0 Ratings
ID

31489

Description

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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Versions (1)
  1. 8/28/18 8/28/18 -
Copyright Holder

GlaxoSmithKline

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August 28, 2018

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Creative Commons BY-NC 3.0
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    Subcutaneous fondaparinux sodium for prevention of venous thromboembolic events; Study ID: 104619

    English

    Unusual Bleeding Form

    1 forms  
    1. StudyEvent: ODM
      1. Unusual Bleeding Form
    Unusual Bleeding
    Description

    Unusual Bleeding

    Alias
    UMLS CUI-1
    C0019080
    UMLS CUI-2
    C0013227C2700116
    Onset date of bleeding
    Description

    Hemorrhage; Onset Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0019080
    UMLS CUI [1,2]
    C0574845
    This bleeding corresponds to the following AE form number(s)
    Description

    Hemorrhage; AE form number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0019080
    UMLS CUI [1,2]
    C1518404
    UMLS CUI [1,3]
    C0237753
    Transfusions
    Description

    Hemorrhage; Blood Transfusion

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019080
    UMLS CUI [1,2]
    C0005841
    Re-operation
    Description

    Hemorrhage; repeat surgery

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019080
    UMLS CUI [1,2]
    C0035110
    Other intervention at surgical site
    Description

    Hemorrhage; Operative site, Interventional procedure, Other

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019080
    UMLS CUI [1,2]
    C0332850
    UMLS CUI [1,3]
    C0184661
    UMLS CUI [1,4]
    C0205394
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    Similar models

    Unusual Bleeding Form

    1 forms
    1. StudyEvent: ODM
      1. Unusual Bleeding Form
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Unusual Bleeding
    C0019080 (UMLS CUI-1)
    C0013227C2700116 (UMLS CUI-2)
    Hemorrhage; Onset Date
    Item
    Onset date of bleeding
    date
    C0019080 (UMLS CUI [1,1])
    C0574845 (UMLS CUI [1,2])
    Hemorrhage; AE form number
    Item
    This bleeding corresponds to the following AE form number(s)
    integer
    C0019080 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Hemorrhage; Blood Transfusion
    Item
    Transfusions
    boolean
    C0019080 (UMLS CUI [1,1])
    C0005841 (UMLS CUI [1,2])
    Hemorrhage; repeat surgery
    Item
    Re-operation
    boolean
    C0019080 (UMLS CUI [1,1])
    C0035110 (UMLS CUI [1,2])
    Hemorrhage; Operative site, Interventional procedure, Other
    Item
    Other intervention at surgical site
    boolean
    C0019080 (UMLS CUI [1,1])
    C0332850 (UMLS CUI [1,2])
    C0184661 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
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