0 Ratings
ID

38425

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 the adjudication of any suspected Pulmonary Embolism (PE), information on which is recorded in a seperate form.

Link

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

Keywords

Versions (1)
  1. 10/17/19 10/17/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 17, 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

    Suspected Pulmonary Embolism Adjudication

    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
    Suspected Pulmonary Embolism Adjudication Form
    Description

    Suspected Pulmonary Embolism Adjudication Form

    Alias
    UMLS CUI-1
    C0680730
    UMLS CUI-2
    C0034065
    UMLS CUI-3
    C0750491
    CRF page number
    Description

    CRF page number

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C1704732
    UMLS CUI [1,2]
    C1516308
    Date of symptoms onset
    Description

    Date of PE symptoms onset

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0034065
    UMLS CUI [1,2]
    C0574845
    UMLS CUI [1,3]
    C1457887
    V/Q Lung Scan
    Description

    V/Q Lung Scan

    Alias
    UMLS CUI-1
    C0560738
    UMLS CUI-2
    C0680730
    UMLS CUI-3
    C1274040
    V/Q scan date
    Description

    V/Q scan date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0560738
    UMLS CUI [1,2]
    C0011008
    Perfusion scan date
    Description

    Record perfusion scan OR ventilation scan date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1518040
    Ventilation scan date
    Description

    Record perfusion scan OR ventilation scan date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2094576
    V/Q Scan Result
    Description

    V/Q Scan Adjudication Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0560738
    UMLS CUI [1,2]
    C0680730
    UMLS CUI [1,3]
    C1274040
    Spiral CT scan
    Description

    Spiral CT scan

    Alias
    UMLS CUI-1
    C0860888
    UMLS CUI-2
    C0680730
    UMLS CUI-3
    C1274040
    Spiral CT Scan Date
    Description

    Spiral CT Scan Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0860888
    Spiral CT Scan Result
    Description

    Spiral CT Scan Adjudication Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0680730
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C0860888
    Pulmonary Angiogram
    Description

    Pulmonary Angiogram

    Alias
    UMLS CUI-1
    C0202910
    UMLS CUI-2
    C0680730
    UMLS CUI-3
    C1274040
    Pulmonary Angiogram Date
    Description

    Pulmonary Angiogram Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0202910
    UMLS CUI [1,2]
    C0011008
    Pulmonary Angiogram Result
    Description

    Pulmonary Angiogram Adjudication Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0202910
    UMLS CUI [1,2]
    C0680730
    UMLS CUI [1,3]
    C1274040
    CUS
    Description

    CUS

    Alias
    UMLS CUI-1
    C2317107
    UMLS CUI-2
    C0680730
    UMLS CUI-3
    C1274040
    Compression ultrasonography: Date
    Description

    Compression ultrasonography: Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2317107
    UMLS CUI [1,2]
    C0011008
    CUS Result
    Description

    CUS Adjudication Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2317107
    UMLS CUI [1,2]
    C0680730
    UMLS CUI [1,3]
    C1274040
    Compression ultrasonography result: Left
    Description

    Compression ultrasonography adjudication result: Left

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2317107
    UMLS CUI [1,2]
    C0680730
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C0205091
    Compression ultrasonography result: Right
    Description

    Compression ultrasonography adjudication result: Right

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2317107
    UMLS CUI [1,2]
    C0680730
    UMLS CUI [1,3]
    C1274040
    UMLS CUI [1,4]
    C0205090
    Other test
    Description

    Other test

    Alias
    UMLS CUI-1
    C0205394
    UMLS CUI-2
    C0039593
    UMLS CUI-3
    C0680730
    UMLS CUI-4
    C1274040
    Specify other test
    Description

    Specify other test

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0039593
    UMLS CUI [1,3]
    C1521902
    Other test date
    Description

    Other test date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0039593
    UMLS CUI [1,3]
    C0011008
    Other test result
    Description

    Other test adjudication result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0039593
    UMLS CUI [1,3]
    C0680730
    UMLS CUI [1,4]
    C1274040
    Venogram
    Description

    Venogram

    Alias
    UMLS CUI-1
    C0031545
    UMLS CUI-2
    C0680730
    UMLS CUI-3
    C1274040
    Bilateral Venogram Date
    Description

    Bilateral Venogram Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0031545
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0238767
    Left leg Venogram Date
    Description

    Record either left leg OR right leg

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0031545
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0205091
    UMLS CUI [1,4]
    C1140621
    Right leg Venogram Date
    Description

    Record either left leg OR right leg

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0031545
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0205090
    UMLS CUI [1,4]
    C1140621
    Venogram Result
    Description

    Also fill in the detailed repeating itemgroup below.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031545
    UMLS CUI [1,2]
    C0680730
    UMLS CUI [1,3]
    C1274040
    Venogram Results
    Description

    Venogram Results

    Alias
    UMLS CUI-1
    C0031545
    UMLS CUI-2
    C0680730
    UMLS CUI-3
    C1274040
    Venogram site
    Description

    Fill in itemgroup for each of the four sites.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031545
    UMLS CUI [1,2]
    C1515974
    Venogram result
    Description

    Venogram adjudication result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031545
    UMLS CUI [1,2]
    C0680730
    UMLS CUI [1,3]
    C1274040
    Classification Status
    Description

    Classification Status

    Alias
    UMLS CUI-1
    C0008902
    UMLS CUI-2
    C0680730
    UMLS CUI-3
    C1274040
    Pulmonary Embolism?
    Description

    Pulmonary Embolism?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0034065
    Comment
    Description

    PE Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0034065
    Adjudicators
    Description

    Adjudicators

    Alias
    UMLS CUI-1
    C0401783
    Adjudicator Signature 1
    Description

    Adjudicator Signature 1

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0401783
    UMLS CUI [1,2]
    C1519316
    Adjudicator Signature 2
    Description

    Adjudicator Signature 2

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0401783
    UMLS CUI [1,2]
    C1519316
    Date of adjudication
    Description

    Date of adjudication

    Data type

    text

    Alias
    UMLS CUI [1]
    C4740194
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    Similar models

    Suspected Pulmonary Embolism Adjudication

    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
    Suspected Pulmonary Embolism Adjudication Form
    C0680730 (UMLS CUI-1)
    C0034065 (UMLS CUI-2)
    C0750491 (UMLS CUI-3)
    CRF page number
    Item
    CRF page number
    float
    C1704732 (UMLS CUI [1,1])
    C1516308 (UMLS CUI [1,2])
    Date of PE symptoms onset
    Item
    Date of symptoms onset
    date
    C0034065 (UMLS CUI [1,1])
    C0574845 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [1,3])
    Item Group
    V/Q Lung Scan
    C0560738 (UMLS CUI-1)
    C0680730 (UMLS CUI-2)
    C1274040 (UMLS CUI-3)
    V/Q scan date
    Item
    V/Q scan date
    date
    C0560738 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Perfusion scan date
    Item
    Perfusion scan date
    date
    C0011008 (UMLS CUI [1,1])
    C1518040 (UMLS CUI [1,2])
    Ventilation scan date
    Item
    Ventilation scan date
    date
    C0011008 (UMLS CUI [1,1])
    C2094576 (UMLS CUI [1,2])
    Item
    V/Q Scan Result
    text
    C0560738 (UMLS CUI [1,1])
    C0680730 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    V/Q Scan Result
    Code List
    V/Q Scan Result
    CL Item
    Normal (Normal)
    CL Item
    High Probability (High Probability)
    CL Item
    Non-High Probability (Non-High Probability)
    CL Item
    Not done (Not done)
    Item Group
    Spiral CT scan
    C0860888 (UMLS CUI-1)
    C0680730 (UMLS CUI-2)
    C1274040 (UMLS CUI-3)
    Spiral CT Scan Date
    Item
    Spiral CT Scan Date
    date
    C0011008 (UMLS CUI [1,1])
    C0860888 (UMLS CUI [1,2])
    Item
    Spiral CT Scan Result
    text
    C0680730 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    C0860888 (UMLS CUI [1,3])
    Spiral CT Scan Result
    Code List
    Spiral CT Scan Result
    CL Item
    Non-Diagnostic (Non-Diagnostic)
    CL Item
    ILFD (ILFD)
    CL Item
    Indeterminate (Indeterminate)
    CL Item
    Not done (Not done)
    Item Group
    Pulmonary Angiogram
    C0202910 (UMLS CUI-1)
    C0680730 (UMLS CUI-2)
    C1274040 (UMLS CUI-3)
    Pulmonary Angiogram Date
    Item
    Pulmonary Angiogram Date
    date
    C0202910 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Pulmonary Angiogram Result
    text
    C0202910 (UMLS CUI [1,1])
    C0680730 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Pulmonary Angiogram Result
    Code List
    Pulmonary Angiogram Result
    CL Item
    Normal (Normal)
    CL Item
    Diagnostic for PE (Diagnostic for PE)
    CL Item
    Indeterminate (Indeterminate)
    CL Item
    Not done (Not done)
    Item Group
    CUS
    C2317107 (UMLS CUI-1)
    C0680730 (UMLS CUI-2)
    C1274040 (UMLS CUI-3)
    Compression ultrasonography: Date
    Item
    Compression ultrasonography: Date
    date
    C2317107 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    CUS Result
    text
    C2317107 (UMLS CUI [1,1])
    C0680730 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    CUS Result
    Code List
    CUS Result
    CL Item
    No Acute DVT (No Acute DVT)
    CL Item
    Acute DVT (Acute DVT)
    CL Item
    Non-Evaluable (Non-Evaluable)
    CL Item
    Not done (Not done)
    Item
    Compression ultrasonography result: Left
    text
    C2317107 (UMLS CUI [1,1])
    C0680730 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C0205091 (UMLS CUI [1,4])
    Compression ultrasonography result: Left
    Code List
    Compression ultrasonography result: Left
    CL Item
    Compressible (Compressible)
    CL Item
    Non compressible (Non compressible)
    CL Item
    Indeterminate (Indeterminate)
    CL Item
    Not done (Not done)
    Item
    Compression ultrasonography result: Right
    text
    C2317107 (UMLS CUI [1,1])
    C0680730 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C0205090 (UMLS CUI [1,4])
    Compression ultrasonography result: Left
    Code List
    Compression ultrasonography result: Right
    CL Item
    Compressible (Compressible)
    CL Item
    Non compressible (Non compressible)
    CL Item
    Indeterminate (Indeterminate)
    CL Item
    Not done (Not done)
    Item Group
    Other test
    C0205394 (UMLS CUI-1)
    C0039593 (UMLS CUI-2)
    C0680730 (UMLS CUI-3)
    C1274040 (UMLS CUI-4)
    Specify other test
    Item
    Specify other test
    text
    C0205394 (UMLS CUI [1,1])
    C0039593 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Other test date
    Item
    Other test date
    date
    C0205394 (UMLS CUI [1,1])
    C0039593 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Other test result
    text
    C0205394 (UMLS CUI [1,1])
    C0039593 (UMLS CUI [1,2])
    C0680730 (UMLS CUI [1,3])
    C1274040 (UMLS CUI [1,4])
    Other test result
    Code List
    Other test result
    CL Item
    Normal (Normal)
    CL Item
    Diagnostic for PE (Diagnostic for PE)
    CL Item
    Indeterminate (Indeterminate)
    CL Item
    Not done (Not done)
    Item Group
    Venogram
    C0031545 (UMLS CUI-1)
    C0680730 (UMLS CUI-2)
    C1274040 (UMLS CUI-3)
    Bilateral Venogram Date
    Item
    Bilateral Venogram Date
    date
    C0031545 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0238767 (UMLS CUI [1,3])
    Left leg Venogram Date
    Item
    Left leg Venogram Date
    date
    C0031545 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0205091 (UMLS CUI [1,3])
    C1140621 (UMLS CUI [1,4])
    Right leg Venogram Date
    Item
    Right leg Venogram Date
    date
    C0031545 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0205090 (UMLS CUI [1,3])
    C1140621 (UMLS CUI [1,4])
    Item
    Venogram Result
    text
    C0031545 (UMLS CUI [1,1])
    C0680730 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Venogram Result
    Code List
    Venogram Result
    CL Item
    No Acute DVT (No Acute DVT)
    CL Item
    Acute DVT (Acute DVT)
    CL Item
    Non-Evaluable (Non-Evaluable)
    CL Item
    Not done (Not done)
    Item Group
    Venogram Results
    C0031545 (UMLS CUI-1)
    C0680730 (UMLS CUI-2)
    C1274040 (UMLS CUI-3)
    Item
    Venogram site
    text
    C0031545 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    Venography site
    Code List
    Venogram site
    CL Item
    Left proximal (Left proximal)
    CL Item
    Left distal (Left distal)
    CL Item
    Right proximal (Right proximal)
    CL Item
    Right distal (Right distal)
    Item
    Venogram result
    text
    C0031545 (UMLS CUI [1,1])
    C0680730 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Venography site
    Code List
    Venogram result
    CL Item
    Normal (Normal)
    CL Item
    ILFD (ILFD)
    CL Item
    Indeterminate (Indeterminate)
    CL Item
    Not Done (Not Done)
    Item Group
    Classification Status
    C0008902 (UMLS CUI-1)
    C0680730 (UMLS CUI-2)
    C1274040 (UMLS CUI-3)
    Pulmonary Embolism?
    Item
    Pulmonary Embolism?
    boolean
    C0034065 (UMLS CUI [1])
    PE Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1,1])
    C0034065 (UMLS CUI [1,2])
    Item Group
    Adjudicators
    C0401783 (UMLS CUI-1)
    Adjudicator Signature 1
    Item
    Adjudicator Signature 1
    text
    C0401783 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    Adjudicator Signature 2
    Item
    Adjudicator Signature 2
    text
    C0401783 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    Date of adjudication
    Item
    Date of adjudication
    text
    C4740194 (UMLS CUI [1])
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