ID
4394
Description
ODM derived from http://clinicaltrials.gov/show/NCT00883337
Link
http://clinicaltrials.gov/show/NCT00883337
Keywords
Versions (3)
- 12/9/13 12/9/13 - Martin Dugas
- 4/17/14 4/17/14 - Julian Varghese
- 9/20/21 9/20/21 -
Uploaded on
December 9, 2013
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0 Legacy
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Eligibility NCT00883337 Multiple Sclerosis
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Description
Patients with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0221099
- SNOMED CT 2011_0131
- 260379002
- UMLS CUI 2011AA
- C0005953
- SNOMED CT 2011_0131
- 14016003
- LOINC Version 232
- MTHU016536
- UMLS CUI 2011AA
- C0542341
- SNOMED CT 2011_0131
- 246464006
- UMLS CUI 2011AA
- C0002871
- SNOMED CT 2011_0131
- 271737000
- MedDRA 14.1
- 10002034
- LOINC Version 232
- MTHU020823
- ICD-10-CM Version 2010
- D64.9
- ICD-9-CM Version 2011
- 285.9
- CTCAE 1105E
- E10010
- UMLS CUI 2011AA
- C0023530
- SNOMED CT 2011_0131
- 84828003
- MedDRA 14.1
- 10024384
- ICD-10-CM Version 2010
- D72.819
- ICD-9-CM Version 2011
- 288.50
- CTCAE 1105E
- E12232
- UMLS CUI 2011AA
- C0040034
- SNOMED CT 2011_0131
- 302215000
- MedDRA 14.1
- 10043554
- ICD-10-CM Version 2010
- D69.6
- ICD-9-CM Version 2011
- 287.5
- CTCAE 1105E
- E12207
Description
Persistent significant or severe infection
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1264606
- SNOMED CT 2011_0131
- 115648009
- UMLS CUI 2011AA
- C0205082
- SNOMED CT 2011_0131
- 24484000
- UMLS CUI 2011AA
- C0021311
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
Description
Liver function impairment or known history of hepatitis
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0086565
- SNOMED CT 2011_0131
- 75183008
- MedDRA 14.1
- 10019670
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0019158
- SNOMED CT 2011_0131
- 29001004
- MedDRA 14.1
- 10019717
Description
Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 2 weeks prior to randomization
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0001655
- SNOMED CT 2011_0131
- 40789008
- LOINC Version 232
- MTHU003098
- UMLS CUI 2011AA
- C0205373
- SNOMED CT 2011_0131
- 31099001
- UMLS CUI 2011AA
- C0001617
- SNOMED CT 2011_0131
- 79440004
Description
Human immunodeficiency virus (HIV) positive patients
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0019699
- SNOMED CT 2011_0131
- 165816005
- MedDRA 14.1
- 10020188
- ICD-10-CM Version 2010
- Z21
Description
Prior use of Rebif, or prior or concomitant use of other interferons in the 3 months prior to randomization
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0982234
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0021747
- SNOMED CT 2011_0131
- 49327004
- LOINC Version 232
- MTHU021353
Description
Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, or natalizumab
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0092801
- SNOMED CT 2011_0131
- 386916009
- UMLS CUI 2011AA
- C0026259
- SNOMED CT 2011_0131
- 386913001
- UMLS CUI 2011AA
- C0021081
- SNOMED CT 2011_0131
- 372823004, 69431002
- UMLS CUI 2011AA
- C0004482
- SNOMED CT 2011_0131
- 372574004
- LOINC Version 232
- MTHU006794
- UMLS CUI 2011AA
- C0010583
- SNOMED CT 2011_0131
- 387420009
- LOINC Version 232
- MTHU029970
- 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
- C0883242
- LOINC Version 232
- MTHU011568
- UMLS CUI 2011AA
- C0665297
- SNOMED CT 2011_0131
- 414804006
Description
Pregnant or breast-feeding women
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
Similar models
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
426373005 (SNOMED CT 2011_0131)
10063399 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0679228 (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)
C0451246 (UMLS CUI 2011AA)
273554001 (SNOMED CT 2011_0131)
55149002 (SNOMED CT 2011_0131)
C2348583 (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)
C0002871 (UMLS CUI 2011AA)
271737000 (SNOMED CT 2011_0131)
10002034 (MedDRA 14.1)
MTHU020823 (LOINC Version 232)
D64.9 (ICD-10-CM Version 2010)
285.9 (ICD-9-CM Version 2011)
E10010 (CTCAE 1105E)
C0023530 (UMLS CUI 2011AA)
84828003 (SNOMED CT 2011_0131)
10024384 (MedDRA 14.1)
D72.819 (ICD-10-CM Version 2010)
288.50 (ICD-9-CM Version 2011)
E12232 (CTCAE 1105E)
C0040034 (UMLS CUI 2011AA)
302215000 (SNOMED CT 2011_0131)
10043554 (MedDRA 14.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
E12207 (CTCAE 1105E)
115648009 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
75183008 (SNOMED CT 2011_0131)
10019670 (MedDRA 14.1)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0019158 (UMLS CUI 2011AA)
29001004 (SNOMED CT 2011_0131)
10019717 (MedDRA 14.1)
260676000 (SNOMED CT 2011_0131)
C0001655 (UMLS CUI 2011AA)
40789008 (SNOMED CT 2011_0131)
MTHU003098 (LOINC Version 232)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
288556008 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0982234 (UMLS CUI 2011AA)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0021747 (UMLS CUI 2011AA)
49327004 (SNOMED CT 2011_0131)
MTHU021353 (LOINC Version 232)
260676000 (SNOMED CT 2011_0131)
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)
C0665297 (UMLS CUI 2011AA)
414804006 (SNOMED CT 2011_0131)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)