age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Men and women at least 18 years of age.
Item
Men and women at least 18 years of age.
boolean
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
Baseline Crohn's Disease Activity Index (CDAI) 250-400.
Item
Baseline Crohn's Disease Activity Index (CDAI) 250-400.
boolean
C1442488 (UMLS CUI 2011AA)
C0451071 (UMLS CUI 2011AA)
273364009 (SNOMED CT 2011_0131)
Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy.
Item
Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy.
boolean
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0009319 (UMLS CUI 2011AA)
64226004 (SNOMED CT 2011_0131)
10009887 (MedDRA 14.1)
K52.9 (ICD-10-CM Version 2010)
E10521 (CTCAE 1105E)
C0020877 (UMLS CUI 2011AA)
52457000 (SNOMED CT 2011_0131)
10021312 (MedDRA 14.1)
K52.9 (ICD-10-CM Version 2010)
C0949272 (UMLS CUI 2011AA)
10062647 (MedDRA 14.1)
C0043299 (UMLS CUI 2011AA)
363680008 (SNOMED CT 2011_0131)
87 (ICD-9-CM Version 2011)
C0014245 (UMLS CUI 2011AA)
423827005 (SNOMED CT 2011_0131)
10014805 (MedDRA 14.1)
MTHU008659 (LOINC Version 232)
Those of childbearing potential were to use a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was recommended that two forms be used.
Item
Those of childbearing potential were to use a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was recommended that two forms be used.
boolean
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
C0042241 (UMLS CUI 2011AA)
20359006 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0025663 (UMLS CUI 2011AA)
260686004 (SNOMED CT 2011_0131)
MTHU024654 (LOINC Version 232)
Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to screening, with the following exceptions:
Item
Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to screening, with the following exceptions:
boolean
C0013227 (UMLS CUI 2011AA)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
those on methotrexate had to be on a stable dose for at least 4 weeks and not be receiving > 25 mg/wk
Item
those on methotrexate had to be on a stable dose for at least 4 weeks and not be receiving > 25 mg/wk
boolean
C0025677 (UMLS CUI 2011AA)
387381009 (SNOMED CT 2011_0131)
MTHU005020 (LOINC Version 232)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks
Item
those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks
boolean
C0004482 (UMLS CUI 2011AA)
372574004 (SNOMED CT 2011_0131)
MTHU006794 (LOINC Version 232)
C0000618 (UMLS CUI 2011AA)
386835005 (SNOMED CT 2011_0131)
MTHU002562 (LOINC Version 232)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205456 (UMLS CUI 2011AA)
3445001 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
those on steroids had to have been on steroids for at least 2 weeks and on a stable dose for those 2 weeks. They were not to be receiving > 20 mg/day prednisone or equivalent
Item
those on steroids had to have been on steroids for at least 2 weeks and on a stable dose for those 2 weeks. They were not to be receiving > 20 mg/day prednisone or equivalent
boolean
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0032952 (UMLS CUI 2011AA)
116602009 (SNOMED CT 2011_0131)
MTHU003245 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
those on mesalazine had to have been on for at least 6 weeks and on a stable dose for at least 2 weeks
Item
those on mesalazine had to have been on for at least 6 weeks and on a stable dose for at least 2 weeks
boolean
C0127615 (UMLS CUI 2011AA)
387501005 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
those on antibiotics for CD had to have been on for at least 2 weeks and on a stable dose for those 2 weeks
Item
those on antibiotics for CD had to have been on for at least 2 weeks and on a stable dose for those 2 weeks
boolean
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Any CD medication which had been discontinued was to have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which was to have been discontinued at least 8 weeks prior to screening.
Item
Any CD medication which had been discontinued was to have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which was to have been discontinued at least 8 weeks prior to screening.
boolean
C0010346 (UMLS CUI 2011AA)
34000006 (SNOMED CT 2011_0131)
10011401 (MedDRA 14.1)
K50.9 (ICD-10-CM Version 2010)
C0013227 (UMLS CUI 2011AA)
C1444662 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C0666743 (UMLS CUI 2011AA)
386891004 (SNOMED CT 2011_0131)
MTHU018219 (LOINC Version 232)
C0205454 (UMLS CUI 2011AA)
7319005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
The screening laboratory tests were to meet the following criteria:
Item
The screening laboratory tests were to meet the following criteria:
boolean
C1409616 (UMLS CUI 2011AA)
C0022885 (UMLS CUI 2011AA)
15220000 (SNOMED CT 2011_0131)
10059938 (MedDRA 14.1)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Hgb >= 8.5 g/dL (5.3 mmol/L) WBC 3.5-20 x 109/L Neutrophils >= 1.5 x 109/L Platelets >= 100 x 109/L ALT (SGPT) <1.5 x the upper limit of normal range Alkaline phosphatase <2.5 x the upper limit of normal range Bilirubin <25 mmol/L (1.5 mg/dl) Creatinine <110 mol/L (1.2 mg/dl)
Item
Hgb >= 8.5 g/dL (5.3 mmol/L) WBC 3.5-20 x 109/L Neutrophils >= 1.5 x 109/L Platelets >= 100 x 109/L ALT (SGPT) <1.5 x the upper limit of normal range Alkaline phosphatase <2.5 x the upper limit of normal range Bilirubin <25 mmol/L (1.5 mg/dl) Creatinine <110 mol/L (1.2 mg/dl)
boolean
C0518015 (UMLS CUI 2011AA)
10018876 (MedDRA 14.1)
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
C0200633 (UMLS CUI 2011AA)
30630007 (SNOMED CT 2011_0131)
10029363 (MedDRA 14.1)
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C0002059 (UMLS CUI 2011AA)
57056007 (SNOMED CT 2011_0131)
MTHU005195 (LOINC Version 232)
C0011221 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
C0010294 (UMLS CUI 2011AA)
15373003 (SNOMED CT 2011_0131)
10011358 (MedDRA 14.1)
38483-4 (LOINC Version 232)
Patients were to be able to adhere to the study visit schedule and/or protocol requirements.
Item
Patients were to be able to adhere to the study visit schedule and/or protocol requirements.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0086960 (UMLS CUI 2011AA)
C1709747 (UMLS CUI 2011AA)
Patients were to be able to give informed consent and the consent was to be obtained prior to any study specific screening procedures.
Item
Patients were to be able to give informed consent and the consent was to be obtained prior to any study specific screening procedures.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0220908 (UMLS CUI 2011AA)
20135006 (SNOMED CT 2011_0131)
Treatment with any other experimental therapeutics within the last 4 weeks before enrolment.
Item
Treatment with any other experimental therapeutics within the last 4 weeks before enrolment.
boolean
C0039798 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
History of tuberculosis, either clinically or as evidenced by a positive chest x-ray (exclusion criterion #8) or PPD.
Item
History of tuberculosis, either clinically or as evidenced by a positive chest x-ray (exclusion criterion #8) or PPD.
boolean
C0375796 (UMLS CUI 2011AA)
Z86.11 (ICD-10-CM Version 2010)
V12.01 (ICD-9-CM Version 2011)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
CL415097 (UMLS CUI 2011AA)
C0039985 (UMLS CUI 2011AA)
399208008 (SNOMED CT 2011_0131)
10008498 (MedDRA 14.1)
C0034131 (UMLS CUI 2011AA)
108731003 (SNOMED CT 2011_0131)
Patients who had received anti-TNF therapy, such as infliximab, within 8 weeks of screening for this study. Patients who had received anti-TNF therapy >8 weeks prior to screening were eligible.
Item
Patients who had received anti-TNF therapy, such as infliximab, within 8 weeks of screening for this study. Patients who had received anti-TNF therapy >8 weeks prior to screening were eligible.
boolean
C0281481 (UMLS CUI 2011AA)
C0666743 (UMLS CUI 2011AA)
386891004 (SNOMED CT 2011_0131)
MTHU018219 (LOINC Version 232)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205454 (UMLS CUI 2011AA)
7319005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
Patients with any ostomy, extensive bowel resection (e.g., > 100cm of small bowel, proctocolectomy or colectomy with ileorectal anastomosis). Segmental colectomy was permitted.
Item
Patients with any ostomy, extensive bowel resection (e.g., > 100cm of small bowel, proctocolectomy or colectomy with ileorectal anastomosis). Segmental colectomy was permitted.
boolean
C0029473 (UMLS CUI 2011AA)
75506009 (SNOMED CT 2011_0131)
C0205231 (UMLS CUI 2011AA)
41118005 (SNOMED CT 2011_0131)
C0741614 (UMLS CUI 2011AA)
10067878 (MedDRA 14.1)
C0192601 (UMLS CUI 2011AA)
107938000 (SNOMED CT 2011_0131)
10041105 (MedDRA 14.1)
C0400076 (UMLS CUI 2011AA)
174059005 (SNOMED CT 2011_0131)
10059848 (MedDRA 14.1)
C0009274 (UMLS CUI 2011AA)
23968004 (SNOMED CT 2011_0131)
10061778 (MedDRA 14.1)
C0192754 (UMLS CUI 2011AA)
81714000 (SNOMED CT 2011_0131)
10021320 (MedDRA 14.1)
C0521104 (UMLS CUI 2011AA)
75554001 (SNOMED CT 2011_0131)
C0149750 (UMLS CUI 2011AA)
43075005 (SNOMED CT 2011_0131)
10009878 (MedDRA 14.1)
Patients immediately in need of surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage.
Item
Patients immediately in need of surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage.
boolean
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0038895 (UMLS CUI 2011AA)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0017181 (UMLS CUI 2011AA)
74474003 (SNOMED CT 2011_0131)
10017955 (MedDRA 14.1)
K92.2 (ICD-10-CM Version 2010)
578 (ICD-9-CM Version 2011)
C0031154 (UMLS CUI 2011AA)
48661000 (SNOMED CT 2011_0131)
10034674 (MedDRA 14.1)
K65 (ICD-10-CM Version 2010)
567.9 (ICD-9-CM Version 2011)
C0021843 (UMLS CUI 2011AA)
81060008 (SNOMED CT 2011_0131)
10022687 (MedDRA 14.1)
K56.60 (ICD-10-CM Version 2010)
560.9 (ICD-9-CM Version 2011)
C0243001 (UMLS CUI 2011AA)
75100008 (SNOMED CT 2011_0131)
10059621 (MedDRA 14.1)
C0238334 (UMLS CUI 2011AA)
69643006 (SNOMED CT 2011_0131)
10048984 (MedDRA 14.1)
K85 (ICD-10-CM Version 2010)
C1514873 (UMLS CUI 2011AA)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0013103 (UMLS CUI 2011AA)
122462000 (SNOMED CT 2011_0131)
Patients with known severe fixed symptomatic stenosis of the small or large intestine.
Item
Patients with known severe fixed symptomatic stenosis of the small or large intestine.
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0151924 (UMLS CUI 2011AA)
10062263 (MedDRA 14.1)
E11032 (CTCAE 1105E)
C1261287 (UMLS CUI 2011AA)
C0021851 (UMLS CUI 2011AA)
14742008 (SNOMED CT 2011_0131)
Evidence at the time of enrolment of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery.
Item
Evidence at the time of enrolment of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery.
boolean
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0021843 (UMLS CUI 2011AA)
81060008 (SNOMED CT 2011_0131)
10022687 (MedDRA 14.1)
K56.60 (ICD-10-CM Version 2010)
560.9 (ICD-9-CM Version 2011)
C0043299 (UMLS CUI 2011AA)
363680008 (SNOMED CT 2011_0131)
87 (ICD-9-CM Version 2011)
C0014245 (UMLS CUI 2011AA)
423827005 (SNOMED CT 2011_0131)
10014805 (MedDRA 14.1)
MTHU008659 (LOINC Version 232)
C0038895 (UMLS CUI 2011AA)
Patients with a clinically significant abnormality or granulomata or any other evidence of primary tuberculosis infection on chest X-ray
Item
Patients with a clinically significant abnormality or granulomata or any other evidence of primary tuberculosis infection on chest X-ray
boolean
C1704258 (UMLS CUI 2011AA)
C0018188 (UMLS CUI 2011AA)
45647009 (SNOMED CT 2011_0131)
10018691 (MedDRA 14.1)
CL414904 (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)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0039985 (UMLS CUI 2011AA)
399208008 (SNOMED CT 2011_0131)
10008498 (MedDRA 14.1)
Patients with current signs or symptoms of clinically significant hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
Item
Patients with current signs or symptoms of clinically significant hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0018939 (UMLS CUI 2011AA)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
C0014130 (UMLS CUI 2011AA)
362969004 (SNOMED CT 2011_0131)
10014695 (MedDRA 14.1)
MTHU021570 (LOINC Version 232)
E34.9 (ICD-10-CM Version 2010)
259.9 (ICD-9-CM Version 2011)
C0024115 (UMLS CUI 2011AA)
19829001 (SNOMED CT 2011_0131)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
C0234387 (UMLS CUI 2011AA)
56681004 (SNOMED CT 2011_0131)
10054938 (MedDRA 14.1)
Patients with previous diagnosis of, or known, malignancies.
Item
Patients with previous diagnosis of, or known, malignancies.
boolean
C0332132 (UMLS CUI 2011AA)
48318009 (SNOMED CT 2011_0131)
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Patients with serious infections, such as hepatitis, HIV, pneumonia or pyelonephritis, within 3 months prior to screening.
Item
Patients with serious infections, such as hepatitis, HIV, pneumonia or pyelonephritis, within 3 months prior to screening.
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0019158 (UMLS CUI 2011AA)
29001004 (SNOMED CT 2011_0131)
10019717 (MedDRA 14.1)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
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)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
History of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of active CMV, active Pneumocystis carinii, drug resistant atypical mycobacterium.
Item
History of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of active CMV, active Pneumocystis carinii, drug resistant atypical mycobacterium.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
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)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0010825 (UMLS CUI 2011AA)
407444007 (SNOMED CT 2011_0131)
10009701 (MedDRA 14.1)
MTHU033986 (LOINC Version 232)
C0032276 (UMLS CUI 2011AA)
C0013203 (UMLS CUI 2011AA)
31438003 (SNOMED CT 2011_0131)
10059866 (MedDRA 14.1)
C0026912 (UMLS CUI 2011AA)
243368001 (SNOMED CT 2011_0131)
Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin.
Item
Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin.
boolean
C0015733 (UMLS CUI 2011AA)
39477002 (SNOMED CT 2011_0131)
MTHU001007 (LOINC Version 232)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
CL415097 (UMLS CUI 2011AA)
C0021853 (UMLS CUI 2011AA)
261093006, 113276009 (SNOMED CT 2011_0131)
MTHU003050, MTHU002653 (LOINC Version 232)
C0450254 (UMLS CUI 2011AA)
264418008 (SNOMED CT 2011_0131)
C0029974 (UMLS CUI 2011AA)
73153001, 308796009, 263828003 (SNOMED CT 2011_0131)
MTHU009318 (LOINC Version 232)
C0030498 (UMLS CUI 2011AA)
37763007 (SNOMED CT 2011_0131)
MTHU007791 (LOINC Version 232)
C0314765 (UMLS CUI 2011AA)
12671002 (SNOMED CT 2011_0131)
Women who were pregnant or breast-feeding.
Item
Women who were pregnant or breast-feeding.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
Item
A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
boolean
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0085281 (UMLS CUI 2011AA)
32709003 (SNOMED CT 2011_0131)
10001125 (MedDRA 14.1)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
Patients who had received CNI-1493 in the past.
Item
Patients who had received CNI-1493 in the past.
boolean
C0384938 (UMLS CUI 2011AA)
C1273865 (UMLS CUI 2011AA)
394829006 (SNOMED CT 2011_0131)
More than three doses of NSAIDs, including aspirin and COX-2 inhibitors, within the two weeks prior to start of study medication
Item
More than three doses of NSAIDs, including aspirin and COX-2 inhibitors, within the two weeks prior to start of study medication
boolean
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
16403005, 372665008 (SNOMED CT 2011_0131)
C0004057 (UMLS CUI 2011AA)
7947003 (SNOMED CT 2011_0131)
C1257954 (UMLS CUI 2011AA)
387050005 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)