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35516

Description

Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). 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: requip Study Indication: Restless Legs Syndrome

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Versions (1)
  1. 3/6/19 3/6/19 -
Copyright Holder

GlaxoSmithKline

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March 6, 2019

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Creative Commons BY-NC 3.0
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    Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

    English

    Study Medication and Compliance Record

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Centre Number
    Description

    Study Coordinating Center, Identification number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2825181
    UMLS CUI [1,2]
    C1300638
    Patient Number
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Patient Initials
    Description

    Person Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Study Medication Record
    Description

    Study Medication Record

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C2734539
    Study Med. Week No.
    Description

    Experimental drug, Week, Numbers

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0439230
    UMLS CUI [1,3]
    C0237753
    Is this a Dose Reduction?
    Description

    if ’No’, continue if ’Yes’, please complete theDose Reductions due to AE on page 64. Do not continue on this page for this visit.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1707814
    Dose Level (Specify 1 - 8)
    Description

    Experimental drug, Dosage, Level

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0441889
    Date First Dose
    Description

    Experimental drug, Medication dose, Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C3174092
    UMLS CUI [1,3]
    C0808070
    Date Last Dose
    Description

    Experimental drug, Date last dose

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1762893
    Number of tablets dispensed
    Description

    Experimental Drug, Dispensed Amount

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0805077
    UMLS CUI [1,2]
    C0805077
    Number of tablets returned
    Description

    Experimental drug, Returned Amount

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2699071
    UMLS CUI [1,2]
    C2699071
    Interruption of ≥ 2 consecutive days?
    Description

    Experimental drug, Interruption

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1512900
    Medication Labels
    Description

    Experimental Drug, Drug Labeling

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0013191
    Dose Reduction Due to Adverse Experiences
    Description

    Dose Reduction Due to Adverse Experiences

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C1707814
    UMLS CUI-3
    C0877248
    Study Med. Week No.
    Description

    Experimental drug, Dose Reduced, Adverse Event, Week, Numbers

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C0439230
    UMLS CUI [1,5]
    C0237753
    Dose Level (Specify 1 - 8)
    Description

    Experimental drug, Dose Reduced, Adverse Event, Dosage, Level

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C0178602
    UMLS CUI [1,5]
    C0441889
    Date First Dose
    Description

    Experimental drug, Dose Reduced, Adverse Event, Medication dose, Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C3174092
    UMLS CUI [1,5]
    C0808070
    Date Last Dose
    Description

    Experimental drug, Dose Reduced, Adverse Event, Date last dose

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C1762893
    Number of tablets dispensed
    Description

    Experimental Drug, Dose Reduced, Adverse Event, Dispensed Amount

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0805077
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C0805077
    Number of tablets returned
    Description

    Experimental drug, Dose Reduced, Adverse Event, Returned Amount

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2699071
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C2699071
    Interruption of ≥ 2 consecutive days?
    Description

    Experimental drug, Dose Reduced, Adverse Event, Interruption

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C1512900
    Medication Labels
    Description

    Experimental Drug, Dose Reduced, Adverse Event, Drug Labeling

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1707814
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [1,4]
    C0013191
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    Similar models

    Study Medication and Compliance Record

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Study Coordinating Center, Identification number
    Item
    Centre Number
    integer
    C2825181 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Clinical Trial Subject Unique Identifier
    Item
    Patient Number
    integer
    C2348585 (UMLS CUI [1])
    Person Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Study Medication Record
    C0304229 (UMLS CUI-1)
    C2734539 (UMLS CUI-2)
    Item
    Study Med. Week No.
    text
    C0304229 (UMLS CUI [1,1])
    C0439230 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Experimental drug, Week, Numbers
    Code List
    Study Med. Week No.
    CL Item
    Wk 1 (Days 1-2) (1)
    CL Item
    Wk 1 (Days 3-7) (2)
    CL Item
    Wk 2 (3)
    CL Item
    Wk 3 (4)
    CL Item
    Wk 4 (5)
    CL Item
    Wk 5 (6)
    CL Item
    Wk 6 (7)
    CL Item
    Wk 7 (8)
    CL Item
    Wk 8 (9)
    CL Item
    Wk 9 (10)
    CL Item
    Wk 10 (11)
    CL Item
    Wk 11 (12)
    CL Item
    Wk 12 (13)
    Experimental drug, Dose Reduced
    Item
    Is this a Dose Reduction?
    boolean
    C0304229 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    Experimental drug, Dosage, Level
    Item
    Dose Level (Specify 1 - 8)
    integer
    C0304229 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0441889 (UMLS CUI [1,3])
    Experimental drug, Medication dose, Start Date
    Item
    Date First Dose
    date
    C0304229 (UMLS CUI [1,1])
    C3174092 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    Experimental drug, Date last dose
    Item
    Date Last Dose
    date
    C0304229 (UMLS CUI [1,1])
    C1762893 (UMLS CUI [1,2])
    Experimental Drug, Dispensed Amount
    Item
    Number of tablets dispensed
    integer
    C0805077 (UMLS CUI [1,1])
    C0805077 (UMLS CUI [1,2])
    Experimental drug, Returned Amount
    Item
    Number of tablets returned
    integer
    C2699071 (UMLS CUI [1,1])
    C2699071 (UMLS CUI [1,2])
    Experimental drug, Interruption
    Item
    Interruption of ≥ 2 consecutive days?
    boolean
    C0304229 (UMLS CUI [1,1])
    C1512900 (UMLS CUI [1,2])
    Experimental Drug, Drug Labeling
    Item
    Medication Labels
    text
    C0304229 (UMLS CUI [1,1])
    C0013191 (UMLS CUI [1,2])
    Item Group
    Dose Reduction Due to Adverse Experiences
    C0304229 (UMLS CUI-1)
    C1707814 (UMLS CUI-2)
    C0877248 (UMLS CUI-3)
    Experimental drug, Dose Reduced, Adverse Event, Week, Numbers
    Item
    Study Med. Week No.
    text
    C0304229 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C0439230 (UMLS CUI [1,4])
    C0237753 (UMLS CUI [1,5])
    Experimental drug, Dose Reduced, Adverse Event, Dosage, Level
    Item
    Dose Level (Specify 1 - 8)
    integer
    C0304229 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C0178602 (UMLS CUI [1,4])
    C0441889 (UMLS CUI [1,5])
    Experimental drug, Dose Reduced, Adverse Event, Medication dose, Start Date
    Item
    Date First Dose
    date
    C0304229 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C3174092 (UMLS CUI [1,4])
    C0808070 (UMLS CUI [1,5])
    Experimental drug, Dose Reduced, Adverse Event, Date last dose
    Item
    Date Last Dose
    date
    C0304229 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C1762893 (UMLS CUI [1,4])
    Experimental Drug, Dose Reduced, Adverse Event, Dispensed Amount
    Item
    Number of tablets dispensed
    integer
    C0805077 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C0805077 (UMLS CUI [1,4])
    Experimental drug, Dose Reduced, Adverse Event, Returned Amount
    Item
    Number of tablets returned
    integer
    C2699071 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C2699071 (UMLS CUI [1,4])
    Experimental drug, Dose Reduced, Adverse Event, Interruption
    Item
    Interruption of ≥ 2 consecutive days?
    boolean
    C0304229 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C1512900 (UMLS CUI [1,4])
    Experimental Drug, Dose Reduced, Adverse Event, Drug Labeling
    Item
    Medication Labels
    text
    C0304229 (UMLS CUI [1,1])
    C1707814 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C0013191 (UMLS CUI [1,4])
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