Eligibility NCT00622700 Multiple Sclerosis

ODM derived from http://clinicaltrials.gov/show/NCT00622700

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 18 Years to 55 Years
Item
age 18 Years to 55 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
First acute or subacute, well-defined neurological event consistent with demyelination (i.e. optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes),
Item
First acute or subacute, well-defined neurological event consistent with demyelination (i.e. optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes),
boolean
C0205435 (UMLS CUI 2011AA)
255216001 (SNOMED CT 2011_0131)
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0205365 (UMLS CUI 2011AA)
19939008 (SNOMED CT 2011_0131)
C1320718 (UMLS CUI 2011AA)
405619009 (SNOMED CT 2011_0131)
C0332290 (UMLS CUI 2011AA)
385433004 (SNOMED CT 2011_0131)
C0011304 (UMLS CUI 2011AA)
32693004 (SNOMED CT 2011_0131)
10012305 (MedDRA 14.1)
C0029134 (UMLS CUI 2011AA)
66760008 (SNOMED CT 2011_0131)
10030942 (MedDRA 14.1)
H46.9 (ICD-10-CM Version 2010)
377.30 (ICD-9-CM Version 2011)
C0750484 (UMLS CUI 2011AA)
C1704292 (UMLS CUI 2011AA)
422234006 (SNOMED CT 2011_0131)
C0560648 (UMLS CUI 2011AA)
282784007 (SNOMED CT 2011_0131)
C1328447 (UMLS CUI 2011AA)
10063292 (MedDRA 14.1)
C0007760 (UMLS CUI 2011AA)
224186005 (SNOMED CT 2011_0131)
10008072 (MedDRA 14.1)
Onset of MS symptoms occurring within 90 days of randomization,
Item
Onset of MS symptoms occurring within 90 days of randomization,
boolean
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C0026769 (UMLS CUI 2011AA)
24700007 (SNOMED CT 2011_0131)
10028245 (MedDRA 14.1)
MTHU020805 (LOINC Version 232)
G35 (ICD-10-CM Version 2010)
340 (ICD-9-CM Version 2011)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
A screening MRI scan with 2 or more T2 lesions at least 3 mm in diameter that are characteristic of MS.
Item
A screening MRI scan with 2 or more T2 lesions at least 3 mm in diameter that are characteristic of MS.
boolean
C1409616 (UMLS CUI 2011AA)
C0917711 (UMLS CUI 2011AA)
C0475373 (UMLS CUI 2011AA)
67673008 (SNOMED CT 2011_0131)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C1301886 (UMLS CUI 2011AA)
81827009 (SNOMED CT 2011_0131)
MTHU002654 (LOINC Version 232)
C1521970 (UMLS CUI 2011AA)
C0026769 (UMLS CUI 2011AA)
24700007 (SNOMED CT 2011_0131)
10028245 (MedDRA 14.1)
MTHU020805 (LOINC Version 232)
G35 (ICD-10-CM Version 2010)
340 (ICD-9-CM Version 2011)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
Item
Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C1869009 (UMLS CUI 2011AA)
20000005 (MedDRA 14.1)
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
C0014130 (UMLS CUI 2011AA)
362969004 (SNOMED CT 2011_0131)
10014695 (MedDRA 14.1)
MTHU021570 (LOINC Version 232)
E34.9 (ICD-10-CM Version 2010)
259.9 (ICD-9-CM Version 2011)
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0442893 (UMLS CUI 2011AA)
56019007, 264578000 (SNOMED CT 2011_0131)
Significantly impaired bone marrow function,
Item
Significantly impaired bone marrow function,
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0542341 (UMLS CUI 2011AA)
246464006 (SNOMED CT 2011_0131)
Pregnancy or nursing,
Item
Pregnancy or nursing,
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Alcohol or drug abuse,
Item
Alcohol or drug abuse,
boolean
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment
Item
Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment
boolean
C0092801 (UMLS CUI 2011AA)
386916009 (SNOMED CT 2011_0131)
C0026259 (UMLS CUI 2011AA)
386913001 (SNOMED CT 2011_0131)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0004482 (UMLS CUI 2011AA)
372574004 (SNOMED CT 2011_0131)
MTHU006794 (LOINC Version 232)
C0010583 (UMLS CUI 2011AA)
387420009 (SNOMED CT 2011_0131)
MTHU029970 (LOINC Version 232)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)
C0025677 (UMLS CUI 2011AA)
387381009 (SNOMED CT 2011_0131)
MTHU005020 (LOINC Version 232)
C0883242 (UMLS CUI 2011AA)
MTHU011568 (LOINC Version 232)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.
Item
Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0680082 (UMLS CUI 2011AA)
C2700409 (UMLS CUI 2011AA)
CL102947 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)