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36916

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Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Baseline Signs And Symptoms for Screening form.

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  1. 21/06/2019 21/06/2019 -
Titular dos direitos

GlaxoSmithKline

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21 de junho de 2019

DOI

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Creative Commons BY-NC 3.0
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    Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

    Inglês

    Baseline Signs And Symptoms for Screening

    1 Formulários  
    Administrative Data
    Descrição

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Volunteer panel number
    Descrição

    identification number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1300638 (Identification number)
    SNOMED
    396278008
    Subject number
    Descrição

    Subject number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Non-serious Adverse Event
    Descrição

    Non-serious Adverse Event

    Alias
    UMLS CUI-1
    C1518404 (Non-serious Adverse Event)
    Were baseline events experienced during the module?
    Descrição

    Non-serious Adverse Event

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1518404 (Non-serious Adverse Event)
    Baseline sign/symptom
    Descrição

    Record any baseline events (using standard medical terminology) observed or elicited by the following direct question to the subject: “How do you feel?“ Provide the diagnosis, NOT symptoms where possible. (One baseline event per column)

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    Onset Date
    Descrição

    day month year

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C2985916 (Adverse Event Onset Date)
    Onset Time
    Descrição

    00:00-23:59

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C0449244 (Time of onset)
    SNOMED
    263501003
    UMLS CUI [1,2]
    C1518404 (Non-serious Adverse Event)
    End Date
    Descrição

    day month year

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C2697886 (Adverse Event End Date)
    End Time
    Descrição

    00:00-23:59

    Tipo de dados

    time

    Alias
    UMLS CUI [1,1]
    C1518404 (Non-serious Adverse Event)
    UMLS CUI [1,2]
    C1522314 (End Time)
    SNOMED
    397898000
    Outcome
    Descrição

    Outcome

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1705586 (Adverse Event Outcome)
    Event course
    Descrição

    Experience Course

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0750729 (Course)
    SNOMED
    288524001
    No. of episodes
    Descrição

    Number of episodes

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C4086638 (Number of Episodes)
    Intensity (maximum)
    Descrição

    MILD: An event which is easily tolerated MODERATE: An event which is sufficiently discomforting to interfere with daily activity SEVERE: An event which prevents normal everyday activities

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1710066 (Severity of Adverse Event)
    Relationship to study procedures performed prior to randomisation
    Descrição

    NOT RELATED: The event is definitely not related to the study procedures UNLIKELY: There are other more likely causes and the study procedures are not suspected as a cause SUSPECTED (REASONABLE POSSIBILITY): A direct cause and effect relationship between the study procedures and the event has not been demonstrated but there is a reasonable possibility that the study procedures were involved PROBABLE: There probably is a direct cause and effect relationship between the event and the study procedures

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C2700391 (Procedure (set of actions))
    Corrective Therapy
    Descrição

    If ‘Yes’, record details in the Concomitant Medication section and/or Healthcare Resource Utilisation form if appropriate

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    Was patient withdrawn due to this specific AE?
    Descrição

    patient withdrawn due to this specific AE

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C1518404 (Non-serious Adverse Event)
    Investigator signature:
    Descrição

    Investigator signature

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    Date:
    Descrição

    day month year

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
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    Similar models

    Baseline Signs And Symptoms for Screening

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    identification number
    Item
    Volunteer panel number
    integer
    C1300638 (UMLS CUI [1])
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Non-serious Adverse Event
    C1518404 (UMLS CUI-1)
    Non-serious Adverse Event
    Item
    Were baseline events experienced during the module?
    boolean
    C1518404 (UMLS CUI [1])
    Baseline sign symptom
    Item
    Baseline sign/symptom
    text
    C0037088 (UMLS CUI [1])
    Onset Date
    Item
    Onset Date
    date
    C2985916 (UMLS CUI [1])
    Onset Time
    Item
    Onset Time
    time
    C0449244 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    End Date
    Item
    End Date
    date
    C2697886 (UMLS CUI [1])
    End Time
    Item
    End Time
    time
    C1518404 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Item
    Outcome
    integer
    C1705586 (UMLS CUI [1])
    Outcome
    Code List
    Outcome
    CL Item
    Resolved (1)
    CL Item
    Ongoing (2)
    CL Item
    Died (3)
    Item
    Event course
    integer
    C0877248 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    Experience Course
    Code List
    Event course
    CL Item
    Intermittent (1)
    CL Item
    Constant (2)
    Number of episodes
    Item
    No. of episodes
    integer
    C0877248 (UMLS CUI [1,1])
    C4086638 (UMLS CUI [1,2])
    Item
    Intensity (maximum)
    integer
    C1710066 (UMLS CUI [1])
    Intensity
    Code List
    Intensity (maximum)
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Relationship to study procedures performed prior to randomisation
    integer
    C0008976 (UMLS CUI [1,1])
    C2700391 (UMLS CUI [1,2])
    Relationship to Investigational Drug
    Code List
    Relationship to study procedures performed prior to randomisation
    CL Item
    Not related (1)
    CL Item
    Unlikely  (2)
    CL Item
    Suspected  (3)
    CL Item
    Probable (4)
    Item
    Corrective Therapy
    text
    C0877248 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    Corrective Therapy
    Code List
    Corrective Therapy
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Was patient withdrawn due to this specific AE?
    text
    C0422727 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    patient withdrawn due to this specific AE
    Code List
    Was patient withdrawn due to this specific AE?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Investigator signature
    Item
    Investigator signature:
    text
    C2346576 (UMLS CUI [1])
    Date
    Item
    Date:
    date
    C0011008 (UMLS CUI [1])
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