0 Ratings
ID

25368

Description

Study part: 12 LEAD ECG Monitoring Week 1 Day 1. A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. 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. Study ID: 101468/201. Clinical Study ID: 101468/201

Keywords

Versions (2)
  1. 9/2/17 9/2/17 -
  2. 6/19/19 6/19/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 2, 2017

DOI

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License

Creative Commons BY-NC 3.0
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    12 LEAD ECG Monitoring Week 1 Day 1 Ropinirole Restless Legs Syndrome 101468/201

    English

    12 LEAD ECG Monitoring Week 1 Day 1

    1 forms  
    12 LEAD ECG MONITORING
    Description

    12 LEAD ECG MONITORING

    Alias
    UMLS CUI-1
    C0430456
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Pre-dose- Actual Time
    Description

    Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    Date
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Heart rate
    Description

    Heart rate

    Data type

    integer

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

    PR

    Data type

    float

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

    QRS

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1880451
    msec
    QT
    Description

    QT

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    QTc
    Description

    QTc

    Data type

    float

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

    ECG normal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0522054
    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    +0.5 hr - Actual Time
    Description

    Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    Heart rate
    Description

    Heart rate

    Data type

    integer

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

    PR

    Data type

    float

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

    QRS

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1880451
    msec
    QT
    Description

    QT

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    QTc
    Description

    QTc

    Data type

    float

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

    ECG normal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0522054
    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    +1 hr - Actual Time
    Description

    Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    Heart rate
    Description

    Heart rate

    Data type

    integer

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

    PR

    Data type

    float

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

    QRS

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1880451
    msec
    QT
    Description

    QT

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    QTc
    Description

    QTc

    Data type

    float

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

    ECG normal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0522054
    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    +1.5 hrs - Actual Time
    Description

    Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    Heart rate
    Description

    Heart rate

    Data type

    integer

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

    PR

    Data type

    float

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

    QRS

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1880451
    msec
    QT
    Description

    QT

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    QTc
    Description

    QTc

    Data type

    float

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

    ECG normal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0522054
    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    +2 hrs - Actual Time
    Description

    Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    Heart rate
    Description

    Heart rate

    Data type

    integer

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

    PR

    Data type

    float

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

    QRS

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1880451
    msec
    QT
    Description

    QT

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    QTc
    Description

    QTc

    Data type

    float

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

    ECG normal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0522054
    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    +3 hrs - Actual Time
    Description

    Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    Heart rate
    Description

    Heart rate

    Data type

    integer

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

    PR

    Data type

    float

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

    QRS

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1880451
    msec
    QT
    Description

    QT

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    QTc
    Description

    QTc

    Data type

    float

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

    ECG normal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0522054
    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    +4 hrs - Actual Time
    Description

    Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    Heart rate
    Description

    Heart rate

    Data type

    integer

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

    PR

    Data type

    float

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

    QRS

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1880451
    msec
    QT
    Description

    QT

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    QTc
    Description

    QTc

    Data type

    float

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

    ECG normal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0522054
    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    +6 hrs - Actual Time
    Description

    Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    Heart rate
    Description

    Heart rate

    Data type

    integer

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

    PR

    Data type

    float

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

    QRS

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1880451
    msec
    QT
    Description

    QT

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    QTc
    Description

    QTc

    Data type

    float

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

    ECG normal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0522054
    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
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    Similar models

    12 LEAD ECG Monitoring Week 1 Day 1

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    12 LEAD ECG MONITORING
    C0430456 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Time
    Item
    Pre-dose- Actual Time
    time
    C0040223 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    PR
    Item
    PR
    float
    C0429087 (UMLS CUI [1])
    QRS
    Item
    QRS
    float
    C1880451 (UMLS CUI [1])
    QT
    Item
    QT
    float
    C1287082 (UMLS CUI [1])
    QTc
    Item
    QTc
    float
    C0489625 (UMLS CUI [1])
    ECG normal
    Item
    ECG normal?
    boolean
    C0522054 (UMLS CUI [1])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Time
    Item
    +0.5 hr - Actual Time
    time
    C0040223 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    PR
    Item
    PR
    float
    C0429087 (UMLS CUI [1])
    QRS
    Item
    QRS
    float
    C1880451 (UMLS CUI [1])
    QT
    Item
    QT
    float
    C1287082 (UMLS CUI [1])
    QTc
    Item
    QTc
    float
    C0489625 (UMLS CUI [1])
    ECG normal
    Item
    ECG normal?
    boolean
    C0522054 (UMLS CUI [1])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Time
    Item
    +1 hr - Actual Time
    time
    C0040223 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    PR
    Item
    PR
    float
    C0429087 (UMLS CUI [1])
    QRS
    Item
    QRS
    float
    C1880451 (UMLS CUI [1])
    QT
    Item
    QT
    float
    C1287082 (UMLS CUI [1])
    QTc
    Item
    QTc
    float
    C0489625 (UMLS CUI [1])
    ECG normal
    Item
    ECG normal?
    boolean
    C0522054 (UMLS CUI [1])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Time
    Item
    +1.5 hrs - Actual Time
    time
    C0040223 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    PR
    Item
    PR
    float
    C0429087 (UMLS CUI [1])
    QRS
    Item
    QRS
    float
    C1880451 (UMLS CUI [1])
    QT
    Item
    QT
    float
    C1287082 (UMLS CUI [1])
    QTc
    Item
    QTc
    float
    C0489625 (UMLS CUI [1])
    ECG normal
    Item
    ECG normal?
    boolean
    C0522054 (UMLS CUI [1])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Time
    Item
    +2 hrs - Actual Time
    time
    C0040223 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    PR
    Item
    PR
    float
    C0429087 (UMLS CUI [1])
    QRS
    Item
    QRS
    float
    C1880451 (UMLS CUI [1])
    QT
    Item
    QT
    float
    C1287082 (UMLS CUI [1])
    QTc
    Item
    QTc
    float
    C0489625 (UMLS CUI [1])
    ECG normal
    Item
    ECG normal?
    boolean
    C0522054 (UMLS CUI [1])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Time
    Item
    +3 hrs - Actual Time
    time
    C0040223 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    PR
    Item
    PR
    float
    C0429087 (UMLS CUI [1])
    QRS
    Item
    QRS
    float
    C1880451 (UMLS CUI [1])
    QT
    Item
    QT
    float
    C1287082 (UMLS CUI [1])
    QTc
    Item
    QTc
    float
    C0489625 (UMLS CUI [1])
    ECG normal
    Item
    ECG normal?
    boolean
    C0522054 (UMLS CUI [1])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Time
    Item
    +4 hrs - Actual Time
    time
    C0040223 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    PR
    Item
    PR
    float
    C0429087 (UMLS CUI [1])
    QRS
    Item
    QRS
    float
    C1880451 (UMLS CUI [1])
    QT
    Item
    QT
    float
    C1287082 (UMLS CUI [1])
    QTc
    Item
    QTc
    float
    C0489625 (UMLS CUI [1])
    ECG normal
    Item
    ECG normal?
    boolean
    C0522054 (UMLS CUI [1])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Time
    Item
    +6 hrs - Actual Time
    time
    C0040223 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    PR
    Item
    PR
    float
    C0429087 (UMLS CUI [1])
    QRS
    Item
    QRS
    float
    C1880451 (UMLS CUI [1])
    QT
    Item
    QT
    float
    C1287082 (UMLS CUI [1])
    QTc
    Item
    QTc
    float
    C0489625 (UMLS CUI [1])
    ECG normal
    Item
    ECG normal?
    boolean
    C0522054 (UMLS CUI [1])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
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