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ID

42790

Description

Ropinirole Case Report Form GSK RRL100013 GSK Study ID: 100013 Clinical Study ID: RRL100013 A 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

Keywords

Versions (5)
  1. 10/5/17 10/5/17 -
  2. 2/22/18 2/22/18 -
  3. 2/22/18 2/22/18 -
  4. 2/22/18 2/22/18 -
  5. 9/17/21 9/17/21 -
Copyright Holder

gsk

Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY-NC 3.0
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    Ropinirole Case Report Form GSK RRL100013

    English

    Ropinirole Case Report Form GSK RRL100013

    9 forms  
    Administrative documentation
    Description

    Administrative documentation

    Alias
    UMLS CUI-1
    C1320722
    STUDY NO.
    Description

    Study Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826693
    Subject No.:
    Description

    Subject No.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID:
    Description

    Panel ID

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0086373
    Visit:
    Description

    Visit

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1549755
    Date:
    Description

    DD/MON/YY

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Other medication
    Description

    Other medication

    Has the subject taken any prescribed medication within 14 days prior to first dosing day or any OTC medicine within 7 days before the first study day?
    Description

    If 'YES', please record the medications below.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3166216
    UMLS CUI [2]
    C0013231
    Prior Medication
    Description

    Prior Medication

    Alias
    UMLS CUI-1
    C2826257
    DRUG NAME
    Description

    (Trade Name Preferred)

    Data type

    text

    Alias
    UMLS CUI [1]
    C2360065
    Single Dose/Unit
    Description

    (e.g.500 mg)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1960417
    Frequency of this Dose (e.g.BID, PR)
    Description

    Frequency of this Dose

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3476109
    Route
    Description

    Route

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013153
    Indication
    Description

    Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C0013227
    Duration of therapy
    Description

    (e.g.6 years)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0444921
    End Date
    Description

    Day/Month/Year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Continuing at end of study?
    Description

    Continuing at end of study

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1562611
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    Similar models

    Ropinirole Case Report Form GSK RRL100013

    9 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative documentation
    C1320722 (UMLS CUI-1)
    Study Identifier
    Item
    STUDY NO.
    text
    C2826693 (UMLS CUI [1])
    Subject No.
    Item
    Subject No.:
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID:
    integer
    C0086373 (UMLS CUI [1])
    Visit
    Item
    Visit:
    integer
    C1549755 (UMLS CUI [1])
    Date
    Item
    Date:
    date
    C0011008 (UMLS CUI [1])
    Item Group
    Other medication
    Prescribed or OTC medication
    Item
    Has the subject taken any prescribed medication within 14 days prior to first dosing day or any OTC medicine within 7 days before the first study day?
    boolean
    C3166216 (UMLS CUI [1])
    C0013231 (UMLS CUI [2])
    Item Group
    Prior Medication
    C2826257 (UMLS CUI-1)
    DRUG NAME
    Item
    DRUG NAME
    text
    C2360065 (UMLS CUI [1])
    Single Dose/Unit
    Item
    Single Dose/Unit
    integer
    C1960417 (UMLS CUI [1])
    Frequency of this Dose
    Item
    Frequency of this Dose (e.g.BID, PR)
    integer
    C3476109 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Indication
    Item
    Indication
    text
    C3146298 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Duration of therapy
    Item
    Duration of therapy
    integer
    C0444921 (UMLS CUI [1])
    End Date
    Item
    End Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Continuing at end of study
    Item
    Continuing at end of study?
    boolean
    C1562611 (UMLS CUI [1])
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