age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
Item
Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
boolean
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)
Have positive antinuclear antibodies (ANA)
Item
ANA positiv
boolean
C0151480 (UMLS CUI 2011AA)
165850001 (SNOMED CT 2011_0131)
10060055 (MedDRA 14.1)
Agree not to become pregnant throughout the course of the trial
Item
Agree not to become pregnant throughout the course of the trial
boolean
C0680240 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
C0489652 (UMLS CUI 2011AA)
MTHU024501 (LOINC Version 232)
Have the appropriate Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)score at screening
Item
Have the appropriate Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)score at screening
boolean
C0814634 (UMLS CUI 2011AA)
C0036043 (UMLS CUI 2011AA)
C0014939 (UMLS CUI 2011AA)
41598000, 61946003 (SNOMED CT 2011_0131)
MTHU003480 (LOINC Version 232)
C0409974 (UMLS CUI 2011AA)
200936003 (SNOMED CT 2011_0131)
10025134 (MedDRA 14.1)
L93 (ICD-10-CM Version 2010)
695.4 (ICD-9-CM Version 2011)
CL415062 (UMLS CUI 2011AA)
C1516048 (UMLS CUI 2011AA)
C0451528 (UMLS CUI 2011AA)
273863009 (SNOMED CT 2011_0131)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
Have active severe Lupus kidney disease
Item
Have active severe Lupus kidney disease
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0409974 (UMLS CUI 2011AA)
200936003 (SNOMED CT 2011_0131)
10025134 (MedDRA 14.1)
L93 (ICD-10-CM Version 2010)
695.4 (ICD-9-CM Version 2011)
C0022646 (UMLS CUI 2011AA)
64033007 (SNOMED CT 2011_0131)
MTHU002935 (LOINC Version 232)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Have active Central Nervous System or peripheral neurologic disease
Item
Have active Central Nervous System or peripheral neurologic disease
boolean
C0007682 (UMLS CUI 2011AA)
23853001 (SNOMED CT 2011_0131)
10007943 (MedDRA 14.1)
G96.9 (ICD-10-CM Version 2010)
C0031117 (UMLS CUI 2011AA)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
Item
Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
boolean
C1514756 (UMLS CUI 2011AA)
C0085297 (UMLS CUI 2011AA)
350344000 (SNOMED CT 2011_0131)
87 (HL7 V3 2006_05)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
Have active or recent infection within 30 days of screening
Item
Have active or recent infection within 30 days of screening
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0332185 (UMLS CUI 2011AA)
6493001 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
Have had a serious infection within 90 days of randomization
Item
Have had a serious infection within 90 days of randomization
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
Have evidence or test positive for Hepatitis B
Item
Have evidence or test positive for Hepatitis B
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0856706 (UMLS CUI 2011AA)
10019738 (MedDRA 14.1)
Have Hepatitis C
Item
Hepatitis C
boolean
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)
Are human immunodeficiency virus (HIV) positive
Item
HIV-positiv
boolean
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
Have evidence of active or latent tuberculosis (TB)
Item
Have evidence of active or latent tuberculosis (TB)
boolean
C0151332 (UMLS CUI 2011AA)
427099000 (SNOMED CT 2011_0131)
10071157 (MedDRA 14.1)
C1609538 (UMLS CUI 2011AA)
10065048 (MedDRA 14.1)
Presence of significant laboratory abnormalities at screening
Item
Presence of significant laboratory abnormalities at screening
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
Item
Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
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)
C1444637 (UMLS CUI 2011AA)
410513005 (SNOMED CT 2011_0131)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
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 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C1521996 (UMLS CUI 2011AA)
Have received > 40 mgs of prednisone or equivalent in the past 30 days
Item
Have received > 40 mgs of prednisone or equivalent in the past 30 days
boolean
C1514756 (UMLS CUI 2011AA)
C0032952 (UMLS CUI 2011AA)
116602009 (SNOMED CT 2011_0131)
MTHU003245 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
C1444637 (UMLS CUI 2011AA)
410513005 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Have changed your dose of antimalarial drug in the past 30 days
Item
Have changed your dose of antimalarial drug in the past 30 days
boolean
C2347524 (UMLS CUI 2011AA)
C0003374 (UMLS CUI 2011AA)
80229008 (SNOMED CT 2011_0131)
C1444637 (UMLS CUI 2011AA)
410513005 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Have changed your dose of immunosuppressive drug in the past 90 days
Item
Have changed your dose of immunosuppressive drug in the past 90 days
boolean
C2347524 (UMLS CUI 2011AA)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C1444637 (UMLS CUI 2011AA)
410513005 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Have previously received rituximab
Item
Have previously received rituximab
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0732355 (UMLS CUI 2011AA)
386919002 (SNOMED CT 2011_0131)