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ID

26033

Beschreibung

Screening 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

Stichworte

Versionen (5)
  1. 29.08.17 29.08.17 -
  2. 05.09.17 05.09.17 -
  3. 06.09.17 06.09.17 -
  4. 05.10.17 05.10.17 -
  5. 09.04.19 09.04.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. Oktober 2017

DOI

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

    Englisch

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

    1 Formulare  
    Header
    Beschreibung

    Header

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

    Study No.:

    Datentyp

    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.:
    Beschreibung

    Subject No.:

    Datentyp

    text

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

    Panel ID

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    Visit:
    Beschreibung

    Visit

    Datentyp

    text

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

    DD/MON/YY

    Datentyp

    date

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

    Alcohol Consumption

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

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

    Datentyp

    integer

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

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

    Datentyp

    integer

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

    Smoking History

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

    if Yes, please complete smoking history details

    Datentyp

    boolean

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

    Smoking years

    Datentyp

    integer

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

    Cigarettes per day

    Datentyp

    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)
    Beschreibung

    Type of tobacco product

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3166496 (Tobacco use type)
    LOINC
    MTHU054376
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    Ähnliche Modelle

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

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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
    C3846158 (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])
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