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ID

15688

Description

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)

Mots-clés

  1. 08/06/2016 08/06/2016 -
Téléchargé le

8 juin 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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    Nerventra Study Study drug dispensing and return

    Nerventra Study Study drug dispensing and return

    Demographic Information
    Description

    Demographic Information

    Protocol Number
    Description

    Protocol Number

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0008971
    UMLS CUI [1,2]
    C0600091
    Visit Type
    Description

    i.e "Screening"

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0545082
    Date of visit
    Description

    Visit date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1320303
    Study site number
    Description

    Study site

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2825164
    Subject number:
    Description

    Subject number

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1709561
    No data to report
    Description

    Blank

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0750479
    Drug dispensed Baseline
    Description

    Drug dispensed Baseline

    Date Study drug dispensed
    Description

    Date Study drug dispensed

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0947323
    No. of capsules dispensed
    Description

    Amount dispensed

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0805077
    Bottle number
    Description

    Bottle number

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1300638
    Batch code
    Description

    Batch code

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C3641829
    Expiry date
    Description

    Expiry date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C3669020
    Drug dispensing and return
    Description

    Drug dispensing and return

    Date study drug returned from previous visit
    Description

    Drug returned

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2699071
    Number of unused capsules
    Description

    Drug returned

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2699071
    Date Study drug dispensed
    Description

    Date Study drug dispensed

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0947323
    No. of capsules dispensed
    Description

    Amount dispensed

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0805077
    Bottle number
    Description

    Bottle number

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1300638
    Batch code
    Description

    Batch code

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C3641829
    Expiry date
    Description

    Expiry date

    Type de données

    date

    Alias
    UMLS CUI [1]
    C3669020
    Was study drug temporarily discontinued? If yes, complete below
    Description

    Discontinued

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1444662
    Start date of temporary discontinuation
    Description

    Start date

    Type de données

    date

    Unités de mesure
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C0808070
    dd/mm/yy
    End date of temporary discontinuation
    Description

    End date

    Type de données

    date

    Unités de mesure
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C0806020
    dd/mm/yy
    Reason for temporary discontinuation
    Description

    Reason

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0392360

    Similar models

    Nerventra Study Study drug dispensing and return

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])

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