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ID

36124

Descrição

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 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 a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Follow-Up Physical Examination form. It has to be filled in for follow-up.

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Versões (1)
  1. 16/04/2019 16/04/2019 -
Titular dos direitos

GlaxoSmithKline

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16 de abril de 2019

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Licença

Creative Commons BY-NC 3.0
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    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    Inglês

    Follow-Up Physical Examination

    1 Formulários  
    Administrative data
    Descrição

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject No.
    Descrição

    Subject No.

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Panel ID
    Descrição

    Panel ID

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    Physical Examination
    Descrição

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Date of Assessment:
    Descrição

    day month year

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C2985720 (Assessment Date)
    Time of Assessment
    Descrição

    00.00-23:59

    Tipo de dados

    time

    Alias
    UMLS CUI [1]
    C2826761 (Physical Examination Time)
    Has there been any change from the last examination (screening)?
    Descrição

    Change from last examination

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0443172 (Changed status)
    SNOMED
    263703002
    If there has been any change from the last examination, please record in this item. Any clinically relevant worsening since the last exam must be record on the Adverse Events page.
    Descrição

    Change, specification

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    UMLS CUI [1,2]
    C0034869 (Records)
    Voltar ao início da página

    Similar models

    Follow-Up Physical Examination

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject No.
    Item
    Subject No.
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (UMLS CUI [1])
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    Date of Assessment
    Item
    Date of Assessment:
    date
    C2985720 (UMLS CUI [1])
    Time of Assessment
    Item
    Time of Assessment
    time
    C2826761 (UMLS CUI [1])
    Item
    Has there been any change from the last examination (screening)?
    text
    C0031809 (UMLS CUI [1,1])
    C0443172 (UMLS CUI [1,2])
    Change from last examination
    Code List
    Has there been any change from the last examination (screening)?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Change, specification
    Item
    If there has been any change from the last examination, please record in this item. Any clinically relevant worsening since the last exam must be record on the Adverse Events page.
    text
    C0031809 (UMLS CUI [1,1])
    C0034869 (UMLS CUI [1,2])
    Voltar ao início da página 

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