0 Evaluaciones
ID

33846

Descripción

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

Palabras clave

Versiones (1)
  1. 3/1/19 3/1/19 -
Titular de derechos de autor

GSK group of companies

Subido en

3 de enero de 2019

DOI

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Licencia

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

    Inglés

    Pregnancy Data

    1 formularios  
    1. StudyEvent: ODM
      1. Pregnancy Data
    Administrative data
    Descripción

    Administrative data

    Site
    Descripción

    Site

    Tipo de datos

    text

    Subject
    Descripción

    Subject

    Tipo de datos

    text

    Visit Name
    Descripción

    Visit Name

    Tipo de datos

    text

    Status
    Descripción

    Status

    Tipo de datos

    text

    Document Number
    Descripción

    Document Number

    Tipo de datos

    integer

    Demography
    Descripción

    Demography

    Subject ID Number
    Descripción

    Subject must discontinue study medication if pregnancy test is positive

    Tipo de datos

    integer

    Race
    Descripción

    Race

    Tipo de datos

    text

    Age
    Descripción

    Age

    Tipo de datos

    float

    Unidades de medida
    • years
    years
    Date of birth
    Descripción

    Date of birth

    Tipo de datos

    date

    Weight
    Descripción

    Weight

    Tipo de datos

    float

    Weight units
    Descripción

    Weight units

    Tipo de datos

    text

    Height
    Descripción

    Height

    Tipo de datos

    float

    Height units
    Descripción

    Height units

    Tipo de datos

    text

    Medical History
    Descripción

    Medical History

    Was the mother using a method of contraception?
    Descripción

    Was the mother using a method of contraception?

    Tipo de datos

    boolean

    If Yes, specify
    Descripción

    If Yes, specify

    Tipo de datos

    text

    Type of conception
    Descripción

    select one

    Tipo de datos

    text

    Relevant laboratory tests and procedures
    Descripción

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

    Tipo de datos

    text

    Known allergies
    Descripción

    Known allergies

    Tipo de datos

    boolean

    If Yes, specify
    Descripción

    If Yes, specify

    Tipo de datos

    text

    Alcohol intake
    Descripción

    Alcohol intake

    Tipo de datos

    boolean

    If Yes, specify
    Descripción

    If Yes, specify

    Tipo de datos

    text

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

    Other significant prior or co-existent medical conditions or history

    Tipo de datos

    boolean

    If Yes, specify
    Descripción

    If Yes, specify

    Tipo de datos

    text

    Pregnancy Information
    Descripción

    Pregnancy Information

    Start date of last menstrual period
    Descripción

    Start date of last menstrual period

    Tipo de datos

    date

    Date of positive pregnancy test
    Descripción

    Date of positive pregnancy test

    Tipo de datos

    date

    Date of last negative pregnancy test
    Descripción

    Date of last negative pregnancy test

    Tipo de datos

    date

    Was pregnancy terminated?
    Descripción

    Was pregnancy terminated?

    Tipo de datos

    boolean

    If Yes, date:
    Descripción

    If Yes, date:

    Tipo de datos

    date

    Was termination elective or spontaneous?
    Descripción

    elective or spontaneous termination?

    Tipo de datos

    text

    Date of expected delivery
    Descripción

    Date of expected delivery

    Tipo de datos

    date

    Number of previous pregnancies
    Descripción

    If none, enter a zero

    Tipo de datos

    integer

    Number of live births
    Descripción

    if none, enter a zero

    Tipo de datos

    integer

    Has subject experienced complications during this or previous pregnancies?
    Descripción

    Has subject experienced complications during this or previous pregnancies?

    Tipo de datos

    boolean

    If Yes, specify below
    Descripción

    If Yes, specify below

    Tipo de datos

    text

    Pregnancy Outcome Information
    Descripción

    Pregnancy Outcome Information

    Subject ID Number
    Descripción

    Subject ID Number

    Tipo de datos

    integer

    Age
    Descripción

    Age

    Tipo de datos

    float

    Unidades de medida
    • years
    years
    Date of Birth
    Descripción

    Date of Birth

    Tipo de datos

    date

    Weight
    Descripción

    Weight

    Tipo de datos

    float

    Weight unit
    Descripción

    Weight unit

    Tipo de datos

    text

    Height
    Descripción

    Height

    Tipo de datos

    float

    Height units
    Descripción

    Height units

    Tipo de datos

    text

    Child Information
    Descripción

    Child Information

    Baby #
    Descripción

    Baby #

    Tipo de datos

    integer

    Sex
    Descripción

    Sex

    Tipo de datos

    text

    Height
    Descripción

    Height

    Tipo de datos

    float

    Height units
    Descripción

    Height units

    Tipo de datos

    text

    Weight
    Descripción

    Weight

    Tipo de datos

    float

    Weight units
    Descripción

    Weight units

    Tipo de datos

    text

    Apgar score 1 min
    Descripción

    Apgar score 1 min

    Tipo de datos

    integer

    Apgar score 5 min
    Descripción

    Apgar score 5 min

    Tipo de datos

    integer

    Outcome of pregnancy
    Descripción

    Outcome of pregnancy

    Tipo de datos

    text

    Comment
    Descripción

    Comment

    Tipo de datos

    text

    If abortion, please record the date
    Descripción

    Date of abortion

    Tipo de datos

    date

    Date of congenital abnormality identified/diagnosed
    Descripción

    Date of congenital abnormality identified/diagnosed

    Tipo de datos

    date

    Pregnancy Outcome Details
    Descripción

    Pregnancy Outcome Details

    Date of delivery
    Descripción

    Date of delivery

    Tipo de datos

    date

    Length of gestation
    Descripción

    Length of gestation

    Tipo de datos

    float

    Unidades de medida
    • weeks
    weeks
    Methods of delivery
    Descripción

    select one

    Tipo de datos

    text

    Number of births as a result of this pregnancy
    Descripción

    include live and stillbirth; if none enter a zero

    Tipo de datos

    integer

    Comments
    Descripción

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

    Tipo de datos

    text

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    Similar models

    Pregnancy Data

    1 formularios
    1. StudyEvent: ODM
      1. Pregnancy Data
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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
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