0 Evaluaciones
ID

26033

Descripción

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

Palabras clave

Versiones (5)
  1. 29/8/17 29/8/17 -
  2. 5/9/17 5/9/17 -
  3. 6/9/17 6/9/17 -
  4. 5/10/17 5/10/17 -
  5. 9/4/19 9/4/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

5 de octubre de 2017

DOI

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Licencia

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

    Inglés

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

    1 formularios  
    Header
    Descripción

    Header

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

    Study No.:

    Tipo de datos

    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.:
    Descripción

    Subject No.:

    Tipo de datos

    text

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

    Panel ID

    Tipo de datos

    text

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

    Visit

    Tipo de datos

    text

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

    DD/MON/YY

    Tipo de datos

    date

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

    Alcohol Consumption

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

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

    Tipo de datos

    integer

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

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

    Tipo de datos

    integer

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

    Smoking History

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

    if Yes, please complete smoking history details

    Tipo de datos

    boolean

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

    Smoking years

    Tipo de datos

    integer

    Unidades de medida
    • years
    Alias
    UMLS CUI [1]
    C3694955 (current smoker duration (___ years))
    years
    Average number of cigarettes smoked per day?
    Descripción

    Cigarettes per day

    Tipo de datos

    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)
    Descripción

    Type of tobacco product

    Tipo de datos

    text

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

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

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    Volver a la parte superior de la página 

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