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29082

Description

Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A 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; Restless Legs Syndrome (RLS)

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Versions (1)
  1. 2/23/18 2/23/18 -
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GlaxoSmithKline (GSK)

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February 23, 2018

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    Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857

    English

    Assessment Week6

    1 forms  
    1. StudyEvent: ODM
      1. Assessment Week6
    Administration
    Description

    Administration

    Alias
    UMLS CUI-1
    C1320722
    Patient number
    Description

    Patient number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Visit date
    Description

    Visit date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Center Number
    Description

    Center Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    IRLS Rating Scale
    Description

    IRLS Rating Scale

    Alias
    UMLS CUI-1
    C0681889
    UMLS CUI-2
    C0035258
    Please complete the IRLS Rating Scale
    Description

    IRLS Rating Scale

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0681889
    UMLS CUI [1,2]
    C0035258
    Orthostatic vital signs
    Description

    Orthostatic vital signs

    Alias
    UMLS CUI-1
    C0518766
    Orthostatic vital signs
    Description

    Orthostatic vital signs

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0518766
    Time Vitals Taken
    Description

    Time Vitals Taken

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Blood pressure systolic/diastolic
    Description

    Blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Pulse
    Description

    Pulse

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
    Description

    Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.

    Alias
    UMLS CUI-1
    C0199171
    Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
    Description

    Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.

    Alias
    UMLS CUI-1
    C2347852
    Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.
    Description

    Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.

    Alias
    UMLS CUI-1
    C0877248
    Clinical Global Impressions
    Description

    Clinical Global Impressions

    Alias
    UMLS CUI-1
    C3639708
    If the patient requires a dose reduction between this and the next visit please complete the Study Medication Record and Dose Reductions Due To Adverse Experiences pages at the back of this book.
    Description

    If the patient requires a dose reduction between this and the next visit please complete the Study Medication Record and Dose Reductions Due To Adverse Experiences pages at the back of this book.

    Alias
    UMLS CUI-1
    C0178602
    UMLS CUI-2
    C0547047
    Ramos Dispensing
    Description

    Ramos Dispensing

    Alias
    UMLS CUI-1
    C0034656
    UMLS CUI-2
    C0947323
    Container Numbers:
    Description

    Container numbers

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0180098
    Back to the top of the page

    Similar models

    Assessment Week6

    1 forms
    1. StudyEvent: ODM
      1. Assessment Week6
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administration
    C1320722 (UMLS CUI-1)
    Patient number
    Item
    Patient number
    integer
    C1830427 (UMLS CUI [1])
    Visit date
    Item
    Visit date
    date
    C1320303 (UMLS CUI [1])
    Center Number
    Item
    Center Number
    integer
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Item Group
    IRLS Rating Scale
    C0681889 (UMLS CUI-1)
    C0035258 (UMLS CUI-2)
    IRLS Rating Scale
    Item
    Please complete the IRLS Rating Scale
    boolean
    C0681889 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    Item Group
    Orthostatic vital signs
    C0518766 (UMLS CUI-1)
    Item
    Orthostatic vital signs
    integer
    C0518766 (UMLS CUI [1])
    Orthostatic vital signs
    Code List
    Orthostatic vital signs
    CL Item
    After 10 minutes semi-supine (1)
    CL Item
    After erect for 1 minute (2)
    Time Vitals Taken
    Item
    Time Vitals Taken
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Blood pressure
    Item
    Blood pressure systolic/diastolic
    integer
    C0005823 (UMLS CUI [1])
    Pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Item Group
    Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
    C0199171 (UMLS CUI-1)
    Item Group
    Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
    C2347852 (UMLS CUI-1)
    Item Group
    Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience and/or SAE section at the back of this book.
    C0877248 (UMLS CUI-1)
    Item Group
    Clinical Global Impressions
    C3639708 (UMLS CUI-1)
    Item Group
    If the patient requires a dose reduction between this and the next visit please complete the Study Medication Record and Dose Reductions Due To Adverse Experiences pages at the back of this book.
    C0178602 (UMLS CUI-1)
    C0547047 (UMLS CUI-2)
    Item Group
    Ramos Dispensing
    C0034656 (UMLS CUI-1)
    C0947323 (UMLS CUI-2)
    Container numbers
    Item
    Container Numbers:
    integer
    C0180098 (UMLS CUI [1])
    Back to the top of the page 

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