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ID

36088

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 Baseline Sign and Symptom form. It has to be filled in for screening.

Keywords

Versions (2)
  1. 4/15/19 4/15/19 -
  2. 4/15/19 4/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 15, 2019

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License

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

    English

    Baseline Sign and Symptom

    1 forms  
    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
    Visit Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    No event
    Description

    No event

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

    No baseline event experienced

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3846032 (No signs/symptoms)
    LOINC
    LA6494-4
    UMLS CUI [1,2]
    C1442488 (Baseline)
    LOINC
    LA16758-7
    Adverse Event
    Description

    Adverse Event

    Alias
    UMLS CUI-1
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    Baseline Sign/Symptom
    Description

    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)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    UMLS CUI [1,2]
    C1442488 (Baseline)
    LOINC
    LA16758-7
    Onset Date
    Description

    day month year

    Data type

    date

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

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

    Data type

    integer

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

    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 is intermittent, please note No. of Episodes
    Description

    No. of Episodes

    Data type

    integer

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

    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 (Severity of Adverse Event)
    Relationship to Study Procedures performed prior to randomisation
    Description

    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]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C1510821 (Adverse Event Attribution to Product or Procedure)
    Corrective Therapy
    Description

    If you tick yes, please record on Prior 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 the 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

    Baseline Sign and Symptom

    1 forms
    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])
    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])
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