
    Left Leg, Popliteal
    Beskrivning

    Ultrasonography, Structure of popliteal vein, left

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0041618
    UMLS CUI [1,2]
    C0032652
    UMLS CUI [1,3]
    C0205091
    Right Leg, Common Femoral
    Beskrivning

    Ultrasonography; Common femoral vein, Right

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0041618
    UMLS CUI [1,2]
    C1275667
    UMLS CUI [1,3]
    C0205090
    Right Leg, Popliteal
    Beskrivning

    Ultrasonography; Structure of popliteal vein, Right

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0041618
    UMLS CUI [1,2]
    C0032652
    UMLS CUI [1,3]
    C0205090
    Venography
    Beskrivning

    Venography

    Alias
    UMLS CUI-1
    C0031545
    Not done
    Beskrivning

    Venography

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0031545
    Bilateral
    Beskrivning

    Venography, Bilateral

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0031545
    UMLS CUI [1,2]
    C0238767
    Bilateral, Date performed
    Beskrivning

    Venography, Bilateral, Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0031545
    UMLS CUI [1,2]
    C0238767
    UMLS CUI [1,3]
    C0011008
    Left Leg
    Beskrivning

    Venography, Structure of left lower leg

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0031545
    UMLS CUI [1,2]
    C0230443
    Left Leg, Date performed
    Beskrivning

    Venography, Structure of left lower leg, Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0031545
    UMLS CUI [1,2]
    C0230443
    UMLS CUI [1,3]
    C0011008
    Right Leg
    Beskrivning

    Venography, Structure of right lower leg

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0031545
    UMLS CUI [1,2]
    C0230442
    Right Leg, Date performed
    Beskrivning

    Venography, Structure of right lower leg, Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0031545
    UMLS CUI [1,2]
    C0230442
    UMLS CUI [1,3]
    C0011008
    If NOT BILATERAL or NOT DONE, tick the primary reason.
    Beskrivning

    Venography; Indication

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0031545
    UMLS CUI [1,2]
    C3146298
    Treatment
    Beskrivning

    Treatment

    Alias
    UMLS CUI-1
    C0149871
    UMLS CUI-2
    C0013227
    Based on signs and symptoms, ultrasound and/or venogram results, was medication given to treat DVT?
    Beskrivning

    Deep vein thrombosis; Pharmaceutical Preparations

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0149871
    UMLS CUI [1,2]
    C0013227
    Tillbaka till toppen

    Similar models

    Unscheduled Assessment of Symptomatic DVT

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Unscheduled Assessment of Symptomatic DVT
    C0149871 (UMLS CUI-1)
    C0220825 (UMLS CUI-2)
    Deep Vein Thrombosis; Date of onset
    Item
    Date of first clinical signs/symptoms of DVT
    date
    C0149871 (UMLS CUI [1,1])
    C0574845 (UMLS CUI [1,2])
    Item
    Side
    text
    C0149871 (UMLS CUI [1,1])
    C0441987 (UMLS CUI [1,2])
    Ultrasonography, Common femoral vein, right
    Code List
    Side
    CL Item
    Fully compressible/Normal (Fully compressible/Normal)
    CL Item
    Non compressible (Non compressible)
    CL Item
    Inadequate (Inadequate)
    CL Item
    Not done (Not done)
    Item Group
    Ultrasonography
    C0041618 (UMLS CUI-1)
    Ultrasonography
    Item
    Not done
    boolean
    C0041618 (UMLS CUI [1])
    Ultrasonography, Date in time
    Item
    Date performed
    date
    C0041618 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Result
    text
    C0041618 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Ultrasonography, Structure of popliteal vein, left
    Code List
    Result
    CL Item
    Fully compressible/Normal (Fully compressible/Normal)
    CL Item
    Non compressible (Non compressible)
    CL Item
    Inadequate (Inadequate)
    CL Item
    Not done (Not done)
    Item
    left Leg, Common Femoral
    text
    C0041618 (UMLS CUI [1,1])
    C1275667 (UMLS CUI [1,2])
    C0205091 (UMLS CUI [1,3])
    Ultrasonography, Common femoral vein, left
    Code List
    left Leg, Common Femoral
    CL Item
    Fully compressible/Normal (Fully compressible/Normal)
    CL Item
    Non compressible (Non compressible)
    CL Item
    Inadequate (Inadequate)
    CL Item
    Not done (Not done)
    Item
    Left Leg, Popliteal
    text
    C0041618 (UMLS CUI [1,1])
    C0032652 (UMLS CUI [1,2])
    C0205091 (UMLS CUI [1,3])
    Ultrasonography, Structure of popliteal vein, left
    Code List
    Left Leg, Popliteal
    CL Item
    Fully compressible/Normal (Fully compressible/Normal)
    CL Item
    Non compressible (Non compressible)
    CL Item
    Inadequate (Inadequate)
    CL Item
    Not done (Not done)
    Item
    Right Leg, Common Femoral
    text
    C0041618 (UMLS CUI [1,1])
    C1275667 (UMLS CUI [1,2])
    C0205090 (UMLS CUI [1,3])
    Ultrasonography; Common femoral vein, Right
    Code List
    Right Leg, Common Femoral
    CL Item
    Fully compressible/Normal (Fully compressible/Normal)
    CL Item
    Non compressible (Non compressible)
    CL Item
    Inadequate (Inadequate)
    CL Item
    Not done (Not done)
    Item
    Right Leg, Popliteal
    text
    C0041618 (UMLS CUI [1,1])
    C0032652 (UMLS CUI [1,2])
    C0205090 (UMLS CUI [1,3])
    Ultrasonography; Common femoral vein, Right
    Code List
    Right Leg, Popliteal
    CL Item
    Fully compressible/Normal (Fully compressible/Normal)
    CL Item
    Non compressible (Non compressible)
    CL Item
    Inadequate (Inadequate)
    CL Item
    Not done (Not done)
    Item Group
    Venography
    C0031545 (UMLS CUI-1)
    Venography
    Item
    Not done
    boolean
    C0031545 (UMLS CUI [1])
    Venography, Bilateral
    Item
    Bilateral
    boolean
    C0031545 (UMLS CUI [1,1])
    C0238767 (UMLS CUI [1,2])
    Venography, Bilateral, Date in time
    Item
    Bilateral, Date performed
    date
    C0031545 (UMLS CUI [1,1])
    C0238767 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Venography, Structure of left lower leg
    Item
    Left Leg
    boolean
    C0031545 (UMLS CUI [1,1])
    C0230443 (UMLS CUI [1,2])
    Venography, Structure of left lower leg, Date in time
    Item
    Left Leg, Date performed
    date
    C0031545 (UMLS CUI [1,1])
    C0230443 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Venography, Structure of right lower leg
    Item
    Right Leg
    boolean
    C0031545 (UMLS CUI [1,1])
    C0230442 (UMLS CUI [1,2])
    Venography, Structure of right lower leg, Date in time
    Item
    Right Leg, Date performed
    date
    C0031545 (UMLS CUI [1,1])
    C0230442 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    If NOT BILATERAL or NOT DONE, tick the primary reason.
    text
    C0031545 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Venography; Indication
    Code List
    If NOT BILATERAL or NOT DONE, tick the primary reason.
    CL Item
    Failed venous access (Failed venous access)
    CL Item
    Subject refused/withdrew consent (Subject refused/withdrew consent)
    CL Item
    Subject amputee (Subject amputee)
    CL Item
    Other, specify (Other, specify)
    Item Group
    Treatment
    C0149871 (UMLS CUI-1)
    C0013227 (UMLS CUI-2)
    Deep vein thrombosis; Pharmaceutical Preparations
    Item
    Based on signs and symptoms, ultrasound and/or venogram results, was medication given to treat DVT?
    boolean
    C0149871 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Tillbaka till toppen 

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