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33809

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Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 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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Versioner (1)
  1. 2018-12-28 2018-12-28 -
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GSK group of companies

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28 december 2018

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Creative Commons BY-NC 3.0
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    Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032

    Engelsk

    Early Term Data: Vital Signs, Physical Examination, ECG, Laboratory Tests

    1 Formulär  
    Administrative data
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    Administrative data

    Site
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    Site

    Datatyp

    text

    Subject
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    Subject

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    text

    Visit Name
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    Visit Name

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    text

    Visit Number
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    Visit Number

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    text

    Status
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    Status

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    text

    Document Number
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    Document Number

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    text

    Visit Date
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    Visit Date

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    date

    Vital Signs - Duplicate 1
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    Vital Signs - Duplicate 1

    Date of Vital Signs
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    Date of Vital Signs

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    date

    Time of Vital Signs
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    Time of Vital Signs

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    time

    Blood Pressure - Systolic
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    Blood Pressure - Systolic

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    float

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    • mmHg
    mmHg
    Blood Pressure - Diastolic
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    Blood Pressure - Diastolic

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    float

    Måttenheter
    • mmHg
    mmHg
    Temperature
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    Temperature

    Datatyp

    integer

    Måttenheter
    • °C
    °C
    Body Position
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    e.g., Sitting

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    text

    Comment
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    Comment

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    text

    Vital Signs - Duplicate 2
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    Vital Signs - Duplicate 2

    Time of Vital Signs
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    Time of Vital Signs

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    time

    Blood Pressure - Systolic
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    Blood Pressure - Systolic

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    float

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    • mmHg
    mmHg
    Blood Pressure - Diastolic
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    Blood Pressure - Diastolic

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    float

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    • mmHg
    mmHg
    Heart Rate
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    Heart Rate

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    integer

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    • bpm
    bpm
    Body Position
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    e.g., Sitting

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    text

    Comment
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    Comment

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    text

    Physical Examination
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    Physical Examination

    Date of Physical Examination
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    Date of Physical Examination

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    date

    Skin including Injection Site
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    Skin including Injection Site

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    text

    Specify Abnormality
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    if applies

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    text

    Lungs
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    Lungs

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    if applies

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    Cardiovascular
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    Cardiovascular

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    if applies

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    Abdomen (Liver and Spleen)
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    Abdomen (Liver and Spleen)

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    text

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    if applies

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    text

    Other
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    specify below

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    text

    Specify details and possible abnormalities
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    Specify details and possible abnormalities

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    text

    Electrocardiogram
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    Electrocardiogram

    Date of ECG performed
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    Date of ECG performed

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    date

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    Time of ECG performed

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    time

    Heart Rate
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    Heart Rate

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    integer

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    • bpm
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    PR Interval
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    PR Interval

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    float

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    • msec
    msec
    QRS Duration
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    QRS Duration

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    float

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    • msec
    msec
    QT Interval
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    QT Interval

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    float

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    • msec
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    QTcB Interval
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    QTcB Interval

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    float

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    QTcF Interval

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    float

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    RR Interval
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    RR Interval

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    float

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    • msec
    msec
    Normal Sinus Rhythm?
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    Normal Sinus Rhythm?

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    boolean

    Overall Interpretation of ECG
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    Overall Interpretation of ECG

    check the result
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    check the result

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    text

    If Abnormal, please specify
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    If Abnormal, please specify

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    text

    Hematologic Test
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    Hematologic Test

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    sample collected?

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    boolean

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    Date

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    Time

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    Sample Date
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    Date

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    date

    Sample Time
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    Time

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    time

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    UA / Urine Chemistry Test
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    UA / Urine Chemistry Test

    Was the laboratory sample collected?
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    sample collected?

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    boolean

    Sample Date
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    Date

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    date

    Sample Time
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    Time

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    time

    Comment
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    text

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    Early Term Data: Vital Signs, Physical Examination, ECG, Laboratory Tests

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
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    Administrative data
    Site
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    text
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    sample collected?
    Item
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    boolean
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    date
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    Sample Time
    time
    Comment
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    Comment
    text
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