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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
Versionen (1)
- 07.06.16 07.06.16 -
Hochgeladen am
7. Juni 2016
DOI
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Creative Commons BY-NC 3.0
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Nerventra Study Baseline
Nerventra Study Baseline
- StudyEvent: ODM
Ähnliche Modelle
Nerventra Study Baseline
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Protocol Number
Item
Protocol Number
text
C0008971 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
CL Item
oral (1)
CL Item
axillary (2)
CL Item
aural (3)
CL Item
temporal (4)
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])
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])
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])
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])
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])
C0205449 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
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])
C0205449 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
Item
9-Hole Peg Test: dominant hand
text
C0451335 (UMLS CUI [1,1])
C0449722 (UMLS CUI [1,2])
C0449722 (UMLS CUI [1,2])
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])
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])
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])
C0449722 (UMLS CUI [1,2])
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])
C0445549 (UMLS CUI [1,2])
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])
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])
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])
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])
C0449722 (UMLS CUI [1,2])
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])
C0445549 (UMLS CUI [1,2])
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])
Binocular low contrast visual acuity
Item
100percent chart: total correct score
integer
C0042812 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
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])
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])
C0042794 (UMLS CUI [1,2])
date MRI
Item
Date of MRI
date
C0011008 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,2])
MRI
Item
MRI not done
boolean
C0024485 (UMLS CUI [1])
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])
Date
Item
Date of MT Scan
date
C0011008 (UMLS CUI [1,1])
C2584640 (UMLS CUI [1,2])
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])
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])
C0424237 (UMLS CUI [1,2])
Date of MRS Scan
Item
Date of MRS Scan
date
C0011008 (UMLS CUI [1,1])
C0024487 (UMLS CUI [1,2])
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])
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])
C0424237 (UMLS CUI [1,2])
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])
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
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])
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])
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])
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])
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])
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
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])
C0039869 (UMLS CUI [1,2])
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
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])
C0439801 (UMLS CUI [1,2])
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])
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
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])
C0439801 (UMLS CUI [1,2])
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])
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Health survey
Item
SF-36 Health survey
text
C0018762 (UMLS CUI [1])
Health survey
Item
EQ5D Questionnaire
text
C0018762 (UMLS CUI [1])
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])
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])
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])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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])
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])
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])
C0013175 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
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])
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])
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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