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ID

29651

Description

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Physical Examination: Vital Signs, pedal oedema. Time: Treatment Period 2, Day 14, pre-dose.

Link

https://clinicaltrials.gov/ct2/show/NCT00318630

Keywords

Versions (1)
  1. 4/10/18 4/10/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

April 10, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630

    English

    Physical examination - Treatment Period 2, Day 14, Pre-dose

    1 forms  
    Vital signs
    Description

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Date
    Description

    Day Month Year e.g., 01 JAN 03

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Planned relative Time
    Description

    e.g. 15 min

    Data type

    text

    Alias
    UMLS CUI [1]
    C0439564
    Actual Time
    Description

    Hr : Min (00:00 - 23:59) e.g. 13:02

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    Systolic Blood Pressure
    Description

    Supine. The subject should be in the supine position for at least 5 minutes before and during the recording. At least three consecutive readings more than 1 minute apart will be recorded. Systolic e.g. 110

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0038846
    mmHg
    Diastolic Blood Pressure
    Description

    Supine. The subject should be in the supine position for at least 5 minutes before and during the recording. At least three consecutive readings more than 1 minute apart will be recorded. Diastolic e.g. 80

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0038846
    mmHg
    Heart rate
    Description

    e.g., 75

    Data type

    text

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Pedal Oedema
    Description

    Pedal Oedema

    Alias
    UMLS CUI-1
    C0574002
    Date of Assessment
    Description

    Date of Assessment

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985720
    Time of Assessment
    Description

    Hr : Min (00:00 - 23:59)

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1516048
    UMLS CUI [1,2]
    C0040223
    Press firmly with thumb anterior to the ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below.
    Description

    Note: Use the same ankle throughout the study.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0574002
    UMLS CUI [1,2]
    C0205125
    Mark the appropriate box below to indicate which ankle was assessed at this visit.
    Description

    Side of assessed ankle

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0574002
    UMLS CUI [1,2]
    C0441987
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    Similar models

    Physical examination - Treatment Period 2, Day 14, Pre-dose

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Item
    Planned relative Time
    text
    C0439564 (UMLS CUI [1])
    Planned relative Time
    Code List
    Planned relative Time
    CL Item
    pre-dose (pre-dose)
    CL Item
    unscheduled (unscheduled)
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    Heart rate
    Item
    Heart rate
    text
    C0018810 (UMLS CUI [1])
    Item Group
    Pedal Oedema
    C0574002 (UMLS CUI-1)
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Time of Assessment
    Item
    Time of Assessment
    time
    C1516048 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Press firmly with thumb anterior to the ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below.
    integer
    C0574002 (UMLS CUI [1,1])
    C0205125 (UMLS CUI [1,2])
    Depth of Indentation
    Code List
    Press firmly with thumb anterior to the ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below.
    CL Item
    <1 mm (1)
    CL Item
    1-2 mm (2)
    CL Item
    3-5 mm (3)
    CL Item
    6-10 mm (4)
    CL Item
    >10 mm (5)
    Item
    Mark the appropriate box below to indicate which ankle was assessed at this visit.
    integer
    C0574002 (UMLS CUI [1,1])
    C0441987 (UMLS CUI [1,2])
    Side of assessed ankle
    Code List
    Mark the appropriate box below to indicate which ankle was assessed at this visit.
    CL Item
    right ankle (1)
    CL Item
    left ankle (2)
    Back to the top of the page 

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