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33809

Description

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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Versions (1)
  1. 12/28/18 12/28/18 -
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GSK group of companies

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December 28, 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

    English

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

    1 forms  
    Administrative data
    Description

    Administrative data

    Site
    Description

    Site

    Data type

    text

    Subject
    Description

    Subject

    Data type

    text

    Visit Name
    Description

    Visit Name

    Data type

    text

    Visit Number
    Description

    Visit Number

    Data type

    text

    Status
    Description

    Status

    Data type

    text

    Document Number
    Description

    Document Number

    Data type

    text

    Visit Date
    Description

    Visit Date

    Data type

    date

    Vital Signs - Duplicate 1
    Description

    Vital Signs - Duplicate 1

    Date of Vital Signs
    Description

    Date of Vital Signs

    Data type

    date

    Time of Vital Signs
    Description

    Time of Vital Signs

    Data type

    time

    Blood Pressure - Systolic
    Description

    Blood Pressure - Systolic

    Data type

    float

    Measurement units
    • mmHg
    mmHg
    Blood Pressure - Diastolic
    Description

    Blood Pressure - Diastolic

    Data type

    float

    Measurement units
    • mmHg
    mmHg
    Temperature
    Description

    Temperature

    Data type

    integer

    Measurement units
    • °C
    °C
    Body Position
    Description

    e.g., Sitting

    Data type

    text

    Comment
    Description

    Comment

    Data type

    text

    Vital Signs - Duplicate 2
    Description

    Vital Signs - Duplicate 2

    Time of Vital Signs
    Description

    Time of Vital Signs

    Data type

    time

    Blood Pressure - Systolic
    Description

    Blood Pressure - Systolic

    Data type

    float

    Measurement units
    • mmHg
    mmHg
    Blood Pressure - Diastolic
    Description

    Blood Pressure - Diastolic

    Data type

    float

    Measurement units
    • mmHg
    mmHg
    Heart Rate
    Description

    Heart Rate

    Data type

    integer

    Measurement units
    • bpm
    bpm
    Body Position
    Description

    e.g., Sitting

    Data type

    text

    Comment
    Description

    Comment

    Data type

    text

    Physical Examination
    Description

    Physical Examination

    Date of Physical Examination
    Description

    Date of Physical Examination

    Data type

    date

    Skin including Injection Site
    Description

    Skin including Injection Site

    Data type

    text

    Specify Abnormality
    Description

    if applies

    Data type

    text

    Lungs
    Description

    Lungs

    Data type

    text

    Specify Abnormality
    Description

    if applies

    Data type

    text

    Cardiovascular
    Description

    Cardiovascular

    Data type

    text

    Specify Abnormality
    Description

    if applies

    Data type

    text

    Abdomen (Liver and Spleen)
    Description

    Abdomen (Liver and Spleen)

    Data type

    text

    Specify Abnormality
    Description

    if applies

    Data type

    text

    Other
    Description

    specify below

    Data type

    text

    Specify details and possible abnormalities
    Description

    Specify details and possible abnormalities

    Data type

    text

    Electrocardiogram
    Description

    Electrocardiogram

    Date of ECG performed
    Description

    Date of ECG performed

    Data type

    date

    Time of ECG performed
    Description

    Time of 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
    QTcB Interval
    Description

    QTcB Interval

    Data type

    float

    Measurement units
    • msec
    msec
    QTcF Interval
    Description

    QTcF Interval

    Data type

    float

    Measurement units
    • msec
    msec
    RR Interval
    Description

    RR Interval

    Data type

    float

    Measurement units
    • msec
    msec
    Normal Sinus Rhythm?
    Description

    Normal Sinus Rhythm?

    Data type

    boolean

    Overall Interpretation of ECG
    Description

    Overall Interpretation of ECG

    check the result
    Description

    check the result

    Data type

    text

    If Abnormal, please specify
    Description

    If Abnormal, please specify

    Data type

    text

    Hematologic Test
    Description

    Hematologic Test

    Was the laboratory sample collected?
    Description

    sample collected?

    Data type

    boolean

    Sample Date
    Description

    Date

    Data type

    date

    Sample Time
    Description

    Time

    Data type

    time

    Comment
    Description

    Comment

    Data type

    text

    Chemistry Test
    Description

    Chemistry Test

    Was the laboratory sample collected?
    Description

    sample collected?

    Data type

    boolean

    Sample Date
    Description

    Date

    Data type

    date

    Sample Time
    Description

    Time

    Data type

    time

    Comment
    Description

    Comment

    Data type

    text

    UA / Urine Chemistry Test
    Description

    UA / Urine Chemistry Test

    Was the laboratory sample collected?
    Description

    sample collected?

    Data type

    boolean

    Sample Date
    Description

    Date

    Data type

    date

    Sample Time
    Description

    Time

    Data type

    time

    Comment
    Description

    Comment

    Data type

    text

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    Similar models

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

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    Site
    Item
    Site
    text
    Subject
    Item
    Subject
    text
    Item
    Visit Name
    text
    Visit Name
    Code List
    Visit Name
    CL Item
    Early Term (1)
    Item
    Visit Number
    text
    Visit Number
    Code List
    Visit Number
    CL Item
    295 (1)
    Status
    Item
    Status
    text
    Document Number
    Item
    Document Number
    text
    Visit Date
    Item
    Visit Date
    date
    Item Group
    Vital Signs - Duplicate 1
    Date of Vital Signs
    Item
    Date of Vital Signs
    date
    Time of Vital Signs
    Item
    Time of Vital Signs
    time
    Blood Pressure - Systolic
    Item
    Blood Pressure - Systolic
    float
    Blood Pressure - Diastolic
    Item
    Blood Pressure - Diastolic
    float
    Temperature
    Item
    Temperature
    integer
    Body Position
    Item
    Body Position
    text
    Comment
    Item
    Comment
    text
    Item Group
    Vital Signs - Duplicate 2
    Time of Vital Signs
    Item
    Time of Vital Signs
    time
    Blood Pressure - Systolic
    Item
    Blood Pressure - Systolic
    float
    Blood Pressure - Diastolic
    Item
    Blood Pressure - Diastolic
    float
    Heart Rate
    Item
    Heart Rate
    integer
    Body Position
    Item
    Body Position
    text
    Comment
    Item
    Comment
    text
    Item Group
    Physical Examination
    Date of Physical Examination
    Item
    Date of Physical Examination
    date
    Item
    Skin including Injection Site
    text
    Skin including Injection Site
    Code List
    Skin including Injection Site
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not Done (3)
    Specify Abnormality
    Item
    Specify Abnormality
    text
    Item
    Lungs
    text
    Lungs
    Code List
    Lungs
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not Done (3)
    Specify Abnormality
    Item
    Specify Abnormality
    text
    Item
    Cardiovascular
    text
    Cardiovascular
    Code List
    Cardiovascular
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not Done (3)
    Specify Abnormality
    Item
    Specify Abnormality
    text
    Item
    Abdomen (Liver and Spleen)
    text
    Abdomen (Liver and Spleen)
    Code List
    Abdomen (Liver and Spleen)
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not Done (3)
    Specify Abnormality
    Item
    Specify Abnormality
    text
    Item
    Other
    text
    Other
    Code List
    Other
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not Done (3)
    Specify details and possible abnormalities
    Item
    Specify details and possible abnormalities
    text
    Item Group
    Electrocardiogram
    Date of ECG performed
    Item
    Date of ECG performed
    date
    Time of ECG performed
    Item
    Time of 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
    QTcB Interval
    Item
    QTcB Interval
    float
    QTcF Interval
    Item
    QTcF Interval
    float
    RR Interval
    Item
    RR Interval
    float
    Normal Sinus Rhythm?
    Item
    Normal Sinus Rhythm?
    boolean
    Item Group
    Overall Interpretation of ECG
    Item
    check the result
    text
    check the result
    Code List
    check the result
    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
    Item Group
    Hematologic Test
    sample collected?
    Item
    Was the laboratory sample collected?
    boolean
    Date
    Item
    Sample Date
    date
    Time
    Item
    Sample Time
    time
    Comment
    Item
    Comment
    text
    Item Group
    Chemistry Test
    sample collected?
    Item
    Was the laboratory sample collected?
    boolean
    Date
    Item
    Sample Date
    date
    Time
    Item
    Sample Time
    time
    Comment
    Item
    Comment
    text
    Item Group
    UA / Urine Chemistry Test
    sample collected?
    Item
    Was the laboratory sample collected?
    boolean
    Date
    Item
    Sample Date
    date
    Time
    Item
    Sample Time
    time
    Comment
    Item
    Comment
    text
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