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21952

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RRL100013 12 Week, Double-Blind, Placebo Controlled, Twice Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

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  1. 09.05.17 09.05.17 -
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gsk

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9. Mai 2017

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    Efficacy and Safety Ropinirole in Patients Suffering from RLS GSK Study

    Englisch

    RLS DIAGNOSTIC CLINICAL INTERVIEW Case Report Form RRL100013

    1 Formulare  
    Header module
    Beschreibung

    Header module

    Protocol Identifier
    Beschreibung

    Protocol Identifier

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2826693
    Subject Identifier
    Beschreibung

    Subject Identifier

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    CLINICAL INTERVIEW - WORKSHEET
    Beschreibung

    CLINICAL INTERVIEW - WORKSHEET

    Diagnosis
    Beschreibung

    Diagnosis

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0011900
    Cause of disease
    Beschreibung

    Cause of disease

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1314792
    Does subject report growing pains?
    Beschreibung

    Growing pains

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0423693
    1. Have you ever had unpleasant or uncomfortable feelings in your legs that occurred mainly while you were either sitting or lying down?
    Beschreibung

    If no, go to #3

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1140621
    UMLS CUI [1,2]
    C1527305
    2. Are these feelings painful rather than just uncomfortable?
    Beschreibung

    Are these feelings painful rather than just uncomfortable?

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0393903
    2a. How would you describe these feelings or sensations?
    Beschreibung

    How would you describe these feelings or sensations?

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0036659
    UMLS CUI [1,2]
    C0678257
    3. Have you ever felt the need or urge to move your legs that occurred mainly while you were either sitting or lying down?
    Beschreibung

    If yes, go to #3a. If no, go to #4.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0560560
    UMLS CUI [1,2]
    C1140621
    3a. Do these feelings in your legs ever become overwhelming to the point that you cannot resist moving your legs?
    Beschreibung

    Ovelwhelmed to move

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C4281815
    UMLS CUI [1,2]
    C0578660
    3b. If you developed these feelings in your legs and you could not move your legs, or if someone were to hold your legs down, how would this effect the feelings in your legs?:
    Beschreibung

    (Mark One) If no to both questions #1 and #3, go to #15.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1280500
    UMLS CUI [1,2]
    C1527305
    UMLS CUI [1,3]
    C1140621
    Do you think these feelings in your legs are due to a Charlie-horse or muscle cramp? .
    Beschreibung

    If yes, go to #4a. If no, go to #5

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0037763
    UMLS CUI [2]
    C0026821
    4a. Are these feelings always due to a Charlie-horse or muscle cramp?
    Beschreibung

    If yes, go to #4a. If no, go to #5

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0037763
    UMLS CUI [1,2]
    C1549493
    UMLS CUI [2,1]
    C0026821
    UMLS CUI [2,2]
    C1549493
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    RLS DIAGNOSTIC CLINICAL INTERVIEW Case Report Form RRL100013

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Header module
    Protocol Identifier
    Item
    Protocol Identifier
    integer
    C2826693 (UMLS CUI [1])
    Subject Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    CLINICAL INTERVIEW - WORKSHEET
    Item
    Diagnosis
    integer
    C0011900 (UMLS CUI [1])
    Diagnosis
    Code List
    Diagnosis
    CL Item
    Definite RLS (1)
    C0035258 (UMLS CUI-1)
    C0439544 (UMLS CUI-2)
    CL Item
    Probable RLS (2)
    C0035258 (UMLS CUI-1)
    C0332148 (UMLS CUI-2)
    CL Item
    Possible RLS (3)
    C0035258 (UMLS CUI-1)
    C2362652 (UMLS CUI-2)
    CL Item
    Not-RLS (4)
    C0035258 (UMLS CUI-1)
    C0497153 (UMLS CUI-2)
    CL Item
    Secondary Definite (5)
    C0035258 (UMLS CUI-1)
    C0439544 (UMLS CUI-2)
    C0332138 (UMLS CUI-3)
    CL Item
    Secondary Possible (6)
    C0035258 (UMLS CUI-1)
    C2362652 (UMLS CUI-2)
    C0332138 (UMLS CUI-3)
    CL Item
    Diagnosis Unknown (7)
    C0011900 (UMLS CUI-1)
    C0439673 (UMLS CUI-2)
    Cause of disease
    Item
    Cause of disease
    integer
    C1314792 (UMLS CUI [1])
    Growing pains
    Item
    Does subject report growing pains?
    boolean
    C0423693 (UMLS CUI [1])
    unpleasant or uncomfortable feelings in your legs
    Item
    1. Have you ever had unpleasant or uncomfortable feelings in your legs that occurred mainly while you were either sitting or lying down?
    boolean
    C1140621 (UMLS CUI [1,1])
    C1527305 (UMLS CUI [1,2])
    Are these feelings painful rather than just uncomfortable?
    Item
    2. Are these feelings painful rather than just uncomfortable?
    boolean
    C0393903 (UMLS CUI [1])
    How would you describe these feelings or sensations?
    Item
    2a. How would you describe these feelings or sensations?
    text
    C0036659 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Urge to move
    Item
    3. Have you ever felt the need or urge to move your legs that occurred mainly while you were either sitting or lying down?
    boolean
    C0560560 (UMLS CUI [1,1])
    C1140621 (UMLS CUI [1,2])
    Ovelwhelmed to move
    Item
    3a. Do these feelings in your legs ever become overwhelming to the point that you cannot resist moving your legs?
    boolean
    C4281815 (UMLS CUI [1,1])
    C0578660 (UMLS CUI [1,2])
    Item
    3b. If you developed these feelings in your legs and you could not move your legs, or if someone were to hold your legs down, how would this effect the feelings in your legs?:
    integer
    C1280500 (UMLS CUI [1,1])
    C1527305 (UMLS CUI [1,2])
    C1140621 (UMLS CUI [1,3])
    Effects on feeling in leg
    Code List
    3b. If you developed these feelings in your legs and you could not move your legs, or if someone were to hold your legs down, how would this effect the feelings in your legs?:
    CL Item
    a lot better (1)
    C4036142 (UMLS CUI-1)
    CL Item
    some better (2)
    C4049139 (UMLS CUI-1)
    CL Item
    no difference (3)
    C3842396 (UMLS CUI-1)
    CL Item
    some worse (4)
    C1279889 (UMLS CUI-1)
    CL Item
    a lot wore (5)
    C3841448 (UMLS CUI-1)
    Charlie-horse or muscle cramp
    Item
    Do you think these feelings in your legs are due to a Charlie-horse or muscle cramp? .
    boolean
    C0037763 (UMLS CUI [1])
    C0026821 (UMLS CUI [2])
    Charlie-horse or muscle cramp always reason
    Item
    4a. Are these feelings always due to a Charlie-horse or muscle cramp?
    boolean
    C0037763 (UMLS CUI [1,1])
    C1549493 (UMLS CUI [1,2])
    C0026821 (UMLS CUI [2,1])
    C1549493 (UMLS CUI [2,2])
    Zum Seitenanfang zurückkehren 

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