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35489

Description

Study ID: 101468/194 Clinical Study ID: 101468/194 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: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

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Versions (1)
  1. 3/6/19 3/6/19 -
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GlaxoSmithKline

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March 6, 2019

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Creative Commons BY-NC 3.0
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    Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

    English

    Week 8

    1 forms  
    1. StudyEvent: ODM
      1. Week 8
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Centre Number
    Description

    Study Coordinating Center, Identification number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2825181
    UMLS CUI [1,2]
    C1300638
    Patient Number
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Patient Initials
    Description

    Person Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Visit Date
    Description

    Date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Study Medication Record Since Last Visit
    Description

    Study Medication Record Since Last Visit

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C2734539
    Please complete the study medication record in the Study Medication Section at the back of this book.
    Description

    Experimental drug, Medication Summary

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C2734539
    RLS Rating Scale
    Description

    RLS Rating Scale

    Alias
    UMLS CUI-1
    C0035258
    UMLS CUI-2
    C0449820
    Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
    Description

    Restless Legs Syndrome, Score

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C0449820
    Paient Rated Scales
    Description

    Paient Rated Scales

    Alias
    UMLS CUI-1
    C0034394
    UMLS CUI-2
    C0035258
    UMLS CUI-3
    C0679830
    Remove the following scales from appropriate visit in the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
    Description

    Questionnaires; Restless Legs Syndrome; patient assessment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0035258
    UMLS CUI [1,2]
    C0034394
    UMLS CUI [1,3]
    C0679830
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Pulse (after 5 minutes sitting)
    Description

    Heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Sitting Blood Pressure (after 5 minutes sitting) - Systolic
    Description

    Systolic Pressure, Sitting position

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0277814
    mmHg
    Sitting Blood Pressure (after 5 minutes sitting) - Distolic
    Description

    Diastolic blood pressure, Sitting position

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0277814
    mmHg
    Medical Procedures
    Description

    Medical Procedures

    Alias
    UMLS CUI-1
    C0199171
    Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
    Description

    Medical procedure

    Data type

    text

    Alias
    UMLS CUI [1]
    C0199171
    Concomitant Medication
    Description

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852
    Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
    Description

    Concomitant Agent

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347852
    Adverse Experiences
    Description

    Adverse Experiences

    Alias
    UMLS CUI-1
    C0877248
    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

    Adverse Event

    Data type

    text

    Alias
    UMLS CUI [1]
    C0877248
    Laboratory Evaluation
    Description

    Laboratory Evaluation

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0220825
    Date of blood sample
    Description

    Collection of blood specimen for laboratory procedure, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Please affix the Quest Diagnostics Laboratory label here.
    Description

    Laboratory Procedures, Laboratory specimen identification label

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C4273937
    Were any clinically significant abnormalities detected?
    Description

    If ’Yes’, please record details in the Adverse Experiences and/or SAE Section at the back of this book and repeat at Follow-up.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C1704258
    Urine Dipstick
    Description

    Urine Dipstick

    Alias
    UMLS CUI-1
    C0430370
    UMLS CUI-2
    C0456984
    What was the result of the urine dipstick performed at this visit?
    Description

    If ’Positive’, please record details in the Adverse Experiences and/or SAE Section at the back of this book, send a sample to Quest Diagnostics for further evaluation and repeat at Follow-up.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430370
    UMLS CUI [1,2]
    C0456984
    Back to the top of the page

    Similar models

    Week 8

    1 forms
    1. StudyEvent: ODM
      1. Week 8
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Study Coordinating Center, Identification number
    Item
    Centre Number
    integer
    C2825181 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Clinical Trial Subject Unique Identifier
    Item
    Patient Number
    integer
    C2348585 (UMLS CUI [1])
    Person Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Date of visit
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Study Medication Record Since Last Visit
    C0304229 (UMLS CUI-1)
    C2734539 (UMLS CUI-2)
    Experimental drug, Medication Summary
    Item
    Please complete the study medication record in the Study Medication Section at the back of this book.
    text
    C0304229 (UMLS CUI [1,1])
    C2734539 (UMLS CUI [1,2])
    Item Group
    RLS Rating Scale
    C0035258 (UMLS CUI-1)
    C0449820 (UMLS CUI-2)
    Restless Legs Syndrome, Score
    Item
    Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
    text
    C0035258 (UMLS CUI [1,1])
    C0449820 (UMLS CUI [1,2])
    Item Group
    Paient Rated Scales
    C0034394 (UMLS CUI-1)
    C0035258 (UMLS CUI-2)
    C0679830 (UMLS CUI-3)
    Questionnaires; Restless Legs Syndrome; patient assessment
    Item
    Remove the following scales from appropriate visit in the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
    text
    C0035258 (UMLS CUI [1,1])
    C0034394 (UMLS CUI [1,2])
    C0679830 (UMLS CUI [1,3])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Heart rate
    Item
    Pulse (after 5 minutes sitting)
    integer
    C0018810 (UMLS CUI [1])
    Systolic Pressure, Sitting position
    Item
    Sitting Blood Pressure (after 5 minutes sitting) - Systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Diastolic blood pressure, Sitting position
    Item
    Sitting Blood Pressure (after 5 minutes sitting) - Distolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Item Group
    Medical Procedures
    C0199171 (UMLS CUI-1)
    Medical procedure
    Item
    Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
    text
    C0199171 (UMLS CUI [1])
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Concomitant Agent
    Item
    Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
    text
    C2347852 (UMLS CUI [1])
    Item Group
    Adverse Experiences
    C0877248 (UMLS CUI-1)
    Adverse Event
    Item
    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.
    text
    C0877248 (UMLS CUI [1])
    Item Group
    Laboratory Evaluation
    C0022885 (UMLS CUI-1)
    C0220825 (UMLS CUI-2)
    Collection of blood specimen for laboratory procedure, Date in time
    Item
    Date of blood sample
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Laboratory Procedures, Laboratory specimen identification label
    Item
    Please affix the Quest Diagnostics Laboratory label here.
    text
    C0022885 (UMLS CUI [1,1])
    C4273937 (UMLS CUI [1,2])
    Laboratory Procedures, Abnormality
    Item
    Were any clinically significant abnormalities detected?
    boolean
    C0022885 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Item Group
    Urine Dipstick
    C0430370 (UMLS CUI-1)
    C0456984 (UMLS CUI-2)
    Item
    What was the result of the urine dipstick performed at this visit?
    text
    C0430370 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Urine dipstick test, Test Result
    Code List
    What was the result of the urine dipstick performed at this visit?
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    Back to the top of the page 

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