0 Ratings
ID

38090

Description

Study ID: 103414 Clinical Study ID: 103414 Study Title: A Multicenter, Randomized, Double-blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression (IPC) Versus IPC Used Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdominal surgery Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00038961 https://clinicaltrials.gov/ct2/show/NCT00038961 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Fondaparinux Sodium Trade Name: Fondaparinux Sodium Study Indication: Thrombosis This phase III placebo-controlled trial studies the efficacy and safety of Fondaparinux as an additional prevention measure of venous thromboembolic events (VTE) in patients above the age of 40 with intermediate or high VTE risk undergoing abdominal surgery. The study consists of a Screening Visit (Visit 0), the baseline visit on Day 1, the day of the surgery (Visit 1), the treatment period (denoted in its entirety as Visit 2) consisting of administration of Fondaparinux (2.5mg subcutaneously once daily) or placebo starting on Day 1 and continuing at least up to Day 5, possibly up to Day 9, in parallel to intermittent pneumatic compression and possibly elastic stockings, followed by a mandatory bilateral venography no longer than 24 hours after study drug cessation, and finally a Follow-up Visit (Visit 3) on Day 30 +/- 2. This form contains information on unusual bleeding events and is to be filled in as appropriate during the study.

Link

https://clinicaltrials.gov/ct2/show/NCT00038961

Keywords

Versions (1)
  1. 9/16/19 9/16/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 16, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961

    English

    Unusual Bleeding Form

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

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Country No.
    Description

    Country No.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0454664 (Country)
    SNOMED
    223369002
    LOINC
    LP120625-1
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Centre No.
    Description

    Centre No.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1301943 (Institution name)
    SNOMED
    398321007
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Subject No.
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Subject Initials
    Description

    Subject Initials

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1997894 (Clinical trial participant (person))
    SNOMED
    428024001
    UMLS CUI [1,2]
    C2986440 (Person Initials)
    Unusual Bleeding
    Description

    Unusual Bleeding

    Alias
    UMLS CUI-1
    C0019080 (Hemorrhage)
    SNOMED
    50960005
    LOINC
    LA7418-2
    UMLS CUI-2
    C2700116 (Unusual)
    Onset date of bleeding
    Description

    Onset date of bleeding

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0019080 (Hemorrhage)
    SNOMED
    50960005
    LOINC
    LA7418-2
    UMLS CUI [1,2]
    C0574845 (Date of onset)
    SNOMED
    298059007
    LOINC
    MTHU048807
    Transfusions
    Description

    If yes, complete transfusion form

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005841 (Blood Transfusion)
    SNOMED
    116859006
    LOINC
    LP32812-7
    Re-operation
    Description

    if yes, specify in next item

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0035110 (Repeat Surgery)
    SNOMED
    261554009
    Specify re-operation
    Description

    if applicable

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1521902 (To specify)
    UMLS CUI [1,2]
    C0035110 (Repeat Surgery)
    SNOMED
    261554009
    Other intervention at surgical site
    Description

    If yes, specify

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,2]
    C0184661 (Interventional procedure)
    SNOMED
    71388002
    UMLS CUI [1,3]
    C0332850 (Operative site)
    SNOMED
    43526002
    Specify other intervention at surgical site
    Description

    if applicable

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1521902 (To specify)
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,3]
    C0184661 (Interventional procedure)
    SNOMED
    71388002
    UMLS CUI [1,4]
    C0332850 (Operative site)
    SNOMED
    43526002
    Bleeding AE form Numbers
    Description

    Bleeding AE form Numbers

    Alias
    UMLS CUI-1
    C0019080 (Hemorrhage)
    SNOMED
    50960005
    LOINC
    LA7418-2
    UMLS CUI-2
    C1300638 (Identification number)
    SNOMED
    396278008
    UMLS CUI-3
    C0684224 (Report (document))
    SNOMED
    229059009
    LOINC
    LP183761-8
    UMLS CUI-4
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    This bleeding corresponds to the following AE form number(s)
    Description

    Bleeding AE form number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1300638 (Identification number)
    SNOMED
    396278008
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,3]
    C0684224 (Report (document))
    SNOMED
    229059009
    LOINC
    LP183761-8
    UMLS CUI [1,4]
    C0019080 (Hemorrhage)
    SNOMED
    50960005
    LOINC
    LA7418-2
    This is the main AE form number
    Description

    only applicable if more than one AE form related to this bleeding Only select for one number

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1542147 (Main)
    UMLS CUI [1,2]
    C1300638 (Identification number)
    SNOMED
    396278008
    UMLS CUI [1,3]
    C0684224 (Report (document))
    SNOMED
    229059009
    LOINC
    LP183761-8
    UMLS CUI [1,4]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
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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
    Administrative data
    C1320722 (UMLS CUI-1)
    Country No.
    Item
    Country No.
    integer
    C0454664 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Centre No.
    Item
    Centre No.
    integer
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Clinical Trial Subject Unique Identifier
    Item
    Subject No.
    integer
    C2348585 (UMLS CUI [1])
    Subject Initials
    Item
    Subject Initials
    text
    C1997894 (UMLS CUI [1,1])
    C2986440 (UMLS CUI [1,2])
    Item Group
    Unusual Bleeding
    C0019080 (UMLS CUI-1)
    C2700116 (UMLS CUI-2)
    Onset date of bleeding
    Item
    Onset date of bleeding
    date
    C0019080 (UMLS CUI [1,1])
    C0574845 (UMLS CUI [1,2])
    Transfusions
    Item
    Transfusions
    boolean
    C0005841 (UMLS CUI [1])
    Re-operation
    Item
    Re-operation
    boolean
    C0035110 (UMLS CUI [1])
    Specify re-operation
    Item
    Specify re-operation
    text
    C1521902 (UMLS CUI [1,1])
    C0035110 (UMLS CUI [1,2])
    Other intervention at surgical site
    Item
    Other intervention at surgical site
    boolean
    C0205394 (UMLS CUI [1,1])
    C0184661 (UMLS CUI [1,2])
    C0332850 (UMLS CUI [1,3])
    Specify other intervention at surgical site
    Item
    Specify other intervention at surgical site
    text
    C1521902 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0184661 (UMLS CUI [1,3])
    C0332850 (UMLS CUI [1,4])
    Item Group
    Bleeding AE form Numbers
    C0019080 (UMLS CUI-1)
    C1300638 (UMLS CUI-2)
    C0684224 (UMLS CUI-3)
    C0877248 (UMLS CUI-4)
    Bleeding AE form number
    Item
    This bleeding corresponds to the following AE form number(s)
    integer
    C1300638 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C0684224 (UMLS CUI [1,3])
    C0019080 (UMLS CUI [1,4])
    Main AE form number
    Item
    This is the main AE form number
    boolean
    C1542147 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    C0684224 (UMLS CUI [1,3])
    C0877248 (UMLS CUI [1,4])
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