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Fehler:
ID
15632
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)
- 06.06.16 06.06.16 -
Hochgeladen am
6. Juni 2016
DOI
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Creative Commons BY-NC 3.0
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Nerventra Study Screening
Nerventra Study Sreening
- StudyEvent: ODM
Ähnliche Modelle
Nerventra Study Sreening
- 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])
Informed consent date
Item
Date of informed consent
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
Previous screening
Item
Has the subject been previously screened?
boolean
C0220908 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,2])
Previous Screening number
Item
Previous Screening number
integer
C0220908 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,2])
Initials
Item
Subjects Initials
text
C2986440 (UMLS CUI [1])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Race
Item
Race
text
C0034510 (UMLS CUI [1])
CL Item
male (1)
CL Item
female (2)
Childbearing potential
Item
Is the subject of childbearing potential?
boolean
C3831118 (UMLS CUI [1])
Childbearing potential
Item
If Female is not of childbearing potential is she post menopausal?
boolean
C3831118 (UMLS CUI [1])
Childbearing potential
Item
If Female is not of childbearing potential did she have hysterectomy and/or oophorectomy (add procedure and reason to medical history form)
boolean
C3831118 (UMLS CUI [1])
Childbearing potential
Item
If Female is not of childbearing potential, please specify other reason
text
C3831118 (UMLS CUI [1])
Item
If Female is of childbearing potential,please specify method of birth control (select all that apply)
integer
C0700589 (UMLS CUI [1])
Code List
If Female is of childbearing potential,please specify method of birth control (select all that apply)
CL Item
Transdermal contraception (1)
CL Item
Oral contraception (2)
CL Item
Injectable contraception (3)
CL Item
IUD (4)
CL Item
Double barrier methods (two of:diaphragm,condom,sponge,spermicide products) (5)
CL Item
Surgical sterilization (6)
CL Item
Partners vasectomy (7)
CL Item
Other, please specify (8)
Date of first symptom
Item
Date of first symptom
date
C3897410 (UMLS CUI [1])
Date of diagnosis
Item
Date of MS diagnosis
date
C2316983 (UMLS CUI [1])
EDSS
Item
EDSS
integer
C0451246 (UMLS CUI [1])
EDSS
Item
EDSS unknown
boolean
C0451246 (UMLS CUI [1])
Exacerbation onset date
Item
Onset date of last exacerbation
date
C0574845 (UMLS CUI [1,1])
C0235874 (UMLS CUI [1,2])
C0235874 (UMLS CUI [1,2])
EDSS
Item
EDSS
integer
C0451246 (UMLS CUI [1])
EDSS
Item
EDSS unknown
boolean
C0451246 (UMLS CUI [1])
Exacerbation stabilization date
Item
Date of stabilization of last exacerbation
date
C1293130 (UMLS CUI [1,1])
C0235874 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0235874 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
EDSS
Item
EDSS
integer
C0451246 (UMLS CUI [1])
EDSS
Item
EDSS unknown
boolean
C0451246 (UMLS CUI [1])
Number of exacerbations
Item
Total number of exacerbations in the last year
integer
C0581392 (UMLS CUI [1])
Number of exacerbations
Item
Total number of exacerbations in the last 2 years
integer
C0581392 (UMLS CUI [1])
Date of last MRI
Item
Date of last MRI with T1-GD enhancing lesions
date
C0024485 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Date of last MRI
Item
Date of last MRI with T1-GD enhancing lesions: not applicable
boolean
C0024485 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Interferon 1beta a (1)
CL Item
Interferon 1beta b (2)
CL Item
Glatiramer Acetate (3)
CL Item
Mitoxantrone (4)
CL Item
Other (5)
Medication name
Item
Medication name,please specify other
text
C2360065 (UMLS CUI [1])
Therapy discontinuation
Item
Therapy discontinuation reason
text
C0457454 (UMLS CUI [1])
IFN NAB titer
Item
IFN NAB titer
integer
C0021747 (UMLS CUI [1,1])
C0475463 (UMLS CUI [1,2])
C0475208 (UMLS CUI [1,3])
C0475463 (UMLS CUI [1,2])
C0475208 (UMLS CUI [1,3])
IFN NAB titer
Item
IFN NAB titer not applicable
boolean
C0021747 (UMLS CUI [1,1])
C0475463 (UMLS CUI [1,2])
C0475208 (UMLS CUI [1,3])
C0475463 (UMLS CUI [1,2])
C0475208 (UMLS CUI [1,3])
Comorbidities
Item
Does the subject have any significant abnormal conditions other than MS?
boolean
C0009488 (UMLS CUI [1])
Comorbidity
Item
Abnormal condition
text
C0009488 (UMLS CUI [1])
Comorbidity related to MS
Item
Comorbidity related to MS
boolean
C0009488 (UMLS CUI [1,1])
C0449379 (UMLS CUI [1,2])
C0026769 (UMLS CUI [1,3])
C0449379 (UMLS CUI [1,2])
C0026769 (UMLS CUI [1,3])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
End date
Item
Date ceased
date
C0806020 (UMLS CUI [1])
Ongoing
Item
Condition ongoing?
boolean
C0549178 (UMLS CUI [1])
CL Item
Never used (1)
CL Item
Former user (2)
CL Item
Currently uses (3)
Former smoker
Item
Date smoking ceased
date
C0337671 (UMLS CUI [1])
CL Item
Cigarettes (1)
CL Item
Pipe (2)
CL Item
Cigars (3)
CL Item
Other (please specify) (4)
Substance use disorder
Item
Type of smoking: please specify other type
text
C0038586 (UMLS CUI [1])
Cigarettes per day
Item
Cigarettes per day
integer
C3694146 (UMLS CUI [1])
Smoking years
Item
Number of smoking years
integer
C1277691 (UMLS CUI [1])
Smoking months
Item
Smoking months
integer
C0037369 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
C0439231 (UMLS CUI [1,2])
Patient Height
Item
Height
float
C0489786 (UMLS CUI [1])
CL Item
inch (1)
CL Item
cm (2)
not done
Item
Measurement not done
boolean
C1272696 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
CL Item
lbs (1)
CL Item
kg (2)
not done
Item
Measurement not done
boolean
C1272696 (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])
Chest x-ray
Item
Date of chest x-ray
date
C0011008 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C0039985 (UMLS CUI [1,2])
Chest x-ray
Item
Chest x-ray not done
boolean
C0039985 (UMLS CUI [1])
Chest x-ray interpretation
Item
Chest x-ray interpretation
text
C0039985 (UMLS CUI [1,1])
C0420833 (UMLS CUI [1,2])
C0420833 (UMLS CUI [1,2])
Chest x-ray
Item
Chest x-ray, if abnormal, please specify
text
C0039985 (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
Head and Neck examination
integer
C0460004 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Not done (2)
CL Item
Abnormal (specify) (3)
Head/neck
Item
Head and Neck examination,if abnormal please specify
text
C0460004 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Not done (2)
CL Item
Abnormal (specify) (3)
ENT
Item
Ear-Nose-Throat examination,if abnormal,please specify
text
C0029896 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (specify) (2)
CL Item
Not done (3)
Eyes
Item
Eyes please specify if abnormal
text
C0015392 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Not done (2)
CL Item
Abnormal (specify) (3)
Item
Lungs/chest examination
integer
C3260980 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Not done (2)
CL Item
Abnormal (specify) (3)
CL Item
Normal (1)
CL Item
Not done (2)
CL Item
Abnormal (specify) (3)
Item
Abdominal examination if abnormal, please specify
text
C0562238 (UMLS CUI [1])
Item
Examination of extremities and back
integer
C0436150 (UMLS CUI [1,1])
C2195214 (UMLS CUI [1,2])
C2195214 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Not done (2)
CL Item
Abnormal (specify) (3)
Item
Examination of extremities and back if abnormal, please specify
text
C0436150 (UMLS CUI [1,1])
C2195214 (UMLS CUI [1,2])
C2195214 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Not done (2)
CL Item
Abnormal (specify) (3)
Item
Examination of lymph nodes, if abnormal please specify
text
C0562297 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Not done (2)
CL Item
Abnormal (specify) (3)
CL Item
Normal (1)
CL Item
Not done (2)
CL Item
Abnormal (specify) (3)
Neurological Examination
Item
Neurological Examination,if abnormal please specify
text
C0437208 (UMLS CUI [1])
Other Examination
Item
Other Examination, please specify Body system
text
C0260879 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Not done (2)
CL Item
Abnormal (specify) (3)
Other Examination
Item
Other Examination, if abnormal please specify
text
C0260879 (UMLS CUI [1])
neurological exam
Item
Complete neurological exam performed?
boolean
C0027853 (UMLS CUI [1])
neurological exam
Item
Complete neurological exam performed? If "no", please specify
text
C0027853 (UMLS CUI [1])
Comorbidities
Item
Additional (not MS-related) findings, that may influence the neurological exam?
boolean
C0009488 (UMLS CUI [1])
Comorbidities
Item
Additional (not MS-related) findings, that may influence the neurological exam? If yes, please specify
boolean
C0009488 (UMLS CUI [1])
Item
EDSS: Visual System Score
text
C0451246 (UMLS CUI [1,1])
C1321512 (UMLS CUI [1,2])
C1321512 (UMLS CUI [1,2])
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
EDSS visual converted
Item
EDSS visual converted 0-4
integer
C0451246 (UMLS CUI [1,1])
C1321512 (UMLS CUI [1,2])
C1321512 (UMLS CUI [1,2])
EDSS Brainstem
Item
EDSS score Brainstem 0-5
integer
C0451246 (UMLS CUI [1,1])
C0006121 (UMLS CUI [1,2])
C0006121 (UMLS CUI [1,2])
EDSS Pyramidal
Item
EDSS score Pyramidal 0-6
integer
C0451246 (UMLS CUI [1,1])
C0228060 (UMLS CUI [1,2])
C0228060 (UMLS CUI [1,2])
EDSS Cerebellar
Item
EDSS score Cerebellar 0-5
integer
C0451246 (UMLS CUI [1,1])
C0007765 (UMLS CUI [1,2])
C0007765 (UMLS CUI [1,2])
EDSS Sensory
Item
EDSS score Sensory 0-6
integer
C0451246 (UMLS CUI [1,1])
C0445254 (UMLS CUI [1,2])
C0445254 (UMLS CUI [1,2])
EDSS Bladder/Bowel
Item
EDSS score Bladder/Bowel 0-6
integer
C0451246 (UMLS CUI [1,1])
C2707247 (UMLS CUI [1,2])
C2707247 (UMLS CUI [1,2])
EDSS Bladder/Bowel converted
Item
EDSS score Bladder/Bowel converted 0-5
integer
C0451246 (UMLS CUI [1,1])
C2707247 (UMLS CUI [1,2])
C2707247 (UMLS CUI [1,2])
EDSS Cerebral/Mental
Item
EDSS score Cerebral/Mental 0,1a,1b,2-5
integer
C0451246 (UMLS CUI [1,1])
C3829397 (UMLS CUI [1,2])
C3829397 (UMLS CUI [1,2])
Ambulation
Item
Was ambulation evaluated?
boolean
C0080331 (UMLS CUI [1])
Ambulation
Item
If ambulation was not evaluated, please specify. Otherwise continue with section A,B or C
text
C0080331 (UMLS CUI [1])
Item
"A": Actual distance without rest or assistance in meters
integer
C0080331 (UMLS CUI [1,1])
C1521721 (UMLS CUI [1,2])
C1521721 (UMLS CUI [1,2])
Code List
"A": Actual distance without rest or assistance in meters
CL Item
>=100-<200 (1)
CL Item
>=200-<300 (2)
CL Item
>=300-<500 (3)
CL Item
>=500 (4)
Item
"B": Needs unilateral assistance to walk up to 100m
integer
C0205092 (UMLS CUI [1,1])
C0036605 (UMLS CUI [1,2])
C0036605 (UMLS CUI [1,2])
CL Item
<50m (1)
CL Item
>50m (2)
Item
"C": Needs bilateral assistance to walk up to 100m
integer
C0238767 (UMLS CUI [1,1])
C0036605 (UMLS CUI [1,2])
C0036605 (UMLS CUI [1,2])
CL Item
<10 (1)
CL Item
>=10-<120 (2)
CL Item
>=120 (3)
Ambulation index
Item
Ambulation index
integer
C0080331 (UMLS CUI [1,1])
C0918012 (UMLS CUI [1,2])
C0918012 (UMLS CUI [1,2])
EDSS
Item
Actual EDSS
integer
C0451246 (UMLS CUI [1])
EDSS converted
Item
EDSS converted
integer
C0451246 (UMLS CUI [1])
EDSS score
Item
EDSS score
float
C0451246 (UMLS CUI [1])
Ankle-Foot-Orthosis
Item
Did the subject wear an Ankle-Foot-Orthosis?
boolean
C0182083 (UMLS CUI [1])
Assistive device
Item
Was assistive device used?
boolean
C0036605 (UMLS CUI [1])
CL Item
unilateral assisstance (1)
CL Item
bilateral assistance (2)
Item
Type of assistive device
integer
C0036605 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
CL Item
Cane (1)
CL Item
crutch (2)
CL Item
Walker/rollator (bilateral only) (3)
CL Item
other (specify) (4)
Other assistive device
Item
Please specify other assistive device used
text
C0036605 (UMLS CUI [1])
Time 25-Foot Walk Trial 1
Item
Timed 25-Foot Walk: Time Trial 1
float
C0430517 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Timed 25-foot walk performance
Item
For a complete trial, please record any circumstances that affected the subjects performance
text
C0430517 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0522485 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0522485 (UMLS CUI [1,3])
Item
Timed 25-Foot Walk: not completed Trial 1
integer
C0430517 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
CL Item
Unable due to physical limitations (1)
CL Item
Other (2)
Timed 25-Foot Walk: not completed Trial 1
Item
Timed 25-Foot Walk: not completed Trial 1 specify physical limitations and/or other reason
text
C0430517 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
Time 25-Foot Walk Trial 2
Item
Timed 25-Foot Walk: Time Trial 2
float
C0430517 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Timed 25-foot walk performance
Item
For a completed trial,record any circumstances that affected the subjects performance
text
C0430517 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0522485 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0522485 (UMLS CUI [1,3])
Item
Timed 25-Foot Walk: not completed Trial 2
integer
C0430517 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
CL Item
Unable due to physical limitations (1)
CL Item
Other (2)
Timed 25-Foot Walk: not completed Trial 2
Item
Timed 25-Foot Walk: not completed Trial 2 specify physical limitations and/or other reason
text
C0430517 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
Walk test
Item
Did it take more than 2 attempts to get two successful trials?
boolean
C0430517 (UMLS CUI [1])
Walk test
Item
If it took more than two attempts, please specify reason(s) why trial had to be repeated
text
C0430517 (UMLS CUI [1])
MS diagnosis
Item
Does the subject have a confirmed and documented MS diagnosis as defined by the revised McDonald criteria [Ann Neuro] 2005:58:840-846], with a relapsing-remitting disease course?
boolean
C0011900 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C0026769 (UMLS CUI [1,2])
Ambulation status
Item
Is the subject ambulatory with converted Kurtzke EDSS score of 0-5.5?
boolean
C0080331 (UMLS CUI [1])
Stable condition
Item
Has the subject been in stable neurological condition for 30 days prior to screening (month-1)
boolean
C0205360 (UMLS CUI [1])
Steroid treatment
Item
Has the subject been free of corticosteroid treatment [intravenous (iv), intramuscular (im), and/or per os (po)] for 30 days prior to screening (month-1)?
boolean
C0149783 (UMLS CUI [1])
Recurrent disease
Item
Has the subject experienced one of the following: -at least one documented relapse in the 12 months prior to screening -at least two documented relapses in the 24 months prior to screening -one documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening
boolean
C0751967 (UMLS CUI [1])
Age
Item
Is the subject between 18 Years and 55 Years of age,inclusive?
boolean
C0001779 (UMLS CUI [1])
Disease duration
Item
Does the subject have a disease duration of at least 6 months (from the first symptom) prior to screening?
boolean
C0872146 (UMLS CUI [1])
Female of childbearing age with adequate contraceptive methods
Item
Is the subject a woman of childbearing potential who practices an acceptable method of birth control [ acceptable methods of birth control in this study include: surgical sterilization,intrauterine devices,oral contraceptives,contraceptive patch,long-acting injectable contraceptive,partners vasectomy, or double barrier method (condom or diaphragm with spermicide)]?
boolean
C1960468 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,2])
Informed consent
Item
Is the subject able to sign and date a written informed consentprior to entering this study?
boolean
C0021430 (UMLS CUI [1])
Compliance behavior
Item
Is the subject willing and able to comply with the protocol requirements for the dureation of the study?
boolean
C1321605 (UMLS CUI [1])
Progressive MS
Item
Does the subject have a progressive form of MS?
boolean
C0751964 (UMLS CUI [1])
Study subject participation status
Item
Has the subject used experimental or investigational drugs and/or participated in drug clinical studies within the 6 months prior to the screening visit?
boolean
C2348568 (UMLS CUI [1])
Cytotoxic agents or Immunosuppressive agents
Item
Has the subject used immunosuppressive (including Mitoxantrone-NovantroneⓇ) or cytotoxic agents within 6 months prior to the screening visit?
boolean
C0304497 (UMLS CUI [1,1])
C0021081 (UMLS CUI [1,2])
C0021081 (UMLS CUI [1,2])
Natalizumab (TysabriⓇ), Cladribine, Laquinimod
Item
Has the subject previously used either of the following: Natalizumab (TysabriⓇ), Cladribine, Laquinimod?
boolean
C1172734 (UMLS CUI [1])
C0092801 (UMLS CUI [2])
C1260208 (UMLS CUI [3])
C0092801 (UMLS CUI [2])
C1260208 (UMLS CUI [3])
glatiramer acetate, Interferon-beta or Ivig
Item
Has the subject had a previous treatment with glatiramer acetate,Interferon-beta (either 1a or 1b) or IVIG, within 2 months prior to screening visit?
boolean
C0289884 (UMLS CUI [1])
C0015980 (UMLS CUI [2])
C0085297 (UMLS CUI [3])
C0015980 (UMLS CUI [2])
C0085297 (UMLS CUI [3])
Systemic steroid treatment
Item
Has the subject had systemic chronic corticosteroid treatment (30 or more consecutive days) within 2 months prior to screening visit?
boolean
C0149783 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,2])
Total body irradiation, total lymphoid irradiation
Item
Has the subject had previous total body irradiation or total lymphoid irradiation?
boolean
C0043162 (UMLS CUI [1])
C0024230 (UMLS CUI [2])
C0024230 (UMLS CUI [2])
Stem cell transplant, autologous bone marrow transplant or allogeneic bone marrow transplant
Item
Has the subject had previous stem cell treatment, autologous bone marrow transplantation or allogeneic bone marrow transplantation
boolean
C1504389 (UMLS CUI [1])
C0194037 (UMLS CUI [2])
C0149615 (UMLS CUI [3])
C0194037 (UMLS CUI [2])
C0149615 (UMLS CUI [3])
History of tuberculosis
Item
Does the subject have a known history of tuberculosis
boolean
C0375796 (UMLS CUI [1])
Eligibility
Item
Please confirm if this exclusion criteria in the amendment was approved
boolean
C0013893 (UMLS CUI [1])
Vascular thrombosis
Item
If not: Does the subject have a history of vascular thrombosis (excluding catheter site superficial venous thrombophlebitis)?
boolean
C0040053 (UMLS CUI [1])
Eligibility
Item
Please confirm if this exclusion criteria in the amendment was approved
boolean
C0013893 (UMLS CUI [1])
Factor V Leiden
Item
If not: Does the subject have a carrier state of factor V Leiden mutation (either homo- or heterozygous as disclosed at screening)?
boolean
C0380964 (UMLS CUI [1])
Eligibility determination:HIV positivity
Item
If this exclusion criteria in the amendment was approved: Does the subject have known human imunodefiency virus (HIV) positive status?
boolean
C0013893 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
C0019699 (UMLS CUI [2])
Screening test:HIV, Hepatitis B,Hepatitis C
Item
If not: Does the subject have a positive screening test for Hepatitits B surface antigen, Hepatitis C antibodies, or HIV antibodies as disclosed at screening visit?
boolean
C0871311 (UMLS CUI [1,1])
C0019683 (UMLS CUI [1,2])
C0019168 (UMLS CUI [1,3])
C0166049 (UMLS CUI [1,4])
C0019683 (UMLS CUI [1,2])
C0019168 (UMLS CUI [1,3])
C0166049 (UMLS CUI [1,4])
Amiodarone
Item
Has the subject used amiodarone within 2 years prior to screening visit?
boolean
C0002598 (UMLS CUI [1])
Item
Is the subject pregnant or breastfeeding?
integer
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
NR (3)
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])
Hypersensitivity Gadolinium
Item
Does the subject have a known history of sensitivity to GD?
boolean
C0020517 (UMLS CUI [1,1])
C0016911 (UMLS CUI [1,2])
C0016911 (UMLS CUI [1,2])
Compliance behavior limited comorbidity
Item
Is the subject unable to successfully undergo MRI scanning?
boolean
C1321605 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
Hypersensitivity
Item
Does the subject have a known drug hypersensitivity that would preclude administration of Laquinimod such as hypersensitivity to mannitol, meglumine or sodium stearyl fumarate
boolean
C0020517 (UMLS CUI [1,1])
C0024730 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0025179 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1509821 (UMLS CUI [3,2])
C0024730 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0025179 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1509821 (UMLS CUI [3,2])
PBMC
Item
Will the subject participate in the ancillary PBMC study?
boolean
C1321301 (UMLS CUI [1])
Immune system proteins, serum cytokines and antibodies
Item
Will the subject participate in the ancillary study of Immune system proteins, serum cytokines and antibodies
boolean
C3516434 (UMLS CUI [1])
C1544815 (UMLS CUI [2])
C0003241 (UMLS CUI [3])
C1544815 (UMLS CUI [2])
C0003241 (UMLS CUI [3])
mRNA
Item
Will the subject participate in the ancillary mRNA study?
boolean
C0035696 (UMLS CUI [1])
PGx
Item
Will the subject participate in the ancillary PGx study?
boolean
C1138555 (UMLS CUI [1])
MRI
Item
Will the subject participate in frequent MRI?
boolean
C0024485 (UMLS CUI [1])
Magnetization Transfer MRI
Item
Will the subject participate in magnetization Transfer MRI ?
boolean
C3898476 (UMLS CUI [1])
Magnetic resonance spectroscopy MRI
Item
Will the subject participate in magnetic resonance spectroscopy MRI?
boolean
C2315284 (UMLS CUI [1])
Informed consent
Item
Was written informed consent for pharmacogenetics obtained?
boolean
C0021430 (UMLS CUI [1])
Date of informed consent
Item
If yes, please give the date of informed consent
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
Informed consent
Item
If informed consent was not obtained, please specify reason
text
C0021430 (UMLS CUI [1])
Country of birth
Item
Country of birth
text
C1300001 (UMLS CUI [1])
Item
Did you immigrate from your birth country?
integer
C0682133 (UMLS CUI [1])
CL Item
yes (1)
CL Item
no (2)
CL Item
do not wish to provide information (3)
Immigration status
Item
If yes, please specify year(s) and place(s)
text
C0682133 (UMLS CUI [1])
CL Item
yes (1)
CL Item
no (2)
CL Item
do not wish to provide information (3)
Family MS history
Item
If yes, please specify how many near relatives (next of kin) with MS?
integer
C0455388 (UMLS CUI [1])
Family MS history
Item
Please specify relationship
text
C0455388 (UMLS CUI [1])
Family MS history
Item
How many other relatives with MS
integer
C0455388 (UMLS CUI [1])
Family MS history
Item
Please specify relationship
text
C0455388 (UMLS CUI [1])
Item
Additional family history of autoimmune diseases (not including MS)
integer
C0004364 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,2])
Code List
Additional family history of autoimmune diseases (not including MS)
CL Item
yes (1)
CL Item
no (2)
CL Item
do not wish to provide information (3)
Autoimmune diseases family history
Item
If yes, please specify how many near relatives (next of kin) with autoimmune disease(s)?
integer
C0004364 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,2])
Autoimmune diseases family history
Item
Please specify autoimmune disease(s)
text
C0004364 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,2])
Autoimmune diseases family history
Item
If yes, please specify how many other relatives with autoimmune disease(s)?
integer
C0004364 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,2])
Autoimmune diseases family history
Item
Please specify autoimmune disease(s)
text
C0004364 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,2])
Eligibility determination
Item
Does the subject qualify to continue this clinical trial?
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])
Section name
Item
Section/Module name
text
C3533179 (UMLS CUI [1])
Deviation
Item
Deviation
boolean
C1705236 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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