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36084

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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 (Day 0) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (Day 21) This document contains the Baseline Sign and Symptom form. It has to be filled in for screening.

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GlaxoSmithKline

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15. April 2019

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    Determination of starting dose and up-titration regimen for a new formulation of Ropinirole, 101468/201

    Englisch

    Baseline Sign and Symptom

    1 Formulare  
    Administrative data
    Beschreibung

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Beschreibung

    Subject No.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Beschreibung

    Panel ID

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3846158
    Visit Date
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    No event
    Beschreibung

    No event

    If no baseline events experienced, please mark box and sign form below.
    Beschreibung

    No baseline event experienced

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3846032
    UMLS CUI [1,2]
    C1442488
    Adverse Event
    Beschreibung

    Adverse Event

    Alias
    UMLS CUI-1
    C0877248
    Baseline Sign/Symptom
    Beschreibung

    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)

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C1442488
    Onset Date
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2985916
    Onset Time
    Beschreibung

    00:00-23:59

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0449244
    UMLS CUI [1,2]
    C0877248
    End Date
    Beschreibung

    day month year (If ongoing, please leave blank)

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0877248
    End Time
    Beschreibung

    00:00-23:59 (If ongoing, please leave blank)

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0877248
    Outcome of AE
    Beschreibung

    If subject died, please inform GSK within 24 hours and complete form D

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1705586
    Event Course
    Beschreibung

    Event Course

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0750729
    If event course is intermittent, please note No. of Episodes
    Beschreibung

    No. of Episodes

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C4086638
    Intensity of AE
    Beschreibung

    MILD: Adverse Event which is easily tolerated. MODERATE: Adverse Event sufficiently discomforting to interfere with daily activity. SEVERE: Adverse Event which prevents normal everyday activities.

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1710066
    Relationship to Study Procedures performed prior to randomisation
    Beschreibung

    NOT RELATED: The adverse event is definitely not related to the test drug. UNLIKELY: There are more likely causes and the drug is not suspected as a cause. SUSPECTED (REASONABLE POSSIBILITY): A direct cause and effect relationship between the drug and the adverse event has not been demonstrated but there is a reasonable possibility that the event was caused by the drug. PROBABLE: There is probably a direct cause and effect relationship between the adverse event and the study drug.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1510821
    Corrective Therapy
    Beschreibung

    If you tick yes, please record on Prior Medication form.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0087111
    Was the subject withdrawn due to this event?
    Beschreibung

    Subject withdrawn

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0422727
    Investigator's Signature:
    Beschreibung

    Investigator's Signature

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date of signature
    Beschreibung

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Baseline Sign and Symptom

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    No event
    No baseline event experienced
    Item
    If no baseline events experienced, please mark box and sign form below.
    boolean
    C3846032 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    Item Group
    Adverse Event
    C0877248 (UMLS CUI-1)
    Baseline Sign/Symptom
    Item
    Baseline Sign/Symptom
    text
    C0037088 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    Onset Date
    Item
    Onset Date
    date
    C2985916 (UMLS CUI [1])
    Onset Time
    Item
    Onset Time
    time
    C0449244 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    End Date
    Item
    End Date
    date
    C0806020 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    End Time
    Item
    End Time
    time
    C1522314 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    Outcome of AE
    integer
    C1705586 (UMLS CUI [1])
    Outcome of AE
    Code List
    Outcome of AE
    CL Item
    Resolved (1)
    CL Item
    Ongoing (2)
    CL Item
    Died (2)
    Item
    Event Course
    integer
    C0877248 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    Event Course
    Code List
    Event Course
    CL Item
    Intermittent (1)
    CL Item
    Constant (2)
    No. of Episodes
    Item
    If event course is intermittent, please note No. of Episodes
    integer
    C0877248 (UMLS CUI [1,1])
    C4086638 (UMLS CUI [1,2])
    Item
    Intensity of AE
    integer
    C1710066 (UMLS CUI [1])
    Intensity of AE
    Code List
    Intensity of AE
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Item
    Relationship to Study Procedures performed prior to randomisation
    integer
    C0877248 (UMLS CUI [1,1])
    C1510821 (UMLS CUI [1,2])
    Relationship to Study Procedures
    Code List
    Relationship to Study Procedures performed prior to randomisation
    CL Item
    Not related (1)
    CL Item
    Unlikely (2)
    CL Item
    Suspected (reasonable possibility) (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 the subject withdrawn due to this event?
    text
    C0422727 (UMLS CUI [1])
    Subject withdrawn
    Code List
    Was the subject withdrawn due to this event?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Investigator's Signature
    Item
    Investigator's Signature:
    text
    C2346576 (UMLS CUI [1])
    Date of signature
    Item
    Date of signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Zum Seitenanfang zurückkehren 

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