0 Ratings
ID

35396

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

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

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

    English

    Part 2 - Treatment Period Day 14 - Physical Examination

    1 forms  
    Administrative data
    Description

    Administrative data

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

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Date of Assessment
    Description

    Physical Examination, Assessment Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C2985720 (Assessment Date)
    Hair and Skin
    Description

    Physical Examination, Hair; Physical Examination, Skin

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0018494 (Hair)
    SNOMED
    386045008
    LOINC
    LP7280-3
    UMLS CUI [2,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [2,2]
    C1123023 (Skin)
    SNOMED
    39937001
    LOINC
    LP76007-1
    Lymph nodes
    Description

    Physical Examination, Lymph nodes

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0024204 (lymph nodes)
    SNOMED
    59441001
    Eyes
    Description

    Physical Examination, Eye

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0015392 (Eye)
    SNOMED
    81745001
    LOINC
    LP7218-3
    Ears, Nose and Throat
    Description

    ENT examination

    Data type

    text

    Alias
    UMLS CUI [1]
    C0278350 (ENT examination)
    SNOMED
    113028003
    Breasts
    Description

    Physical Examination, Examination of breast

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0199850 (Examination of breast)
    SNOMED
    46662001
    Respiratory
    Description

    Physical Examination, Respiratory System

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0035237 (Respiratory System)
    SNOMED
    20139000
    Cardiovascular
    Description

    Physical Examination, Cardiovascular system

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0007226 (Cardiovascular system)
    SNOMED
    113257007
    LOINC
    LP7118-5
    Abdomen
    Description

    Physical Examination, Abdomen

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0000726 (Abdomen)
    SNOMED
    818983003
    LOINC
    LP6990-8
    Urogenital
    Description

    Physical Examination, Genitourinary assessment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C1828035 (Genitourinary assessment)
    SNOMED
    424067002
    LOINC
    MTHU051480
    Pelvic
    Description

    Physical Examination, Pelvis

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0030797 (Pelvis)
    SNOMED
    12921003
    LOINC
    LP7467-6
    Rectal
    Description

    Physical Examination, Rectal examination

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0199900 (Rectal examination)
    SNOMED
    410006001
    Musculoskeletal
    Description

    Physical Examination, Musculoskeletal System

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0026860 (Musculoskeletal System)
    SNOMED
    26107004
    Neurological
    Description

    Physical Examination, Neurologic Examination

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0027853 (Neurologic Examination)
    SNOMED
    225398001
    LOINC
    LP133273-5
    Mental Status
    Description

    Physical Examination, Mental state

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0278060 (Mental state)
    SNOMED
    363871006
    LOINC
    MTHU001424
    Back to the top of the page

    Similar models

    Part 2 - Treatment Period Day 14 - 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])
    C0018494 (UMLS CUI [1,2])
    C0031809 (UMLS CUI [2,1])
    C1123023 (UMLS CUI [2,2])
    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 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial