ID
3750
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT01190839
Link
http://clinicaltrials.gov/show/NCT01190839
Palabras clave
Versiones (2)
- 19/3/13 19/3/13 - Martin Dugas
- 20/9/21 20/9/21 -
Subido en
19 de marzo de 2013
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY 4.0
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Eligibility NCT01190839 Crohn's Disease
Eligibility
- StudyEvent: Eligibility
Descripción
Exclusion Criteria
Descripción
Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening
Tipo de datos
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
Descripción
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
Tipo de datos
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
- C0021311
- 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
Descripción
Have macroscopically active CD which was not resected at the time of surgery
Tipo de datos
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
Descripción
Do not meet the criteria for being at an increased risk of postoperative recurrence of active CD as outlined in the inclusion criteria
Tipo de datos
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
Descripción
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
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0205404
- SNOMED CT 2011_0131
- 42745003
- UMLS CUI 2011AA
- C0021311
- 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
Descripción
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
Tipo de datos
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
Descripción
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)
Tipo de datos
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
Descripción
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.
Tipo de datos
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
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