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ID

42790

Beskrivning

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

Nyckelord

Versioner (5)
  1. 2017-10-05 2017-10-05 -
  2. 2018-02-22 2018-02-22 -
  3. 2018-02-22 2018-02-22 -
  4. 2018-02-22 2018-02-22 -
  5. 2021-09-17 2021-09-17 -
Rättsinnehavare

gsk

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17 september 2021

DOI

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Creative Commons BY-NC 3.0
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    Ropinirole Case Report Form GSK RRL100013

    Engelsk

    Ropinirole Case Report Form GSK RRL100013

    9 Formulär  
    Administrative documentation
    Beskrivning

    Administrative documentation

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

    Study Identifier

    Datatyp

    text

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

    Subject No.

    Datatyp

    text

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

    Panel ID

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0086373 (Group Identification)
    Visit:
    Beskrivning

    Visit

    Datatyp

    integer

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

    DD/MON/YY

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Other medication
    Beskrivning

    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?
    Beskrivning

    If 'YES', please record the medications below.

    Datatyp

    boolean

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

    Prior Medication

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

    (Trade Name Preferred)

    Datatyp

    text

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

    (e.g.500 mg)

    Datatyp

    integer

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

    Frequency of this Dose

    Datatyp

    integer

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

    Route

    Datatyp

    text

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

    Indication

    Datatyp

    text

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

    (e.g.6 years)

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0444921 (Duration of treatment)
    SNOMED
    261773006
    End Date
    Beskrivning

    Day/Month/Year

    Datatyp

    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?
    Beskrivning

    Continuing at end of study

    Datatyp

    boolean

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

    Similar models

    Ropinirole Case Report Form GSK RRL100013

    9 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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
    C0444921 (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])
    Tillbaka till toppen 

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