ID

15668

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. 07/06/16 07/06/16 -
Caricato su

7 giugno 2016

DOI

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Licenza

Creative Commons BY-NC 3.0

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Nerventra Study Baseline

Nerventra Study Baseline

Informed Consent and Demography Data
Descrizione

Informed Consent and Demography Data

Protocol Number
Descrizione

Protocol Number

Tipo di dati

text

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

i.e "Screening"

Tipo di dati

text

Alias
UMLS CUI [1]
C0545082
Date of visit
Descrizione

Visit date

Tipo di dati

date

Alias
UMLS CUI [1]
C1320303
Study site number
Descrizione

Study site

Tipo di dati

integer

Alias
UMLS CUI [1]
C2825164
Subject number:
Descrizione

Subject number

Tipo di dati

integer

Alias
UMLS CUI [1]
C1709561
Section blank?
Descrizione

Blank

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0750479
Safety measurements
Descrizione

Safety measurements

Temperature
Descrizione

Temperature

Tipo di dati

float

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

Temperature

Tipo di dati

integer

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

Units used for measurement

Tipo di dati

integer

Alias
UMLS CUI [1]
C1519795
Measurement not done
Descrizione

not done

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1272696
Blood pressure measurement
Descrizione

Blood pressure

Tipo di dati

text

Unità di misura
  • mm/Hg
Alias
UMLS CUI [1]
C0005823
mm/Hg
Measurement not done
Descrizione

not done

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1272696
Pulse
Descrizione

Pulse Rate

Tipo di dati

integer

Unità di misura
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Measurement not done
Descrizione

not done

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1272696
Investigators ECG interpretation
Descrizione

ECG

Tipo di dati

text

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

ECG

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1623258
ECG Repetition
Descrizione

ECG Repetition

Tipo di dati

boolean

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

ECG

Tipo di dati

text

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

ECG

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1623258
ECG second Repetition
Descrizione

ECG Repetition

Tipo di dati

boolean

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

ECG

Tipo di dati

text

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

ECG

Tipo di dati

boolean

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

Laboratory specimen

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0200345
Menstruation
Descrizione

Menstruation

Tipo di dati

boolean

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

Pasat Summary Score Sheet

PASAT Form used
Descrizione

PASAT Form used

Tipo di dati

text

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

PASAT3 total correct

Tipo di dati

integer

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

PASAT

Tipo di dati

text

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

PASAT3: not completed

Tipo di dati

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
Descrizione

PASAT3: not completed

Tipo di dati

text

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

9-Hole Peg test

9-Hole Peg Test: dominant hand
Descrizione

Dominant hand

Tipo di dati

text

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

9 hole peg test dominant hand

Tipo di dati

float

Unità di misura
  • sec
Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0449722
sec
9-Hole Peg Test: Time non-dominant hand Trial 1
Descrizione

9-Hole Peg Test

Tipo di dati

float

Unità di misura
  • 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
Descrizione

9-hole peg test

Tipo di dati

text

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

9-Hole Peg Test: not completed

Tipo di dati

integer

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

9-Hole Peg Test: not completed

Tipo di dati

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
Descrizione

9-hole peg test

Tipo di dati

text

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

9 hole peg test dominant hand

Tipo di dati

float

Unità di misura
  • sec
Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0449722
sec
9-Hole Peg Test: Time non-dominant hand Trial 2
Descrizione

9-Hole Peg Test

Tipo di dati

float

Unità di misura
  • 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
Descrizione

9-hole peg test

Tipo di dati

text

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

9-Hole Peg Test: not completed

Tipo di dati

integer

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

9-Hole Peg Test: not completed

Tipo di dati

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
Descrizione

9-hole peg test

Tipo di dati

text

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

Binocular low contrast visual acuity

100percent chart: total correct score
Descrizione

Binocular low contrast visual acuity

Tipo di dati

integer

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

Binocular low contrast visual acuity

Tipo di dati

integer

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

Binocular low contrast visual acuity

Tipo di dati

integer

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

MRI Scan performance

Date of MRI
Descrizione

date MRI

Tipo di dati

date

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

MRI

Tipo di dati

boolean

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

Contrast agent

Tipo di dati

integer

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

Contrast agent

Tipo di dati

text

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

MRI performed

Tipo di dati

boolean

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

MRI

Tipo di dati

text

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

Findings

Tipo di dati

boolean

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

Findings

Tipo di dati

text

Alias
UMLS CUI [1]
C0243095
MT Scan Performance
Descrizione

MT Scan Performance

Date of MT Scan
Descrizione

Date

Tipo di dati

date

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

MT Scan

Tipo di dati

boolean

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

MT-Scan completed

Tipo di dati

boolean

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

MT-Scan not completed

Tipo di dati

text

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

MRS Scan Performance

Date of MRS Scan
Descrizione

Date of MRS Scan

Tipo di dati

date

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

MRS scan

Tipo di dati

boolean

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

MRS-Scan completed

Tipo di dati

boolean

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

MRS-Scan not completed

Tipo di dati

text

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

Modified Fatigue Impact Scale

I have been less alert
Descrizione

Being alert

Tipo di dati

integer

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

Pay attention

Tipo di dati

integer

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

Unable to think clearly

Tipo di dati

integer

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

Impaired coordination

Tipo di dati

integer

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

Forgetful

Tipo di dati

integer

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

Physical activity behavior

Tipo di dati

integer

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

Low Motivation

Tipo di dati

integer

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

Low motivation

Tipo di dati

integer

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

limited ability to do things away from home

Tipo di dati

integer

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

Maintaining physical effort

Tipo di dati

integer

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

Ability to make decisions

Tipo di dati

integer

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

Low motivation to think

Tipo di dati

integer

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

Muscle weakness

Tipo di dati

integer

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

Physical Discomfort

Tipo di dati

integer

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

Ability to concentrate

Tipo di dati

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
Descrizione

Stay focused

Tipo di dati

integer

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

Physical effort

Tipo di dati

integer

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

Thought retardation

Tipo di dati

integer

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

ability to concentrate

Tipo di dati

integer

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

Physical activity limited

Tipo di dati

integer

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

Need for rest

Tipo di dati

integer

Alias
UMLS CUI [1]
C3641751
General Health assessment
Descrizione

General Health assessment

SF-36 Health survey
Descrizione

copyrighted evaluation tool

Tipo di dati

text

Alias
UMLS CUI [1]
C0018762
EQ5D Questionnaire
Descrizione

copyrighted evaluation tool

Tipo di dati

text

Alias
UMLS CUI [1]
C0018762
Final eligibility
Descrizione

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?
Descrizione

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

Tipo di dati

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)?
Descrizione

Steroid treatment

Tipo di dati

boolean

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

Acute infection

Tipo di dati

boolean

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

Major trauma or Surgery

Tipo di dati

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?
Descrizione

CYP3A4 inhibitors or Fluoxetine

Tipo di dati

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?
Descrizione

Comorbidities

Tipo di dati

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?
Descrizione

Compliance behavior limited comorbidity

Tipo di dati

boolean

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

Subject disposition

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

Eligibility determination

Tipo di dati

boolean

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

Reason subject is not eligible

Tipo di dati

text

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

Subject screening number

Tipo di dati

integer

Alias
UMLS CUI [1]
C1710477
Subject number:
Descrizione

Subject number

Tipo di dati

integer

Alias
UMLS CUI [1]
C1709561
Date of Randomization
Descrizione

Date of Randomization

Tipo di dati

date

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

Date and time Study drug administration

Tipo di dati

datetime

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

Post -Dose Vital signs

Blood pressure 30 min post Dose
Descrizione

Blood pressure

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Measurement not done
Descrizione

Blood pressure

Tipo di dati

boolean

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

Blood pressure

Tipo di dati

integer

Unità di misura
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Measurement not done
Descrizione

Blood pressure

Tipo di dati

boolean

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

Heart rate

Tipo di dati

integer

Unità di misura
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Measurement not done
Descrizione

Heart rate

Tipo di dati

boolean

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

Heart rate

Tipo di dati

integer

Unità di misura
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Measurement not done
Descrizione

Heart rate

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0018810
Phone thrombosis questionnaire
Descrizione

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?
Descrizione

pain or leg swelling

Tipo di dati

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?
Descrizione

Shortness of breath

Tipo di dati

boolean

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

Chest pain

Tipo di dati

boolean

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

Abdominal pain

Tipo di dati

boolean

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

Headache

Tipo di dati

boolean

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

Further evaluation

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1736113

Similar models

Nerventra Study Baseline

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