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ID

15693

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)

Keywords

  1. 6/8/16 6/8/16 -
Uploaded on

June 8, 2016

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Creative Commons BY-NC 3.0

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    Nerventra Study Unscheduled Visit

    Nerventra Study Unscheduled Visit

    Demographic Information
    Description

    Demographic Information

    Protocol Number
    Description

    Protocol Number

    Data type

    text

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

    i.e "Screening"

    Data type

    text

    Alias
    UMLS CUI [1]
    C0545082
    Date of visit
    Description

    Visit date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Study site number
    Description

    Study site

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2825164
    Subject number:
    Description

    Subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1709561
    Section blank?
    Description

    Blank

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0750479
    Reason for unscheduled visit
    Description

    Reason for unscheduled visit

    Reason for unscheduled visit
    Description

    Reason

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0392360
    Other reason
    Description

    Other reason

    Data type

    text

    Alias
    UMLS CUI [1]
    C3840932
    Safety measurements
    Description

    Safety measurements

    Temperature
    Description

    Temperature

    Data type

    float

    Alias
    UMLS CUI [1]
    C0005903
    Temperature type of measurement
    Description

    Temperature

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0005903
    Units used for measurement
    Description

    Units used for measurement

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1519795
    Measurement not done
    Description

    not done

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1272696
    Blood pressure measurement
    Description

    Blood pressure

    Data type

    text

    Measurement units
    • mm/Hg
    Alias
    UMLS CUI [1]
    C0005823
    mm/Hg
    Measurement not done
    Description

    not done

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1272696
    Pulse
    Description

    Pulse Rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Measurement not done
    Description

    not done

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1272696
    Investigators ECG interpretation
    Description

    ECG

    Data type

    text

    Alias
    UMLS CUI [1]
    C1623258
    ECG interpretation not done
    Description

    ECG

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1623258
    Date of chest x-ray
    Description

    Chest x-ray

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0039985
    Chest x-ray not done
    Description

    Chest x-ray

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0039985
    Chest x-ray interpretation
    Description

    Chest x-ray interpretation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0039985
    UMLS CUI [1,2]
    C0420833
    Chest x-ray, if abnormal, please specify
    Description

    Chest x-ray

    Data type

    text

    Alias
    UMLS CUI [1]
    C0039985
    Where all required laboratory samples obtained?
    Description

    Laboratory specimen

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0200345
    Menstruation
    Description

    Menstruation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0025344
    Exacerbation
    Description

    Exacerbation

    Date of onset of symptoms of suspected exacerbation
    Description

    Date of onset

    Data type

    date

    Alias
    UMLS CUI [1]
    C0574845
    Relatively stable or improving neurological state for 30 days prior to onset
    Description

    Any answer "No" in this section indicates that exacerbation is not confirmed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0581392
    UMLS CUI [1,2]
    C0521091
    One or more neurological abnormalities appeared or re-appeared if seen previously
    Description

    Any answer "No" in this section indicates that exacerbation is not confirmed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0581392
    UMLS CUI [1,2]
    C0521091
    Neurological abnormalities lasted 48 hours or more
    Description

    Any answer "No" in this section indicates that exacerbation is not confirmed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0581392
    UMLS CUI [1,2]
    C0521091
    In the opinion of the investigator, the change in EDSS score is not solely attributed to normal fluctuations of the subjects MS symptoms and is consistent with acute exacerbation
    Description

    Any answer "No" in this section indicates that exacerbation is not confirmed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0581392
    UMLS CUI [1,2]
    C0521091
    There was an increase of at least one of the below: 0.5 or more on EDSS or 2 grades in score for one function of the FS or one grade in score for 2 or more functions of the FS
    Description

    Any answer "No" in this section indicates that exacerbation is not confirmed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0581392
    UMLS CUI [1,2]
    C0521091
    Change in EDSS or FS scores cannot be attributed solely to change in bowel/bladder function or to change in cognitive function
    Description

    Any answer "No" in this section indicates that exacerbation is not confirmed

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0581392
    UMLS CUI [1,2]
    C0521091
    Based on neuroexam visit date
    Description

    Exacerbation confirmation neuroexam visit date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0581392
    UMLS CUI [1,2]
    C0521091
    Did subject experience a confirmed exacerbation?
    Description

    Exacerbation of multiple sclerosis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0581392
    Re- consent signed
    Description

    If nor, complete ET visit

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0514044
    Was i.v Methylprednisolone treatment instituted? If yes, complete concomitant medication log
    Description

    Treatment of exacerbation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0087111
    Event resulted in a hospitalization
    Description

    Hospitalization

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0019993
    Approximate date of stabilization
    Description

    Stabilization date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1293130
    UMLS CUI [1,2]
    C0011008
    Based on neuroexam visit date
    Description

    Visit date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303

    Similar models

    Nerventra Study Unscheduled Visit

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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
    Section blank?
    boolean
    C0750479 (UMLS CUI [1])
    Item Group
    Reason for unscheduled visit
    Item
    Reason for unscheduled visit
    integer
    C0392360 (UMLS CUI [1])
    Code List
    Reason for unscheduled visit
    CL Item
    Adverse event (complete AE-Log) (1)
    CL Item
    Change in concomitant medication (complete concomitant medication log) (2)
    CL Item
    A possible exacerbation (Complete neuro-exam and exacerbation confirmation form) (3)
    CL Item
    Follow-up of exacerbation (Complete neuro-exam and exacerbation confirmation form if applicable) (4)
    CL Item
    Unscheduled study drug dispensing (complete dispensing and compliance log) (5)
    CL Item
    Laboratory follow-up (6)
    CL Item
    ET follow-up visit (7)
    CL Item
    Other, specify (8)
    Other reason
    Item
    Other reason
    text
    C3840932 (UMLS CUI [1])
    Item Group
    Safety measurements
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item
    Temperature type of measurement
    integer
    C0005903 (UMLS CUI [1])
    Code List
    Temperature type of measurement
    CL Item
    oral (1)
    CL Item
    axillary (2)
    CL Item
    aural (3)
    CL Item
    temporal (4)
    Item
    Units used for measurement
    integer
    C1519795 (UMLS CUI [1])
    Code List
    Units used for measurement
    CL Item
    F (1)
    CL Item
    C (2)
    not done
    Item
    Measurement not done
    boolean
    C1272696 (UMLS CUI [1])
    Blood pressure
    Item
    Blood pressure measurement
    text
    C0005823 (UMLS CUI [1])
    not done
    Item
    Measurement not done
    boolean
    C1272696 (UMLS CUI [1])
    Pulse Rate
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    not done
    Item
    Measurement not done
    boolean
    C1272696 (UMLS CUI [1])
    ECG
    Item
    Investigators ECG interpretation
    text
    C1623258 (UMLS CUI [1])
    ECG
    Item
    ECG interpretation not done
    boolean
    C1623258 (UMLS CUI [1])
    Chest x-ray
    Item
    Date of chest x-ray
    date
    C0011008 (UMLS CUI [1,1])
    C0039985 (UMLS CUI [1,2])
    Chest x-ray
    Item
    Chest x-ray not done
    boolean
    C0039985 (UMLS CUI [1])
    Chest x-ray interpretation
    Item
    Chest x-ray interpretation
    text
    C0039985 (UMLS CUI [1,1])
    C0420833 (UMLS CUI [1,2])
    Chest x-ray
    Item
    Chest x-ray, if abnormal, please specify
    text
    C0039985 (UMLS CUI [1])
    Laboratory specimen
    Item
    Where all required laboratory samples obtained?
    boolean
    C0200345 (UMLS CUI [1])
    Menstruation
    Item
    Menstruation
    boolean
    C0025344 (UMLS CUI [1])
    Item Group
    Exacerbation
    Date of onset
    Item
    Date of onset of symptoms of suspected exacerbation
    date
    C0574845 (UMLS CUI [1])
    Exacerbation confirmation
    Item
    Relatively stable or improving neurological state for 30 days prior to onset
    boolean
    C0581392 (UMLS CUI [1,1])
    C0521091 (UMLS CUI [1,2])
    Exacerbation confirmation
    Item
    One or more neurological abnormalities appeared or re-appeared if seen previously
    boolean
    C0581392 (UMLS CUI [1,1])
    C0521091 (UMLS CUI [1,2])
    Exacerbation confirmation
    Item
    Neurological abnormalities lasted 48 hours or more
    boolean
    C0581392 (UMLS CUI [1,1])
    C0521091 (UMLS CUI [1,2])
    Exacerbation confirmation
    Item
    In the opinion of the investigator, the change in EDSS score is not solely attributed to normal fluctuations of the subjects MS symptoms and is consistent with acute exacerbation
    boolean
    C0581392 (UMLS CUI [1,1])
    C0521091 (UMLS CUI [1,2])
    Exacerbation confirmation
    Item
    There was an increase of at least one of the below: 0.5 or more on EDSS or 2 grades in score for one function of the FS or one grade in score for 2 or more functions of the FS
    boolean
    C0581392 (UMLS CUI [1,1])
    C0521091 (UMLS CUI [1,2])
    Exacerbation confirmation
    Item
    Change in EDSS or FS scores cannot be attributed solely to change in bowel/bladder function or to change in cognitive function
    boolean
    C0581392 (UMLS CUI [1,1])
    C0521091 (UMLS CUI [1,2])
    Exacerbation confirmation neuroexam visit date
    Item
    Based on neuroexam visit date
    date
    C0581392 (UMLS CUI [1,1])
    C0521091 (UMLS CUI [1,2])
    Exacerbation of multiple sclerosis
    Item
    Did subject experience a confirmed exacerbation?
    boolean
    C0581392 (UMLS CUI [1])
    Consent
    Item
    Re- consent signed
    boolean
    C0514044 (UMLS CUI [1])
    Treatment of exacerbation
    Item
    Was i.v Methylprednisolone treatment instituted? If yes, complete concomitant medication log
    boolean
    C0087111 (UMLS CUI [1])
    Item
    Event resulted in a hospitalization
    integer
    C0019993 (UMLS CUI [1])
    Code List
    Event resulted in a hospitalization
    CL Item
    No (1)
    CL Item
    Yes-due to neurological deterioration (2)
    CL Item
    Yes-due to i.v methylprednisolone treatment (3)
    Stabilization date
    Item
    Approximate date of stabilization
    date
    C1293130 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Visit date
    Item
    Based on neuroexam visit date
    date
    C1320303 (UMLS CUI [1])

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