0 Ratings
ID

38418

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 diagnostics (in particular imaging) used to assess a suspected pulmnoary embolism and is to be filled in as appropriate during the study.

Link

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

Keywords

Versions (1)
  1. 10/16/19 10/16/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 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

    Assessment of Suspected Pulmonary Embolism

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Country No.
    Description

    Country No.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0454664
    UMLS CUI [1,2]
    C0600091
    Centre No.
    Description

    Centre No.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Subject No.
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Subject Initials
    Description

    Subject Initials

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1997894
    UMLS CUI [1,2]
    C2986440
    General Pulmonary Embolism Information
    Description

    General Pulmonary Embolism Information

    Alias
    UMLS CUI-1
    C1508263
    UMLS CUI-2
    C0034065
    Date of first clinical signs/symptoms of PE
    Description

    Date of first PE signs/symptoms

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0034065
    UMLS CUI [1,2]
    C0574845
    UMLS CUI [1,3]
    C0037088
    Perfusion and/or Ventilation Lung Scan
    Description

    Perfusion and/or Ventilation Lung Scan

    Alias
    UMLS CUI-1
    C0203702
    PE Assessment Imaging Modality
    Description

    If test performed, record date.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034065
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [1,3]
    C1275506
    Date of PE Assessment
    Description

    Date of PE Assessment

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0034065
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [1,3]
    C0011008
    Result
    Description

    High probability defect(s) is taken as evidence of PE. Study treatment if ongoing, must be discontinued. Non-high probability defect(s): If the mandatory venography has not yet been done: perform first an Ultrasonography. If negative, continue study drug until mandatory venography. If positive, confirm diagnosis with a venography or a pulmonary angiography. If the mandatory venography has been done: perform a venography or a pulmonary angiography. If no defect(s), the subject should continue study treatment if still ongoing

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034065
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [1,3]
    C1274040
    Ultrasonography
    Description

    Ultrasonography

    Alias
    UMLS CUI-1
    C0041618
    Not done
    Description

    If done, record date

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0041618
    UMLS CUI [1,2]
    C1272696
    Date performed
    Description

    Ultrasonography date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0041618
    UMLS CUI [1,2]
    C0011008
    Ultrasonography Result of Left Common Femoral
    Description

    Ultrasonography Result of Left Common Femoral

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0041618
    UMLS CUI [1,2]
    C1275667
    UMLS CUI [1,3]
    C0205091
    UMLS CUI [1,4]
    C1274040
    Ultrasonography Result of Left Popliteal
    Description

    Ultrasonography Result of Left Popliteal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0041618
    UMLS CUI [1,2]
    C0032652
    UMLS CUI [1,3]
    C0205091
    UMLS CUI [1,4]
    C1274040
    Ultrasonography Result of Right Common Femoral
    Description

    Ultrasonography Result of Right Common Femoral

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0041618
    UMLS CUI [1,2]
    C1275667
    UMLS CUI [1,3]
    C0205090
    UMLS CUI [1,4]
    C1274040
    Ultrasonography Result of Right Popliteal
    Description

    Ultrasonography Result of Right Popliteal

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0041618
    UMLS CUI [1,2]
    C0032652
    UMLS CUI [1,3]
    C0205090
    UMLS CUI [1,4]
    C1274040
    Venography
    Description

    Venography

    Alias
    UMLS CUI-1
    C0031545
    Venography Type
    Description

    For bilateral/left leg/right leg, record date in next item. For not done/left leg/right leg, record primary reason.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031545
    UMLS CUI [1,2]
    C0332307
    Date performed
    Description

    Venography Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0031545
    UMLS CUI [1,2]
    C0011008
    If NOT BILATERAL or NOT DONE, select the primary reason
    Description

    if other reason, specify in next item

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1549995
    UMLS CUI [1,2]
    C0031545
    UMLS CUI [1,3]
    C1272696
    UMLS CUI [2,1]
    C1549995
    UMLS CUI [2,2]
    C0205092
    UMLS CUI [2,3]
    C0031545
    Specify other reason venography not done/not bilateral
    Description

    if applicable

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1521902
    UMLS CUI [1,2]
    C3840932
    UMLS CUI [1,3]
    C0031545
    UMLS CUI [1,4]
    C1272696
    UMLS CUI [2,1]
    C1521902
    UMLS CUI [2,2]
    C3840932
    UMLS CUI [2,3]
    C0205092
    UMLS CUI [2,4]
    C0031545
    Angiography
    Description

    Angiography

    Alias
    UMLS CUI-1
    C0002978
    Not done
    Description

    if done, record date

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1272696
    UMLS CUI [1,2]
    C0002978
    Date performed
    Description

    Angiography date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0002978
    UMLS CUI [1,2]
    C0011008
    Spiral CT scan
    Description

    Spiral CT scan

    Alias
    UMLS CUI-1
    C0860888
    Not done
    Description

    if done, record date

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1272696
    UMLS CUI [1,2]
    C0860888
    Date performed
    Description

    Spiral CT date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0860888
    UMLS CUI [1,2]
    C0011008
    Other tests
    Description

    Other tests

    Alias
    UMLS CUI-1
    C0039593
    UMLS CUI-2
    C0205394
    Not done
    Description

    if done, record type of test and date

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1272696
    UMLS CUI [1,2]
    C0039593
    UMLS CUI [1,3]
    C0205394
    Other test, specify
    Description

    Specify other test

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1521902
    UMLS CUI [1,2]
    C0039593
    UMLS CUI [1,3]
    C0205394
    Date performed
    Description

    Other test date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0039593
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0011008
    Treatment
    Description

    Treatment

    Alias
    UMLS CUI-1
    C0087111
    Based on signs and symptoms, and all above detailed examinations, was medication given to treat PE?
    Description

    If medication was given, record in the medication form

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0034065
    UMLS CUI [1,3]
    C0566251
    UMLS CUI [1,4]
    C0037088
    UMLS CUI [2,1]
    C0013216
    UMLS CUI [2,2]
    C0034065
    UMLS CUI [2,3]
    C0566251
    UMLS CUI [2,4]
    C0220825
    Suspected PE fatal
    Description

    Suspected PE fatal

    Alias
    UMLS CUI-1
    C0034065
    UMLS CUI-2
    C1302234
    UMLS CUI-3
    C0750491
    Was the suspected PE fatal?
    Description

    If yes, specify date of death

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0034065
    UMLS CUI [1,2]
    C1302234
    UMLS CUI [1,3]
    C0750491
    If yes, specify date of death
    Description

    Date of death if fatal PE

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1148348
    UMLS CUI [1,2]
    C0034065
    UMLS CUI [1,3]
    C1302234
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    Similar models

    Assessment of Suspected Pulmonary Embolism

    1 forms
    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
    General Pulmonary Embolism Information
    C1508263 (UMLS CUI-1)
    C0034065 (UMLS CUI-2)
    Date of first PE signs/symptoms
    Item
    Date of first clinical signs/symptoms of PE
    date
    C0034065 (UMLS CUI [1,1])
    C0574845 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [1,3])
    Item Group
    Perfusion and/or Ventilation Lung Scan
    C0203702 (UMLS CUI-1)
    Item
    PE Assessment Imaging Modality
    text
    C0034065 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    C1275506 (UMLS CUI [1,3])
    PE Assessment Imaging Modality
    Code List
    PE Assessment Imaging Modality
    CL Item
    Not done (Not done)
    CL Item
    V/Q scan (V/Q scan)
    CL Item
    Perfusion scan (Perfusion scan)
    CL Item
    Ventilation scan (Ventilation scan)
    Date of PE Assessment
    Item
    Date of PE Assessment
    date
    C0034065 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Result
    text
    C0034065 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Results
    Code List
    Result
    CL Item
    High probability defect(s) (High probability defect(s))
    CL Item
    Non high probability defect(s) (Non high probability defect(s))
    CL Item
    No defect(s) (No defect(s))
    Item Group
    Ultrasonography
    C0041618 (UMLS CUI-1)
    Ultrasonography not done
    Item
    Not done
    boolean
    C0041618 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    Ultrasonography date
    Item
    Date performed
    date
    C0041618 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Ultrasonography Result of Left Common Femoral
    text
    C0041618 (UMLS CUI [1,1])
    C1275667 (UMLS CUI [1,2])
    C0205091 (UMLS CUI [1,3])
    C1274040 (UMLS CUI [1,4])
    Ultrasonography, Common Femoral vein, left, Result
    Code List
    Ultrasonography Result of Left 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
    Ultrasonography Result of Left Popliteal
    text
    C0041618 (UMLS CUI [1,1])
    C0032652 (UMLS CUI [1,2])
    C0205091 (UMLS CUI [1,3])
    C1274040 (UMLS CUI [1,4])
    Ultrasonography, Common Femoral vein, left, Result
    Code List
    Ultrasonography Result of Left 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
    Ultrasonography Result of Right Common Femoral
    text
    C0041618 (UMLS CUI [1,1])
    C1275667 (UMLS CUI [1,2])
    C0205090 (UMLS CUI [1,3])
    C1274040 (UMLS CUI [1,4])
    Ultrasonography, Common Femoral vein, left, Result
    Code List
    Ultrasonography Result of Right 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
    Ultrasonography Result of Right Popliteal
    text
    C0041618 (UMLS CUI [1,1])
    C0032652 (UMLS CUI [1,2])
    C0205090 (UMLS CUI [1,3])
    C1274040 (UMLS CUI [1,4])
    Ultrasonography, Common Femoral vein, left, Result
    Code List
    Ultrasonography Result of Right 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)
    Item
    Venography Type
    text
    C0031545 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Venography Type
    Code List
    Venography Type
    CL Item
    Not done (ND)
    CL Item
    Bilateral (BI)
    CL Item
    Left leg (L)
    CL Item
    Right leg (R)
    Venography Date
    Item
    Date performed
    date
    C0031545 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    If NOT BILATERAL or NOT DONE, select the primary reason
    text
    C1549995 (UMLS CUI [1,1])
    C0031545 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    C1549995 (UMLS CUI [2,1])
    C0205092 (UMLS CUI [2,2])
    C0031545 (UMLS CUI [2,3])
    Venography; Indication
    Code List
    If NOT BILATERAL or NOT DONE, select 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)
    Specify other reason venography not done/unilateral
    Item
    Specify other reason venography not done/not bilateral
    text
    C1521902 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    C0031545 (UMLS CUI [1,3])
    C1272696 (UMLS CUI [1,4])
    C1521902 (UMLS CUI [2,1])
    C3840932 (UMLS CUI [2,2])
    C0205092 (UMLS CUI [2,3])
    C0031545 (UMLS CUI [2,4])
    Item Group
    Angiography
    C0002978 (UMLS CUI-1)
    Angiography not done?
    Item
    Not done
    boolean
    C1272696 (UMLS CUI [1,1])
    C0002978 (UMLS CUI [1,2])
    Angiography date
    Item
    Date performed
    date
    C0002978 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Spiral CT scan
    C0860888 (UMLS CUI-1)
    Spiral CT scan not done?
    Item
    Not done
    boolean
    C1272696 (UMLS CUI [1,1])
    C0860888 (UMLS CUI [1,2])
    Spiral CT date
    Item
    Date performed
    date
    C0860888 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Other tests
    C0039593 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    Other tests not done?
    Item
    Not done
    boolean
    C1272696 (UMLS CUI [1,1])
    C0039593 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Specify other test
    Item
    Other test, specify
    text
    C1521902 (UMLS CUI [1,1])
    C0039593 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Other test date
    Item
    Date performed
    date
    C0039593 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    Treatment
    C0087111 (UMLS CUI-1)
    Medication for PE treatment given due to signs/symptoms/examinations?
    Item
    Based on signs and symptoms, and all above detailed examinations, was medication given to treat PE?
    boolean
    C0013216 (UMLS CUI [1,1])
    C0034065 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    C0037088 (UMLS CUI [1,4])
    C0013216 (UMLS CUI [2,1])
    C0034065 (UMLS CUI [2,2])
    C0566251 (UMLS CUI [2,3])
    C0220825 (UMLS CUI [2,4])
    Item Group
    Suspected PE fatal
    C0034065 (UMLS CUI-1)
    C1302234 (UMLS CUI-2)
    C0750491 (UMLS CUI-3)
    Suspected PE fatal?
    Item
    Was the suspected PE fatal?
    boolean
    C0034065 (UMLS CUI [1,1])
    C1302234 (UMLS CUI [1,2])
    C0750491 (UMLS CUI [1,3])
    Date of death if fatal PE
    Item
    If yes, specify date of death
    date
    C1148348 (UMLS CUI [1,1])
    C0034065 (UMLS CUI [1,2])
    C1302234 (UMLS CUI [1,3])
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