ID

36916

Descripción

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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Versiones (1)
  1. 21/6/19 21/6/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

21 de junio de 2019

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Licencia

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

    Inglés

    Baseline Signs And Symptoms for Screening

    1 formularios  
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Volunteer panel number
    Descripción

    identification number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1300638
    Subject number
    Descripción

    Subject number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Non-serious Adverse Event
    Descripción

    Non-serious Adverse Event

    Alias
    UMLS CUI-1
    C1518404
    Were baseline events experienced during the module?
    Descripción

    Non-serious Adverse Event

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1518404
    Baseline sign/symptom
    Descripción

    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 datos

    text

    Alias
    UMLS CUI [1]
    C0037088
    Onset Date
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985916
    Onset Time
    Descripción

    00:00-23:59

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0449244
    UMLS CUI [1,2]
    C1518404
    End Date
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2697886
    End Time
    Descripción

    00:00-23:59

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C1522314
    Outcome
    Descripción

    Outcome

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1705586
    Event course
    Descripción

    Experience Course

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0750729
    No. of episodes
    Descripción

    Number of episodes

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C4086638
    Intensity (maximum)
    Descripción

    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 datos

    integer

    Alias
    UMLS CUI [1]
    C1710066
    Relationship to study procedures performed prior to randomisation
    Descripción

    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 datos

    integer

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C2700391
    Corrective Therapy
    Descripción

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

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0087111
    Was patient withdrawn due to this specific AE?
    Descripción

    patient withdrawn due to this specific AE

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C1518404
    Investigator signature:
    Descripción

    Investigator signature

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date:
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0011008
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    Similar models

    Baseline Signs And Symptoms for Screening

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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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