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
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Nerventra Study Baseline
Nerventra Study Baseline
- StudyEvent: ODM
Beschreibung
Safety measurements
Beschreibung
Temperature
Datentyp
float
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Temperature
Datentyp
integer
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Units used for measurement
Datentyp
integer
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
not done
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
Blood pressure
Datentyp
text
Maßeinheiten
- mm/Hg
Alias
- UMLS CUI [1]
- C0005823
Beschreibung
not done
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
Pulse Rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Beschreibung
not done
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1272696
Beschreibung
ECG
Datentyp
text
Alias
- UMLS CUI [1]
- C1623258
Beschreibung
ECG
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1623258
Beschreibung
ECG Repetition
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0205341
Beschreibung
ECG
Datentyp
text
Alias
- UMLS CUI [1]
- C1623258
Beschreibung
ECG
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1623258
Beschreibung
ECG Repetition
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0205341
Beschreibung
ECG
Datentyp
text
Alias
- UMLS CUI [1]
- C1623258
Beschreibung
ECG
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1623258
Beschreibung
Laboratory specimen
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0200345
Beschreibung
Menstruation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0025344
Beschreibung
Pasat Summary Score Sheet
Beschreibung
PASAT Form used
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0589060
- UMLS CUI [1,2]
- C0180975
Beschreibung
PASAT3 total correct
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3898055
- UMLS CUI [1,2]
- C0205449
Beschreibung
PASAT
Datentyp
text
Alias
- UMLS CUI [1]
- C0589060
Beschreibung
PASAT3: not completed
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0589060
- UMLS CUI [1,2]
- C0205449
- UMLS CUI [1,3]
- C2732579
Beschreibung
PASAT3: not completed
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0589060
- UMLS CUI [1,2]
- C0205449
- UMLS CUI [1,3]
- C2732579
Beschreibung
9-Hole Peg test
Beschreibung
Dominant hand
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0449722
Beschreibung
9 hole peg test dominant hand
Datentyp
float
Maßeinheiten
- sec
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0449722
Beschreibung
9-Hole Peg Test
Datentyp
float
Maßeinheiten
- sec
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0445549
Beschreibung
9-hole peg test
Datentyp
text
Alias
- UMLS CUI [1]
- C0451335
Beschreibung
9-Hole Peg Test: not completed
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0449722
Beschreibung
9-Hole Peg Test: not completed
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0445549
Beschreibung
9-hole peg test
Datentyp
text
Alias
- UMLS CUI [1]
- C0451335
Beschreibung
9 hole peg test dominant hand
Datentyp
float
Maßeinheiten
- sec
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0449722
Beschreibung
9-Hole Peg Test
Datentyp
float
Maßeinheiten
- sec
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0445549
Beschreibung
9-hole peg test
Datentyp
text
Alias
- UMLS CUI [1]
- C0451335
Beschreibung
9-Hole Peg Test: not completed
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0449722
Beschreibung
9-Hole Peg Test: not completed
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0451335
- UMLS CUI [1,2]
- C0445549
Beschreibung
9-hole peg test
Datentyp
text
Alias
- UMLS CUI [1]
- C0451335
Beschreibung
Binocular low contrast visual acuity
Beschreibung
Binocular low contrast visual acuity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042812
- UMLS CUI [1,2]
- C0042794
Beschreibung
Binocular low contrast visual acuity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042812
- UMLS CUI [1,2]
- C0042794
Beschreibung
Binocular low contrast visual acuity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042812
- UMLS CUI [1,2]
- C0042794
Beschreibung
MRI Scan performance
Beschreibung
date MRI
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0024485
Beschreibung
MRI
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0024485
Beschreibung
Contrast agent
Datentyp
integer
Alias
- UMLS CUI [1]
- C0009924
Beschreibung
Contrast agent
Datentyp
text
Alias
- UMLS CUI [1]
- C0009924
Beschreibung
MRI performed
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0024485
Beschreibung
MRI
Datentyp
text
Alias
- UMLS CUI [1]
- C0024485
Beschreibung
Findings
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0243095
Beschreibung
Findings
Datentyp
text
Alias
- UMLS CUI [1]
- C0243095
Beschreibung
MT Scan Performance
Beschreibung
Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2584640
Beschreibung
MT Scan
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2584640
Beschreibung
MT-Scan completed
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2584640
- UMLS CUI [1,2]
- C0205197
Beschreibung
MT-Scan not completed
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205197
- UMLS CUI [1,2]
- C0424237
Beschreibung
MRS Scan Performance
Beschreibung
Date of MRS Scan
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0024487
Beschreibung
MRS scan
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0024487
Beschreibung
MRS-Scan completed
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0024487
- UMLS CUI [1,2]
- C0205197
Beschreibung
MRS-Scan not completed
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0024487
- UMLS CUI [1,2]
- C0424237
Beschreibung
Modified Fatigue Impact Scale
Beschreibung
Being alert
Datentyp
integer
Alias
- UMLS CUI [1]
- C0723445
Beschreibung
Pay attention
Datentyp
integer
Alias
- UMLS CUI [1]
- C0238707
Beschreibung
Unable to think clearly
Datentyp
integer
Alias
- UMLS CUI [1]
- C0423994
Beschreibung
Impaired coordination
Datentyp
integer
Alias
- UMLS CUI [1]
- C0520966
Beschreibung
Forgetful
Datentyp
integer
Alias
- UMLS CUI [1]
- C0542476
Beschreibung
Physical activity behavior
Datentyp
integer
Alias
- UMLS CUI [1]
- C0946284
Beschreibung
Low Motivation
Datentyp
integer
Alias
- UMLS CUI [1]
- C0558078
Beschreibung
Low motivation
Datentyp
integer
Alias
- UMLS CUI [1]
- C0558078
Beschreibung
limited ability to do things away from home
Datentyp
integer
Alias
- UMLS CUI [1]
- C3829094
Beschreibung
Maintaining physical effort
Datentyp
integer
Alias
- UMLS CUI [1]
- C0031807
Beschreibung
Ability to make decisions
Datentyp
integer
Alias
- UMLS CUI [1]
- C1531797
Beschreibung
Low motivation to think
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0558078
- UMLS CUI [1,2]
- C0039869
Beschreibung
Muscle weakness
Datentyp
integer
Alias
- UMLS CUI [1]
- C0151786
Beschreibung
Physical Discomfort
Datentyp
integer
Alias
- UMLS CUI [1]
- C4062607
Beschreibung
Ability to concentrate
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0424098
- UMLS CUI [1,2]
- C0439801
Beschreibung
Stay focused
Datentyp
integer
Alias
- UMLS CUI [1]
- C0589098
Beschreibung
Physical effort
Datentyp
integer
Alias
- UMLS CUI [1]
- C0031807
Beschreibung
Thought retardation
Datentyp
integer
Alias
- UMLS CUI [1]
- C0233633
Beschreibung
ability to concentrate
Datentyp
integer
Alias
- UMLS CUI [1]
- C0424098
Beschreibung
Physical activity limited
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0026606
- UMLS CUI [1,2]
- C0439801
Beschreibung
Need for rest
Datentyp
integer
Alias
- UMLS CUI [1]
- C3641751
Beschreibung
General Health assessment
Beschreibung
Final eligibility
Beschreibung
Any question in this section answered "yes",excludes the subject from the study
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0443343
Beschreibung
Steroid treatment
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0149783
Beschreibung
Acute infection
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0275518
Beschreibung
Major trauma or Surgery
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0332677
- UMLS CUI [1,2]
- C0543467
Beschreibung
CYP3A4 inhibitors or Fluoxetine
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3830624
- UMLS CUI [2]
- C0016365
Beschreibung
Comorbidities
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschreibung
Compliance behavior limited comorbidity
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C0439801
- UMLS CUI [1,3]
- C0009488
Beschreibung
Subject disposition
Beschreibung
Eligibility determination
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013893
Beschreibung
Reason subject is not eligible
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C2828389
Beschreibung
Subject screening number
Datentyp
integer
Alias
- UMLS CUI [1]
- C1710477
Beschreibung
Subject number
Datentyp
integer
Alias
- UMLS CUI [1]
- C1709561
Beschreibung
Date of Randomization
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0011008
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
Beschreibung
Post -Dose Vital signs
Beschreibung
Blood pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschreibung
Blood pressure
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005823
Beschreibung
Blood pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschreibung
Blood pressure
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005823
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Heart rate
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Heart rate
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Phone thrombosis questionnaire
Beschreibung
pain or leg swelling
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0745977
Beschreibung
Shortness of breath
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013404
Beschreibung
Chest pain
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0008031
Beschreibung
Abdominal pain
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0000737
Beschreibung
Headache
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0018681
Beschreibung
Further evaluation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1736113
Ähnliche Modelle
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])
Keine Kommentare