ID

3715

Description

ODM derived from http://clinicaltrials.gov/show/NCT01261793

Link

http://clinicaltrials.gov/show/NCT01261793

Keywords

Versions (2)
  1. 2/22/13 2/22/13 - Martin Dugas
  2. 9/20/21 9/20/21 -
Uploaded on

February 22, 2013

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT01261793 Systemic Lupus Erythematosus

German English

Eligibility

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

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Positive antinuclear antibodies (ANA) at Screening (Visit 1)
Description

Positive antinuclear antibodies (ANA) at Screening (Visit 1)

Data type

boolean

Alias
UMLS CUI 2011AA
C0151480
SNOMED CT 2011_0131
165850001
MedDRA 14.1
10060055
UMLS CUI 2011AA
C1409616
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0332140
SNOMED CT 2011_0131
39154008
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
CL430579
Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
Description

Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C1299393
SNOMED CT 2011_0131
371924009
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
C1704788
UMLS CUI 2011AA
C0451046
SNOMED CT 2011_0131
273339006
Active moderate to severe SLE disease as demonstrated by SLE disease activity index (SLEDAI) total score
Description

Active moderate to severe SLE disease as demonstrated by SLE disease activity index (SLEDAI) total score

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C1299393
SNOMED CT 2011_0131
371924009
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
C0205396
SNOMED CT 2011_0131
7882003
LOINC Version 232
MTHU014964
UMLS CUI 2011AA
C0451528
SNOMED CT 2011_0131
273863009
On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials
Description

On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials

Data type

boolean

Alias
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
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
CL031856
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
UMLS CUI 2011AA
C0003374
SNOMED CT 2011_0131
80229008
Exclusion Criteria
Description

Exclusion Criteria

Subjects who are breastfeeding, pregnant, or plan to become pregnant
Description

Subjects who are breastfeeding, pregnant, or plan to become pregnant

Data type

boolean

Alias
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0032992
SNOMED CT 2011_0131
169565003
Subjects with active, severe SLE disease activity which involves the renal system
Description

Subjects with active, severe SLE disease activity which involves the renal system

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
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
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0022646
SNOMED CT 2011_0131
64033007
LOINC Version 232
MTHU002935
UMLS CUI 2011AA
C0449913
SNOMED CT 2011_0131
246333005
LOINC Version 232
MTHU025766
Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
Description

Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0752335
MedDRA 14.1
10063663
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0451046
SNOMED CT 2011_0131
273339006
UMLS CUI 2011AA
C0456079
SNOMED CT 2011_0131
276625007
UMLS CUI 2011AA
C1706281
SNOMED CT 2011_0131
422097006
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
Subjects with the evidence of an immunosuppressive state
Description

Subjects with the evidence of an immunosuppressive state

Data type

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
UMLS CUI 2011AA
C1442792
Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
Description

Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection

Data type

boolean

Alias
UMLS CUI 2011AA
C0442824
SNOMED CT 2011_0131
260358002
UMLS CUI 2011AA
C0332167
SNOMED CT 2011_0131
15508007
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0021311
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
Description

History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.

Data type

boolean

Alias
UMLS CUI 2011AA
C2735088
LOINC Version 232
MTHU034770
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0851140
SNOMED CT 2011_0131
92564006
MedDRA 14.1
10061809
ICD-10-CM Version 2010
D06.9
ICD-9-CM Version 2011
233.1
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007, 254701007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0553723
SNOMED CT 2011_0131
254651007
MedDRA 14.1
10041834
Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
Description

Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0042211
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
Description

Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0021311
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0019163
SNOMED CT 2011_0131
66071002
MedDRA 14.1
10019731
UMLS CUI 2011AA
C0019196
SNOMED CT 2011_0131
50711007
MedDRA 14.1
10019744
ICD-10-CM Version 2010
B19.20
ICD-9-CM Version 2011
070.7
UMLS CUI 2011AA
C0524909
SNOMED CT 2011_0131
61977001
MedDRA 14.1
10008910
ICD-10-CM Version 2010
B18.1
UMLS CUI 2011AA
C0524910
SNOMED CT 2011_0131
128302006
MedDRA 14.1
10008912
ICD-10-CM Version 2010
B18.2
Subjects with substance abuse or dependence or other relevant concurrent medical condition
Description

Subjects with substance abuse or dependence or other relevant concurrent medical condition

Data type

boolean

Alias
UMLS CUI 2011AA
C0740858
SNOMED CT 2011_0131
66214007
MedDRA 14.1
10066169
LOINC Version 232
MTHU019364
UMLS CUI 2011AA
C0038580
SNOMED CT 2011_0131
2403008
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
Subjects with history of thromboembolic events within 1 year of screening Visit.
Description

Subjects with history of thromboembolic events within 1 year of screening Visit.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0857496
MedDRA 14.1
10043565
Subjects with significant hematologic abnormalities
Description

Subjects with significant hematologic abnormalities

Data type

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0205488
SNOMED CT 2011_0131
57407000
UMLS CUI 2011AA
C1704258
Subject has received treatment with other anti-B cell antibodies within 12 months prior to screening (visit 1)
Description

Subject has received treatment with other anti-B cell antibodies within 12 months prior to screening (visit 1)

Data type

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0003250
SNOMED CT 2011_0131
49616005
UMLS CUI 2011AA
C0521124
SNOMED CT 2011_0131
65897001
UMLS CUI 2011AA
C0004561
SNOMED CT 2011_0131
112130006
LOINC Version 232
MTHU002435
Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
Description

Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0003280
SNOMED CT 2011_0131
372862008
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0003211
SNOMED CT 2011_0131
16403005, 372665008
Subject has previously participated in this study or has previously received epratuzumab treatment.
Description

Subject has previously participated in this study or has previously received epratuzumab treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C1120776
UMLS CUI 2011AA
C0039798
Back to the top of the page

Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
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)
Item Group
Exclusion Criteria
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)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial