0 Ratings
ID

36892

Description

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: 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 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 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the 12 LEAD ECG Monitoring form. It has to be filled in for Day 1, Day 6, Day 8, Day 12, Day 15 and Day 19.

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

GlaxoSmithKline

Uploaded on

June 19, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

    English

    12 LEAD ECG Monitoring 1

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Study Week
    Description

    Study Week

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0008972
    UMLS CUI [1,2]
    C0439230
    Study Day
    Description

    Study Day

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2826182
    12 LEAD ECG MONITORING
    Description

    12 LEAD ECG MONITORING

    Alias
    UMLS CUI-1
    C0430456
    Study Time
    Description

    Note: Pre-dose only has to be measured for Day 1.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2348563
    UMLS CUI [1,2]
    C0040223
    Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Actual Time
    Description

    00:00-23:59

    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

    text

    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 1

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item
    Study Week
    integer
    C0008972 (UMLS CUI [1,1])
    C0439230 (UMLS CUI [1,2])
    Study Week
    Code List
    Study Week
    CL Item
    Week 1 (1)
    CL Item
    Week 2 (2)
    CL Item
    Week 3 (3)
    Item
    Study Day
    integer
    C2826182 (UMLS CUI [1])
    Study Day
    Code List
    Study Day
    CL Item
    Day 1 (1)
    CL Item
    Day 6 (2)
    CL Item
    Day 8 (3)
    CL Item
    Day 12 (4)
    CL Item
    Day 15 (5)
    CL Item
    Day 19 (6)
    Item Group
    12 LEAD ECG MONITORING
    C0430456 (UMLS CUI-1)
    Item
    Study Time
    integer
    C2348563 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Study Time
    Code List
    Study Time
    CL Item
    Pre-dose  (1)
    CL Item
    +0.5 hr  (2)
    CL Item
    +1 hr  (3)
    CL Item
    +1.5 hrs (4)
    CL Item
    +2 hrs (5)
    CL Item
    +3 hrs  (6)
    CL Item
    +4 hrs  (7)
    CL Item
    +6 hrs (8)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Actual Time
    Item
    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])
    Item
    ECG normal?
    text
    C0522054 (UMLS CUI [1])
    ECG normal
    Code List
    ECG normal?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
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