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ID

34072

Beschrijving

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

Trefwoorden

  1. 22-10-18 22-10-18 -
  2. 14-01-19 14-01-19 -
  3. 04-03-19 04-03-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

14 januari 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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    Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

    Part 2 - Screening Visit - Physical Examination

    Administrative data
    Beschrijving

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beschrijving

    Clinical Trial Subject Unique Identifier

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Physical Examination
    Beschrijving

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Date of Assessment
    Beschrijving

    Physical Examination, Assessment Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C2985720
    Hair and Skin
    Beschrijving

    Physical Examination, Hair, Skin

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0018494
    UMLS CUI [1,3]
    C1123023
    Lymph nodes
    Beschrijving

    Physical Examination, Lymph nodes

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0024204
    Eyes
    Beschrijving

    Physical Examination, Eye

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0015392
    Ears, Nose and Throat
    Beschrijving

    ENT examination

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0278350
    Breasts
    Beschrijving

    Physical Examination, Examination of breast

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0199850
    Respiratory
    Beschrijving

    Physical Examination, Respiratory System

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0035237
    Cardiovascular
    Beschrijving

    Physical Examination, Cardiovascular system

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0007226
    Abdomen
    Beschrijving

    Physical Examination, Abdomen

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0000726
    Urogenital
    Beschrijving

    Physical Examination, Genitourinary assessment

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C1828035
    Pelvic
    Beschrijving

    Physical Examination, Pelvis

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0030797
    Rectal
    Beschrijving

    Physical Examination, Rectal examination

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0199900
    Musculoskeletal
    Beschrijving

    Physical Examination, Musculoskeletal System

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0026860
    Neurological
    Beschrijving

    Physical Examination, Neurologic Examination

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0027853
    Mental Status
    Beschrijving

    Physical Examination, Mental state

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0278060

    Similar models

    Part 2 - Screening Visit - Physical Examination

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Physical Examination, Assessment Date
    Item
    Date of Assessment
    date
    C0031809 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Item
    Hair and Skin
    text
    C0031809 (UMLS CUI [1,1])
    C0018494 (UMLS CUI [1,2])
    C1123023 (UMLS CUI [1,3])
    Code List
    Hair and Skin
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Item
    Lymph nodes
    text
    C0031809 (UMLS CUI [1,1])
    C0024204 (UMLS CUI [1,2])
    Code List
    Lymph nodes
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Item
    Eyes
    text
    C0031809 (UMLS CUI [1,1])
    C0015392 (UMLS CUI [1,2])
    Code List
    Eyes
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Item
    Ears, Nose and Throat
    text
    C0278350 (UMLS CUI [1])
    Code List
    Ears, Nose and Throat
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Item
    Breasts
    text
    C0031809 (UMLS CUI [1,1])
    C0199850 (UMLS CUI [1,2])
    Code List
    Breasts
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not Done (3)
    Item
    Respiratory
    text
    C0031809 (UMLS CUI [1,1])
    C0035237 (UMLS CUI [1,2])
    Code List
    Respiratory
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Item
    Cardiovascular
    text
    C0031809 (UMLS CUI [1,1])
    C0007226 (UMLS CUI [1,2])
    Code List
    Cardiovascular
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Item
    Abdomen
    text
    C0031809 (UMLS CUI [1,1])
    C0000726 (UMLS CUI [1,2])
    Code List
    Abdomen
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Item
    Urogenital
    text
    C0031809 (UMLS CUI [1,1])
    C1828035 (UMLS CUI [1,2])
    Code List
    Urogenital
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not Done (3)
    Item
    Pelvic
    text
    C0031809 (UMLS CUI [1,1])
    C0030797 (UMLS CUI [1,2])
    Code List
    Pelvic
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not Done (3)
    Item
    Rectal
    text
    C0031809 (UMLS CUI [1,1])
    C0199900 (UMLS CUI [1,2])
    Code List
    Rectal
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not Done (3)
    Item
    Musculoskeletal
    text
    C0031809 (UMLS CUI [1,1])
    C0026860 (UMLS CUI [1,2])
    Code List
    Musculoskeletal
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Item
    Neurological
    text
    C0031809 (UMLS CUI [1,1])
    C0027853 (UMLS CUI [1,2])
    Code List
    Neurological
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Item
    Mental Status
    text
    C0031809 (UMLS CUI [1,1])
    C0278060 (UMLS CUI [1,2])
    Code List
    Mental Status
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)

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