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ID

29051

Beschreibung

Prior Medication Ropinirole Case Report Form GSK RRL100013 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

Stichworte

  1. 05.10.17 05.10.17 -
  2. 22.02.18 22.02.18 -
  3. 22.02.18 22.02.18 -
  4. 22.02.18 22.02.18 -
  5. 17.09.21 17.09.21 -
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gsk

Hochgeladen am

22. Februar 2018

DOI

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Creative Commons BY-NC 3.0

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    Prior Medication Ropinirole Case Report Form GSK RRL100013

    Prior Medication Ropinirole Case Report Form GSK RRL100013

    Administrative documentation
    Beschreibung

    Administrative documentation

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    STUDY NO.
    Beschreibung

    Study Identifier

    Datentyp

    text

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

    Subject No.

    Datentyp

    text

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

    Panel ID

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0086373 (Group Identification)
    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
    Other medication
    Beschreibung

    Other medication

    Has the subject taken any prescribed medication within 14 days prior to first dosing day or any OTC medicine within 7 days before the first study day?
    Beschreibung

    If 'YES', please record the medications below.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3166216 (Prescribed medications)
    LOINC
    LP124834-5
    UMLS CUI [2]
    C0013231 (Drugs, Non-Prescription)
    Prior Medication
    Beschreibung

    Prior Medication

    Alias
    UMLS CUI-1
    C2826257 (Prior Medication Usage)
    DRUG NAME
    Beschreibung

    (Trade Name Preferred)

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Single Dose/Unit
    Beschreibung

    (e.g.500 mg)

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1960417 (Single dose characteristic)
    SNOMED
    426146003
    Frequency of this Dose (e.g.BID, PR)
    Beschreibung

    Frequency of this Dose

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3476109 (Medication frequency)
    LOINC
    LP149758-7
    Route
    Beschreibung

    Route

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Indication
    Beschreibung

    Indication

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C3146298 (Indication)
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Duration of therapy
    Beschreibung

    (e.g.6 years)

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0444917 (undefined)
    End Date
    Beschreibung

    Day/Month/Year

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Continuing at end of study?
    Beschreibung

    Continuing at end of study

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1562611 (Continuous use of drugs)
    SNOMED
    416262000

    Ähnliche Modelle

    Prior Medication Ropinirole Case Report Form GSK RRL100013

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative documentation
    C1320722 (UMLS CUI-1)
    Study Identifier
    Item
    STUDY NO.
    text
    C2826693 (UMLS CUI [1])
    Subject No.
    Item
    Subject No.:
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID:
    integer
    C0086373 (UMLS CUI [1])
    Visit
    Item
    Visit:
    integer
    C1549755 (UMLS CUI [1])
    Date
    Item
    Date:
    date
    C0011008 (UMLS CUI [1])
    Item Group
    Other medication
    Prescribed or OTC medication
    Item
    Has the subject taken any prescribed medication within 14 days prior to first dosing day or any OTC medicine within 7 days before the first study day?
    boolean
    C3166216 (UMLS CUI [1])
    C0013231 (UMLS CUI [2])
    Item Group
    Prior Medication
    C2826257 (UMLS CUI-1)
    DRUG NAME
    Item
    DRUG NAME
    text
    C2360065 (UMLS CUI [1])
    Single Dose/Unit
    Item
    Single Dose/Unit
    integer
    C1960417 (UMLS CUI [1])
    Frequency of this Dose
    Item
    Frequency of this Dose (e.g.BID, PR)
    integer
    C3476109 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Indication
    Item
    Indication
    text
    C3146298 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Duration of therapy
    Item
    Duration of therapy
    integer
    C0444917 (UMLS CUI [1])
    End Date
    Item
    End Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Continuing at end of study
    Item
    Continuing at end of study?
    boolean
    C1562611 (UMLS CUI [1])

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