Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 16 Years
Item
Alter mindestens 16 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Disease history of at least six months meeting at least 4 ACR criteria for SLE
Item
Disease history of at least six months meeting at least 4 ACR criteria for SLE
boolean
C0683519 (UMLS CUI 2011AA)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0596070 (UMLS CUI 2011AA)
C0557806 (UMLS CUI 2011AA)
224864007 (SNOMED CT 2011_0131)
C0035452 (UMLS CUI 2011AA)
394810000 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
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)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
BILAG flare A or B at screening requiring a change in corticosteroids
Item
BILAG flare A or B at screening requiring a change in corticosteroids
boolean
C0451046 (UMLS CUI 2011AA)
273339006 (SNOMED CT 2011_0131)
C1517205 (UMLS CUI 2011AA)
C1706281 (UMLS CUI 2011AA)
422097006 (SNOMED CT 2011_0131)
C0439105 (UMLS CUI 2011AA)
421151005 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0392747 (UMLS CUI 2011AA)
243326001 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
a positive ANA or anti-dsDNA at screening
Item
a positive ANA or anti-dsDNA at screening
boolean
C0151480 (UMLS CUI 2011AA)
165850001 (SNOMED CT 2011_0131)
10060055 (MedDRA 14.1)
C2747927 (UMLS CUI 2011AA)
10069914 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
Female subjects must be willing to avoid pregnancy
Item
Female subjects must be willing to avoid pregnancy
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0870186 (UMLS CUI 2011AA)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
Active moderate to severe glomerulonephritis (kidney impairment)
Item
Active moderate to severe glomerulonephritis (kidney impairment)
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1881878 (UMLS CUI 2011AA)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0017658 (UMLS CUI 2011AA)
36171008 (SNOMED CT 2011_0131)
10018364 (MedDRA 14.1)
N08 (ICD-10-CM Version 2010)
C0341697 (UMLS CUI 2011AA)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
Active central nervous system SLE deemed to be severe/progressive
Item
Active central nervous system SLE deemed to be severe/progressive
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C1269563 (UMLS CUI 2011AA)
278199004 (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)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0205329 (UMLS CUI 2011AA)
255314001 (SNOMED CT 2011_0131)
Previous treatment with rituximab, abatacept, or belimumab
Item
Previous treatment with rituximab, abatacept, or belimumab
boolean
C1514463 (UMLS CUI 2011AA)
C0732355 (UMLS CUI 2011AA)
386919002 (SNOMED CT 2011_0131)
C1619966 (UMLS CUI 2011AA)
421777009 (SNOMED CT 2011_0131)
C1723401 (UMLS CUI 2011AA)
449043000 (SNOMED CT 2011_0131)
History of demyelinating disease or optic neuritis
Item
History of demyelinating disease or optic neuritis
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0011304 (UMLS CUI 2011AA)
32693004 (SNOMED CT 2011_0131)
10012305 (MedDRA 14.1)
C0029134 (UMLS CUI 2011AA)
66760008 (SNOMED CT 2011_0131)
10030942 (MedDRA 14.1)
H46.9 (ICD-10-CM Version 2010)
377.30 (ICD-9-CM Version 2011)

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