0 Evaluaciones
ID

35396

Descripción

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

Palabras clave

Versiones (3)
  1. 23/10/18 23/10/18 -
  2. 14/1/19 14/1/19 -
  3. 4/3/19 4/3/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

4 de marzo de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

    Inglés

    Part 2 - Treatment Period Day 14 - Physical Examination

    1 formularios  
    Administrative data
    Descripción

    Administrative data

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

    Clinical Trial Subject Unique Identifier

    Tipo de datos

    integer

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

    Physical Examination

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

    Physical Examination, Assessment Date

    Tipo de datos

    date

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

    Physical Examination, Hair; Physical Examination, Skin

    Tipo de datos

    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
    Descripción

    Physical Examination, Lymph nodes

    Tipo de datos

    text

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

    Physical Examination, Eye

    Tipo de datos

    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
    Descripción

    ENT examination

    Tipo de datos

    text

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

    Physical Examination, Examination of breast

    Tipo de datos

    text

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

    Physical Examination, Respiratory System

    Tipo de datos

    text

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

    Physical Examination, Cardiovascular system

    Tipo de datos

    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
    Descripción

    Physical Examination, Abdomen

    Tipo de datos

    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
    Descripción

    Physical Examination, Genitourinary assessment

    Tipo de datos

    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
    Descripción

    Physical Examination, Pelvis

    Tipo de datos

    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
    Descripción

    Physical Examination, Rectal examination

    Tipo de datos

    text

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

    Physical Examination, Musculoskeletal System

    Tipo de datos

    text

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

    Physical Examination, Neurologic Examination

    Tipo de datos

    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
    Descripción

    Physical Examination, Mental state

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0278060 (Mental state)
    SNOMED
    363871006
    LOINC
    MTHU001424
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    Similar models

    Part 2 - Treatment Period Day 14 - Physical Examination

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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)
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