age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Positive antinuclear antibodies (ANA) at Screening (Visit 1)
Item
Positive antinuclear antibodies (ANA) at Screening (Visit 1)
boolean
C0151480 (UMLS CUI 2011AA)
165850001 (SNOMED CT 2011_0131)
10060055 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
Item
Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0332140 (UMLS CUI 2011AA)
39154008 (SNOMED CT 2011_0131)
C0024141 (UMLS CUI 2011AA)
55464009 (SNOMED CT 2011_0131)
10042945 (MedDRA 14.1)
M32.9 (ICD-10-CM Version 2010)
710.0 (ICD-9-CM Version 2011)
CL430579 (UMLS CUI 2011AA)
Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
Item
Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1299393 (UMLS CUI 2011AA)
371924009 (SNOMED CT 2011_0131)
C0024141 (UMLS CUI 2011AA)
55464009 (SNOMED CT 2011_0131)
10042945 (MedDRA 14.1)
M32.9 (ICD-10-CM Version 2010)
710.0 (ICD-9-CM Version 2011)
C1704788 (UMLS CUI 2011AA)
C0451046 (UMLS CUI 2011AA)
273339006 (SNOMED CT 2011_0131)
Active moderate to severe SLE disease as demonstrated by SLE disease activity index (SLEDAI) total score
Item
Active moderate to severe SLE disease as demonstrated by SLE disease activity index (SLEDAI) total score
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1299393 (UMLS CUI 2011AA)
371924009 (SNOMED CT 2011_0131)
C0024141 (UMLS CUI 2011AA)
55464009 (SNOMED CT 2011_0131)
10042945 (MedDRA 14.1)
M32.9 (ICD-10-CM Version 2010)
710.0 (ICD-9-CM Version 2011)
C0205396 (UMLS CUI 2011AA)
7882003 (SNOMED CT 2011_0131)
MTHU014964 (LOINC Version 232)
C0451528 (UMLS CUI 2011AA)
273863009 (SNOMED CT 2011_0131)
On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials
Item
On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0024141 (UMLS CUI 2011AA)
55464009 (SNOMED CT 2011_0131)
10042945 (MedDRA 14.1)
M32.9 (ICD-10-CM Version 2010)
710.0 (ICD-9-CM Version 2011)
CL031856 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0003374 (UMLS CUI 2011AA)
80229008 (SNOMED CT 2011_0131)
Subjects who are breastfeeding, pregnant, or plan to become pregnant
Item
Subjects who are breastfeeding, pregnant, or plan to become pregnant
boolean
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
Subjects with active, severe SLE disease activity which involves the renal system
Item
Subjects with active, severe SLE disease activity which involves the renal system
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0024141 (UMLS CUI 2011AA)
55464009 (SNOMED CT 2011_0131)
10042945 (MedDRA 14.1)
M32.9 (ICD-10-CM Version 2010)
710.0 (ICD-9-CM Version 2011)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0022646 (UMLS CUI 2011AA)
64033007 (SNOMED CT 2011_0131)
MTHU002935 (LOINC Version 232)
C0449913 (UMLS CUI 2011AA)
246333005 (SNOMED CT 2011_0131)
MTHU025766 (LOINC Version 232)
Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
Item
Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0752335 (UMLS CUI 2011AA)
10063663 (MedDRA 14.1)
C1704788 (UMLS CUI 2011AA)
C0451046 (UMLS CUI 2011AA)
273339006 (SNOMED CT 2011_0131)
C0456079 (UMLS CUI 2011AA)
276625007 (SNOMED CT 2011_0131)
C1706281 (UMLS CUI 2011AA)
422097006 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Subjects with the evidence of an immunosuppressive state
Item
Subjects with the evidence of an immunosuppressive state
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
C1442792 (UMLS CUI 2011AA)
Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
Item
Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
boolean
C0442824 (UMLS CUI 2011AA)
260358002 (SNOMED CT 2011_0131)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
Item
History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
boolean
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
CL415147 (UMLS CUI 2011AA)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
C0007117 (UMLS CUI 2011AA)
1338007, 254701007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
Item
Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
boolean
C1514756 (UMLS CUI 2011AA)
C0042211 (UMLS CUI 2011AA)
C0205454 (UMLS CUI 2011AA)
7319005 (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)
Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
Item
Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
C0524909 (UMLS CUI 2011AA)
61977001 (SNOMED CT 2011_0131)
10008910 (MedDRA 14.1)
B18.1 (ICD-10-CM Version 2010)
C0524910 (UMLS CUI 2011AA)
128302006 (SNOMED CT 2011_0131)
10008912 (MedDRA 14.1)
B18.2 (ICD-10-CM Version 2010)
Subjects with substance abuse or dependence or other relevant concurrent medical condition
Item
Subjects with substance abuse or dependence or other relevant concurrent medical condition
boolean
C0740858 (UMLS CUI 2011AA)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
C0038580 (UMLS CUI 2011AA)
2403008 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
Subjects with history of thromboembolic events within 1 year of screening Visit.
Item
Subjects with history of thromboembolic events within 1 year of screening Visit.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0857496 (UMLS CUI 2011AA)
10043565 (MedDRA 14.1)
Subjects with significant hematologic abnormalities
Item
Subjects with significant hematologic abnormalities
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0205488 (UMLS CUI 2011AA)
57407000 (SNOMED CT 2011_0131)
C1704258 (UMLS CUI 2011AA)
Subject has received treatment with other anti-B cell antibodies within 12 months prior to screening (visit 1)
Item
Subject has received treatment with other anti-B cell antibodies within 12 months prior to screening (visit 1)
boolean
C1514756 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0003250 (UMLS CUI 2011AA)
49616005 (SNOMED CT 2011_0131)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C0004561 (UMLS CUI 2011AA)
112130006 (SNOMED CT 2011_0131)
MTHU002435 (LOINC Version 232)
Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
Item
Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0003280 (UMLS CUI 2011AA)
372862008 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0003211 (UMLS CUI 2011AA)
16403005, 372665008 (SNOMED CT 2011_0131)
Subject has previously participated in this study or has previously received epratuzumab treatment.
Item
Subject has previously participated in this study or has previously received epratuzumab treatment.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C1120776 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)