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ID

21952

Description

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

Mots-clés

Versions (1)
  1. 09/05/2017 09/05/2017 -
Détendeur de droits

gsk

Téléchargé le

9 mai 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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    Efficacy and Safety Ropinirole in Patients Suffering from RLS GSK Study

    Anglais

    RLS DIAGNOSTIC CLINICAL INTERVIEW Case Report Form RRL100013

    1 Formulaires  
    Header module
    Description

    Header module

    Protocol Identifier
    Description

    Protocol Identifier

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2826693
    Subject Identifier
    Description

    Subject Identifier

    Type de données

    integer

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

    CLINICAL INTERVIEW - WORKSHEET

    Diagnosis
    Description

    Diagnosis

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0011900
    Cause of disease
    Description

    Cause of disease

    Type de données

    integer

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

    Growing pains

    Type de données

    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?
    Description

    If no, go to #3

    Type de données

    boolean

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

    Are these feelings painful rather than just uncomfortable?

    Type de données

    boolean

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

    How would you describe these feelings or sensations?

    Type de données

    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?
    Description

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

    Type de données

    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?
    Description

    Ovelwhelmed to move

    Type de données

    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?:
    Description

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

    Type de données

    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? .
    Description

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

    Type de données

    boolean

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

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

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0037763
    UMLS CUI [1,2]
    C1549493
    UMLS CUI [2,1]
    C0026821
    UMLS CUI [2,2]
    C1549493
    Retour au début de la page

    Similar models

    RLS DIAGNOSTIC CLINICAL INTERVIEW Case Report Form RRL100013

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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