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ID

25568

Description

Alcohol Consumption/Smoking History form 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

Keywords

Versions (5)
  1. 8/29/17 8/29/17 -
  2. 9/5/17 9/5/17 -
  3. 9/6/17 9/6/17 -
  4. 10/5/17 10/5/17 -
  5. 4/9/19 4/9/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 6, 2017

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License

Creative Commons BY-NC 3.0
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    Alcohol Consumption/Smoking History Ropinirole Restless Legs Syndrome 101468/198

    English

    Alcohol Consumption/Smoking History Ropinirole Restless Legs Syndrome 101468/198

    1 forms  
    Header
    Description

    Header

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

    Study No.:

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    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]
    C3826248 (Group identity)
    Visit:
    Description

    Visit

    Data type

    text

    Alias
    UMLS CUI [1]
    C0545082 (Visit)
    Date
    Description

    DD/MON/YY

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Alcohol Consumption
    Description

    Alcohol Consumption

    Alias
    UMLS CUI-1
    C0001948 (Alcohol consumption)
    SNOMED
    897148007
    LOINC
    MTHU047472
    Average number of units per day
    Description

    1 unit is equivalent to half a pint of beer (ca. 0,57 l), one measure of spirits or one glass of wine.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0560578 (alcohol units/day)
    SNOMED
    228957004
    Average number of units per week
    Description

    1 unit is equivalent to half a pint of beer (ca. 0,57 l), one measure of spirits or one glass of wine.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0560579 (alcohol units/week)
    SNOMED
    228958009
    Smoking History
    Description

    Smoking History

    Alias
    UMLS CUI-1
    C1519384 (Tobacco Smoking History)
    Is the subject a smoker?
    Description

    if Yes, please complete smoking history details

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0543414 (Tobacco use)
    Number of years the subject has been a smoker?
    Description

    Smoking years

    Data type

    integer

    Measurement units
    • years
    Alias
    UMLS CUI [1]
    C3694955 (current smoker duration (___ years))
    years
    Average number of cigarettes smoked per day?
    Description

    Cigarettes per day

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3694146 (number of cigarettes per day)
    Please state what type of tobacco product (eg. pipe, chigar, chewing tobacco or cigarette)
    Description

    Type of tobacco product

    Data type

    text

    Alias
    UMLS CUI [1]
    C3166496 (Tobacco use type)
    LOINC
    MTHU054376
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    Similar models

    Alcohol Consumption/Smoking History Ropinirole Restless Legs Syndrome 101468/198

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Header
    C1320722 (UMLS CUI-1)
    Study No.:
    Item
    Study No.:
    text
    C0008976 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Subject No.:
    Item
    Subject No.:
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID:
    text
    C3826248 (UMLS CUI [1])
    Visit
    Item
    Visit:
    text
    C0545082 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Item Group
    Alcohol Consumption
    C0001948 (UMLS CUI-1)
    Units per day
    Item
    Average number of units per day
    integer
    C0560578 (UMLS CUI [1])
    Units per week
    Item
    Average number of units per week
    integer
    C0560579 (UMLS CUI [1])
    Item Group
    Smoking History
    C1519384 (UMLS CUI-1)
    Smoker
    Item
    Is the subject a smoker?
    boolean
    C0543414 (UMLS CUI [1])
    Smoking years
    Item
    Number of years the subject has been a smoker?
    integer
    C3694955 (UMLS CUI [1])
    Cigarettes per day
    Item
    Average number of cigarettes smoked per day?
    integer
    C3694146 (UMLS CUI [1])
    Type of tobacco product
    Item
    Please state what type of tobacco product (eg. pipe, chigar, chewing tobacco or cigarette)
    text
    C3166496 (UMLS CUI [1])
    Back to the top of the page 

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