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ID

24583

Description

Study part: RLS Concomitant Medications . A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients with Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Clinicaltrials.gov Identifier: NCT00355641. 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. Study ID: 101468/206. Clinical Study ID: 101468/206.

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Versions (1)
  1. 8/7/17 8/7/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 7, 2017

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License

Creative Commons BY-NC 3.0
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    RLS Concomitant Medications (CM RLS) Ropinirole Restless Legs Syndrom NCT00355641

    English

    RLS Concomitant Medications

    1 forms  
    RLS CONCOMITANT MEDICATIONS
    Description

    RLS CONCOMITANT MEDICATIONS

    Alias
    UMLS CUI-1
    C2347852
    1. Cabergoline. Was drug ever used?
    Description

    cabergoline

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0107994
    Start Date:
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    End Date:
    Description

    End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    Did the subject respond to treatment?
    Description

    respond to treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0150839
    Did the subject tolerate treatment?
    Description

    tolerate treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013220
    2. Pergolide. Was drug ever used?
    Description

    Pergolide

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0031007
    Start Date:
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    End Date:
    Description

    End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    Did the subject respond to treatment?
    Description

    respond to treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0150839
    Did the subject tolerate treatment?
    Description

    tolerate treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013220
    3. lisuride. Was drug ever used?
    Description

    lisuride

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023863
    Start Date:
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    End Date:
    Description

    End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    Did the subject respond to treatment?
    Description

    respond to treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0150839
    Did the subject tolerate treatment?
    Description

    tolerate treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013220
    4.Bromocriptine. Was drug ever used?
    Description

    bromocriptine

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006230
    Start Date:
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    End Date:
    Description

    End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    Did the subject respond to treatment?
    Description

    respond to treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0150839
    Did the subject tolerate treatment?
    Description

    tolerate treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013220
    5. Pramipexole. Was drug ever used?
    Description

    pramipexole

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0074710
    Start Date:
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    End Date:
    Description

    End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    Did the subject respond to treatment?
    Description

    respond to treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0150839
    Did the subject tolerate treatment?
    Description

    tolerate treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013220
    6. Levodopa
    Description

    Levodopa

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023570
    Start Date:
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    End Date:
    Description

    End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    Did the subject respond to treatment?
    Description

    respond to treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0150839
    Did the subject tolerate treatment?
    Description

    tolerate treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013220
    Other RLS Medications
    Description

    Other RLS Medications

    Alias
    UMLS CUI-1
    C2347852
    7a. Drug name
    Description

    Drug name

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013227
    7b. Modified reported term
    Description

    Modified reported term

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826819
    GSK Drug synonym
    Description

    Drug synonym

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0871468
    GSK Drug Collection code
    Description

    Drug Collection code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C1516698
    UMLS CUI [1,3]
    C0805701
    Failed coding
    Description

    Failed coding Concomitant Agent

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0805701
    UMLS CUI [1,2]
    C0231175
    UMLS CUI [1,3]
    C2347852
    7c. Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    7d. End Date
    Description

    End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    7e. Did the subject respond to treatment?
    Description

    respond to treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0150839
    7f. Did the subject tolerate treatment?
    Description

    tolerate treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013220
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    Similar models

    RLS Concomitant Medications

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    RLS CONCOMITANT MEDICATIONS
    C2347852 (UMLS CUI-1)
    cabergoline
    Item
    1. Cabergoline. Was drug ever used?
    boolean
    C0107994 (UMLS CUI [1])
    Start Date
    Item
    Start Date:
    date
    C0808070 (UMLS CUI [1])
    End Date
    Item
    End Date:
    date
    C0806020 (UMLS CUI [1])
    respond to treatment
    Item
    Did the subject respond to treatment?
    boolean
    C0150839 (UMLS CUI [1])
    tolerate treatment
    Item
    Did the subject tolerate treatment?
    boolean
    C0013220 (UMLS CUI [1])
    Pergolide
    Item
    2. Pergolide. Was drug ever used?
    boolean
    C0031007 (UMLS CUI [1])
    Start Date
    Item
    Start Date:
    date
    C0808070 (UMLS CUI [1])
    End Date
    Item
    End Date:
    date
    C0806020 (UMLS CUI [1])
    respond to treatment
    Item
    Did the subject respond to treatment?
    boolean
    C0150839 (UMLS CUI [1])
    tolerate treatment
    Item
    Did the subject tolerate treatment?
    boolean
    C0013220 (UMLS CUI [1])
    lisuride
    Item
    3. lisuride. Was drug ever used?
    boolean
    C0023863 (UMLS CUI [1])
    Start Date
    Item
    Start Date:
    date
    C0808070 (UMLS CUI [1])
    End Date
    Item
    End Date:
    date
    C0806020 (UMLS CUI [1])
    respond to treatment
    Item
    Did the subject respond to treatment?
    boolean
    C0150839 (UMLS CUI [1])
    tolerate treatment
    Item
    Did the subject tolerate treatment?
    boolean
    C0013220 (UMLS CUI [1])
    bromocriptine
    Item
    4.Bromocriptine. Was drug ever used?
    boolean
    C0006230 (UMLS CUI [1])
    Start Date
    Item
    Start Date:
    date
    C0808070 (UMLS CUI [1])
    End Date
    Item
    End Date:
    date
    C0806020 (UMLS CUI [1])
    respond to treatment
    Item
    Did the subject respond to treatment?
    boolean
    C0150839 (UMLS CUI [1])
    tolerate treatment
    Item
    Did the subject tolerate treatment?
    boolean
    C0013220 (UMLS CUI [1])
    pramipexole
    Item
    5. Pramipexole. Was drug ever used?
    boolean
    C0074710 (UMLS CUI [1])
    Start Date
    Item
    Start Date:
    date
    C0808070 (UMLS CUI [1])
    End Date
    Item
    End Date:
    date
    C0806020 (UMLS CUI [1])
    respond to treatment
    Item
    Did the subject respond to treatment?
    boolean
    C0150839 (UMLS CUI [1])
    tolerate treatment
    Item
    Did the subject tolerate treatment?
    boolean
    C0013220 (UMLS CUI [1])
    Levodopa
    Item
    6. Levodopa
    boolean
    C0023570 (UMLS CUI [1])
    Start Date
    Item
    Start Date:
    date
    C0808070 (UMLS CUI [1])
    End Date
    Item
    End Date:
    date
    C0806020 (UMLS CUI [1])
    respond to treatment
    Item
    Did the subject respond to treatment?
    boolean
    C0150839 (UMLS CUI [1])
    tolerate treatment
    Item
    Did the subject tolerate treatment?
    boolean
    C0013220 (UMLS CUI [1])
    Item Group
    Other RLS Medications
    C2347852 (UMLS CUI-1)
    Drug name
    Item
    7a. Drug name
    text
    C0013227 (UMLS CUI [1])
    Modified reported term
    Item
    7b. Modified reported term
    text
    C2826819 (UMLS CUI [1])
    Drug synonym
    Item
    GSK Drug synonym
    text
    C0013227 (UMLS CUI [1,1])
    C0871468 (UMLS CUI [1,2])
    Drug Collection code
    Item
    GSK Drug Collection code
    text
    C0013227 (UMLS CUI [1,1])
    C1516698 (UMLS CUI [1,2])
    C0805701 (UMLS CUI [1,3])
    Failed coding Concomitant Agent
    Item
    Failed coding
    text
    C0805701 (UMLS CUI [1,1])
    C0231175 (UMLS CUI [1,2])
    C2347852 (UMLS CUI [1,3])
    Start Date
    Item
    7c. Start Date
    date
    C0808070 (UMLS CUI [1])
    End Date
    Item
    7d. End Date
    date
    C0806020 (UMLS CUI [1])
    respond to treatment
    Item
    7e. Did the subject respond to treatment?
    boolean
    C0150839 (UMLS CUI [1])
    tolerate treatment
    Item
    7f. Did the subject tolerate treatment?
    boolean
    C0013220 (UMLS CUI [1])
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