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ID

41717

Description

Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

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Versions (1)
  1. 1/6/21 1/6/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 6, 2021

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Creative Commons BY 4.0
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    Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096)

    English

    Screening - Demography; Child-bearing Potential; Pregnancy Test; Physical Examination; Vital Signs; Medical Conditions

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Volunteer Identifier
    Description

    Volunteer Identifier

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1300638
    UMLS CUI [1,2]
    C0020155
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Centre Number
    Description

    Centre Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Demography
    Description

    Demography

    Alias
    UMLS CUI-1
    C0011298
    Date of birth
    Description

    Date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Description

    Sex

    Data type

    text

    Alias
    UMLS CUI [1]
    C0079399
    Ethnicity
    Description

    Check one

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0015031
    Race
    Description

    Chek one

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0034510
    Child-Bearing Potential
    Description

    Child-Bearing Potential

    Alias
    UMLS CUI-1
    C3831118
    Child-Bearing Potential
    Description

    Check one

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3831118
    Pregnancy Test
    Description

    Pregnancy Test

    Alias
    UMLS CUI-1
    C0032976
    Date of test
    Description

    Date of test

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0011008
    Results
    Description

    Results

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C1274040
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Physical Examination
    Description

    Physical Examination

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0031809
    Physical Examination Not Done
    Description

    Physical Examination Not Done

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C1272696
    Physical Examination Result
    Description

    Physical Examination Result

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0456984
    If Abnormal, specify
    Description

    If Abnormal, specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0243095
    UMLS CUI [1,2]
    C0205161
    UMLS CUI [1,3]
    C2348235
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Height
    Description

    Height

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body mass index
    Description

    Body mass index

    Data type

    float

    Measurement units
    • kg/m^2
    Alias
    UMLS CUI [1]
    C1305855
    kg/m^2
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Date (Vital Signs)
    Description

    Date (Vital Signs)

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826644
    Planned Relative Time (Vital Signs)
    Description

    Planned Relative Time (Vital Signs)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0439564
    UMLS CUI [1,3]
    C1301732
    Actual Time (Vital Signs)
    Description

    Actual Time (Vital Signs)

    Data type

    time

    Alias
    UMLS CUI [1]
    C2826762
    Systolic Blood Pressure
    Description

    Systolic Blood Pressure

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Diastolic Blood Pressure
    Description

    Diastolic Blood Pressure

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Heart Rate (Vital Signs)
    Description

    Heart Rate (Vital Signs)

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0018810
    beats/min
    Medical Conditions
    Description

    Medical Conditions

    Alias
    UMLS CUI-1
    C0012634
    Diagnosis
    Description

    Only in the absence of a diagnosis, record the signs and symptoms on separate lines

    Data type

    text

    Alias
    UMLS CUI [1]
    C0011900
    Medical Condition Status
    Description

    Medical Condition Status

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0449438
    Back to the top of the page

    Similar models

    Screening - Demography; Child-bearing Potential; Pregnancy Test; Physical Examination; Vital Signs; Medical Conditions

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Volunteer Identifier
    Item
    Volunteer Identifier
    text
    C1300638 (UMLS CUI [1,1])
    C0020155 (UMLS CUI [1,2])
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Item Group
    Demography
    C0011298 (UMLS CUI-1)
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Sex
    text
    C0079399 (UMLS CUI [1])
    Sex
    Code List
    Sex
    CL Item
    Male (M)
    CL Item
    Female (F)
    Item
    Ethnicity
    integer
    C0015031 (UMLS CUI [1])
    Ethnicity
    Code List
    Ethnicity
    CL Item
    Hispanic (1)
    CL Item
    Not Hispanic or Latino (2)
    Item
    Race
    integer
    C0034510 (UMLS CUI [1])
    Race
    Code List
    Race
    CL Item
    African American/African Heritage (11)
    CL Item
    American Indian or Alaskan Native (12)
    CL Item
    Asian - Central/South Asian Heritage (13)
    CL Item
    Asian - East Asian Heritage (14)
    CL Item
    Asian - Japanese Hertiage (15)
    CL Item
    Asian - South East Asian Heritage (16)
    CL Item
    Native Hawaiian or Other Pacific Islander (17)
    CL Item
    White - Arabic/North African Heritage (18)
    CL Item
    White - White/Caucasian/European Heritage (19)
    Item Group
    Child-Bearing Potential
    C3831118 (UMLS CUI-1)
    Item
    Child-Bearing Potential
    integer
    C3831118 (UMLS CUI [1])
    Child-Bearing Potential
    Code List
    Child-Bearing Potential
    CL Item
    Post-menopausal (1)
    CL Item
    Sterile (of child-bearing age) (2)
    Item Group
    Pregnancy Test
    C0032976 (UMLS CUI-1)
    Date of test
    Item
    Date of test
    date
    C0032976 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Results
    integer
    C0032976 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Results
    Code List
    Results
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Item
    Physical Examination
    integer
    C0031809 (UMLS CUI [1])
    Physical Examination
    Code List
    Physical Examination
    CL Item
    Hair and Skin (1)
    CL Item
    Lymph nodes (2)
    CL Item
    Eyes (3)
    CL Item
    Ears, Nose and Throat (4)
    CL Item
    Breast (5)
    CL Item
    Respiratory (6)
    CL Item
    Cardiovascular (7)
    CL Item
    Abdomen (8)
    CL Item
    Urogenital (9)
    CL Item
    Pelvic (10)
    CL Item
    Rectal (11)
    CL Item
    Musculoskeletal (12)
    CL Item
    Neurological (13)
    CL Item
    Mental Status (14)
    Item
    Physical Examination Not Done
    integer
    C0031809 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    Physical Examination Not Done
    Code List
    Physical Examination Not Done
    CL Item
    Not Done (1)
    Item
    Physical Examination Result
    integer
    C0031809 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Physical Examination Result
    Code List
    Physical Examination Result
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    If Abnormal, specify
    Item
    If Abnormal, specify
    text
    C0243095 (UMLS CUI [1,1])
    C0205161 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Body mass index
    Item
    Body mass index
    float
    C1305855 (UMLS CUI [1])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Date (Vital Signs)
    Item
    Date (Vital Signs)
    date
    C2826644 (UMLS CUI [1])
    Item
    Planned Relative Time (Vital Signs)
    integer
    C0518766 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    C1301732 (UMLS CUI [1,3])
    Planned Relative Time (Vital Signs)
    Code List
    Planned Relative Time (Vital Signs)
    CL Item
    Screening (1)
    Actual Time (Vital Signs)
    Item
    Actual Time (Vital Signs)
    time
    C2826762 (UMLS CUI [1])
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0428883 (UMLS CUI [1])
    Heart Rate (Vital Signs)
    Item
    Heart Rate (Vital Signs)
    integer
    C0518766 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    Item Group
    Medical Conditions
    C0012634 (UMLS CUI-1)
    Diagnosis
    Item
    Diagnosis
    text
    C0011900 (UMLS CUI [1])
    Item
    Medical Condition Status
    integer
    C0012634 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Medical Condition Status
    Code List
    Medical Condition Status
    CL Item
    Current (1)
    CL Item
    Past (2)
    Back to the top of the page 

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