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26065

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Exclusion Criteria second visit Ropinirole Case Report Form Concomitant Medication Ropinirole Case Report Form GSK Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

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  1. 05.10.17 05.10.17 -
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gsk

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5. Oktober 2017

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    Exclusion Criteria second visit Ropinirole Case Report Form GSK RRL100013

    Englisch

    Exclusion Criteria second visit Ropinirole Case Report Form GSK RRL100013

    1 Formulare  
    Administrative documentation
    Beschreibung

    Administrative documentation

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

    Study No

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2826693 (Study Identifier)
    Subject No.:
    Beschreibung

    Subject No.

    Datentyp

    integer

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

    Group identity

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3826248 (Group identity)
    Visit:
    Beschreibung

    Visit

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1549755 (Visit Number)
    Date
    Beschreibung

    DD/MON/YY

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251 (Exclusion Criteria)
    7. Does the subject have an abuse of alcohol, defined as an average weekly intake of greater than 21 units or an average daily intake greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women?
    Beschreibung

    One unit is equivalent to half a pint of beer, one measure of spirits or one glass of wine.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0038586 (Substance Use Disorders)
    8. Has the subject participated in another clinical trial, blood donation or has the subject lost blood less than 90 days before the present study?
    Beschreibung

    Other clinical trial, blood donation or blood loss

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0679823 (Participation)
    UMLS CUI [1,2]
    C1516648 (Clinical Trial, Other)
    UMLS CUI [2]
    C0005794 (Blood Donation)
    UMLS CUI [3]
    C3163616 (Blood Loss)
    9. Does the subject have a positive pre-study screening result for hepatitis B surface antigen, hepatitis C antibody or HIV-1/2 antibodies?
    Beschreibung

    Hepatitis B, C or HIV antibodies

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2711110 (Hepatitis B and hepatitis C)
    SNOMED
    442374005
    UMLS CUI [2]
    C0019683 (HIV Antibodies)
    SNOMED
    259855002
    10. Is the subject pregnant and/or breast-feeding?
    Beschreibung

    Pregnant or breast-feeding

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0549206 (Patient currently pregnant)
    SNOMED
    77386006
    LOINC
    LA14670-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    11. Is the subject a female of child-bearing potential who is not practising a clinically accepted method of contraception such as surgical sterilisation, 1.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant)?
    Beschreibung

    No contraception

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118 (Childbearing Potential)
    UMLS CUI [1,2]
    C0445107 (Not used)
    SNOMED
    262009000
    LOINC
    LA157-0
    UMLS CUI [1,3]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    12. Is the subject a female with positive urine/serum pregnancy test result at screening?
    Beschreibung

    Positive pregnancy test

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0240802 (Pregnancy test positive)
    SNOMED
    250423000
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    Ähnliche Modelle

    Exclusion Criteria second visit Ropinirole Case Report Form GSK RRL100013

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative documentation
    C1320722 (UMLS CUI-1)
    Study No
    Item
    Study No
    integer
    C2826693 (UMLS CUI [1])
    Subject No.
    Item
    Subject No.:
    integer
    C2348585 (UMLS CUI [1])
    Group identity
    Item
    Panel ID:
    integer
    C3826248 (UMLS CUI [1])
    Visit
    Item
    Visit:
    integer
    C1549755 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Alcohol abuse
    Item
    7. Does the subject have an abuse of alcohol, defined as an average weekly intake of greater than 21 units or an average daily intake greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women?
    boolean
    C0038586 (UMLS CUI [1])
    Other clinical trial, blood donation or blood loss
    Item
    8. Has the subject participated in another clinical trial, blood donation or has the subject lost blood less than 90 days before the present study?
    boolean
    C0679823 (UMLS CUI [1,1])
    C1516648 (UMLS CUI [1,2])
    C0005794 (UMLS CUI [2])
    C3163616 (UMLS CUI [3])
    Hepatitis B, C or HIV antibodies
    Item
    9. Does the subject have a positive pre-study screening result for hepatitis B surface antigen, hepatitis C antibody or HIV-1/2 antibodies?
    boolean
    C2711110 (UMLS CUI [1])
    C0019683 (UMLS CUI [2])
    Pregnant or breast-feeding
    Item
    10. Is the subject pregnant and/or breast-feeding?
    boolean
    C0549206 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    No contraception
    Item
    11. Is the subject a female of child-bearing potential who is not practising a clinically accepted method of contraception such as surgical sterilisation, 1.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant)?
    boolean
    C3831118 (UMLS CUI [1,1])
    C0445107 (UMLS CUI [1,2])
    C0700589 (UMLS CUI [1,3])
    Positive pregnancy test
    Item
    12. Is the subject a female with positive urine/serum pregnancy test result at screening?
    boolean
    C0240802 (UMLS CUI [1])
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