0 Ratings

ID

32911

Description

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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

  1. 11/20/18 11/20/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 20, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :


    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085

    Thyroid Nodules

    1. StudyEvent: ODM
      1. Thyroid Nodules
    Administrative data
    Description

    Administrative data

    Study Name
    Description

    Study Name

    Data type

    text

    Site
    Description

    Site

    Data type

    text

    Subject
    Description

    Subject

    Data type

    text

    Visit Name
    Description

    Visit Name

    Data type

    text

    DCI Name/Shortname
    Description

    DCI Name/Shortname

    Data type

    text

    Status
    Description

    Status

    Data type

    text

    Doc#
    Description

    Doc#

    Data type

    integer

    Visit #
    Description

    Visit #

    Data type

    float

    New Thyroid Nodules
    Description

    New Thyroid Nodules

    Date of evaluation at which new nodule appeared
    Description

    Date of evaluation at which new nodule appeared

    Data type

    date

    AE/SAE reference number
    Description

    AE/SAE reference number

    Data type

    integer

    Type
    Description

    check one

    Data type

    text

    Location
    Description

    Location

    Data type

    text

    Bidimentional Measurement
    Description

    Bidimentional Measurement

    Data type

    text

    Measurement units
    • cm
    cm
    Treatment
    Description

    Treatment

    Was an action taken?
    Description

    Was an action taken?

    Data type

    boolean

    If Yes, please check all that apply
    Description

    If Yes, please check all that apply

    Data type

    text

    If Diagnostic method was Fine needle aspirate, please provide pathology results
    Description

    check only one

    Data type

    text

    If Malignant, thyroid cancer
    Description

    check all that apply

    Data type

    text

    Was the action taken due to fine needle aspirate pathology result?
    Description

    Was the action taken due to fine needle aspirate pathology result?

    Data type

    boolean

    If yes, please provide details below
    Description

    If yes, please provide details below

    Data type

    text

    Lab Tests
    Description

    Lab Tests

    record all relevant data
    Description

    record all relevant data

    Data type

    text

    Free T4
    Description

    Free T4

    Result
    Description

    Result

    Data type

    text

    Unit
    Description

    Unit

    Data type

    text

    LLN
    Description

    LLN

    Data type

    text

    ULN
    Description

    ULN

    Data type

    text

    T4
    Description

    T4

    Result
    Description

    Result

    Data type

    text

    Unit
    Description

    Unit

    Data type

    text

    LLN
    Description

    LLN

    Data type

    text

    ULN
    Description

    ULN

    Data type

    text

    TSH
    Description

    TSH

    Result
    Description

    Result

    Data type

    text

    Unit
    Description

    Unit

    Data type

    text

    LLN
    Description

    LLN

    Data type

    text

    ULN
    Description

    ULN

    Data type

    text

    Free T3
    Description

    Free T3

    Result
    Description

    Result

    Data type

    text

    Unit
    Description

    Unit

    Data type

    text

    LLN
    Description

    LLN

    Data type

    text

    ULN
    Description

    ULN

    Data type

    text

    T3 Uptake
    Description

    T3 Uptake

    Result
    Description

    Result

    Data type

    text

    Unit
    Description

    Unit

    Data type

    text

    LLN
    Description

    LLN

    Data type

    text

    ULN
    Description

    ULN

    Data type

    text

    Similar models

    Thyroid Nodules

    1. StudyEvent: ODM
      1. Thyroid Nodules
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    Study Name
    Item
    Study Name
    text
    Site
    Item
    Site
    text
    Subject
    Item
    Subject
    text
    Visit Name
    Item
    Visit Name
    text
    DCI Name/Shortname
    Item
    DCI Name/Shortname
    text
    Status
    Item
    Status
    text
    Doc#
    Item
    Doc#
    integer
    Visit #
    Item
    Visit #
    float
    Item Group
    New Thyroid Nodules
    Date of evaluation at which new nodule appeared
    Item
    Date of evaluation at which new nodule appeared
    date
    AE/SAE reference number
    Item
    AE/SAE reference number
    integer
    Item
    Type
    text
    Code List
    Type
    CL Item
    Solitary nodule (1)
    CL Item
    Multinodular (2)
    Item
    Location
    text
    Code List
    Location
    CL Item
    Right upper lobe (1)
    CL Item
    Left upper lobe (2)
    CL Item
    Right lower lobe (3)
    CL Item
    Left lower lobe (4)
    CL Item
    Isthmus (5)
    Bidimentional Measurement
    Item
    Bidimentional Measurement
    text
    Item Group
    Treatment
    Was an action taken?
    Item
    Was an action taken?
    boolean
    Item
    If Yes, please check all that apply
    text
    Code List
    If Yes, please check all that apply
    CL Item
    Ultrasound (1)
    CL Item
    RIU (2)
    CL Item
    Technetium scan (3)
    CL Item
    Physical exam (4)
    CL Item
    Fine needle aspirate (5)
    CL Item
    Surgery (6)
    CL Item
    Thyroid functions tests (7)
    Item
    If Diagnostic method was Fine needle aspirate, please provide pathology results
    text
    Code List
    If Diagnostic method was Fine needle aspirate, please provide pathology results
    CL Item
    Non-diagnostic (1)
    CL Item
    Benign (2)
    CL Item
    Malignant, thyroid cancer (3)
    Item
    If Malignant, thyroid cancer
    text
    Code List
    If Malignant, thyroid cancer
    CL Item
    Papillary (1)
    CL Item
    Follicular (2)
    CL Item
    Metastatic (3)
    CL Item
    Medullary (4)
    CL Item
    Aplastic (5)
    Was the action taken due to fine needle aspirate pathology result?
    Item
    Was the action taken due to fine needle aspirate pathology result?
    boolean
    If yes, please provide details below
    Item
    If yes, please provide details below
    text
    Item Group
    Lab Tests
    record all relevant data
    Item
    record all relevant data
    text
    Item Group
    Free T4
    Result
    Item
    Result
    text
    Unit
    Item
    Unit
    text
    LLN
    Item
    LLN
    text
    ULN
    Item
    ULN
    text
    Item Group
    T4
    Result
    Item
    Result
    text
    Unit
    Item
    Unit
    text
    LLN
    Item
    LLN
    text
    ULN
    Item
    ULN
    text
    Item Group
    TSH
    Result
    Item
    Result
    text
    Unit
    Item
    Unit
    text
    LLN
    Item
    LLN
    text
    ULN
    Item
    ULN
    text
    Item Group
    Free T3
    Result
    Item
    Result
    text
    Unit
    Item
    Unit
    text
    LLN
    Item
    LLN
    text
    ULN
    Item
    ULN
    text
    Item Group
    T3 Uptake
    Result
    Item
    Result
    text
    Unit
    Item
    Unit
    text
    LLN
    Item
    LLN
    text
    ULN
    Item
    ULN
    text

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial