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ID

36029

Description

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 AE form. It has to be filled in if the subject experienced an AE during the study trial.

Keywords

Versions (1)
  1. 4/9/19 4/9/19 -
Copyright Holder

GlaxoSmithKline

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April 9, 2019

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

    English

    Adverse Events

    1 forms  
    1. StudyEvent: ODM
      1. Adverse Events
    Administrative data
    Description

    Administrative data

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

    Subject No.

    Data type

    text

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

    Panel ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    Adverse Event
    Description

    Adverse Event

    Alias
    UMLS CUI-1
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    If no adverse event, please mark box and sign form below.
    Description

    No adverse event

    Data type

    boolean

    Adverse Event
    Description

    Record any Adverse events (using standard medical terminology) observed or elicited by the following direct question to the subject: "Have you felt different in any way since starting the new treatment or since the last visit?" Provide the diagnosis NOT symptoms where possible. (One adverse event per column)

    Data type

    text

    Alias
    UMLS CUI [1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Comment for GSK
    Description

    Comment for GSK

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0947611 (Comment)
    LOINC
    LP72293-1
    UMLS CUI [1,3]
    C0008961 (Clinical Investigators)
    AE Onset Date
    Description

    day month year

    Data type

    date

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

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0449244 (Time of onset)
    SNOMED
    263501003
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    AE End Date
    Description

    day month year (If ongoing, please leave blank)

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    AE End Time
    Description

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

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1522314 (End Time)
    SNOMED
    397898000
    UMLS CUI [1,2]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Outcome
    Description

    Outcome

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1705586 (Adverse Event Outcome)
    AE Event Course
    Description

    AE Event Course

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0750729 (Course)
    SNOMED
    288524001
    If event course intermittent, please note the number of episodes
    Description

    Number of Episodes

    Data type

    integer

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

    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

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1710066 (Severity of Adverse Event)
    Action taken with respect to investigational drug
    Description

    Action taken with respect to investigational drug

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2826626 (Adverse Event Action Taken with Study Treatment)
    Relationship to Investigational Drug
    Description

    NOT RELATED: The event is definitely not related to the study procedured 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

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404 (Non-serious Adverse Event)
    UMLS CUI [1,2]
    C0013230 (Investigational New Drugs)
    UMLS CUI [1,3]
    C0439849 (Relationships)
    SNOMED
    263498003
    LOINC
    LP146886-9
    Corrective Therapy
    Description

    If "Yes", please record on Concomitant Medication form.

    Data type

    text

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

    Subject withdrawn

    Data type

    text

    Alias
    UMLS CUI [1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    Investigator's Signature
    Description

    Investigator's Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    Date of signature
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576 (Investigator Signature)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
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    Similar models

    Adverse Events

    1 forms
    1. StudyEvent: ODM
      1. Adverse Events
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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
    Adverse Event
    C0877248 (UMLS CUI-1)
    No adverse event
    Item
    If no adverse event, please mark box and sign form below.
    boolean
    Adverse Event
    Item
    Adverse Event
    text
    C0877248 (UMLS CUI [1])
    Comment for GSK
    Item
    Comment for GSK
    text
    C0877248 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    C0008961 (UMLS CUI [1,3])
    AE Onset Date
    Item
    AE Onset Date
    date
    C2985916 (UMLS CUI [1])
    AE Onset Time
    Item
    AE Onset Time
    time
    C0449244 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    AE End Date
    Item
    AE End Date
    date
    C0806020 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    AE End Time
    Item
    AE End Time
    time
    C1522314 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    Outcome
    integer
    C1705586 (UMLS CUI [1])
    Outcome
    Code List
    Outcome
    CL Item
    Resolved (1)
    CL Item
    Ongoing (2)
    Item
    AE Event Course
    integer
    C0877248 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    AE Event Course
    Code List
    AE Event Course
    CL Item
    Intermittent (1)
    CL Item
    Constant (2)
    Number of Episodes
    Item
    If event course intermittent, please note the number of episodes
    integer
    C0877248 (UMLS CUI [1,1])
    C4086638 (UMLS CUI [1,2])
    Item
    AE Intensity (maximum)
    integer
    C1710066 (UMLS CUI [1])
    AE Intensity
    Code List
    AE 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 (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 subject withdrawn due to this event?
    text
    C0422727 (UMLS CUI [1])
    Subject withdrawn
    Code List
    Was 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])
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