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ID

35393

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

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Versions (3)
  1. 10/23/18 10/23/18 -
  2. 1/14/19 1/14/19 -
  3. 3/4/19 3/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 4, 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

    English

    Part 2 - Treatment Period Day -1 - Physical Examination

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Date of Assessment
    Description

    Physical Examination, Assessment Date

    Data type

    date

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

    Physical Examination, Hair; Physical Examination, Skin

    Data type

    text

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

    Physical Examination, Lymph nodes

    Data type

    text

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

    Physical Examination, Eye

    Data type

    text

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

    ENT examination

    Data type

    text

    Alias
    UMLS CUI [1]
    C0278350
    Breasts
    Description

    Physical Examination, Examination of breast

    Data type

    text

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

    Physical Examination, Respiratory System

    Data type

    text

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

    Physical Examination, Cardiovascular system

    Data type

    text

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

    Physical Examination, Abdomen

    Data type

    text

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

    Physical Examination, Genitourinary assessment

    Data type

    text

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

    Physical Examination, Pelvis

    Data type

    text

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

    Physical Examination, Rectal examination

    Data type

    text

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

    Physical Examination, Musculoskeletal System

    Data type

    text

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

    Physical Examination, Neurologic Examination

    Data type

    text

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

    Physical Examination, Mental state

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0278060
    Back to the top of the page

    Similar models

    Part 2 - Treatment Period Day -1 - Physical Examination

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    C0031809 (UMLS CUI [1,2])
    C1123023 (UMLS CUI [1,3])
    Hair and Skin
    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])
    Lymph nodes
    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])
    Eyes
    Code List
    Eyes
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Item
    Ears, Nose and Throat
    text
    C0278350 (UMLS CUI [1])
    Ears. Nose and Throat
    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])
    Breasts
    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])
    Respiratory
    Code List
    Respiratory
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Item
    Cardiovascular
    text
    C0031809 (UMLS CUI [1,1])
    C0007226 (UMLS CUI [1,2])
    Cardiovascular
    Code List
    Cardiovascular
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Item
    Abdomen
    text
    C0031809 (UMLS CUI [1,1])
    C0000726 (UMLS CUI [1,2])
    Abdomen
    Code List
    Abdomen
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Item
    Urogenital
    text
    C0031809 (UMLS CUI [1,1])
    C1828035 (UMLS CUI [1,2])
    Urogenital
    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])
    Pelvic
    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])
    Rectal
    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])
    Musculoskeletal
    Code List
    Musculoskeletal
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Item
    Neurological
    text
    C0031809 (UMLS CUI [1,1])
    C0027853 (UMLS CUI [1,2])
    Neurological
    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])
    Mental Status
    Code List
    Mental Status
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    Back to the top of the page 

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