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ID

34086

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

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Versies (2)
  1. 23-10-18 23-10-18 -
  2. 14-01-19 14-01-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

14 januari 2019

DOI

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

    Engels

    Part 2 - Treatment Period day -1 - 12-lead ECG (Semi-Supine)

    1 Formulieren  
    12-Lead ECG
    Beschrijving

    12-Lead ECG

    Alias
    UMLS CUI-1
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    Start Date of ECG
    Beschrijving

    12 lead ECG, Start Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    UMLS CUI [1,2]
    C0808070 (Start Date)
    Start Time of ECG
    Beschrijving

    12 lead ECG, Start Time

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    UMLS CUI [1,2]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    Ventricular Rate
    Beschrijving

    Ventricular Rate

    Datatype

    integer

    Maateenheden
    • bpm
    Alias
    UMLS CUI [1]
    C2189285 (electrocardiogram: ventricular rate)
    bpm
    PR Interval
    Beschrijving

    PR Interval

    Datatype

    integer

    Maateenheden
    • msec
    Alias
    UMLS CUI [1]
    C0429087 (Electrocardiogram: P-R interval)
    SNOMED
    365411005
    msec
    QRS Interval
    Beschrijving

    Mean QRS Duration

    Datatype

    integer

    Maateenheden
    • msec
    Alias
    UMLS CUI [1]
    C1880451 (Mean QRS Duration)
    msec
    Uncorrected QT Interval
    Beschrijving

    QT Interval - finding

    Datatype

    integer

    Maateenheden
    • msec
    Alias
    UMLS CUI [1]
    C1287082 (QT interval - finding)
    SNOMED
    365417009
    msec
    QTc Interval
    Beschrijving

    QTc Interval

    Datatype

    integer

    Maateenheden
    • msec
    Alias
    UMLS CUI [1]
    C0489625 (QTC interval)
    LOINC
    LP31071-1
    msec
    Result of the ECG
    Beschrijving

    12 lead ECG, Result

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    UMLS CUI [1,2]
    C1274040 (Result)
    SNOMED
    394617004
    Terug naar het begin van de pagina

    Similar models

    Part 2 - Treatment Period day -1 - 12-lead ECG (Semi-Supine)

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    12-Lead ECG
    C0430456 (UMLS CUI-1)
    12 lead ECG, Start Date
    Item
    Start Date of ECG
    date
    C0430456 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    12 lead ECG, Start Time
    Item
    Start Time of ECG
    time
    C0430456 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Ventricular Rate
    Item
    Ventricular Rate
    integer
    C2189285 (UMLS CUI [1])
    PR Interval
    Item
    PR Interval
    integer
    C0429087 (UMLS CUI [1])
    Mean QRS Duration
    Item
    QRS Interval
    integer
    C1880451 (UMLS CUI [1])
    QT Interval - finding
    Item
    Uncorrected QT Interval
    integer
    C1287082 (UMLS CUI [1])
    QTc Interval
    Item
    QTc Interval
    integer
    C0489625 (UMLS CUI [1])
    Item
    Result of the ECG
    integer
    C0430456 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Result of the ECG
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically significant  (2)
    CL Item
    Abnormal - clinically significant (Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.) (3)
    CL Item
    No result (not available) (4)
    Terug naar het begin van de pagina 

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