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ID

35677

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 concomitant medication form. It has to be filled in if the subject takes concomitant medication during the study.

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Versions (1)
  1. 15/03/2019 15/03/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

15 mars 2019

DOI

Pour une demande vous connecter.

Licence

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

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    Concomitant Medication

    1 Formulaires  
    1. StudyEvent: ODM
      1. Concomitant Medication
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Centre Number
    Description

    Centre Number

    Type de données

    integer

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

    Patient Initials

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2986440
    Concomitant Medication
    Description

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852
    No new/change in concomitant medication
    Description

    Please mark if no new or change in concomitant medication during the module

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1298908
    UMLS CUI [1,3]
    C0580105
    Drug Name
    Description

    Drug Name

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0013227
    Total Daily Dose
    Description

    Total Daily Dose

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348070
    Medical illness/ Diagnosis
    Description

    (or symptom in absence of diagnosis)

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0011900
    Start Date
    Description

    Start Date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C0808070
    End Date
    Description

    End Date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C0806020
    Retour au début de la page

    Similar models

    Concomitant Medication

    1 Formulaires
    1. StudyEvent: ODM
      1. Concomitant Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    No new/change in concomitant medication
    Item
    No new/change in concomitant medication
    boolean
    C2347852 (UMLS CUI [1,1])
    C1298908 (UMLS CUI [1,2])
    C0580105 (UMLS CUI [1,3])
    Drug Name
    Item
    Drug Name
    text
    C0013227 (UMLS CUI [1])
    Total Daily Dose
    Item
    Total Daily Dose
    integer
    C2348070 (UMLS CUI [1])
    Diagnosis
    Item
    Medical illness/ Diagnosis
    text
    C0011900 (UMLS CUI [1])
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1])
    End Date
    Item
    End Date
    date
    C0806020 (UMLS CUI [1])
    Retour au début de la page 

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