0 Ratings
ID

26425

Description

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

Keywords

Versions (1)
  1. 10/17/17 10/17/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 17, 2017

DOI

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License

Creative Commons BY-NC 3.0
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    visit week 24 compliance Ropinirole CR Ropinirole IR Monotherapy 101468/168

    English

    visit week 24 compliance Ropinirole CR Ropinirole IR Monotherapy 101468/168

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    RANDOMISATION NUMBER
    Description

    randomisation number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    INVESTIGATIONAL PRODUCT
    Description

    INVESTIGATIONAL PRODUCT

    Alias
    UMLS CUI-1
    C0304229
    Investigational Product
    Description

    investigational product

    Data type

    text

    Alias
    UMLS CUI [1]
    C0304229
    Blinded Dose Level
    Description

    medication dosage

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0304229
    Start Date
    Description

    start date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070
    Stop Date
    Description

    stop date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020
    Investigational product Container Number
    Description

    investigational product container number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C3898691
    UMLS CUI [1,2]
    C0449788
    COMPLIANCE
    Description

    COMPLIANCE

    Alias
    UMLS CUI-1
    C1321605
    Total Number of Tablets Dispensed
    Description

    total number of tablets dispensed

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0805077
    UMLS CUI [1,2]
    C0039225
    Total Number of Tablets Returned
    Description

    total number of tablets returned

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2699071
    UMLS CUI [1,2]
    C0039225
    Has the subject missed investigational product for > 3 consecutive days?
    Description

    investigational product compliance

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1321605
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    visit week 24 compliance Ropinirole CR Ropinirole IR Monotherapy 101468/168

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    subject number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    randomisation number
    Item
    RANDOMISATION NUMBER
    integer
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Item Group
    INVESTIGATIONAL PRODUCT
    C0304229 (UMLS CUI-1)
    Item
    Investigational Product
    text
    C0304229 (UMLS CUI [1])
    investigational product
    Code List
    Investigational Product
    CL Item
    Bottle A (Bottle A)
    CL Item
    Bottle B (Bottle B)
    medication dosage
    Item
    Blinded Dose Level
    integer
    C0178602 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    start date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1])
    stop date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1])
    investigational product container number
    Item
    Investigational product Container Number
    integer
    C3898691 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Item Group
    COMPLIANCE
    C1321605 (UMLS CUI-1)
    total number of tablets dispensed
    Item
    Total Number of Tablets Dispensed
    integer
    C0805077 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    total number of tablets returned
    Item
    Total Number of Tablets Returned
    integer
    C2699071 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    Item
    Has the subject missed investigational product for > 3 consecutive days?
    text
    C0304229 (UMLS CUI [1,1])
    C1321605 (UMLS CUI [1,2])
    investigational product compliance
    Code List
    Has the subject missed investigational product for > 3 consecutive days?
    CL Item
    Yes (Y)
    CL Item
    No (N)
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