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ID

36392

Description

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 non serious AE form. It has to be filled in if the subject experiences non serious AE during the study.

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Versions (2)
  1. 9/5/17 9/5/17 -
  2. 5/10/19 5/10/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 10, 2019

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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

    English

    Non- Serious Adverse Experiences (non serious AE)

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    ADVERSE EXPERIENCES (Non-serious)
    Description

    ADVERSE EXPERIENCES (Non-serious)

    Alias
    UMLS CUI-1
    C1518404
    Did adverse experiences occurr?
    Description

    Record any adverse event (using standard medical terminology) observed or elicited by the following direct question to the subject: “Do you feel different in any way since starting the treatment or since the last visit?” Provide the diagnosis not symptoms where possible. (One adverse event per column) If no adverse events, please mark box and sign form below.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1518404
    Onset Date of AE
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985916
    Onset Time of AE
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0449244
    UMLS CUI [1,2]
    C0877248
    End Date of AE
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C2697886
    End Time of AE
    Description

    00:00-23:59

    Data type

    time

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

    Outcome of AE

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1705586
    Event course of AE
    Description

    Experience Course of AE

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0750729
    If AE is interemittent, please specify number of episodes
    Description

    Number of episodes

    Data type

    integer

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

    INTENSITY (Maximum) Definition: 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.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1710066
    Action Taken with Respect to Investigational Drug
    Description

    Action Taken with Respect to Investigational Drug

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2826626
    Relationship to Investigational Drug
    Description

    Definition: 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.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0439849
    Corrective Therapy
    Description

    If ‘Yes’, please record on Concomitant Medication form.

    Data type

    text

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

    Patient withdrawn due to this specific AE

    Data type

    text

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

    Investigator signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date of signature
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    Similar models

    Non- Serious Adverse Experiences (non serious AE)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    ADVERSE EXPERIENCES (Non-serious)
    C1518404 (UMLS CUI-1)
    Non-serious Adverse Event
    Item
    Did adverse experiences occurr?
    boolean
    C1518404 (UMLS CUI [1])
    Onset Date of AE
    Item
    Onset Date of AE
    date
    C2985916 (UMLS CUI [1])
    Onset Time of AE
    Item
    Onset Time of AE
    time
    C0449244 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    End Date of AE
    Item
    End Date of AE
    date
    C2697886 (UMLS CUI [1])
    End Time of AE
    Item
    End Time of AE
    time
    C1522314 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    Outcome of AE
    integer
    C1705586 (UMLS CUI [1])
    Outcome
    Code List
    Outcome of AE
    CL Item
    Resolved (1)
    CL Item
    Ongoing (2)
    Item
    Event course of AE
    integer
    C0877248 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    Experience Course
    Code List
    Event course of AE
    CL Item
    Intermittent (1)
    CL Item
    Constant (2)
    Number of episodes
    Item
    If AE is interemittent, please specify number 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
    Action Taken with Respect to Investigational Drug
    integer
    C2826626 (UMLS CUI [1])
    Action Taken with Respect to Investigational Drug
    Code List
    Action Taken with Respect to Investigational Drug
    CL Item
    None (1)
    CL Item
    Dose reduced (2)
    CL Item
    Dose increased (3)
    CL Item
    Drug interrupted/restarted (4)
    CL Item
    Drug stopped (5)
    Item
    Relationship to Investigational Drug
    integer
    C1518404 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    Relationship to Investigational Drug
    Code List
    Relationship to Investigational Drug
    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 of signature
    Item
    Date of signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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