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ID

15693

Descrizione

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. 08/06/16 08/06/16 -
Caricato su

8 giugno 2016

DOI

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Licenza

Creative Commons BY-NC 3.0

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    Nerventra Study Unscheduled Visit

    Nerventra Study Unscheduled Visit

    Demographic Information
    Descrizione

    Demographic Information

    Protocol Number
    Descrizione

    Protocol Number

    Tipo di dati

    text

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

    i.e "Screening"

    Tipo di dati

    text

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

    Visit date

    Tipo di dati

    date

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

    Study site

    Tipo di dati

    integer

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

    Subject number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1709561 (Planned Subject Number)
    Section blank?
    Descrizione

    Blank

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0750479 (blank)
    Reason for unscheduled visit
    Descrizione

    Reason for unscheduled visit

    Reason for unscheduled visit
    Descrizione

    Reason

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    Other reason
    Descrizione

    Other reason

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C3840932 (Other Reason)
    LOINC
    LA6535-4
    Safety measurements
    Descrizione

    Safety measurements

    Temperature
    Descrizione

    Temperature

    Tipo di dati

    float

    Alias
    UMLS CUI [1]
    C0005903 (Body Temperature)
    SNOMED
    722490005
    LOINC
    LP36617-6
    Temperature type of measurement
    Descrizione

    Temperature

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0005903 (Body Temperature)
    SNOMED
    722490005
    LOINC
    LP36617-6
    Units used for measurement
    Descrizione

    Units used for measurement

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1519795 (Unit of Measure)
    SNOMED
    767524001
    Measurement not done
    Descrizione

    not done

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1272696 (Not Done)
    SNOMED
    385660001
    Blood pressure measurement
    Descrizione

    Blood pressure

    Tipo di dati

    text

    Unità di misura
    • mm/Hg
    Alias
    UMLS CUI [1]
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    mm/Hg
    Measurement not done
    Descrizione

    not done

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1272696 (Not Done)
    SNOMED
    385660001
    Pulse
    Descrizione

    Pulse Rate

    Tipo di dati

    integer

    Unità di misura
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117 (Pulse Rate)
    SNOMED
    78564009
    beats/min
    Measurement not done
    Descrizione

    not done

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1272696 (Not Done)
    SNOMED
    385660001
    Investigators ECG interpretation
    Descrizione

    ECG

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C1623258 (Electrocardiography)
    SNOMED
    29303009
    LOINC
    LP6244-0
    ECG interpretation not done
    Descrizione

    ECG

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1623258 (Electrocardiography)
    SNOMED
    29303009
    LOINC
    LP6244-0
    Date of chest x-ray
    Descrizione

    Chest x-ray

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0039985 (Plain chest X-ray)
    SNOMED
    399208008
    Chest x-ray not done
    Descrizione

    Chest x-ray

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0039985 (Plain chest X-ray)
    SNOMED
    399208008
    Chest x-ray interpretation
    Descrizione

    Chest x-ray interpretation

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0039985 (Plain chest X-ray)
    SNOMED
    399208008
    UMLS CUI [1,2]
    C0420833 (Interpretation of findings)
    SNOMED
    243814003
    Chest x-ray, if abnormal, please specify
    Descrizione

    Chest x-ray

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0039985 (Plain chest X-ray)
    SNOMED
    399208008
    Where all required laboratory samples obtained?
    Descrizione

    Laboratory specimen

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0200345 (Specimen Collection)
    SNOMED
    17636008
    Menstruation
    Descrizione

    Menstruation

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0025344 (Menstruation)
    SNOMED
    248957007
    Exacerbation
    Descrizione

    Exacerbation

    Date of onset of symptoms of suspected exacerbation
    Descrizione

    Date of onset

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C0574845 (Date of onset)
    SNOMED
    298059007
    LOINC
    MTHU048807
    Relatively stable or improving neurological state for 30 days prior to onset
    Descrizione

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

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0581392 (Exacerbation of multiple sclerosis)
    SNOMED
    192929006
    UMLS CUI [1,2]
    C0521091 (Confirmation of)
    SNOMED
    74996004
    One or more neurological abnormalities appeared or re-appeared if seen previously
    Descrizione

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

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0581392 (Exacerbation of multiple sclerosis)
    SNOMED
    192929006
    UMLS CUI [1,2]
    C0521091 (Confirmation of)
    SNOMED
    74996004
    Neurological abnormalities lasted 48 hours or more
    Descrizione

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

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0581392 (Exacerbation of multiple sclerosis)
    SNOMED
    192929006
    UMLS CUI [1,2]
    C0521091 (Confirmation of)
    SNOMED
    74996004
    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
    Descrizione

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

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0581392 (Exacerbation of multiple sclerosis)
    SNOMED
    192929006
    UMLS CUI [1,2]
    C0521091 (Confirmation of)
    SNOMED
    74996004
    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
    Descrizione

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

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0581392 (Exacerbation of multiple sclerosis)
    SNOMED
    192929006
    UMLS CUI [1,2]
    C0521091 (Confirmation of)
    SNOMED
    74996004
    Change in EDSS or FS scores cannot be attributed solely to change in bowel/bladder function or to change in cognitive function
    Descrizione

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

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0581392 (Exacerbation of multiple sclerosis)
    SNOMED
    192929006
    UMLS CUI [1,2]
    C0521091 (Confirmation of)
    SNOMED
    74996004
    Based on neuroexam visit date
    Descrizione

    Exacerbation confirmation neuroexam visit date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0581392 (Exacerbation of multiple sclerosis)
    SNOMED
    192929006
    UMLS CUI [1,2]
    C0521091 (Confirmation of)
    SNOMED
    74996004
    Did subject experience a confirmed exacerbation?
    Descrizione

    Exacerbation of multiple sclerosis

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0581392 (Exacerbation of multiple sclerosis)
    SNOMED
    192929006
    Re- consent signed
    Descrizione

    If nor, complete ET visit

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0514044 (Informed consent obtained)
    LOINC
    MTHU008888
    Was i.v Methylprednisolone treatment instituted? If yes, complete concomitant medication log
    Descrizione

    Treatment of exacerbation

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    Event resulted in a hospitalization
    Descrizione

    Hospitalization

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    Approximate date of stabilization
    Descrizione

    Stabilization date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C1293130 (Stabilization)
    SNOMED
    115979005
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Based on neuroexam visit date
    Descrizione

    Visit date

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005

    Similar models

    Nerventra Study Unscheduled Visit

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    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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