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ID

34497

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

Mots-clés

Versions (2)
  1. 24/10/2018 24/10/2018 -
  2. 17/01/2019 17/01/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

17 janvier 2019

DOI

Pour une demande vous connecter.

Licence

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

    Anglais

    Part 2 - Repeat Dose Phase - Day 25 - Urinalysis

    1 Formulaires  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Clinical Trial Subject Unique Identifier

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Urinalysis
    Description

    Urinalysis

    Alias
    UMLS CUI-1
    C0042014
    Date and time sample taken
    Description

    Urinalysis, Sampling, Date in time, Time

    Type de données

    datetime

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Laboratory Name
    Description

    Urinalysis, Performing Laboratory Name

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C3258037
    Address
    Description

    Urinalysis, Performing Laboratory, Street Address

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C1882331
    UMLS CUI [1,3]
    C1301826
    Lab ID
    Description

    Urinalysis, Laboratory Identifier

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C2986056
    Result of dipstick
    Description

    Urine dipstick test, Test result

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0430370
    UMLS CUI [1,2]
    C0456984
    Urinalysis (Dipstick) Test
    Description

    Urinalysis (Dipstick) Test

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C0430370
    Specific gravity
    Description

    Urinalysis, Specific gravity measurement, urine

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0202517
    Micro
    Description

    Microscopic urinalysis

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0430397
    pH
    Description

    Urinalysis, Urine pH measurement

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0042044
    Glucose
    Description

    Urinalysis, Glucose measurement, urine

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0004076
    Protein
    Description

    Urinalysis, Proteins

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0033684
    Blood
    Description

    Urinalysis, Urine screening for blood

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0202514
    Ketones
    Description

    Urinalysis, Ketones

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C1991100
    Urinalysis (Microscopy) Test
    Description

    Urinalysis (Microscopy) Test

    Alias
    UMLS CUI-1
    C0430397
    Was sedimentary microscopy performed?
    Description

    NOTE: Sedimentary microscopy should only be performed if any of the dipstick results are abnormal.

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0430397
    UMLS CUI [1,2]
    C2700128
    WBC
    Description

    Urinalysis, White Blood Cell Count Procedure

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0023508
    RBC
    Description

    Urinalysis, Red Blood Cell Count measurement

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0014772
    Hyaline casts
    Description

    Urine Hyaline Casts Test

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1254537
    Granular casts
    Description

    Urine Sediment Analysis Measurement; Granular Cast Measurement

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2700128
    UMLS CUI [1,2]
    C2697521
    Cellular casts
    Description

    Urine Sediment Analysis Measurement; Cellular Cast Measurement

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2700128
    UMLS CUI [1,2]
    C2699157
    Retour au début de la page

    Similar models

    Part 2 - Repeat Dose Phase - Day 25 - Urinalysis

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Urinalysis
    C0042014 (UMLS CUI-1)
    Urinalysis, Sampling, Date in time, Time
    Item
    Date and time sample taken
    datetime
    C0042014 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Urinalysis, Performing Laboratory Name
    Item
    Laboratory Name
    text
    C0042014 (UMLS CUI [1,1])
    C3258037 (UMLS CUI [1,2])
    Urinalysis, Performing Laboratory, Street Address
    Item
    Address
    text
    C0042014 (UMLS CUI [1,1])
    C1882331 (UMLS CUI [1,2])
    C1301826 (UMLS CUI [1,3])
    Urinalysis, Laboratory Identifier
    Item
    Lab ID
    text
    C0042014 (UMLS CUI [1,1])
    C2986056 (UMLS CUI [1,2])
    Item
    Result of dipstick
    text
    C0430370 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Result of dipstick
    Code List
    Result of dipstick
    CL Item
    [NEG] Negative (1)
    CL Item
    [POS] Positive -> If positive, record results of individual tests below. (2)
    CL Item
    [NR] No Result (3)
    Item Group
    Urinalysis (Dipstick) Test
    C0042014 (UMLS CUI-1)
    C0430370 (UMLS CUI-2)
    Urinalysis, Specific gravity measurement, urine
    Item
    Specific gravity
    text
    C0042014 (UMLS CUI [1,1])
    C0202517 (UMLS CUI [1,2])
    Microscopic urinalysis
    Item
    Micro
    text
    C0430397 (UMLS CUI [1])
    Urinalysis, Urine pH measurement
    Item
    pH
    text
    C0042014 (UMLS CUI [1,1])
    C0042044 (UMLS CUI [1,2])
    Urinalysis, Glucose measurement, urine
    Item
    Glucose
    text
    C0042014 (UMLS CUI [1,1])
    C0004076 (UMLS CUI [1,2])
    Urinalysis, Proteins
    Item
    Protein
    text
    C0042014 (UMLS CUI [1,1])
    C0033684 (UMLS CUI [1,2])
    Urinalysis, Urine screening for blood
    Item
    Blood
    text
    C0042014 (UMLS CUI [1,1])
    C0202514 (UMLS CUI [1,2])
    Urinalysis, Ketones
    Item
    Ketones
    text
    C0042014 (UMLS CUI [1,1])
    C1991100 (UMLS CUI [1,2])
    Item Group
    Urinalysis (Microscopy) Test
    C0430397 (UMLS CUI-1)
    Microscopic urinalysis; Urine Sediment Analysis Measurement
    Item
    Was sedimentary microscopy performed?
    boolean
    C0430397 (UMLS CUI [1,1])
    C2700128 (UMLS CUI [1,2])
    Urinalysis, White Blood Cell Count Procedure
    Item
    WBC
    text
    C0042014 (UMLS CUI [1,1])
    C0023508 (UMLS CUI [1,2])
    Urinalysis, Red Blood Cell Count measurement
    Item
    RBC
    text
    C0042014 (UMLS CUI [1,1])
    C0014772 (UMLS CUI [1,2])
    Urine Hyaline Casts Test
    Item
    Hyaline casts
    text
    C1254537 (UMLS CUI [1])
    Urine Sediment Analysis Measurement; Granular Cast Measurement
    Item
    Granular casts
    text
    C2700128 (UMLS CUI [1,1])
    C2697521 (UMLS CUI [1,2])
    Urine Sediment Analysis Measurement; Cellular Cast Measurement
    Item
    Cellular casts
    text
    C2700128 (UMLS CUI [1,1])
    C2699157 (UMLS CUI [1,2])
    Retour au début de la page 

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