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ID

15688

Beskrivning

Nerventra Study (Eudra CT 2007-003226-19) Study MS-LAQ-301: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS)

Nyckelord

Versioner (1)
  1. 2016-06-08 2016-06-08 -
Uppladdad den

8 juni 2016

DOI

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Creative Commons BY-NC 3.0
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    Nerventra Study Study drug dispensing and return

    Engelsk

    Nerventra Study Study drug dispensing and return

    1 Formulär  
    Demographic Information
    Beskrivning

    Demographic Information

    Protocol Number
    Beskrivning

    Protocol Number

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0008971 (Clinical Protocols)
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Visit Type
    Beskrivning

    i.e "Screening"

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0545082 (Visit)
    Date of visit
    Beskrivning

    Visit date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Study site number
    Beskrivning

    Study site

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2825164 (Study Site)
    Subject number:
    Beskrivning

    Subject number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1709561 (Planned Subject Number)
    No data to report
    Beskrivning

    Blank

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0750479 (blank)
    Drug dispensed Baseline
    Beskrivning

    Drug dispensed Baseline

    Date Study drug dispensed
    Beskrivning

    Date Study drug dispensed

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0947323 (Dispensing medication)
    SNOMED
    373784005
    No. of capsules dispensed
    Beskrivning

    Amount dispensed

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0805077 (Dispensed Amount)
    Bottle number
    Beskrivning

    Bottle number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1300638 (Identification number)
    SNOMED
    396278008
    Batch code
    Beskrivning

    Batch code

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3641829 (Batch Number)
    Expiry date
    Beskrivning

    Expiry date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C3669020 (Expiration date)
    LOINC
    MTHU047376
    Drug dispensing and return
    Beskrivning

    Drug dispensing and return

    Date study drug returned from previous visit
    Beskrivning

    Drug returned

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C2699071 (Returned Amount)
    Number of unused capsules
    Beskrivning

    Drug returned

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2699071 (Returned Amount)
    Date Study drug dispensed
    Beskrivning

    Date Study drug dispensed

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0947323 (Dispensing medication)
    SNOMED
    373784005
    No. of capsules dispensed
    Beskrivning

    Amount dispensed

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0805077 (Dispensed Amount)
    Bottle number
    Beskrivning

    Bottle number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1300638 (Identification number)
    SNOMED
    396278008
    Batch code
    Beskrivning

    Batch code

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C3641829 (Batch Number)
    Expiry date
    Beskrivning

    Expiry date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C3669020 (Expiration date)
    LOINC
    MTHU047376
    Was study drug temporarily discontinued? If yes, complete below
    Beskrivning

    Discontinued

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1444662 (Discontinued)
    SNOMED
    410546004
    Start date of temporary discontinuation
    Beskrivning

    Start date

    Datatyp

    date

    Måttenheter
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C0808070 (Start Date)
    dd/mm/yy
    End date of temporary discontinuation
    Beskrivning

    End date

    Datatyp

    date

    Måttenheter
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    dd/mm/yy
    Reason for temporary discontinuation
    Beskrivning

    Reason

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    Tillbaka till toppen

    Similar models

    Nerventra Study Study drug dispensing and return

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Demographic Information
    Protocol Number
    Item
    Protocol Number
    text
    C0008971 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Visit
    Item
    Visit Type
    text
    C0545082 (UMLS CUI [1])
    Visit date
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Study site
    Item
    Study site number
    integer
    C2825164 (UMLS CUI [1])
    Subject number
    Item
    Subject number:
    integer
    C1709561 (UMLS CUI [1])
    Blank
    Item
    No data to report
    boolean
    C0750479 (UMLS CUI [1])
    Item Group
    Drug dispensed Baseline
    Date Study drug dispensed
    Item
    Date Study drug dispensed
    date
    C0011008 (UMLS CUI [1,1])
    C0947323 (UMLS CUI [1,2])
    Amount dispensed
    Item
    No. of capsules dispensed
    integer
    C0805077 (UMLS CUI [1])
    Bottle number
    Item
    Bottle number
    integer
    C1300638 (UMLS CUI [1])
    Batch code
    Item
    Batch code
    integer
    C3641829 (UMLS CUI [1])
    Expiry date
    Item
    Expiry date
    date
    C3669020 (UMLS CUI [1])
    Item Group
    Drug dispensing and return
    Drug returned
    Item
    Date study drug returned from previous visit
    date
    C0011008 (UMLS CUI [1,1])
    C2699071 (UMLS CUI [1,2])
    Drug returned
    Item
    Number of unused capsules
    integer
    C2699071 (UMLS CUI [1])
    Date Study drug dispensed
    Item
    Date Study drug dispensed
    date
    C0011008 (UMLS CUI [1,1])
    C0947323 (UMLS CUI [1,2])
    Amount dispensed
    Item
    No. of capsules dispensed
    integer
    C0805077 (UMLS CUI [1])
    Bottle number
    Item
    Bottle number
    integer
    C1300638 (UMLS CUI [1])
    Batch code
    Item
    Batch code
    integer
    C3641829 (UMLS CUI [1])
    Expiry date
    Item
    Expiry date
    date
    C3669020 (UMLS CUI [1])
    Discontinued
    Item
    Was study drug temporarily discontinued? If yes, complete below
    boolean
    C1444662 (UMLS CUI [1])
    Start date
    Item
    Start date of temporary discontinuation
    date
    C0808070 (UMLS CUI [1])
    End date
    Item
    End date of temporary discontinuation
    date
    C0806020 (UMLS CUI [1])
    Reason
    Item
    Reason for temporary discontinuation
    text
    C0392360 (UMLS CUI [1])
    Tillbaka till toppen 

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