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ID

35678

Descrição

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 medical procedure form. It has to be filled in for each visit.

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Versões (1)
  1. 15/03/2019 15/03/2019 -
Titular dos direitos

GlaxoSmithKline

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15 de março de 2019

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Licença

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

    Inglês

    Medical Procedures

    1 Formulários  
    1. StudyEvent: ODM
      1. Medical Procedures
    Administrative data
    Descrição

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Centre Number
    Descrição

    Centre Number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    UMLS CUI [1,2]
    C0019994 (Hospitals)
    Patient number
    Descrição

    Patient number

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1830427 (undefined)
    Patient Initials
    Descrição

    Patient Initials

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Visit type
    Descrição

    Visit type

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Medical Procedures
    Descrição

    Medical Procedures

    Alias
    UMLS CUI-1
    C0199171 (Medical procedure)
    Have any non-medication, therapeutic, diagnostic or surgical procedures been performed during the module?
    Descrição

    If you tick yes, please record details in the following items using standard medical terminology

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0199171 (Medical procedure)
    Procedure
    Descrição

    All indications for procedures should be recorded in either the Adverse Experiences and/or SAE sections as appropriate.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0199171 (Medical procedure)
    Indication
    Descrição

    Indication

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3146298 (Indication)
    Procedure Start Date
    Descrição

    Start Date Procedure

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0808070 (Start Date)
    UMLS CUI [1,2]
    C0199171 (Medical procedure)
    Procedure End Date
    Descrição

    End Date Procedure

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    UMLS CUI [1,2]
    C0184661 (Interventional procedure)
    SNOMED
    71388002
    Comment for SB
    Descrição

    Comment for SB

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
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    Similar models

    Medical Procedures

    1 Formulários
    1. StudyEvent: ODM
      1. Medical Procedures
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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 number
    Item
    Patient number
    text
    C1830427 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (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
    Medical Procedures
    C0199171 (UMLS CUI-1)
    Item
    Have any non-medication, therapeutic, diagnostic or surgical procedures been performed during the module?
    text
    C0199171 (UMLS CUI [1])
    Medical Procedures
    Code List
    Have any non-medication, therapeutic, diagnostic or surgical procedures been performed during the module?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Medical Procedures
    Item
    Procedure
    text
    C0199171 (UMLS CUI [1])
    Indication
    Item
    Indication
    text
    C3146298 (UMLS CUI [1])
    Start Date Procedure
    Item
    Procedure Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C0199171 (UMLS CUI [1,2])
    End Date Procedure
    Item
    Procedure End Date
    date
    C0806020 (UMLS CUI [1,1])
    C0184661 (UMLS CUI [1,2])
    Comment for SB
    Item
    Comment for SB
    text
    C0947611 (UMLS CUI [1])
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