ID

42692

Descripción

ODM derived from http://clinicaltrials.gov/show/NCT01196091

Link

http://clinicaltrials.gov/show/NCT01196091

Palabras clave

Versiones (2)
  1. 6/12/13 6/12/13 - Martin Dugas
  2. 17/9/21 17/9/21 -
Subido en

17 de septiembre de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility NCT01196091 Systemic Lupus Erythematosus

Alemán Inglés

Eligibility

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Descripción

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter mindestens 18 Jahre
Descripción

age at least 18 Years

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
Descripción

Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria

Tipo de datos

boolean

Alias
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
ANA positiv
Descripción

Have positive antinuclear antibodies (ANA)

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0151480
SNOMED CT 2011_0131
165850001
MedDRA 14.1
10060055
Agree not to become pregnant throughout the course of the trial
Descripción

Agree not to become pregnant throughout the course of the trial

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0032992
SNOMED CT 2011_0131
169565003
UMLS CUI 2011AA
C0489652
LOINC Version 232
MTHU024501
Have the appropriate Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)score at screening
Descripción

Have the appropriate Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)score at screening

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0814634
UMLS CUI 2011AA
C0036043
UMLS CUI 2011AA
C0014939
SNOMED CT 2011_0131
41598000, 61946003
LOINC Version 232
MTHU003480
UMLS CUI 2011AA
C0409974
SNOMED CT 2011_0131
200936003
MedDRA 14.1
10025134
ICD-10-CM Version 2010
L93
ICD-9-CM Version 2011
695.4
UMLS CUI 2011AA
CL415062
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C0451528
SNOMED CT 2011_0131
273863009
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
Ausschlusskriterien
Descripción

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
Have active severe Lupus kidney disease
Descripción

Have active severe Lupus kidney disease

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0409974
SNOMED CT 2011_0131
200936003
MedDRA 14.1
10025134
ICD-10-CM Version 2010
L93
ICD-9-CM Version 2011
695.4
UMLS CUI 2011AA
C0022646
SNOMED CT 2011_0131
64033007
LOINC Version 232
MTHU002935
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
Have active Central Nervous System or peripheral neurologic disease
Descripción

Have active Central Nervous System or peripheral neurologic disease

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0007682
SNOMED CT 2011_0131
23853001
MedDRA 14.1
10007943
ICD-10-CM Version 2010
G96.9
UMLS CUI 2011AA
C0031117
MedDRA 14.1
10029331
ICD-10-CM Version 2010
G64
ICD-9-CM Version 2011
350-359.99
Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
Descripción

Have received intravenous immunoglobulin (IVIg) within 180 days of randomization

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0085297
SNOMED CT 2011_0131
350344000
HL7 V3 2006_05
87
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0034656
Have active or recent infection within 30 days of screening
Descripción

Have active or recent infection within 30 days of screening

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0332185
SNOMED CT 2011_0131
6493001
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C1409616
Have had a serious infection within 90 days of randomization
Descripción

Have had a serious infection within 90 days of randomization

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0034656
Have evidence or test positive for Hepatitis B
Descripción

Have evidence or test positive for Hepatitis B

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0856706
MedDRA 14.1
10019738
Hepatitis C
Descripción

Have Hepatitis C

Tipo de datos

boolean

Alias
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
HIV-positiv
Descripción

Are human immunodeficiency virus (HIV) positive

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0019699
SNOMED CT 2011_0131
165816005
MedDRA 14.1
10020188
ICD-10-CM Version 2010
Z21
Have evidence of active or latent tuberculosis (TB)
Descripción

Have evidence of active or latent tuberculosis (TB)

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0151332
SNOMED CT 2011_0131
427099000
MedDRA 14.1
10071157
UMLS CUI 2011AA
C1609538
MedDRA 14.1
10065048
Presence of significant laboratory abnormalities at screening
Descripción

Presence of significant laboratory abnormalities at screening

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0438215
SNOMED CT 2011_0131
165346000
MedDRA 14.1
10023547
UMLS CUI 2011AA
C1409616
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
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C1444637
SNOMED CT 2011_0131
410513005
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
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
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0553723
SNOMED CT 2011_0131
254651007
MedDRA 14.1
10041834
UMLS CUI 2011AA
C0205197
SNOMED CT 2011_0131
255594003
UMLS CUI 2011AA
C1521996
Have received > 40 mgs of prednisone or equivalent in the past 30 days
Descripción

Have received > 40 mgs of prednisone or equivalent in the past 30 days

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0032952
SNOMED CT 2011_0131
116602009
LOINC Version 232
MTHU003245
UMLS CUI 2011AA
CL415123
UMLS CUI 2011AA
C1444637
SNOMED CT 2011_0131
410513005
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Have changed your dose of antimalarial drug in the past 30 days
Descripción

Have changed your dose of antimalarial drug in the past 30 days

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C2347524
UMLS CUI 2011AA
C0003374
SNOMED CT 2011_0131
80229008
UMLS CUI 2011AA
C1444637
SNOMED CT 2011_0131
410513005
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Have changed your dose of immunosuppressive drug in the past 90 days
Descripción

Have changed your dose of immunosuppressive drug in the past 90 days

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C2347524
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
UMLS CUI 2011AA
C1444637
SNOMED CT 2011_0131
410513005
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Have previously received rituximab
Descripción

Have previously received rituximab

Tipo de datos

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0732355
SNOMED CT 2011_0131
386919002
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Similar models

Eligibility

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
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)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
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)
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