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ID

32743

Description

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

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Versions (1)
  1. 11/14/18 11/14/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 14, 2018

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License

Creative Commons BY-NC 3.0
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    The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085

    English

    Screening Visit: Electrocardiogram

    1 forms  
    Administrative data
    Description

    Administrative data

    Study Name
    Description

    Study Name

    Data type

    text

    Site
    Description

    Site

    Data type

    text

    Subject
    Description

    Subject

    Data type

    text

    Visit Name
    Description

    Visit Name

    Data type

    text

    DCI Name/Shortname
    Description

    DCI Name/Shortname

    Data type

    text

    Status
    Description

    Status

    Data type

    text

    Doc#
    Description

    Doc#

    Data type

    integer

    Visit #
    Description

    Visit #

    Data type

    float

    Visit Date
    Description

    Visit Date

    Data type

    date

    ECG
    Description

    ECG

    Date ECG Performed
    Description

    Date ECG Performed

    Data type

    date

    Time ECG Performed
    Description

    Time ECG Performed

    Data type

    time

    Heart Rate
    Description

    Heart Rate

    Data type

    integer

    Measurement units
    • bpm
    bpm
    PR Interval
    Description

    PR Interval

    Data type

    float

    Measurement units
    • msec
    msec
    QRS Duration
    Description

    QRS Duration

    Data type

    float

    Measurement units
    • msec
    msec
    QT Interval
    Description

    QT Interval

    Data type

    float

    Measurement units
    • msec
    msec
    QTcF Interval
    Description

    QTcF Interval

    Data type

    float

    Measurement units
    • msec
    msec
    QTcB Interval
    Description

    QTcB Interval

    Data type

    float

    Measurement units
    • msec
    msec
    RR Interval
    Description

    RR Interval

    Data type

    float

    Measurement units
    • msec
    msec
    Interpretation of ECG
    Description

    Interpretation of ECG

    Normal sinus rhythm?
    Description

    Normal sinus rhythm?

    Data type

    boolean

    Overall interpretation of ECG:
    Description

    Overall interpretation of ECG:

    Data type

    text

    If Abnormal, please specify
    Description

    If Abnormal, please specify

    Data type

    text

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    Similar models

    Screening Visit: Electrocardiogram

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    Study Name
    Item
    Study Name
    text
    Site
    Item
    Site
    text
    Subject
    Item
    Subject
    text
    Visit Name
    Item
    Visit Name
    text
    DCI Name/Shortname
    Item
    DCI Name/Shortname
    text
    Status
    Item
    Status
    text
    Doc#
    Item
    Doc#
    integer
    Visit #
    Item
    Visit #
    float
    Visit Date
    Item
    Visit Date
    date
    Item Group
    ECG
    Date ECG Performed
    Item
    Date ECG Performed
    date
    Time ECG Performed
    Item
    Time ECG Performed
    time
    Heart Rate
    Item
    Heart Rate
    integer
    PR Interval
    Item
    PR Interval
    float
    QRS Duration
    Item
    QRS Duration
    float
    QT Interval
    Item
    QT Interval
    float
    QTcF Interval
    Item
    QTcF Interval
    float
    QTcB Interval
    Item
    QTcB Interval
    float
    RR Interval
    Item
    RR Interval
    float
    Item Group
    Interpretation of ECG
    Normal sinus rhythm?
    Item
    Normal sinus rhythm?
    boolean
    Item
    Overall interpretation of ECG:
    text
    Overall interpretation of ECG:
    Code List
    Overall interpretation of ECG:
    CL Item
    Normal (1)
    CL Item
    Abnormal, Not Clinically Significant (2)
    CL Item
    Abnormal, Clinically Significant (3)
    If Abnormal, please specify
    Item
    If Abnormal, please specify
    text
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