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ID

33846

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. 1/3/19 1/3/19 -
Copyright Holder

GSK group of companies

Uploaded on

January 3, 2019

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License

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

    English

    Pregnancy Data

    1 forms  
    1. StudyEvent: ODM
      1. Pregnancy Data
    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

    Status
    Description

    Status

    Data type

    text

    Document Number
    Description

    Document Number

    Data type

    integer

    Demography
    Description

    Demography

    Subject ID Number
    Description

    Subject must discontinue study medication if pregnancy test is positive

    Data type

    integer

    Race
    Description

    Race

    Data type

    text

    Age
    Description

    Age

    Data type

    float

    Measurement units
    • years
    years
    Date of birth
    Description

    Date of birth

    Data type

    date

    Weight
    Description

    Weight

    Data type

    float

    Weight units
    Description

    Weight units

    Data type

    text

    Height
    Description

    Height

    Data type

    float

    Height units
    Description

    Height units

    Data type

    text

    Medical History
    Description

    Medical History

    Was the mother using a method of contraception?
    Description

    Was the mother using a method of contraception?

    Data type

    boolean

    If Yes, specify
    Description

    If Yes, specify

    Data type

    text

    Type of conception
    Description

    select one

    Data type

    text

    Relevant laboratory tests and procedures
    Description

    e.g., ultrasound, amniocentesis, chronic villi sampling, including dates of test and procedures

    Data type

    text

    Known allergies
    Description

    Known allergies

    Data type

    boolean

    If Yes, specify
    Description

    If Yes, specify

    Data type

    text

    Alcohol intake
    Description

    Alcohol intake

    Data type

    boolean

    If Yes, specify
    Description

    If Yes, specify

    Data type

    text

    Other significant prior or co-existent medical conditions or history
    Description

    Other significant prior or co-existent medical conditions or history

    Data type

    boolean

    If Yes, specify
    Description

    If Yes, specify

    Data type

    text

    Pregnancy Information
    Description

    Pregnancy Information

    Start date of last menstrual period
    Description

    Start date of last menstrual period

    Data type

    date

    Date of positive pregnancy test
    Description

    Date of positive pregnancy test

    Data type

    date

    Date of last negative pregnancy test
    Description

    Date of last negative pregnancy test

    Data type

    date

    Was pregnancy terminated?
    Description

    Was pregnancy terminated?

    Data type

    boolean

    If Yes, date:
    Description

    If Yes, date:

    Data type

    date

    Was termination elective or spontaneous?
    Description

    elective or spontaneous termination?

    Data type

    text

    Date of expected delivery
    Description

    Date of expected delivery

    Data type

    date

    Number of previous pregnancies
    Description

    If none, enter a zero

    Data type

    integer

    Number of live births
    Description

    if none, enter a zero

    Data type

    integer

    Has subject experienced complications during this or previous pregnancies?
    Description

    Has subject experienced complications during this or previous pregnancies?

    Data type

    boolean

    If Yes, specify below
    Description

    If Yes, specify below

    Data type

    text

    Pregnancy Outcome Information
    Description

    Pregnancy Outcome Information

    Subject ID Number
    Description

    Subject ID Number

    Data type

    integer

    Age
    Description

    Age

    Data type

    float

    Measurement units
    • years
    years
    Date of Birth
    Description

    Date of Birth

    Data type

    date

    Weight
    Description

    Weight

    Data type

    float

    Weight unit
    Description

    Weight unit

    Data type

    text

    Height
    Description

    Height

    Data type

    float

    Height units
    Description

    Height units

    Data type

    text

    Child Information
    Description

    Child Information

    Baby #
    Description

    Baby #

    Data type

    integer

    Sex
    Description

    Sex

    Data type

    text

    Height
    Description

    Height

    Data type

    float

    Height units
    Description

    Height units

    Data type

    text

    Weight
    Description

    Weight

    Data type

    float

    Weight units
    Description

    Weight units

    Data type

    text

    Apgar score 1 min
    Description

    Apgar score 1 min

    Data type

    integer

    Apgar score 5 min
    Description

    Apgar score 5 min

    Data type

    integer

    Outcome of pregnancy
    Description

    Outcome of pregnancy

    Data type

    text

    Comment
    Description

    Comment

    Data type

    text

    If abortion, please record the date
    Description

    Date of abortion

    Data type

    date

    Date of congenital abnormality identified/diagnosed
    Description

    Date of congenital abnormality identified/diagnosed

    Data type

    date

    Pregnancy Outcome Details
    Description

    Pregnancy Outcome Details

    Date of delivery
    Description

    Date of delivery

    Data type

    date

    Length of gestation
    Description

    Length of gestation

    Data type

    float

    Measurement units
    • weeks
    weeks
    Methods of delivery
    Description

    select one

    Data type

    text

    Number of births as a result of this pregnancy
    Description

    include live and stillbirth; if none enter a zero

    Data type

    integer

    Comments
    Description

    Reminder: If pregnancy outcome is serious (spontaneous abortion, congenital abnormality, stillbirth, prolonged hospitalization, etc.) please submit the SAE report.

    Data type

    text

    Back to the top of the page

    Similar models

    Pregnancy Data

    1 forms
    1. StudyEvent: ODM
      1. Pregnancy Data
    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
    Pregnancy Info (1)
    Status
    Item
    Status
    text
    Document Number
    Item
    Document Number
    integer
    Item Group
    Demography
    Subject ID Number
    Item
    Subject ID Number
    integer
    Race
    Item
    Race
    text
    Age
    Item
    float
    Date of birth
    Item
    Date of birth
    date
    Weight
    Item
    Weight
    float
    Item
    Weight units
    text
    Weight units
    Code List
    Weight units
    CL Item
    kg (1)
    CL Item
    pounds (2)
    Height
    Item
    Height
    float
    Item
    Height units
    text
    Height units
    Code List
    Height units
    CL Item
    cm (1)
    CL Item
    inches (2)
    Item Group
    Medical History
    Was the mother using a method of contraception?
    Item
    Was the mother using a method of contraception?
    boolean
    If Yes, specify
    Item
    If Yes, specify
    text
    Item
    Type of conception
    text
    Type of conception
    Code List
    Type of conception
    CL Item
    Normal (1)
    CL Item
    IVF (in vitro fertilization) (2)
    Relevant laboratory tests and procedures
    Item
    Relevant laboratory tests and procedures
    text
    Known allergies
    Item
    Known allergies
    boolean
    If Yes, specify
    Item
    If Yes, specify
    text
    Alcohol intake
    Item
    Alcohol intake
    boolean
    If Yes, specify
    Item
    If Yes, specify
    text
    Other significant prior or co-existent medical conditions or history
    Item
    Other significant prior or co-existent medical conditions or history
    boolean
    If Yes, specify
    Item
    If Yes, specify
    text
    Item Group
    Pregnancy Information
    Start date of last menstrual period
    Item
    Start date of last menstrual period
    date
    Date of positive pregnancy test
    Item
    Date of positive pregnancy test
    date
    Date of last negative pregnancy test
    Item
    Date of last negative pregnancy test
    date
    Was pregnancy terminated?
    Item
    Was pregnancy terminated?
    boolean
    If Yes, date:
    Item
    If Yes, date:
    date
    Item
    Was termination elective or spontaneous?
    text
    elective or spontaneous termination?
    Code List
    Was termination elective or spontaneous?
    CL Item
    Elective (1)
    CL Item
    Spontaneous (2)
    Date of expected delivery
    Item
    Date of expected delivery
    date
    Number of previous pregnancies
    Item
    Number of previous pregnancies
    integer
    Number of live births
    Item
    Number of live births
    integer
    Has subject experienced complications during this or previous pregnancies?
    Item
    Has subject experienced complications during this or previous pregnancies?
    boolean
    If Yes, specify below
    Item
    If Yes, specify below
    text
    Item Group
    Pregnancy Outcome Information
    Subject ID Number
    Item
    Subject ID Number
    integer
    Age
    Item
    Age
    float
    Date of Birth
    Item
    Date of Birth
    date
    Weight
    Item
    Weight
    float
    Item
    Weight unit
    text
    Weight unit
    Code List
    Weight unit
    CL Item
    kg (1)
    CL Item
    pounds (2)
    Height
    Item
    Height
    float
    Item
    Height units
    text
    Height units
    Code List
    Height units
    CL Item
    cm (1)
    CL Item
    inches (2)
    Item Group
    Child Information
    Baby #
    Item
    Baby #
    integer
    Item
    Sex
    text
    Sex
    Code List
    Sex
    CL Item
    Male (1)
    CL Item
    Female (2)
    Height
    Item
    Height
    float
    Item
    Height units
    text
    Height units
    Code List
    Height units
    CL Item
    cm (1)
    CL Item
    inches (2)
    Weight
    Item
    Weight
    float
    Item
    Weight units
    text
    Weight units
    Code List
    Weight units
    CL Item
    kg (1)
    CL Item
    lbs/oz (2)
    Apgar score 1 min
    Item
    Apgar score 1 min
    integer
    Apgar score 5 min
    Item
    Apgar score 5 min
    integer
    Item
    Outcome of pregnancy
    text
    Outcome of pregnancy
    Code List
    Outcome of pregnancy
    CL Item
    Spontaneous abortion (1)
    CL Item
    Elective abortion (2)
    CL Item
    Normal (3)
    CL Item
    Abnormal baby (specify below) (4)
    CL Item
    Congenital abnormality (specify below) (5)
    CL Item
    Stillborn (specify below) (6)
    CL Item
    Died at birth (specify below) (7)
    Comment
    Item
    Comment
    text
    Date of abortion
    Item
    If abortion, please record the date
    date
    Date of congenital abnormality identified/diagnosed
    Item
    Date of congenital abnormality identified/diagnosed
    date
    Item Group
    Pregnancy Outcome Details
    Date of delivery
    Item
    Date of delivery
    date
    Length of gestation
    Item
    Length of gestation
    float
    Item
    Methods of delivery
    text
    Methods of delivery
    Code List
    Methods of delivery
    CL Item
    Vaginal (1)
    CL Item
    Cesarean section (2)
    Number of births as a result of this pregnancy
    Item
    Number of births as a result of this pregnancy
    integer
    Comments
    Item
    Comments
    text
    Back to the top of the page 

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