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ID

35684

Description

Study ID: 101468/192 Clinical Study ID: 101468/192 Study Title:A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The study consists of 16 visits which are devided in 3 study books: Book 1: Screening (+Baseline), Day 2, Week 1, Week 2 , Week 3 , Week 4, Week 5, Week 6, Week 7, Week 8 Book 2: Week 12, Week 24, Week 36, Week 48, Week 52, Follow-up Book 3: Early withdrawal and Follow-up Each follow-up Visit takes place 7 +/- 3 days after last dose This document contains the Study Medication And Compliance Record form. It has to be filled in for each Visit. It also cntains the Dose reduction due to AE form. It has to be filled in for Week 12-48 and Follow-up.

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Versions (1)
  1. 3/15/19 3/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 15, 2019

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Creative Commons BY-NC 3.0
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    Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192

    English

    Study Medication And Compliance Record, Dose reduction due to AE

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Centre Number
    Description

    Centre Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Patient Initials
    Description

    Patient Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C1830427
    Visit type
    Description

    Visit type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Study Medication And Compliance Record
    Description

    Study Medication And Compliance Record

    Alias
    UMLS CUI-1
    C2734539
    UMLS CUI-2
    C0008972
    UMLS CUI-3
    C1321605
    Study Medication Week Number
    Description

    Week Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439230
    UMLS CUI [1,2]
    C0237753
    Dose Level (Specify 1 - 8)
    Description

    Dose Level

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0178602
    Date First Dose
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C3173309
    Last Dose Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C1517741
    UMLS CUI [1,3]
    C0011008
    Number of tablets dispensed
    Description

    Number of tablets dispensed

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0805077
    UMLS CUI [1,2]
    C0304229
    Number of tablets returned
    Description

    Number of tablets returned

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2699071
    UMLS CUI [1,2]
    C0304229
    Dose Reductions Due to Adverse Experiences
    Description

    Dose Reductions Due to Adverse Experiences

    Alias
    UMLS CUI-1
    C1707814
    UMLS CUI-2
    C0559546
    Week
    Description

    Week

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0439230
    Dose Level
    Description

    Dose Level

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0178602
    Date First Dose
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C3173309
    Last Dose Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C1517741
    UMLS CUI [1,3]
    C0011008
    Number of tablets dispensed
    Description

    Number of tablets dispensed

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0805077
    UMLS CUI [1,2]
    C0304229
    Number of tablets returned
    Description

    Number of tablets returned

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2699071
    UMLS CUI [1,2]
    C0304229
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    Similar models

    Study Medication And Compliance Record, Dose reduction due to AE

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Centre Number
    Item
    Centre Number
    integer
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Patient Number
    Item
    Patient Number
    text
    C1830427 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit type
    Code List
    Visit type
    CL Item
    Screening/Baseline (1)
    CL Item
    Day 2 (2)
    CL Item
    Week 1 (3)
    CL Item
    Week 2  (4)
    CL Item
    Week 3  (5)
    CL Item
    Week 4 (6)
    CL Item
    Week 5 (7)
    CL Item
    Week 6 (8)
    CL Item
    Week 7 (9)
    CL Item
    Week 8  (10)
    CL Item
    Week 12 (11)
    CL Item
    Week 24 (12)
    CL Item
    Week 36 (13)
    CL Item
    Week 48 (14)
    CL Item
    Week 52 (15)
    CL Item
    Early withdrawal (16)
    CL Item
    Follow-up (17)
    Item Group
    Study Medication And Compliance Record
    C2734539 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    C1321605 (UMLS CUI-3)
    Item
    Study Medication Week Number
    integer
    C0439230 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Week Number
    Code List
    Study Medication Week Number
    CL Item
    Week 1 (Days 1-2) (1)
    CL Item
    Week 1 (Days 3-7) (2)
    CL Item
    Week 2 (3)
    CL Item
    Week 3 (4)
    CL Item
    Week 4 (5)
    CL Item
    Week 5 (6)
    CL Item
    Week 6 (7)
    CL Item
    Week 7 (8)
    CL Item
    Week 8 (9)
    CL Item
    Week 9-12 (10)
    CL Item
    Week 13-24 (11)
    CL Item
    Week 25-36 (12)
    CL Item
    Week 37-48 (13)
    CL Item
    Week 49-52 (14)
    Dose Level
    Item
    Dose Level (Specify 1 - 8)
    integer
    C0178602 (UMLS CUI [1])
    First Dose Date
    Item
    Date First Dose
    date
    C3173309 (UMLS CUI [1])
    last Dose Date
    Item
    Last Dose Date
    date
    C0178602 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Number of tablets dispensed
    Item
    Number of tablets dispensed
    integer
    C0805077 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Number of tablets returned
    Item
    Number of tablets returned
    integer
    C2699071 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Item Group
    Dose Reductions Due to Adverse Experiences
    C1707814 (UMLS CUI-1)
    C0559546 (UMLS CUI-2)
    Week
    Item
    Week
    integer
    C0439230 (UMLS CUI [1])
    Dose Level
    Item
    Dose Level
    integer
    C0178602 (UMLS CUI [1])
    First Dose Date
    Item
    Date First Dose
    date
    C3173309 (UMLS CUI [1])
    last Dose Date
    Item
    Last Dose Date
    date
    C0178602 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Number of tablets dispensed
    Item
    Number of tablets dispensed
    integer
    C0805077 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    Number of tablets returned
    Item
    Number of tablets returned
    integer
    C2699071 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
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