ID

3750

Description

ODM derived from http://clinicaltrials.gov/show/NCT01190839

Link

http://clinicaltrials.gov/show/NCT01190839

Keywords

  1. 3/19/13 3/19/13 - Martin Dugas
  2. 9/20/21 9/20/21 -
Uploaded on

March 19, 2013

DOI

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License

Creative Commons BY 4.0

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Eligibility NCT01190839 Crohn's Disease

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Have a documented diagnosis of CD confirmed by endoscopic, histologic and/or radiologic studies prior to resection or by tissue obtained at resection
Description

Have a documented diagnosis of CD confirmed by endoscopic, histologic and/or radiologic studies prior to resection or by tissue obtained at resection

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0010346
SNOMED CT 2011_0131
34000006
MedDRA 14.1
10011401
ICD-10-CM Version 2010
K50.9
UMLS CUI 2011AA
C0750484
UMLS CUI 2011AA
C0014245
SNOMED CT 2011_0131
423827005
MedDRA 14.1
10014805
LOINC Version 232
MTHU008659
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0205483
SNOMED CT 2011_0131
5526005
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0728940
SNOMED CT 2011_0131
65801008
Have undergone an ileocolonic surgical resection
Description

Have undergone an ileocolonic surgical resection

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0728940
SNOMED CT 2011_0131
65801008
UMLS CUI 2011AA
C0677648
Patients must also be at an increased risk of recurrence of active CD
Description

Patients must also be at an increased risk of recurrence of active CD

Data type

boolean

Alias
UMLS CUI 2011AA
C0332167
SNOMED CT 2011_0131
15508007
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
Patients must not have previously discontinued infliximab as a result of tolerability issues or they must be naive to treatment with infliximab. Provided patients meet the above criteria pertaining to infliximab, they are eligible to enroll if they received prior treatment with adalimumab and/or certolizumab
Description

Patients must not have previously discontinued infliximab as a result of tolerability issues or they must be naive to treatment with infliximab. Provided patients meet the above criteria pertaining to infliximab, they are eligible to enroll if they received prior treatment with adalimumab and/or certolizumab

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1444662
SNOMED CT 2011_0131
410546004
UMLS CUI 2011AA
C0666743
SNOMED CT 2011_0131
386891004
LOINC Version 232
MTHU018219
UMLS CUI 2011AA
CL414906
UMLS CUI 2011AA
C0919936
MedDRA 14.1
10051259
Patients must undergo screening for HBV
Description

Patients must undergo screening for HBV

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0220908
SNOMED CT 2011_0131
20135006
UMLS CUI 2011AA
C0019169
SNOMED CT 2011_0131
81665004
Baseline CDAI < 200
Description

Baseline CDAI < 200

Data type

boolean

Alias
UMLS CUI 2011AA
C1442488
UMLS CUI 2011AA
C0451071
SNOMED CT 2011_0131
273364009
Have adequate blood and liver test values
Description

Have adequate blood and liver test values

Data type

boolean

Alias
UMLS CUI 2011AA
C0205411
SNOMED CT 2011_0131
88323005
UMLS CUI 2011AA
C0005768
UMLS CUI 2011AA
C0023884
SNOMED CT 2011_0131
10200004
LOINC Version 232
MTHU002039
UMLS CUI 2011AA
C0022885
SNOMED CT 2011_0131
15220000
MedDRA 14.1
10059938
UMLS CUI 2011AA
C1522609
Exclusion Criteria
Description

Exclusion Criteria

Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening
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
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
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
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
Have macroscopically active CD which was not resected at the time of surgery
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
Do not meet the criteria for being at an increased risk of postoperative recurrence of active CD as outlined in the inclusion criteria
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
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
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
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
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
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
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)
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
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.
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

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Have a documented diagnosis of CD confirmed by endoscopic, histologic and/or radiologic studies prior to resection or by tissue obtained at resection
Item
Have a documented diagnosis of CD confirmed by endoscopic, histologic and/or radiologic studies prior to resection or by tissue obtained at resection
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0750484 (UMLS CUI 2011AA)
C0014245 (UMLS CUI 2011AA)
423827005 (SNOMED CT 2011_0131)
10014805 (MedDRA 14.1)
MTHU008659 (LOINC Version 232)
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0205483 (UMLS CUI 2011AA)
5526005 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
Have undergone an ileocolonic surgical resection
Item
Have undergone an ileocolonic surgical resection
boolean
C1514756 (UMLS CUI 2011AA)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C0677648 (UMLS CUI 2011AA)
Patients must also be at an increased risk of recurrence of active CD
Item
Patients must also be at an increased risk of recurrence of active CD
boolean
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
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)
Patients must not have previously discontinued infliximab as a result of tolerability issues or they must be naive to treatment with infliximab. Provided patients meet the above criteria pertaining to infliximab, they are eligible to enroll if they received prior treatment with adalimumab and/or certolizumab
Item
Patients must not have previously discontinued infliximab as a result of tolerability issues or they must be naive to treatment with infliximab. Provided patients meet the above criteria pertaining to infliximab, they are eligible to enroll if they received prior treatment with adalimumab and/or certolizumab
boolean
C1518422 (UMLS CUI 2011AA)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1444662 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
C0666743 (UMLS CUI 2011AA)
386891004 (SNOMED CT 2011_0131)
MTHU018219 (LOINC Version 232)
CL414906 (UMLS CUI 2011AA)
C0919936 (UMLS CUI 2011AA)
10051259 (MedDRA 14.1)
Patients must undergo screening for HBV
Item
Patients must undergo screening for HBV
boolean
C1514756 (UMLS CUI 2011AA)
C0220908 (UMLS CUI 2011AA)
20135006 (SNOMED CT 2011_0131)
C0019169 (UMLS CUI 2011AA)
81665004 (SNOMED CT 2011_0131)
Baseline CDAI < 200
Item
Baseline CDAI < 200
boolean
C1442488 (UMLS CUI 2011AA)
C0451071 (UMLS CUI 2011AA)
273364009 (SNOMED CT 2011_0131)
Have adequate blood and liver test values
Item
Have adequate blood and liver test values
boolean
C0205411 (UMLS CUI 2011AA)
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)
Item Group
Exclusion Criteria
Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening
Item
Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening
boolean
CL421546 (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)
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
Item
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
boolean
C0436503 (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)
C0021311 (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)
Have macroscopically active CD which was not resected at the time of surgery
Item
Have macroscopically active CD which was not resected at the time of surgery
boolean
C0439806 (UMLS CUI 2011AA)
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)
Do not meet the criteria for being at an increased risk of postoperative recurrence of active CD as outlined in the inclusion criteria
Item
Do not meet the criteria for being at an increased risk of postoperative recurrence of active CD as outlined in the inclusion criteria
boolean
C0332197 (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)
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
Item
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
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0021311 (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)
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
Item
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
boolean
C0029118 (UMLS CUI 2011AA)
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)
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)
Item
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)
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0553723 (UMLS CUI 2011AA)
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)
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.
Item
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.
boolean
C0348080 (UMLS CUI 2011AA)
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)

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