ID
43295
Description
ODM derived from http://clinicaltrials.gov/show/NCT01190839
Link
http://clinicaltrials.gov/show/NCT01190839
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 NCT01190839 Crohn's Disease
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Description
Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0205275
- SNOMED CT 2011_0131
- 44104002
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C1610637
- MedDRA 14.1
- 10064904
- UMLS CUI 2011AA
- C0019655
- SNOMED CT 2011_0131
- 12962009
- MedDRA 14.1
- 10020141
- ICD-10-CM Version 2010
- B39.9
- ICD-9-CM Version 2011
- 115.90
- UMLS CUI 2011AA
- C0262426
Description
Have a chest radiograph within 3 months prior to the first infusion of study agent that shows a clinically significant abnormality, such as a malignancy or infection, or any abnormalities suggestive of TB
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0436503
- SNOMED CT 2011_0131
- 168734001
- MedDRA 14.1
- 10008499
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- UMLS CUI 2011AA
- C1704258
- UMLS CUI 2011AA
- C0038659
- UMLS CUI 2011AA
- C0041296
- SNOMED CT 2011_0131
- 56717001
- MedDRA 14.1
- 10044755
- LOINC Version 232
- MTHU020835
- ICD-10-CM Version 2010
- A15-A19
- ICD-9-CM Version 2011
- 010-018.99
Description
Have macroscopically active CD which was not resected at the time of surgery
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0439806
- SNOMED CT 2011_0131
- 255344003
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0010346
- SNOMED CT 2011_0131
- 34000006
- MedDRA 14.1
- 10011401
- ICD-10-CM Version 2010
- K50.9
- UMLS CUI 2011AA
- C1518422
- UMLS CUI 2011AA
- C1521996
Description
Do not meet the criteria for being at an increased risk of postoperative recurrence of active CD as outlined in the inclusion criteria
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0332197
- SNOMED CT 2011_0131
- 2667000
- UMLS CUI 2011AA
- C0332167
- SNOMED CT 2011_0131
- 15508007
- UMLS CUI 2011AA
- C0241311
- UMLS CUI 2011AA
- C2825055
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0010346
- SNOMED CT 2011_0131
- 34000006
- MedDRA 14.1
- 10011401
- ICD-10-CM Version 2010
- K50.9
Description
Have evidence of an active infection at the time of randomization or have had a serious infection not related to CD (e.g., hepatitis, pneumonia, or pyelonephritis), within 6 months prior to screening
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0205404
- SNOMED CT 2011_0131
- 42745003
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- UMLS CUI 2011AA
- CL414700
- UMLS CUI 2011AA
- C0010346
- SNOMED CT 2011_0131
- 34000006
- MedDRA 14.1
- 10011401
- ICD-10-CM Version 2010
- K50.9
- UMLS CUI 2011AA
- C0019158
- SNOMED CT 2011_0131
- 29001004
- MedDRA 14.1
- 10019717
- UMLS CUI 2011AA
- C0032285
- SNOMED CT 2011_0131
- 233604007
- MedDRA 14.1
- 10035664
- LOINC Version 232
- MTHU020831
- ICD-10-CM Version 2010
- J18.9
- CTCAE 1105E
- E13502
- UMLS CUI 2011AA
- C0034186
- SNOMED CT 2011_0131
- 45816000
- MedDRA 14.1
- 10037596
- ICD-10-CM Version 2010
- N16
- ICD-9-CM Version 2011
- 590.80
- CTCAE 1105E
- E11431
Description
Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0029118
- SNOMED CT 2011_0131
- 61274003
- MedDRA 14.1
- 10030901
- UMLS CUI 2011AA
- C0019360
- SNOMED CT 2011_0131
- 4740000
- MedDRA 14.1
- 10019974
- ICD-10-CM Version 2010
- B02
- ICD-9-CM Version 2011
- 53
- UMLS CUI 2011AA
- C0010825
- SNOMED CT 2011_0131
- 407444007
- MedDRA 14.1
- 10009701
- LOINC Version 232
- MTHU033986
- UMLS CUI 2011AA
- C0032276
- UMLS CUI 2011AA
- C0004030
- SNOMED CT 2011_0131
- 65553006
- MedDRA 14.1
- 10003488
- ICD-10-CM Version 2010
- B44
- ICD-9-CM Version 2011
- 117.3
- UMLS CUI 2011AA
- C0019655
- SNOMED CT 2011_0131
- 12962009
- MedDRA 14.1
- 10020141
- ICD-10-CM Version 2010
- B39.9
- ICD-9-CM Version 2011
- 115.90
- UMLS CUI 2011AA
- C0026912
- SNOMED CT 2011_0131
- 243368001
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0041296
- SNOMED CT 2011_0131
- 56717001
- MedDRA 14.1
- 10044755
- LOINC Version 232
- MTHU020835
- ICD-10-CM Version 2010
- A15-A19
- ICD-9-CM Version 2011
- 010-018.99
Description
Have any known malignancy or history of malignancy within the 5-year period prior to screening (with the exception of squamous or basal cell carcinoma of the skin that has been completely excised without evidence of recurrence)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
- UMLS CUI 2011AA
- C2735088
- LOINC Version 232
- MTHU034770
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- C0553723
- SNOMED CT 2011_0131
- 254651007
- MedDRA 14.1
- 10041834
- UMLS CUI 2011AA
- C0007117
- SNOMED CT 2011_0131
- 1338007, 254701007
- MedDRA 14.1
- 10004146
- UMLS CUI 2011AA
- C0205197
- SNOMED CT 2011_0131
- 255594003
- UMLS CUI 2011AA
- C0728940
- SNOMED CT 2011_0131
- 65801008
Description
Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C0221099
- SNOMED CT 2011_0131
- 260379002
- UMLS CUI 2011AA
- C0018684
- SNOMED CT 2011_0131
- 263775005
- UMLS CUI 2011AA
- C0030705
- SNOMED CT 2011_0131
- 116154003
- UMLS CUI 2011AA
- CL414898
- UMLS CUI 2011AA
- C1321605
- SNOMED CT 2011_0131
- 405078008
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C1514873
Similar models
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
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K50.9 (ICD-10-CM Version 2010)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1444662 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
C0666743 (UMLS CUI 2011AA)
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MTHU018219 (LOINC Version 232)
CL414906 (UMLS CUI 2011AA)
C0919936 (UMLS CUI 2011AA)
10051259 (MedDRA 14.1)
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20135006 (SNOMED CT 2011_0131)
C0019169 (UMLS CUI 2011AA)
81665004 (SNOMED CT 2011_0131)
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273364009 (SNOMED CT 2011_0131)
88323005 (SNOMED CT 2011_0131)
C0005768 (UMLS CUI 2011AA)
C0023884 (UMLS CUI 2011AA)
10200004 (SNOMED CT 2011_0131)
MTHU002039 (LOINC Version 232)
C0022885 (UMLS CUI 2011AA)
15220000 (SNOMED CT 2011_0131)
10059938 (MedDRA 14.1)
C1522609 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205275 (UMLS CUI 2011AA)
44104002 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1610637 (UMLS CUI 2011AA)
10064904 (MedDRA 14.1)
C0019655 (UMLS CUI 2011AA)
12962009 (SNOMED CT 2011_0131)
10020141 (MedDRA 14.1)
B39.9 (ICD-10-CM Version 2010)
115.90 (ICD-9-CM Version 2011)
C0262426 (UMLS CUI 2011AA)
168734001 (SNOMED CT 2011_0131)
10008499 (MedDRA 14.1)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1704258 (UMLS CUI 2011AA)
C0038659 (UMLS CUI 2011AA)
C0041296 (UMLS CUI 2011AA)
56717001 (SNOMED CT 2011_0131)
10044755 (MedDRA 14.1)
MTHU020835 (LOINC Version 232)
A15-A19 (ICD-10-CM Version 2010)
010-018.99 (ICD-9-CM Version 2011)
255344003 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C1518422 (UMLS CUI 2011AA)
C1521996 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0241311 (UMLS CUI 2011AA)
C2825055 (UMLS CUI 2011AA)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
55561003 (SNOMED CT 2011_0131)
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
CL414700 (UMLS CUI 2011AA)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0019158 (UMLS CUI 2011AA)
29001004 (SNOMED CT 2011_0131)
10019717 (MedDRA 14.1)
C0032285 (UMLS CUI 2011AA)
233604007 (SNOMED CT 2011_0131)
10035664 (MedDRA 14.1)
MTHU020831 (LOINC Version 232)
J18.9 (ICD-10-CM Version 2010)
E13502 (CTCAE 1105E)
C0034186 (UMLS CUI 2011AA)
45816000 (SNOMED CT 2011_0131)
10037596 (MedDRA 14.1)
N16 (ICD-10-CM Version 2010)
590.80 (ICD-9-CM Version 2011)
E11431 (CTCAE 1105E)
61274003 (SNOMED CT 2011_0131)
10030901 (MedDRA 14.1)
C0019360 (UMLS CUI 2011AA)
4740000 (SNOMED CT 2011_0131)
10019974 (MedDRA 14.1)
B02 (ICD-10-CM Version 2010)
53 (ICD-9-CM Version 2011)
C0010825 (UMLS CUI 2011AA)
407444007 (SNOMED CT 2011_0131)
10009701 (MedDRA 14.1)
MTHU033986 (LOINC Version 232)
C0032276 (UMLS CUI 2011AA)
C0004030 (UMLS CUI 2011AA)
65553006 (SNOMED CT 2011_0131)
10003488 (MedDRA 14.1)
B44 (ICD-10-CM Version 2010)
117.3 (ICD-9-CM Version 2011)
C0019655 (UMLS CUI 2011AA)
12962009 (SNOMED CT 2011_0131)
10020141 (MedDRA 14.1)
B39.9 (ICD-10-CM Version 2010)
115.90 (ICD-9-CM Version 2011)
C0026912 (UMLS CUI 2011AA)
243368001 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0041296 (UMLS CUI 2011AA)
56717001 (SNOMED CT 2011_0131)
10044755 (MedDRA 14.1)
MTHU020835 (LOINC Version 232)
A15-A19 (ICD-10-CM Version 2010)
010-018.99 (ICD-9-CM Version 2011)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
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C00-C96 (ICD-10-CM Version 2010)
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254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C0007117 (UMLS CUI 2011AA)
1338007, 254701007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0018684 (UMLS CUI 2011AA)
263775005 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
CL414898 (UMLS CUI 2011AA)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)