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ID

41717

Beschrijving

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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Versies (1)
  1. 06-01-21 06-01-21 -
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GlaxoSmithKline

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6 januari 2021

DOI

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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)

    Engels

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

    1 Formulieren  
    Administrative
    Beschrijving

    Administrative

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Volunteer Identifier
    Beschrijving

    Volunteer Identifier

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1300638 (Identification number)
    SNOMED
    396278008
    UMLS CUI [1,2]
    C0020155 (Human Volunteers)
    Subject Identifier
    Beschrijving

    Subject Identifier

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Centre Number
    Beschrijving

    Centre Number

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    UMLS CUI [1,2]
    C0019994 (Hospitals)
    Demography
    Beschrijving

    Demography

    Alias
    UMLS CUI-1
    C0011298 (Demography)
    LOINC
    LP204151-7
    Date of birth
    Beschrijving

    Date of birth

    Datatype

    date

    Alias
    UMLS CUI [1]
    C0421451 (Patient date of birth)
    SNOMED
    184099003
    LOINC
    LP57552-9
    Sex
    Beschrijving

    Sex

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    Ethnicity
    Beschrijving

    Check one

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0015031 (Ethnic group)
    SNOMED
    398089004
    LOINC
    LP36231-6
    Race
    Beschrijving

    Chek one

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0034510 (Racial group)
    SNOMED
    415229000
    LOINC
    LP7528-5
    Child-Bearing Potential
    Beschrijving

    Child-Bearing Potential

    Alias
    UMLS CUI-1
    C3831118 (Childbearing Potential)
    Child-Bearing Potential
    Beschrijving

    Check one

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C3831118 (Childbearing Potential)
    Pregnancy Test
    Beschrijving

    Pregnancy Test

    Alias
    UMLS CUI-1
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    Date of test
    Beschrijving

    Date of test

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Results
    Beschrijving

    Results

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    UMLS CUI [1,2]
    C1274040 (Result)
    SNOMED
    394617004
    Physical Examination
    Beschrijving

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Physical Examination
    Beschrijving

    Physical Examination

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Physical Examination Not Done
    Beschrijving

    Physical Examination Not Done

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C1272696 (Not Done)
    SNOMED
    385660001
    Physical Examination Result
    Beschrijving

    Physical Examination Result

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0456984 (Test Result)
    SNOMED
    277775005
    If Abnormal, specify
    Beschrijving

    If Abnormal, specify

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0243095 (Finding)
    LOINC
    LA9042-8
    UMLS CUI [1,2]
    C0205161 (Abnormal)
    SNOMED
    263654008
    LOINC
    LP28764-6
    UMLS CUI [1,3]
    C2348235 (Specification)
    Vital Signs
    Beschrijving

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Height
    Beschrijving

    Height

    Datatype

    integer

    Maateenheden
    • cm
    Alias
    UMLS CUI [1]
    C0005890 (Body Height)
    SNOMED
    50373000
    cm
    Weight
    Beschrijving

    Weight

    Datatype

    float

    Maateenheden
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Body mass index
    Beschrijving

    Body mass index

    Datatype

    float

    Maateenheden
    • kg/m^2
    Alias
    UMLS CUI [1]
    C1305855 (Body mass index)
    SNOMED
    60621009
    LOINC
    LP35925-4
    kg/m^2
    Vital Signs
    Beschrijving

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Date (Vital Signs)
    Beschrijving

    Date (Vital Signs)

    Datatype

    date

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

    Planned Relative Time (Vital Signs)

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI [1,2]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    UMLS CUI [1,3]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    Actual Time (Vital Signs)
    Beschrijving

    Actual Time (Vital Signs)

    Datatype

    time

    Alias
    UMLS CUI [1]
    C2826762 (Vital Signs Time)
    Systolic Blood Pressure
    Beschrijving

    Systolic Blood Pressure

    Datatype

    integer

    Maateenheden
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mm[Hg]
    Diastolic Blood Pressure
    Beschrijving

    Diastolic Blood Pressure

    Datatype

    integer

    Maateenheden
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    mm[Hg]
    Heart Rate (Vital Signs)
    Beschrijving

    Heart Rate (Vital Signs)

    Datatype

    integer

    Maateenheden
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI [1,2]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/min
    Medical Conditions
    Beschrijving

    Medical Conditions

    Alias
    UMLS CUI-1
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    Diagnosis
    Beschrijving

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

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    Medical Condition Status
    Beschrijving

    Medical Condition Status

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [1,2]
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
    Terug naar het begin van de pagina

    Similar models

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

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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)
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