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ID

34081

Description

Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Keywords

  1. 23/10/18 23/10/18 -
  2. 14/01/19 14/01/19 -
  3. 04/03/19 04/03/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

14 gennaio 2019

DOI

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License

Creative Commons BY-NC 3.0

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    Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

    Part 2 - Screening Visit - Local Laboratory Result Data (PSA)

    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Description

    Subject Identifier

    Data type

    integer

    Local Laboratory Result Data - PSA
    Description

    Local Laboratory Result Data - PSA

    Alias
    UMLS CUI-1
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    UMLS CUI-2
    C0201544 (Prostate specific antigen measurement)
    SNOMED
    63476009
    Date and time sample taken
    Description

    Prostate specific antigen measurement Sampling, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0201544 (Prostate specific antigen measurement)
    SNOMED
    63476009
    UMLS CUI [1,2]
    C0870078 (Sampling)
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,4]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Has the subject fasted?
    Description

    Prostate specific antigen measurement, Fasting

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0201544 (Prostate specific antigen measurement)
    SNOMED
    63476009
    UMLS CUI [1,2]
    C0015663 (Fasting)
    SNOMED
    16985007
    LOINC
    LA11831-7
    PSA
    Description

    Prostate specific antigen measurement

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    UMLS CUI [1,1]
    C0201544 (Prostate specific antigen measurement)
    SNOMED
    63476009
    UMLS CUI [1,2]
    C0337438 (Glucose measurement)
    SNOMED
    36048009
    mg/dL

    Similar models

    Part 2 - Screening Visit - Local Laboratory Result Data (PSA)

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    integer
    Item Group
    Local Laboratory Result Data - PSA
    C0022885 (UMLS CUI-1)
    C0201544 (UMLS CUI-2)
    Prostate specific antigen measurement Sampling, Date in time, Time
    Item
    Date and time sample taken
    datetime
    C0201544 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Prostate specific antigen measurement, Fasting
    Item
    Has the subject fasted?
    boolean
    C0201544 (UMLS CUI [1,1])
    C0015663 (UMLS CUI [1,2])
    Prostate specific antigen measurement
    Item
    PSA
    float
    C0201544 (UMLS CUI [1,1])
    C0337438 (UMLS CUI [1,2])

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