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ID

15668

Beschreibung

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)

Stichworte

  1. 07.06.16 07.06.16 -
Hochgeladen am

7. Juni 2016

DOI

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    Nerventra Study Baseline

    Nerventra Study Baseline

    Informed Consent and Demography Data
    Beschreibung

    Informed Consent and Demography Data

    Protocol Number
    Beschreibung

    Protocol Number

    Datentyp

    text

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

    i.e "Screening"

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0545082
    Date of visit
    Beschreibung

    Visit date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Study site number
    Beschreibung

    Study site

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2825164
    Subject number:
    Beschreibung

    Subject number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1709561
    Section blank?
    Beschreibung

    Blank

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0750479
    Safety measurements
    Beschreibung

    Safety measurements

    Temperature
    Beschreibung

    Temperature

    Datentyp

    float

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

    Temperature

    Datentyp

    integer

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

    Units used for measurement

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1519795
    Measurement not done
    Beschreibung

    not done

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1272696
    Blood pressure measurement
    Beschreibung

    Blood pressure

    Datentyp

    text

    Maßeinheiten
    • mm/Hg
    Alias
    UMLS CUI [1]
    C0005823
    mm/Hg
    Measurement not done
    Beschreibung

    not done

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1272696
    Pulse
    Beschreibung

    Pulse Rate

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0232117
    beats/min
    Measurement not done
    Beschreibung

    not done

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1272696
    Investigators ECG interpretation
    Beschreibung

    ECG

    Datentyp

    text

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

    ECG

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1623258
    ECG Repetition
    Beschreibung

    ECG Repetition

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0205341
    Investigators ECG interpretation
    Beschreibung

    ECG

    Datentyp

    text

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

    ECG

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1623258
    ECG second Repetition
    Beschreibung

    ECG Repetition

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0205341
    Investigators ECG interpretation
    Beschreibung

    ECG

    Datentyp

    text

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

    ECG

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1623258
    Where all required laboratory samples obtained?
    Beschreibung

    Laboratory specimen

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0200345
    Menstruation
    Beschreibung

    Menstruation

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0025344
    Pasat Summary Score Sheet
    Beschreibung

    Pasat Summary Score Sheet

    PASAT Form used
    Beschreibung

    PASAT Form used

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0589060
    UMLS CUI [1,2]
    C0180975
    PASAT3: Total correct (range 0-60)
    Beschreibung

    PASAT3 total correct

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C3898055
    UMLS CUI [1,2]
    C0205449
    For a complete PASAT3, record any circumstances that affected the subjects performance
    Beschreibung

    PASAT

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0589060
    PASAT3: if test was not completed
    Beschreibung

    PASAT3: not completed

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0589060
    UMLS CUI [1,2]
    C0205449
    UMLS CUI [1,3]
    C2732579
    PASAT3: please specify physical limitations and/or other reason
    Beschreibung

    PASAT3: not completed

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0589060
    UMLS CUI [1,2]
    C0205449
    UMLS CUI [1,3]
    C2732579
    9-Hole Peg test
    Beschreibung

    9-Hole Peg test

    9-Hole Peg Test: dominant hand
    Beschreibung

    Dominant hand

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0451335
    UMLS CUI [1,2]
    C0449722
    9-Hole Peg Test: Time dominant hand Trial 1
    Beschreibung

    9 hole peg test dominant hand

    Datentyp

    float

    Maßeinheiten
    • sec
    Alias
    UMLS CUI [1,1]
    C0451335
    UMLS CUI [1,2]
    C0449722
    sec
    9-Hole Peg Test: Time non-dominant hand Trial 1
    Beschreibung

    9-Hole Peg Test

    Datentyp

    float

    Maßeinheiten
    • sec
    Alias
    UMLS CUI [1,1]
    C0451335
    UMLS CUI [1,2]
    C0445549
    sec
    For a complete trial, record any circumstances that affected the subjects performance
    Beschreibung

    9-hole peg test

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0451335
    9-Hole Peg Test: not completed dominant hand Trial 1
    Beschreibung

    9-Hole Peg Test: not completed

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0451335
    UMLS CUI [1,2]
    C0449722
    9-Hole Peg Test: not completed non-dominant hand Trial 1
    Beschreibung

    9-Hole Peg Test: not completed

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0451335
    UMLS CUI [1,2]
    C0445549
    If trial was not completed, please specify physical limitations and/or other reasons
    Beschreibung

    9-hole peg test

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0451335
    9-Hole Peg Test: Time dominant hand Trial 2
    Beschreibung

    9 hole peg test dominant hand

    Datentyp

    float

    Maßeinheiten
    • sec
    Alias
    UMLS CUI [1,1]
    C0451335
    UMLS CUI [1,2]
    C0449722
    sec
    9-Hole Peg Test: Time non-dominant hand Trial 2
    Beschreibung

    9-Hole Peg Test

    Datentyp

    float

    Maßeinheiten
    • sec
    Alias
    UMLS CUI [1,1]
    C0451335
    UMLS CUI [1,2]
    C0445549
    sec
    For a complete trial, record any circumstances that affected the subjects performance
    Beschreibung

    9-hole peg test

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0451335
    9-Hole Peg Test: not completed dominant hand Trial 2
    Beschreibung

    9-Hole Peg Test: not completed

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0451335
    UMLS CUI [1,2]
    C0449722
    9-Hole Peg Test: not completed non-dominant hand Trial 2
    Beschreibung

    9-Hole Peg Test: not completed

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0451335
    UMLS CUI [1,2]
    C0445549
    If trial was not completed, please specify physical limitations and/or other reasons
    Beschreibung

    9-hole peg test

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0451335
    Binocular low contrast visual acuity
    Beschreibung

    Binocular low contrast visual acuity

    100percent chart: total correct score
    Beschreibung

    Binocular low contrast visual acuity

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0042812
    UMLS CUI [1,2]
    C0042794
    2,5 percent chart: total correct score
    Beschreibung

    Binocular low contrast visual acuity

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0042812
    UMLS CUI [1,2]
    C0042794
    1,25 percent chart: total correct score
    Beschreibung

    Binocular low contrast visual acuity

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0042812
    UMLS CUI [1,2]
    C0042794
    MRI Scan performance
    Beschreibung

    MRI Scan performance

    Date of MRI
    Beschreibung

    date MRI

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0024485
    MRI not done
    Beschreibung

    MRI

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0024485
    Type of Gadolinium-based contrast agent used
    Beschreibung

    Contrast agent

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0009924
    Other contrast agent used
    Beschreibung

    Contrast agent

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0009924
    Was MRI completed according to the protocol?
    Beschreibung

    MRI performed

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0024485
    Reason MRI was not completed
    Beschreibung

    MRI

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0024485
    Where there any pathological,non-MS findings?
    Beschreibung

    Findings

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0243095
    Please specify pathological findings
    Beschreibung

    Findings

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0243095
    MT Scan Performance
    Beschreibung

    MT Scan Performance

    Date of MT Scan
    Beschreibung

    Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2584640
    MT-Scan not done
    Beschreibung

    MT Scan

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2584640
    Was MT-Scan completed according to protocol?
    Beschreibung

    MT-Scan completed

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2584640
    UMLS CUI [1,2]
    C0205197
    If not completed, specify
    Beschreibung

    MT-Scan not completed

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0205197
    UMLS CUI [1,2]
    C0424237
    MRS Scan Performance
    Beschreibung

    MRS Scan Performance

    Date of MRS Scan
    Beschreibung

    Date of MRS Scan

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0024487
    MRS scan not done
    Beschreibung

    MRS scan

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0024487
    Was MRS-Scan completed according to protocol?
    Beschreibung

    MRS-Scan completed

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0024487
    UMLS CUI [1,2]
    C0205197
    If MRS-Scan was not completed,specify
    Beschreibung

    MRS-Scan not completed

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0024487
    UMLS CUI [1,2]
    C0424237
    Modified Fatigue Impact Scale
    Beschreibung

    Modified Fatigue Impact Scale

    I have been less alert
    Beschreibung

    Being alert

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0723445
    I have difficulty paying attention for long periods of time
    Beschreibung

    Pay attention

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0238707
    I have been unable to think clearly
    Beschreibung

    Unable to think clearly

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0423994
    I have been clumsy and uncoordinated
    Beschreibung

    Impaired coordination

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0520966
    I have been forgetful
    Beschreibung

    Forgetful

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0542476
    I have had to pace myself in my physical activities
    Beschreibung

    Physical activity behavior

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0946284
    I have been less motivated to do anything that requires physical effort
    Beschreibung

    Low Motivation

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0558078
    I have been less motivated to participate in social activities
    Beschreibung

    Low motivation

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0558078
    I have been limited in my ability to do things away from home
    Beschreibung

    limited ability to do things away from home

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3829094
    I have had trouble maintaining physical effort for long periods
    Beschreibung

    Maintaining physical effort

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0031807
    I have difficulties making decisions
    Beschreibung

    Ability to make decisions

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1531797
    I have been less motivated to do anything that requires thinking
    Beschreibung

    Low motivation to think

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0558078
    UMLS CUI [1,2]
    C0039869
    My muscles have felt weak
    Beschreibung

    Muscle weakness

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0151786
    I have been physicaly uncomfortable
    Beschreibung

    Physical Discomfort

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C4062607
    I have trouble finishing tasks that require thinking
    Beschreibung

    Ability to concentrate

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0424098
    UMLS CUI [1,2]
    C0439801
    I have had difficulty organizing my thoughts when doing things at home or at work
    Beschreibung

    Stay focused

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0589098
    I have been less able to complete tasks that require physical effort
    Beschreibung

    Physical effort

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0031807
    My thinking has slowed down
    Beschreibung

    Thought retardation

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0233633
    I have trouble concentrating
    Beschreibung

    ability to concentrate

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0424098
    I have limited my physical activities
    Beschreibung

    Physical activity limited

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0026606
    UMLS CUI [1,2]
    C0439801
    I have needed to rest more often or for longer periods
    Beschreibung

    Need for rest

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C3641751
    General Health assessment
    Beschreibung

    General Health assessment

    SF-36 Health survey
    Beschreibung

    copyrighted evaluation tool

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0018762
    EQ5D Questionnaire
    Beschreibung

    copyrighted evaluation tool

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0018762
    Final eligibility
    Beschreibung

    Final eligibility

    Has the subject been in an unstable neurological condition or experienced an onset of relapse between screening (month-1) and baseline (month 0) visits?
    Beschreibung

    Any question in this section answered "yes",excludes the subject from the study

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0443343
    Has the subject undergone any treatment with corticosteroids (intravenous[iv], intramuscular[im], and/or per os [po]) or ACTH between month -1 (screening) and 0 (baseline)?
    Beschreibung

    Steroid treatment

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0149783
    Has the subject experienced acute infection within 2 weeks prior to baseline visit?
    Beschreibung

    Acute infection

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0275518
    Has the subject experienced major trauma or surgery within 2 weeks prior to baseline visit?
    Beschreibung

    Major trauma or Surgery

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332677
    UMLS CUI [1,2]
    C0543467
    Has the subject used inhibitors of CYP3A4 within 2 weeks, for fluoxetine 1 month, prior to baseline visit?
    Beschreibung

    CYP3A4 inhibitors or Fluoxetine

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3830624
    UMLS CUI [2]
    C0016365
    Were any pathologies other than MS found in MRI, and confirmed by local radiologist, that would jeopardize the subjects participation in the study?
    Beschreibung

    Comorbidities

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    Does the subject have a clinically significant or unstable medical or surgical condition, as defined by protocol, that would preclude safe and complete study participation?
    Beschreibung

    Compliance behavior limited comorbidity

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    Subject disposition
    Beschreibung

    Subject disposition

    Does the subject qualify to continue this clinical trial? If no, complete below
    Beschreibung

    Eligibility determination

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0013893
    Please specify reason why subject is not eligible
    Beschreibung

    Reason subject is not eligible

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C2828389
    Subject screening number
    Beschreibung

    Subject screening number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1710477
    Subject number:
    Beschreibung

    Subject number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1709561
    Date of Randomization
    Beschreibung

    Date of Randomization

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0011008
    Date and time of Study drug administration
    Beschreibung

    Date and time Study drug administration

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0013175
    UMLS CUI [1,3]
    C3469597
    Post -Dose Vital signs
    Beschreibung

    Post -Dose Vital signs

    Blood pressure 30 min post Dose
    Beschreibung

    Blood pressure

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Measurement not done
    Beschreibung

    Blood pressure

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0005823
    Blood pressure 60 min post Dose
    Beschreibung

    Blood pressure

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Measurement not done
    Beschreibung

    Blood pressure

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0005823
    Pulse 30 min post Dose
    Beschreibung

    Heart rate

    Datentyp

    integer

    Maßeinheiten
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Measurement not done
    Beschreibung

    Heart rate

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0018810
    Pulse 60 min post Dose
    Beschreibung

    Heart rate

    Datentyp

    integer

    Maßeinheiten
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Measurement not done
    Beschreibung

    Heart rate

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0018810
    Phone thrombosis questionnaire
    Beschreibung

    Phone thrombosis questionnaire

    Have you been suffering in the last two weeks from a new pain or swelling in the back part of one of your legs?
    Beschreibung

    pain or leg swelling

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0030193
    UMLS CUI [1,2]
    C0745977
    Have you been suffering from shortness of breath in the last two weeks?
    Beschreibung

    Shortness of breath

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0013404
    Have you been suffering from a new chest pain in the last two weeks?
    Beschreibung

    Chest pain

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0008031
    Have you been suffering from a new,intensifying, abdominal pain for more than 3 days?
    Beschreibung

    Abdominal pain

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0000737
    Have you been suffering from a new continuous, intensifying headache in the last two weeks?
    Beschreibung

    Headache

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0018681
    If the answer to any of the above is yes, Does the subject need any further evaluation?
    Beschreibung

    Further evaluation

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1736113

    Ähnliche Modelle

    Nerventra Study Baseline

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Informed Consent and Demography Data
    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
    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])
    ECG Repetition
    Item
    ECG Repetition
    boolean
    C0013798 (UMLS CUI [1,1])
    C0205341 (UMLS CUI [1,2])
    ECG
    Item
    Investigators ECG interpretation
    text
    C1623258 (UMLS CUI [1])
    ECG
    Item
    ECG interpretation not done
    boolean
    C1623258 (UMLS CUI [1])
    ECG Repetition
    Item
    ECG second Repetition
    boolean
    C0013798 (UMLS CUI [1,1])
    C0205341 (UMLS CUI [1,2])
    ECG
    Item
    Investigators ECG interpretation
    text
    C1623258 (UMLS CUI [1])
    ECG
    Item
    ECG interpretation not done
    boolean
    C1623258 (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
    Pasat Summary Score Sheet
    Item
    PASAT Form used
    text
    C0589060 (UMLS CUI [1,1])
    C0180975 (UMLS CUI [1,2])
    Code List
    PASAT Form used
    CL Item
    Form A (1)
    CL Item
    Form B (2)
    PASAT3 total correct
    Item
    PASAT3: Total correct (range 0-60)
    integer
    C3898055 (UMLS CUI [1,1])
    C0205449 (UMLS CUI [1,2])
    PASAT
    Item
    For a complete PASAT3, record any circumstances that affected the subjects performance
    text
    C0589060 (UMLS CUI [1])
    Item
    PASAT3: if test was not completed
    integer
    C0589060 (UMLS CUI [1,1])
    C0205449 (UMLS CUI [1,2])
    C2732579 (UMLS CUI [1,3])
    Code List
    PASAT3: if test was not completed
    CL Item
    Unable due to physical limitations (1)
    CL Item
    Other (2)
    PASAT3: not completed
    Item
    PASAT3: please specify physical limitations and/or other reason
    text
    C0589060 (UMLS CUI [1,1])
    C0205449 (UMLS CUI [1,2])
    C2732579 (UMLS CUI [1,3])
    Item Group
    9-Hole Peg test
    Item
    9-Hole Peg Test: dominant hand
    text
    C0451335 (UMLS CUI [1,1])
    C0449722 (UMLS CUI [1,2])
    Code List
    9-Hole Peg Test: dominant hand
    CL Item
    right (1)
    CL Item
    left (2)
    9 hole peg test dominant hand
    Item
    9-Hole Peg Test: Time dominant hand Trial 1
    float
    C0451335 (UMLS CUI [1,1])
    C0449722 (UMLS CUI [1,2])
    9-Hole Peg Test
    Item
    9-Hole Peg Test: Time non-dominant hand Trial 1
    float
    C0451335 (UMLS CUI [1,1])
    C0445549 (UMLS CUI [1,2])
    9-hole peg test
    Item
    For a complete trial, record any circumstances that affected the subjects performance
    text
    C0451335 (UMLS CUI [1])
    Item
    9-Hole Peg Test: not completed dominant hand Trial 1
    integer
    C0451335 (UMLS CUI [1,1])
    C0449722 (UMLS CUI [1,2])
    Code List
    9-Hole Peg Test: not completed dominant hand Trial 1
    CL Item
    Unable due to physical limitations (1)
    CL Item
    Other (2)
    Item
    9-Hole Peg Test: not completed non-dominant hand Trial 1
    integer
    C0451335 (UMLS CUI [1,1])
    C0445549 (UMLS CUI [1,2])
    Code List
    9-Hole Peg Test: not completed non-dominant hand Trial 1
    CL Item
    Unable due to physical limitations (1)
    CL Item
    Other (2)
    9-hole peg test
    Item
    If trial was not completed, please specify physical limitations and/or other reasons
    text
    C0451335 (UMLS CUI [1])
    9 hole peg test dominant hand
    Item
    9-Hole Peg Test: Time dominant hand Trial 2
    float
    C0451335 (UMLS CUI [1,1])
    C0449722 (UMLS CUI [1,2])
    9-Hole Peg Test
    Item
    9-Hole Peg Test: Time non-dominant hand Trial 2
    float
    C0451335 (UMLS CUI [1,1])
    C0445549 (UMLS CUI [1,2])
    9-hole peg test
    Item
    For a complete trial, record any circumstances that affected the subjects performance
    text
    C0451335 (UMLS CUI [1])
    Item
    9-Hole Peg Test: not completed dominant hand Trial 2
    integer
    C0451335 (UMLS CUI [1,1])
    C0449722 (UMLS CUI [1,2])
    Code List
    9-Hole Peg Test: not completed dominant hand Trial 2
    CL Item
    Unable due to physical limitations (1)
    CL Item
    Other (2)
    Item
    9-Hole Peg Test: not completed non-dominant hand Trial 2
    integer
    C0451335 (UMLS CUI [1,1])
    C0445549 (UMLS CUI [1,2])
    Code List
    9-Hole Peg Test: not completed non-dominant hand Trial 2
    CL Item
    Unable due to physical limitations (1)
    CL Item
    Other (2)
    9-hole peg test
    Item
    If trial was not completed, please specify physical limitations and/or other reasons
    text
    C0451335 (UMLS CUI [1])
    Item Group
    Binocular low contrast visual acuity
    Binocular low contrast visual acuity
    Item
    100percent chart: total correct score
    integer
    C0042812 (UMLS CUI [1,1])
    C0042794 (UMLS CUI [1,2])
    Binocular low contrast visual acuity
    Item
    2,5 percent chart: total correct score
    integer
    C0042812 (UMLS CUI [1,1])
    C0042794 (UMLS CUI [1,2])
    Binocular low contrast visual acuity
    Item
    1,25 percent chart: total correct score
    integer
    C0042812 (UMLS CUI [1,1])
    C0042794 (UMLS CUI [1,2])
    Item Group
    MRI Scan performance
    date MRI
    Item
    Date of MRI
    date
    C0011008 (UMLS CUI [1,1])
    C0024485 (UMLS CUI [1,2])
    MRI
    Item
    MRI not done
    boolean
    C0024485 (UMLS CUI [1])
    Item
    Type of Gadolinium-based contrast agent used
    integer
    C0009924 (UMLS CUI [1])
    Code List
    Type of Gadolinium-based contrast agent used
    CL Item
    Magnevist (1)
    CL Item
    Omniscan (2)
    CL Item
    Dotarem (3)
    CL Item
    Other (specify) (4)
    Contrast agent
    Item
    Other contrast agent used
    text
    C0009924 (UMLS CUI [1])
    MRI performed
    Item
    Was MRI completed according to the protocol?
    boolean
    C0024485 (UMLS CUI [1])
    MRI
    Item
    Reason MRI was not completed
    text
    C0024485 (UMLS CUI [1])
    Findings
    Item
    Where there any pathological,non-MS findings?
    boolean
    C0243095 (UMLS CUI [1])
    Findings
    Item
    Please specify pathological findings
    text
    C0243095 (UMLS CUI [1])
    Item Group
    MT Scan Performance
    Date
    Item
    Date of MT Scan
    date
    C0011008 (UMLS CUI [1,1])
    C2584640 (UMLS CUI [1,2])
    MT Scan
    Item
    MT-Scan not done
    boolean
    C2584640 (UMLS CUI [1])
    MT-Scan completed
    Item
    Was MT-Scan completed according to protocol?
    boolean
    C2584640 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    MT-Scan not completed
    Item
    If not completed, specify
    text
    C0205197 (UMLS CUI [1,1])
    C0424237 (UMLS CUI [1,2])
    Item Group
    MRS Scan Performance
    Date of MRS Scan
    Item
    Date of MRS Scan
    date
    C0011008 (UMLS CUI [1,1])
    C0024487 (UMLS CUI [1,2])
    MRS scan
    Item
    MRS scan not done
    boolean
    C0024487 (UMLS CUI [1])
    MRS-Scan completed
    Item
    Was MRS-Scan completed according to protocol?
    boolean
    C0024487 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    MRS-Scan not completed
    Item
    If MRS-Scan was not completed,specify
    text
    C0024487 (UMLS CUI [1,1])
    C0424237 (UMLS CUI [1,2])
    Item Group
    Modified Fatigue Impact Scale
    Item
    I have been less alert
    integer
    C0723445 (UMLS CUI [1])
    Code List
    I have been less alert
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have difficulty paying attention for long periods of time
    integer
    C0238707 (UMLS CUI [1])
    Code List
    I have difficulty paying attention for long periods of time
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have been unable to think clearly
    integer
    C0423994 (UMLS CUI [1])
    Code List
    I have been unable to think clearly
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have been clumsy and uncoordinated
    integer
    C0520966 (UMLS CUI [1])
    Code List
    I have been clumsy and uncoordinated
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have been forgetful
    integer
    C0542476 (UMLS CUI [1])
    Code List
    I have been forgetful
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have had to pace myself in my physical activities
    integer
    C0946284 (UMLS CUI [1])
    Code List
    I have had to pace myself in my physical activities
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have been less motivated to do anything that requires physical effort
    integer
    C0558078 (UMLS CUI [1])
    Code List
    I have been less motivated to do anything that requires physical effort
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have been less motivated to participate in social activities
    integer
    C0558078 (UMLS CUI [1])
    Code List
    I have been less motivated to participate in social activities
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have been limited in my ability to do things away from home
    integer
    C3829094 (UMLS CUI [1])
    Code List
    I have been limited in my ability to do things away from home
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have had trouble maintaining physical effort for long periods
    integer
    C0031807 (UMLS CUI [1])
    Code List
    I have had trouble maintaining physical effort for long periods
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have difficulties making decisions
    integer
    C1531797 (UMLS CUI [1])
    Code List
    I have difficulties making decisions
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have been less motivated to do anything that requires thinking
    integer
    C0558078 (UMLS CUI [1,1])
    C0039869 (UMLS CUI [1,2])
    Code List
    I have been less motivated to do anything that requires thinking
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    My muscles have felt weak
    integer
    C0151786 (UMLS CUI [1])
    Code List
    My muscles have felt weak
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have been physicaly uncomfortable
    integer
    C4062607 (UMLS CUI [1])
    Code List
    I have been physicaly uncomfortable
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have trouble finishing tasks that require thinking
    integer
    C0424098 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    Code List
    I have trouble finishing tasks that require thinking
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have had difficulty organizing my thoughts when doing things at home or at work
    integer
    C0589098 (UMLS CUI [1])
    Code List
    I have had difficulty organizing my thoughts when doing things at home or at work
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have been less able to complete tasks that require physical effort
    integer
    C0031807 (UMLS CUI [1])
    Code List
    I have been less able to complete tasks that require physical effort
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    My thinking has slowed down
    integer
    C0233633 (UMLS CUI [1])
    Code List
    My thinking has slowed down
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have trouble concentrating
    integer
    C0424098 (UMLS CUI [1])
    Code List
    I have trouble concentrating
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have limited my physical activities
    integer
    C0026606 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    Code List
    I have limited my physical activities
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item
    I have needed to rest more often or for longer periods
    integer
    C3641751 (UMLS CUI [1])
    Code List
    I have needed to rest more often or for longer periods
    CL Item
    Never (1)
    CL Item
    Rarely (2)
    CL Item
    Sometimes (3)
    CL Item
    Often (4)
    CL Item
    Almost always (5)
    Item Group
    General Health assessment
    Health survey
    Item
    SF-36 Health survey
    text
    C0018762 (UMLS CUI [1])
    Health survey
    Item
    EQ5D Questionnaire
    text
    C0018762 (UMLS CUI [1])
    Item Group
    Final eligibility
    Unstable condition
    Item
    Has the subject been in an unstable neurological condition or experienced an onset of relapse between screening (month-1) and baseline (month 0) visits?
    boolean
    C0443343 (UMLS CUI [1])
    Steroid treatment
    Item
    Has the subject undergone any treatment with corticosteroids (intravenous[iv], intramuscular[im], and/or per os [po]) or ACTH between month -1 (screening) and 0 (baseline)?
    boolean
    C0149783 (UMLS CUI [1])
    Acute infection
    Item
    Has the subject experienced acute infection within 2 weeks prior to baseline visit?
    boolean
    C0275518 (UMLS CUI [1])
    Major trauma or Surgery
    Item
    Has the subject experienced major trauma or surgery within 2 weeks prior to baseline visit?
    boolean
    C0332677 (UMLS CUI [1,1])
    C0543467 (UMLS CUI [1,2])
    CYP3A4 inhibitors or Fluoxetine
    Item
    Has the subject used inhibitors of CYP3A4 within 2 weeks, for fluoxetine 1 month, prior to baseline visit?
    boolean
    C3830624 (UMLS CUI [1])
    C0016365 (UMLS CUI [2])
    Comorbidities
    Item
    Were any pathologies other than MS found in MRI, and confirmed by local radiologist, that would jeopardize the subjects participation in the study?
    boolean
    C0009488 (UMLS CUI [1])
    Compliance behavior limited comorbidity
    Item
    Does the subject have a clinically significant or unstable medical or surgical condition, as defined by protocol, that would preclude safe and complete study participation?
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    Item Group
    Subject disposition
    Eligibility determination
    Item
    Does the subject qualify to continue this clinical trial? If no, complete below
    boolean
    C0013893 (UMLS CUI [1])
    Reason subject is not eligible
    Item
    Please specify reason why subject is not eligible
    text
    C0566251 (UMLS CUI [1,1])
    C2828389 (UMLS CUI [1,2])
    Subject screening number
    Item
    Subject screening number
    integer
    C1710477 (UMLS CUI [1])
    Subject number
    Item
    Subject number:
    integer
    C1709561 (UMLS CUI [1])
    Date of Randomization
    Item
    Date of Randomization
    date
    C0034656 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Date and time Study drug administration
    Item
    Date and time of Study drug administration
    datetime
    C0011008 (UMLS CUI [1,1])
    C0013175 (UMLS CUI [1,2])
    C3469597 (UMLS CUI [1,3])
    Item Group
    Post -Dose Vital signs
    Blood pressure
    Item
    Blood pressure 30 min post Dose
    integer
    C0005823 (UMLS CUI [1])
    Blood pressure
    Item
    Measurement not done
    boolean
    C0005823 (UMLS CUI [1])
    Blood pressure
    Item
    Blood pressure 60 min post Dose
    integer
    C0005823 (UMLS CUI [1])
    Blood pressure
    Item
    Measurement not done
    boolean
    C0005823 (UMLS CUI [1])
    Heart rate
    Item
    Pulse 30 min post Dose
    integer
    C0018810 (UMLS CUI [1])
    Heart rate
    Item
    Measurement not done
    boolean
    C0018810 (UMLS CUI [1])
    Heart rate
    Item
    Pulse 60 min post Dose
    integer
    C0018810 (UMLS CUI [1])
    Heart rate
    Item
    Measurement not done
    boolean
    C0018810 (UMLS CUI [1])
    Item Group
    Phone thrombosis questionnaire
    pain or leg swelling
    Item
    Have you been suffering in the last two weeks from a new pain or swelling in the back part of one of your legs?
    boolean
    C0030193 (UMLS CUI [1,1])
    C0745977 (UMLS CUI [1,2])
    Shortness of breath
    Item
    Have you been suffering from shortness of breath in the last two weeks?
    boolean
    C0013404 (UMLS CUI [1])
    Chest pain
    Item
    Have you been suffering from a new chest pain in the last two weeks?
    boolean
    C0008031 (UMLS CUI [1])
    Abdominal pain
    Item
    Have you been suffering from a new,intensifying, abdominal pain for more than 3 days?
    boolean
    C0000737 (UMLS CUI [1])
    Headache
    Item
    Have you been suffering from a new continuous, intensifying headache in the last two weeks?
    boolean
    C0018681 (UMLS CUI [1])
    Further evaluation
    Item
    If the answer to any of the above is yes, Does the subject need any further evaluation?
    boolean
    C1736113 (UMLS CUI [1])

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