ID
15668
Description
Nerventra Study (Eudra CT 2007-003226-19) Study MS-LAQ-301: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS)
Mots-clés
Versions (1)
- 07/06/2016 07/06/2016 -
Téléchargé le
7 juin 2016
DOI
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Licence
Creative Commons BY-NC 3.0
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Nerventra Study Baseline
Nerventra Study Baseline
- StudyEvent: ODM
Description
Safety measurements
Description
Temperature
Type de données
float
Alias
- UMLS CUI [1]
- C0005903
Description
Temperature
Type de données
integer
Alias
- UMLS CUI [1]
- C0005903
Description
Units used for measurement
Type de données
integer
Alias
- UMLS CUI [1]
- C1519795
Description
not done
Type de données
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
Blood pressure
Type de données
text
Unités de mesure
- mm/Hg
Alias
- UMLS CUI [1]
- C0005823
Description
not done
Type de données
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
Pulse Rate
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Description
not done
Type de données
boolean
Alias
- UMLS CUI [1]
- C1272696
Description
ECG
Type de données
text
Alias
- UMLS CUI [1]
- C1623258
Description
ECG
Type de données
boolean
Alias
- UMLS CUI [1]
- C1623258
Description
ECG Repetition
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0205341
Description
ECG
Type de données
text
Alias
- UMLS CUI [1]
- C1623258
Description
ECG
Type de données
boolean
Alias
- UMLS CUI [1]
- C1623258
Description
ECG Repetition
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0205341
Description
ECG
Type de données
text
Alias
- UMLS CUI [1]
- C1623258
Description
ECG
Type de données
boolean
Alias
- UMLS CUI [1]
- C1623258
Description
Laboratory specimen
Type de données
boolean
Alias
- UMLS CUI [1]
- C0200345
Description
Menstruation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0025344
Description
Pasat Summary Score Sheet
Description
PASAT Form used
Type de données
text
Alias
- UMLS CUI [1,1]
- C0589060
- UMLS CUI [1,2]
- C0180975
Description
PASAT3 total correct
Type de données
integer
Alias
- UMLS CUI [1,1]
- C3898055
- UMLS CUI [1,2]
- C0205449
Description
PASAT
Type de données
text
Alias
- UMLS CUI [1]
- C0589060
Description
PASAT3: not completed
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0589060
- UMLS CUI [1,2]
- C0205449
- UMLS CUI [1,3]
- C2732579
Description
PASAT3: not completed
Type de données
text
Alias
- UMLS CUI [1,1]
- C0589060
- UMLS CUI [1,2]
- C0205449
- UMLS CUI [1,3]
- C2732579
Description
9-Hole Peg test
Description
Dominant hand
Type de données
text
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0449722
Description
9 hole peg test dominant hand
Type de données
float
Unités de mesure
- sec
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0449722
Description
9-Hole Peg Test
Type de données
float
Unités de mesure
- sec
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0445549
Description
9-hole peg test
Type de données
text
Alias
- UMLS CUI [1]
- C0451335
Description
9-Hole Peg Test: not completed
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0449722
Description
9-Hole Peg Test: not completed
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0445549
Description
9-hole peg test
Type de données
text
Alias
- UMLS CUI [1]
- C0451335
Description
9 hole peg test dominant hand
Type de données
float
Unités de mesure
- sec
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0449722
Description
9-Hole Peg Test
Type de données
float
Unités de mesure
- sec
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0445549
Description
9-hole peg test
Type de données
text
Alias
- UMLS CUI [1]
- C0451335
Description
9-Hole Peg Test: not completed
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0449722
Description
9-Hole Peg Test: not completed
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0445549
Description
9-hole peg test
Type de données
text
Alias
- UMLS CUI [1]
- C0451335
Description
Binocular low contrast visual acuity
Description
Binocular low contrast visual acuity
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0042812
- UMLS CUI [1,2]
- C0042794
Description
Binocular low contrast visual acuity
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0042812
- UMLS CUI [1,2]
- C0042794
Description
Binocular low contrast visual acuity
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0042812
- UMLS CUI [1,2]
- C0042794
Description
MRI Scan performance
Description
date MRI
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0024485
Description
MRI
Type de données
boolean
Alias
- UMLS CUI [1]
- C0024485
Description
Contrast agent
Type de données
integer
Alias
- UMLS CUI [1]
- C0009924
Description
Contrast agent
Type de données
text
Alias
- UMLS CUI [1]
- C0009924
Description
MRI performed
Type de données
boolean
Alias
- UMLS CUI [1]
- C0024485
Description
MRI
Type de données
text
Alias
- UMLS CUI [1]
- C0024485
Description
Findings
Type de données
boolean
Alias
- UMLS CUI [1]
- C0243095
Description
Findings
Type de données
text
Alias
- UMLS CUI [1]
- C0243095
Description
MT Scan Performance
Description
Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2584640
Description
MT Scan
Type de données
boolean
Alias
- UMLS CUI [1]
- C2584640
Description
MT-Scan completed
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2584640
- UMLS CUI [1,2]
- C0205197
Description
MT-Scan not completed
Type de données
text
Alias
- UMLS CUI [1,1]
- C0205197
- UMLS CUI [1,2]
- C0424237
Description
MRS Scan Performance
Description
Date of MRS Scan
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0024487
Description
MRS scan
Type de données
boolean
Alias
- UMLS CUI [1]
- C0024487
Description
MRS-Scan completed
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0024487
- UMLS CUI [1,2]
- C0205197
Description
MRS-Scan not completed
Type de données
text
Alias
- UMLS CUI [1,1]
- C0024487
- UMLS CUI [1,2]
- C0424237
Description
Modified Fatigue Impact Scale
Description
Being alert
Type de données
integer
Alias
- UMLS CUI [1]
- C0723445
Description
Pay attention
Type de données
integer
Alias
- UMLS CUI [1]
- C0238707
Description
Unable to think clearly
Type de données
integer
Alias
- UMLS CUI [1]
- C0423994
Description
Impaired coordination
Type de données
integer
Alias
- UMLS CUI [1]
- C0520966
Description
Forgetful
Type de données
integer
Alias
- UMLS CUI [1]
- C0542476
Description
Physical activity behavior
Type de données
integer
Alias
- UMLS CUI [1]
- C0946284
Description
Low Motivation
Type de données
integer
Alias
- UMLS CUI [1]
- C0558078
Description
Low motivation
Type de données
integer
Alias
- UMLS CUI [1]
- C0558078
Description
limited ability to do things away from home
Type de données
integer
Alias
- UMLS CUI [1]
- C3829094
Description
Maintaining physical effort
Type de données
integer
Alias
- UMLS CUI [1]
- C0031807
Description
Ability to make decisions
Type de données
integer
Alias
- UMLS CUI [1]
- C1531797
Description
Low motivation to think
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0558078
- UMLS CUI [1,2]
- C0039869
Description
Muscle weakness
Type de données
integer
Alias
- UMLS CUI [1]
- C0151786
Description
Physical Discomfort
Type de données
integer
Alias
- UMLS CUI [1]
- C4062607
Description
Ability to concentrate
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0424098
- UMLS CUI [1,2]
- C0439801
Description
Stay focused
Type de données
integer
Alias
- UMLS CUI [1]
- C0589098
Description
Physical effort
Type de données
integer
Alias
- UMLS CUI [1]
- C0031807
Description
Thought retardation
Type de données
integer
Alias
- UMLS CUI [1]
- C0233633
Description
ability to concentrate
Type de données
integer
Alias
- UMLS CUI [1]
- C0424098
Description
Physical activity limited
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0026606
- UMLS CUI [1,2]
- C0439801
Description
Need for rest
Type de données
integer
Alias
- UMLS CUI [1]
- C3641751
Description
General Health assessment
Description
Final eligibility
Description
Any question in this section answered "yes",excludes the subject from the study
Type de données
boolean
Alias
- UMLS CUI [1]
- C0443343
Description
Steroid treatment
Type de données
boolean
Alias
- UMLS CUI [1]
- C0149783
Description
Acute infection
Type de données
boolean
Alias
- UMLS CUI [1]
- C0275518
Description
Major trauma or Surgery
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0332677
- UMLS CUI [1,2]
- C0543467
Description
CYP3A4 inhibitors or Fluoxetine
Type de données
boolean
Alias
- UMLS CUI [1]
- C3830624
- UMLS CUI [2]
- C0016365
Description
Comorbidities
Type de données
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
Compliance behavior limited comorbidity
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0439801
- UMLS CUI [1,3]
- C0009488
Description
Subject disposition
Description
Eligibility determination
Type de données
boolean
Alias
- UMLS CUI [1]
- C0013893
Description
Reason subject is not eligible
Type de données
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C2828389
Description
Subject screening number
Type de données
integer
Alias
- UMLS CUI [1]
- C1710477
Description
Subject number
Type de données
integer
Alias
- UMLS CUI [1]
- C1709561
Description
Date of Randomization
Type de données
date
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0011008
Description
Date and time Study drug administration
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0013175
- UMLS CUI [1,3]
- C3469597
Description
Post -Dose Vital signs
Description
Blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Blood pressure
Type de données
boolean
Alias
- UMLS CUI [1]
- C0005823
Description
Blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Description
Blood pressure
Type de données
boolean
Alias
- UMLS CUI [1]
- C0005823
Description
Heart rate
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Heart rate
Type de données
boolean
Alias
- UMLS CUI [1]
- C0018810
Description
Heart rate
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Heart rate
Type de données
boolean
Alias
- UMLS CUI [1]
- C0018810
Description
Phone thrombosis questionnaire
Description
pain or leg swelling
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0745977
Description
Shortness of breath
Type de données
boolean
Alias
- UMLS CUI [1]
- C0013404
Description
Chest pain
Type de données
boolean
Alias
- UMLS CUI [1]
- C0008031
Description
Abdominal pain
Type de données
boolean
Alias
- UMLS CUI [1]
- C0000737
Description
Headache
Type de données
boolean
Alias
- UMLS CUI [1]
- C0018681
Description
Further evaluation
Type de données
boolean
Alias
- UMLS CUI [1]
- C1736113
Similar models
Nerventra Study Baseline
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0205449 (UMLS CUI [1,2])
C0205449 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0205449 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0449722 (UMLS CUI [1,2])
C0449722 (UMLS CUI [1,2])
C0445549 (UMLS CUI [1,2])
C0449722 (UMLS CUI [1,2])
C0445549 (UMLS CUI [1,2])
C0449722 (UMLS CUI [1,2])
C0445549 (UMLS CUI [1,2])
C0449722 (UMLS CUI [1,2])
C0445549 (UMLS CUI [1,2])
C0042794 (UMLS CUI [1,2])
C0042794 (UMLS CUI [1,2])
C0042794 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,2])
C2584640 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
C0424237 (UMLS CUI [1,2])
C0024487 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
C0424237 (UMLS CUI [1,2])
C0039869 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,2])
C0016365 (UMLS CUI [2])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C2828389 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0013175 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0745977 (UMLS CUI [1,2])
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