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24328

Description

Part 1 of Module 12: Wk 52, Follow-Up & Study Conc 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 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

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  1. 30/07/2017 30/07/2017 -
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glaxoSmithKline

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30 de julho de 2017

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Creative Commons BY-NC 3.0
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    GSK study: Ropinirole in RLS patients 101468/243 - Week 52

    English

    GSK study: Ropinirole in RLS patients 101468/243 - Week 52

    1 forms  
    Study medication record since last visit
    Description

    Study medication record since last visit

    Alias
    UMLS CUI-1
    C2734539
    UMLS CUI-2
    C0008972
    Study medication record since last visit
    Description

    Please complete the study medication record in the Study Medication and Compliance Section at the back of this module.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2734539
    UMLS CUI [1,2]
    C0008972
    RLS Rating scale
    Description

    RLS Rating scale

    Alias
    UMLS CUI-1
    C0681889
    UMLS CUI-2
    C0035258
    RLS Rating scale
    Description

    Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book

    Data type

    text

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

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    Weight in kg
    Description

    Weight in kg

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0005910
    UMLS CUI [1,2]
    C0439209
    Weight in lbs
    Description

    Weight in lbs

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005910
    UMLS CUI [1,2]
    C0439219
    Weight (without shoes)
    Description

    Weight

    Data type

    float

    Alias
    UMLS CUI [1]
    C0005910
    Pulse
    Description

    after 5min sitting

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Sitting systolic blood pressure
    Description

    after 5 minutes sitting

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0277814
    mmHg
    Sitting diastolic blood pressure
    Description

    after 5 minutes sitting

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0277814
    mmHg
    Laboratory evaluation
    Description

    Laboratory evaluation

    Alias
    UMLS CUI-1
    C0022885
    Date of blood sample
    Description

    Please take a blood sample for routine analysis.

    Data type

    date

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

    Laboratory label

    Data type

    text

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

    If ’Yes’, please record details in the Adverse Experiences and/or SAE section and repeat at Follow-up

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C1704258
    Urine dipstick
    Description

    Urine dipstick

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

    Please perform a urine dipstick test for presence of blood or protein. If ’Positive’, please record details in the Adverse Experiences and/or SAE section at the back of this book and repeat at Follow-up. Please send a sample to Quest Diagnostics for further evaluation.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0430370
    UMLS CUI [1,2]
    C0456984
    Pregnancy dipstick
    Description

    Pregnancy dipstick

    Alias
    UMLS CUI-1
    C0430056
    Is the patient a female of child-bearing potential?
    Description

    If ’Yes’, please perform a pregnancy dipstick test and record result below.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1960468
    Record the result of the pregnancy dipstick, if the patient is a female of child-bearing potential
    Description

    If ’Positive’, please record details on the Pregnancy Notification Form.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0430056
    UMLS CUI [1,2]
    C0456984
    Medical procedures
    Description

    Medical procedures

    Alias
    UMLS CUI-1
    C0199171
    Medical Procedures
    Description

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

    Data type

    text

    Alias
    UMLS CUI [1]
    C0199171
    Concomitant Medication
    Description

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852
    Concomitant Medication
    Description

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

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347852
    Adverse reaction
    Description

    Adverse reaction

    Alias
    UMLS CUI-1
    C0559546
    Adverse reaction
    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 section at the back of this module

    Data type

    text

    Alias
    UMLS CUI [1]
    C0559546
    Clinical global impression
    Description

    Clinical global impression

    Alias
    UMLS CUI-1
    C3639708
    Clinical global impression
    Description

    This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

    Data type

    text

    Alias
    UMLS CUI [1]
    C3639708
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    Similar models

    GSK study: Ropinirole in RLS patients 101468/243 - Week 52

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Study medication record since last visit
    C2734539 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Study medication record since last visit
    Item
    Study medication record since last visit
    text
    C2734539 (UMLS CUI [1,1])
    C0008972 (UMLS CUI [1,2])
    Item Group
    RLS Rating scale
    C0681889 (UMLS CUI-1)
    C0035258 (UMLS CUI-2)
    RLS Rating scale
    Item
    RLS Rating scale
    text
    C0681889 (UMLS CUI [1,1])
    C0035258 (UMLS CUI [1,2])
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Weight in kg
    Item
    Weight in kg
    integer
    C0005910 (UMLS CUI [1,1])
    C0439209 (UMLS CUI [1,2])
    Weight in lbs
    Item
    Weight in lbs
    boolean
    C0005910 (UMLS CUI [1,1])
    C0439219 (UMLS CUI [1,2])
    Weight
    Item
    Weight (without shoes)
    float
    C0005910 (UMLS CUI [1])
    Pulse rate
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Sitting systolic blood pressure
    Item
    Sitting systolic blood pressure
    integer
    C0871470 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Sitting diastolic blood pressure
    Item
    Sitting diastolic blood pressure
    integer
    C0428883 (UMLS CUI [1,1])
    C0277814 (UMLS CUI [1,2])
    Item Group
    Laboratory evaluation
    C0022885 (UMLS CUI-1)
    Date of blood sample
    Item
    Date of blood sample
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Laboratory label
    Item
    Please affix the Quest Diagnostics Laboratory label here.
    text
    C4273937 (UMLS CUI [1])
    laboratory results abnormalities
    Item
    Were any clinically significant abnormalities detected?
    boolean
    C0005834 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    Item Group
    Urine dipstick
    C0430370 (UMLS CUI-1)
    Item
    What was the result of the urine dipstick performed at this visit?
    integer
    C0430370 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    urine dipstick result
    Code List
    What was the result of the urine dipstick performed at this visit?
    CL Item
    negative (1)
    CL Item
    positive (2)
    Item Group
    Pregnancy dipstick
    C0430056 (UMLS CUI-1)
    female child-bearing potential
    Item
    Is the patient a female of child-bearing potential?
    boolean
    C1960468 (UMLS CUI [1])
    Item
    Record the result of the pregnancy dipstick, if the patient is a female of child-bearing potential
    integer
    C0430056 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Pregnancy dipstick result
    Code List
    Record the result of the pregnancy dipstick, if the patient is a female of child-bearing potential
    CL Item
    negative (1)
    CL Item
    positive (2)
    Item Group
    Medical procedures
    C0199171 (UMLS CUI-1)
    Medical Procedures
    Item
    Medical Procedures
    text
    C0199171 (UMLS CUI [1])
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Concomitant Medication
    Item
    Concomitant Medication
    text
    C2347852 (UMLS CUI [1])
    Item Group
    Adverse reaction
    C0559546 (UMLS CUI-1)
    Adverse reaction
    Item
    Adverse reaction
    text
    C0559546 (UMLS CUI [1])
    Item Group
    Clinical global impression
    C3639708 (UMLS CUI-1)
    Clinical global impression
    Item
    Clinical global impression
    text
    C3639708 (UMLS CUI [1])
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