0 Ratings

ID

36013

Description

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Electrocardiography form. It has to be filled in for all Sessions each for both Day 1 and Day 2.

Keywords

  1. 4/9/19 4/9/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 9, 2019

DOI

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License

Creative Commons BY-NC 3.0

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    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    Electrocardiography

    1. StudyEvent: ODM
      1. Electrocardiography
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Description

    Subject No.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Description

    Panel ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C3846158
    Visit type
    Description

    Visit type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    12 LEAD ECG
    Description

    12 LEAD ECG

    Alias
    UMLS CUI-1
    C0430456
    Planned relative time, Day 1
    Description

    Only for Day 1.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C1623258
    Planned relative time, Day 2
    Description

    Only for Day 2.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C1623258
    ECG Time
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1301880
    heart rate
    Description

    heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    PR interval
    Description

    PR interval

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    QRS duration
    Description

    QRS duration

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    QT duration
    Description

    QT duration

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1880452
    msec
    QTc interval
    Description

    QTc interval

    Data type

    integer

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0489625
    msec
    Is the ECG normal?
    Description

    ECG normal

    Data type

    text

    Alias
    UMLS CUI [1]
    C0522054
    Comments (Include Clinically Significant ECG Abnormalities)
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611

    Similar models

    Electrocardiography

    1. StudyEvent: ODM
      1. Electrocardiography
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject No.
    Item
    Subject No.
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Code List
    Visit type
    CL Item
    Session 1 day 1 (1)
    CL Item
    Session 1 day 2 (2)
    CL Item
    Session 2 day 1  (3)
    CL Item
    Session 2 day 2 (4)
    CL Item
    Session 3 day 1 (5)
    CL Item
    Session 3 day 2 (6)
    CL Item
    Session 4 day 1 (7)
    CL Item
    Session 4 day 2 (8)
    CL Item
    Session 5 day 1 (9)
    CL Item
    Session 5 day 2 (10)
    Item Group
    12 LEAD ECG
    C0430456 (UMLS CUI-1)
    Item
    Planned relative time, Day 1
    integer
    C0439564 (UMLS CUI [1,1])
    C1623258 (UMLS CUI [1,2])
    Code List
    Planned relative time, Day 1
    CL Item
    predose (1)
    CL Item
    +1h (2)
    CL Item
    +2h (3)
    CL Item
    +3h (4)
    CL Item
    +4h (5)
    CL Item
    +5h (6)
    CL Item
    +6h (7)
    Item
    Planned relative time, Day 2
    integer
    C0439564 (UMLS CUI [1,1])
    C1623258 (UMLS CUI [1,2])
    Code List
    Planned relative time, Day 2
    CL Item
    +16h (1)
    CL Item
    +24h (2)
    ECG Time
    Item
    ECG Time
    time
    C0430456 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    heart rate
    Item
    heart rate
    integer
    C0018810 (UMLS CUI [1])
    PR interval
    Item
    PR interval
    integer
    C0429087 (UMLS CUI [1])
    QRS duration
    Item
    QRS duration
    integer
    C0429025 (UMLS CUI [1])
    QT duration
    Item
    QT duration
    integer
    C1880452 (UMLS CUI [1])
    QTc interval
    Item
    QTc interval
    integer
    C0489625 (UMLS CUI [1])
    Item
    Is the ECG normal?
    text
    C0522054 (UMLS CUI [1])
    Code List
    Is the ECG normal?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Comments
    Item
    Comments (Include Clinically Significant ECG Abnormalities)
    text
    C0947611 (UMLS CUI [1])

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