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Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 16 Years
Description

age at least 16 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Disease history of at least six months meeting at least 4 ACR criteria for SLE
Description

Disease history of at least six months meeting at least 4 ACR criteria for SLE

Data type

boolean

Alias
UMLS CUI 2011AA
C0683519
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C1550543
HL7 V3 2006_05
FLFS
UMLS CUI 2011AA
C0596070
UMLS CUI 2011AA
C0557806
SNOMED CT 2011_0131
224864007
UMLS CUI 2011AA
C0035452
SNOMED CT 2011_0131
394810000
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C0024141
SNOMED CT 2011_0131
55464009
MedDRA 14.1
10042945
ICD-10-CM Version 2010
M32.9
ICD-9-CM Version 2011
710.0
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
BILAG flare A or B at screening requiring a change in corticosteroids
Description

BILAG flare A or B at screening requiring a change in corticosteroids

Data type

boolean

Alias
UMLS CUI 2011AA
C0451046
SNOMED CT 2011_0131
273339006
UMLS CUI 2011AA
C1517205
UMLS CUI 2011AA
C1706281
SNOMED CT 2011_0131
422097006
UMLS CUI 2011AA
C0439105
SNOMED CT 2011_0131
421151005
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0392747
SNOMED CT 2011_0131
243326001
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
a positive ANA or anti-dsDNA at screening
Description

a positive ANA or anti-dsDNA at screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0151480
SNOMED CT 2011_0131
165850001
MedDRA 14.1
10060055
UMLS CUI 2011AA
C2747927
MedDRA 14.1
10069914
UMLS CUI 2011AA
C1409616
Female subjects must be willing to avoid pregnancy
Description

Female subjects must be willing to avoid pregnancy

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0870186
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Active moderate to severe glomerulonephritis (kidney impairment)
Description

Active moderate to severe glomerulonephritis (kidney impairment)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C1881878
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0017658
SNOMED CT 2011_0131
36171008
MedDRA 14.1
10018364
ICD-10-CM Version 2010
N08
UMLS CUI 2011AA
C1565489
SNOMED CT 2011_0131
236423003
MedDRA 14.1
10062237
Active central nervous system SLE deemed to be severe/progressive
Description

Active central nervous system SLE deemed to be severe/progressive

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C1269563
SNOMED CT 2011_0131
278199004
UMLS CUI 2011AA
C0024141
SNOMED CT 2011_0131
55464009
MedDRA 14.1
10042945
ICD-10-CM Version 2010
M32.9
ICD-9-CM Version 2011
710.0
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0205329
SNOMED CT 2011_0131
255314001
Previous treatment with rituximab, abatacept, or belimumab
Description

Previous treatment with rituximab, abatacept, or belimumab

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0732355
SNOMED CT 2011_0131
386919002
UMLS CUI 2011AA
C1619966
SNOMED CT 2011_0131
421777009
UMLS CUI 2011AA
C1723401
SNOMED CT 2011_0131
449043000
History of demyelinating disease or optic neuritis
Description

History of demyelinating disease or optic neuritis

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0011304
SNOMED CT 2011_0131
32693004
MedDRA 14.1
10012305
UMLS CUI 2011AA
C0029134
SNOMED CT 2011_0131
66760008
MedDRA 14.1
10030942
ICD-10-CM Version 2010
H46.9
ICD-9-CM Version 2011
377.30
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 16 Years
Item
age at least 16 Years
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
C0086287 (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
Exclusion Criteria
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)
C1565489 (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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