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ID

33708

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

Keywords

Versions (3)
  1. 12/12/18 12/12/18 -
  2. 12/20/18 12/20/18 -
  3. 12/20/18 12/20/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 20, 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

    Visit 20: Prior and Concomitant Medications + Gen-consent

    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

    Status
    Description

    Status

    Data type

    text

    Doc №
    Description

    Doc №

    Data type

    integer

    Is Page Blank?
    Description

    blank page?

    Data type

    boolean

    Prior and Concomitant Medications/Non-Drug Therapies
    Description

    Prior and Concomitant Medications/Non-Drug Therapies

    Concomitant Medication
    Description

    Concomitant Medication

    Data type

    boolean

    Non-Drug Therapy
    Description

    including procedures and surgeries

    Data type

    boolean

    Drug Name
    Description

    Trade name preferred

    Data type

    text

    Unit Dose
    Description

    Unit Dose

    Data type

    text

    Unit
    Description

    Unit

    Data type

    text

    Frequency
    Description

    Frequency

    Data type

    text

    Route
    Description

    Route

    Data type

    text

    Indication
    Description

    If AE/SAE enter Event Term

    Data type

    text

    AE/SAE Event Number
    Description

    AE/SAE Event Number

    Data type

    integer

    Start date
    Description

    Start date

    Data type

    date

    Stop date
    Description

    Stop date

    Data type

    date

    Ongoing?
    Description

    Ongoing?

    Data type

    boolean

    Taken prior to study?
    Description

    Taken prior to study?

    Data type

    boolean

    PGx-Pharmacogenetic Research Consent
    Description

    PGx-Pharmacogenetic Research Consent

    Has the informed consent been obtained for PGx-Pharmacogenetic Research?
    Description

    Has the informed consent been obtained for PGx-Pharmacogenetic Research?

    Data type

    boolean

    Date informed consent obtained
    Description

    Date informed consent obtained

    Data type

    date

    If no consent obtained, check the reason
    Description

    If no consent obtained, check the reason

    Data type

    text

    If other, specify
    Description

    If other, specify

    Data type

    text

    Blood Sample
    Description

    Blood Sample

    Has a blood sample been collected for PGx research?
    Description

    Has a blood sample been collected for PGx research?

    Data type

    boolean

    Record the date sample taken
    Description

    Record the date sample taken

    Data type

    date

    If no, check the reason
    Description

    If no, check the reason

    Data type

    text

    If Other, specify
    Description

    If Other, specify

    Data type

    text

    PGx-Pharmacogenetic Research Consent Withdrawal
    Description

    PGx-Pharmacogenetic Research Consent Withdrawal

    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    Description

    Has subject withdrawn consent for PGx-Pharmacogenetic research?

    Data type

    boolean

    Has a request been made for sample destruction?
    Description

    Has a request been made for sample destruction?

    Data type

    boolean

    If Yes, enter the reason
    Description

    If Yes, enter the reason

    Data type

    text

    If Other, specify
    Description

    If Other, specify

    Data type

    text

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    Visit 20: Prior and Concomitant Medications + Gen-consent

    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
    Adverse Events (1)
    Status
    Item
    Status
    text
    Doc №
    Item
    Doc №
    integer
    blank page?
    Item
    Is Page Blank?
    boolean
    Item Group
    Prior and Concomitant Medications/Non-Drug Therapies
    Concomitant Medication
    Item
    Concomitant Medication
    boolean
    Non-Drug Therapy
    Item
    Non-Drug Therapy
    boolean
    Drug Name
    Item
    Drug Name
    text
    Unit Dose
    Item
    Unit Dose
    text
    Unit
    Item
    Unit
    text
    Frequency
    Item
    Frequency
    text
    Route
    Item
    Route
    text
    Indication
    Item
    Indication
    text
    AE/SAE Event Number
    Item
    AE/SAE Event Number
    integer
    Start date
    Item
    Start date
    date
    Stop date
    Item
    Stop date
    date
    Ongoing?
    Item
    Ongoing?
    boolean
    Taken prior to study?
    Item
    Taken prior to study?
    boolean
    Has the informed consent been obtained for PGx-Pharmacogenetic Research?
    Item
    Has the informed consent been obtained for PGx-Pharmacogenetic Research?
    boolean
    Date informed consent obtained
    Item
    Date informed consent obtained
    date
    Item
    If no consent obtained, check the reason
    text
    If no consent obtained, check the reason
    Code List
    If no consent obtained, check the reason
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by investigator (2)
    CL Item
    Other (3)
    If other, specify
    Item
    If other, specify
    text
    Item Group
    Blood Sample
    Has a blood sample been collected for PGx research?
    Item
    Has a blood sample been collected for PGx research?
    boolean
    Record the date sample taken
    Item
    Record the date sample taken
    date
    Item
    If no, check the reason
    text
    If no, check the reason
    Code List
    If no, check the reason
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by investigator (2)
    CL Item
    Other (3)
    If Other, specify
    Item
    If Other, specify
    text
    Item Group
    PGx-Pharmacogenetic Research Consent Withdrawal
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    Item
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    boolean
    Has a request been made for sample destruction?
    Item
    Has a request been made for sample destruction?
    boolean
    Item
    If Yes, enter the reason
    text
    If Yes, enter the reason
    Code List
    If Yes, enter the reason
    CL Item
    Subject requested (1)
    CL Item
    Other (2)
    If Other, specify
    Item
    If Other, specify
    text
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