0 Ratings
ID

36913

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 Physical Examination Follow- Up form. It has to be filled in at follow-up.

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Versions (2)
  1. 9/5/17 9/5/17 -
  2. 6/21/19 6/21/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 21, 2019

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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

    Physical Examination Follow- Up

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    PHYSICAL EXAMINATION
    Description

    PHYSICAL EXAMINATION

    Alias
    UMLS CUI-1
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Time
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Has there been any change from the last examination (screening)?
    Description

    Physical Examination

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0443172 (Changed status)
    SNOMED
    263703002
    If change form the last examination, please record here.
    Description

    Any clinically relevant worsening since the last exam must be recorded on the Adverse Events page.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0443172 (Changed status)
    SNOMED
    263703002
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    Similar models

    Physical Examination Follow- Up

    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 Group
    PHYSICAL EXAMINATION
    C0031809 (UMLS CUI-1)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Time
    Item
    Time
    time
    C0040223 (UMLS CUI [1])
    Item
    Has there been any change from the last examination (screening)?
    text
    C0031809 (UMLS CUI [1,1])
    C0443172 (UMLS CUI [1,2])
    Physical Examination
    Code List
    Has there been any change from the last examination (screening)?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Change in ohysical examination
    Item
    If change form the last examination, please record here.
    text
    C0031809 (UMLS CUI [1,1])
    C0443172 (UMLS CUI [1,2])
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