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ID

32190

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

GSK group of companies

Uploaded on

October 23, 2018

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 1 - 12-LEAD ECG Results

    1 forms  
    Administrative data
    Description

    Administrative data

    Subject Identifier
    Description

    Subject Identifier

    Data type

    integer

    Visit Date
    Description

    Visit Date

    Data type

    date

    12-lead ECG (Semi-Supine)
    Description

    12-lead ECG (Semi-Supine)

    Start Date of ECG
    Description

    Start Date of ECG

    Data type

    date

    Start Time of ECG
    Description

    Start Time of ECG

    Data type

    time

    Ventricular Rate
    Description

    Ventricular Rate

    Data type

    integer

    Measurement units
    • bpm
    bpm
    PR Interval
    Description

    PR Interval

    Data type

    integer

    Measurement units
    • msec
    msec
    QRS Duration
    Description

    QRS Duration

    Data type

    integer

    Measurement units
    • msec
    msec
    Uncorrected QT Interval
    Description

    Uncorrected QT Interval

    Data type

    text

    Measurement units
    • msec
    msec
    QTc Interval
    Description

    QTc Interval

    Data type

    integer

    Measurement units
    • msec
    msec
    Result of the ECG
    Description

    mark one:

    Data type

    text

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    Similar models

    Part 2: Treatment Period 1 - 12-LEAD ECG Results

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    Subject Identifier
    Item
    Subject Identifier
    integer
    Visit Date
    Item
    Visit Date
    date
    Item Group
    12-lead ECG (Semi-Supine)
    Start Date of ECG
    Item
    Start Date of ECG
    date
    Start Time of ECG
    Item
    Start Time of ECG
    time
    Ventricular Rate
    Item
    Ventricular Rate
    integer
    PR Interval
    Item
    PR Interval
    integer
    QRS Duration
    Item
    QRS Duration
    integer
    Uncorrected QT Interval
    Item
    Uncorrected QT Interval
    text
    QTc Interval
    Item
    QTc Interval
    integer
    Item
    Result of the ECG
    text
    Result of the ECG
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinocally significant (2)
    CL Item
    Abnormal - Clinically significant (3)
    CL Item
    No result (not available) (4)
    Back to the top of the page 

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