ID
43297
Description
ODM derived from http://clinicaltrials.gov/show/NCT01194570
Link
http://clinicaltrials.gov/show/NCT01194570
Keywords
Versions (2)
- 3/19/13 3/19/13 - Martin Dugas
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT01194570 Multiple Sclerosis, Primary Progressive
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Description
History of relapsing remitting multiple sclerosis, secondary progressive, or progressive relapsing multiple sclerosis at screening
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0751967
- SNOMED CT 2011_0131
- 426373005
- MedDRA 14.1
- 10063399
- UMLS CUI 2011AA
- C0751965
- SNOMED CT 2011_0131
- 425500002
- MedDRA 14.1
- 10063400
- UMLS CUI 2011AA
- C0393666
- SNOMED CT 2011_0131
- 230374002
- MedDRA 14.1
- 10067063
- UMLS CUI 2011AA
- C1409616
Description
Contraindications for Magnetic Resonance Imaging (MRI)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1301624
- SNOMED CT 2011_0131
- 397745006
- UMLS CUI 2011AA
- C0024485
- SNOMED CT 2011_0131
- 113091000
- MedDRA 14.1
- 10028049
Description
Known presence of other neurologic disorders
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0150312
- SNOMED CT 2011_0131
- 52101004
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0027765
- SNOMED CT 2011_0131
- 118940003
- MedDRA 14.1
- 10029202
- ICD-10-CM Version 2010
- G98.8
- ICD-9-CM Version 2011
- 349.9
Description
Known active infection or history of or presence of recurrent or chronic infection
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0205191
- SNOMED CT 2011_0131
- 90734009
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- UMLS CUI 2011AA
- C0239998
- MedDRA 14.1
- 10067860
Description
History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C2735088
- LOINC Version 232
- MTHU034770
- UMLS CUI 2011AA
- C0280100
- MedDRA 14.1
- 10065252
- UMLS CUI 2011AA
- C0376545
- SNOMED CT 2011_0131
- 129154003
- MedDRA 14.1
- 10066476
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0007117
- SNOMED CT 2011_0131
- 1338007, 254701007
- MedDRA 14.1
- 10004146
- UMLS CUI 2011AA
- C0334245
- SNOMED CT 2011_0131
- 59529006
- MedDRA 14.1
- 10022782
- UMLS CUI 2011AA
- C0851140
- SNOMED CT 2011_0131
- 92564006
- MedDRA 14.1
- 10061809
- ICD-10-CM Version 2010
- D06.9
- ICD-9-CM Version 2011
- 233.1
- UMLS CUI 2011AA
- C0728940
- SNOMED CT 2011_0131
- 65801008
- UMLS CUI 2011AA
- C1514893
Description
Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514463
- UMLS CUI 2011AA
- C0004561
- SNOMED CT 2011_0131
- 112130006
- LOINC Version 232
- MTHU002435
- UMLS CUI 2011AA
- CL421608
- UMLS CUI 2011AA
- C0732355
- SNOMED CT 2011_0131
- 386919002
- UMLS CUI 2011AA
- C1882138
- UMLS CUI 2011AA
- C2351058
- UMLS CUI 2011AA
- C1723401
- SNOMED CT 2011_0131
- 449043000
- UMLS CUI 2011AA
- C1832027
- SNOMED CT 2011_0131
- 444609007
Description
Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-CD4, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514463
- UMLS CUI 2011AA
- C0024264
- SNOMED CT 2011_0131
- 56972008
- MedDRA 14.1
- 10025263
- LOINC Version 232
- MTHU004645
- UMLS CUI 2011AA
- C0599896
- UMLS CUI 2011AA
- C0243077
- UMLS CUI 2011AA
- C0383429
- SNOMED CT 2011_0131
- 391864003
- UMLS CUI 2011AA
- C0003250
- SNOMED CT 2011_0131
- 49616005
- UMLS CUI 2011AA
- C0521124
- SNOMED CT 2011_0131
- 65897001
- UMLS CUI 2011AA
- C1332714
- UMLS CUI 2011AA
- C0092801
- SNOMED CT 2011_0131
- 386916009
- UMLS CUI 2011AA
- C0010583
- SNOMED CT 2011_0131
- 387420009
- LOINC Version 232
- MTHU029970
- UMLS CUI 2011AA
- C0026259
- SNOMED CT 2011_0131
- 386913001
- UMLS CUI 2011AA
- C0004482
- SNOMED CT 2011_0131
- 372574004
- LOINC Version 232
- MTHU006794
- UMLS CUI 2011AA
- C0209368
- SNOMED CT 2011_0131
- 386976000
- UMLS CUI 2011AA
- C0010592
- SNOMED CT 2011_0131
- 387467008
- LOINC Version 232
- MTHU005140
- UMLS CUI 2011AA
- C0025677
- SNOMED CT 2011_0131
- 387381009
- LOINC Version 232
- MTHU005020
- UMLS CUI 2011AA
- C0043162
- SNOMED CT 2011_0131
- 47479005
- UMLS CUI 2011AA
- C0005961
- SNOMED CT 2011_0131
- 23719005
- MedDRA 14.1
- 10061730
- ICD-9-CM Version 2011
- 41.00
Description
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0243087
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0205191
- SNOMED CT 2011_0131
- 90734009
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0205373
- SNOMED CT 2011_0131
- 31099001
- UMLS CUI 2011AA
- C0001617
- SNOMED CT 2011_0131
- 79440004
- UMLS CUI 2011AA
- C0021081
- SNOMED CT 2011_0131
- 372823004, 69431002
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Eligibility
- StudyEvent: Eligibility
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C0086582 (UMLS CUI 2011AA)
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M (HL7 V3 2006_05)
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C0035150 (UMLS CUI 2011AA)
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C0027552 (UMLS CUI 2011AA)
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426373005 (SNOMED CT 2011_0131)
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230374002 (SNOMED CT 2011_0131)
10067063 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
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113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
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74964007 (SNOMED CT 2011_0131)
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
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349.9 (ICD-9-CM Version 2011)
55561003 (SNOMED CT 2011_0131)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
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10067860 (MedDRA 14.1)
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10004146 (MedDRA 14.1)
C0334245 (UMLS CUI 2011AA)
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10022782 (MedDRA 14.1)
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92564006 (SNOMED CT 2011_0131)
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D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C1514893 (UMLS CUI 2011AA)
C0004561 (UMLS CUI 2011AA)
112130006 (SNOMED CT 2011_0131)
MTHU002435 (LOINC Version 232)
CL421608 (UMLS CUI 2011AA)
C0732355 (UMLS CUI 2011AA)
386919002 (SNOMED CT 2011_0131)
C1882138 (UMLS CUI 2011AA)
C2351058 (UMLS CUI 2011AA)
C1723401 (UMLS CUI 2011AA)
449043000 (SNOMED CT 2011_0131)
C1832027 (UMLS CUI 2011AA)
444609007 (SNOMED CT 2011_0131)
C0024264 (UMLS CUI 2011AA)
56972008 (SNOMED CT 2011_0131)
10025263 (MedDRA 14.1)
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C0599896 (UMLS CUI 2011AA)
C0243077 (UMLS CUI 2011AA)
C0383429 (UMLS CUI 2011AA)
391864003 (SNOMED CT 2011_0131)
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49616005 (SNOMED CT 2011_0131)
C0521124 (UMLS CUI 2011AA)
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C1332714 (UMLS CUI 2011AA)
C0092801 (UMLS CUI 2011AA)
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23719005 (SNOMED CT 2011_0131)
10061730 (MedDRA 14.1)
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