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ID

35510

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

Uploaded on

March 6, 2019

DOI

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License

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

    English

    Concomitant Medication

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

    Administrative data

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

    Study Coordinating Center, Identification number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2825181 (Study Coordinating Center)
    UMLS CUI [1,2]
    C1300638 (Identification number)
    SNOMED
    396278008
    Patient Number
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Patient Initials
    Description

    Person Initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Concomitant Medication
    Description

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Please mark if no new or change in concomitant medication since the previous visit.
    Description

    Concomitant Agent, No status change

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0442739 (No status change)
    SNOMED
    260388006
    LOINC
    LA17181-1
    Drug Name (Trade Name Preferred)
    Description

    Concomitant Agent, Medication name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Total Daily Dose
    Description

    Concomitant Medication Daily Dose, Total

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2826638 (Concomitant Medication Daily Dose)
    UMLS CUI [1,2]
    C0439810 (Total)
    SNOMED
    255619001
    LOINC
    LP21089-5
    Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
    Description

    Concomitant Agent, Disease

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    Start Date (be as precise as possible)
    Description

    Concomitant Medication Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826734 (Concomitant Medication Start Date)
    End Date
    Description

    Concomitant Medication End Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826744 (Concomitant Medication End Date)
    If Continuing mark box
    Description

    Concomitant Medication Ongoing

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666 (Concomitant Medication Ongoing)
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    Similar models

    Concomitant Medication

    1 forms
    1. StudyEvent: ODM
      1. Concomitant Medication
    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
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Concomitant Agent, No status change
    Item
    Please mark if no new or change in concomitant medication since the previous visit.
    boolean
    C2347852 (UMLS CUI [1,1])
    C0442739 (UMLS CUI [1,2])
    Concomitant Agent, Medication name
    Item
    Drug Name (Trade Name Preferred)
    text
    C2347852 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    Concomitant Medication Daily Dose, Total
    Item
    Total Daily Dose
    text
    C2826638 (UMLS CUI [1,1])
    C0439810 (UMLS CUI [1,2])
    Concomitant Agent, Disease
    Item
    Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
    text
    C2347852 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    Concomitant Medication Start Date
    Item
    Start Date (be as precise as possible)
    date
    C2826734 (UMLS CUI [1])
    Concomitant Medication End Date
    Item
    End Date
    date
    C2826744 (UMLS CUI [1])
    Concomitant Medication Ongoing
    Item
    If Continuing mark box
    boolean
    C2826666 (UMLS CUI [1])
    Back to the top of the page 

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