ID

42796

Description

ODM derived from http://clinicaltrials.gov/show/NCT00683930

Link

http://clinicaltrials.gov/show/NCT00683930

Keywords

Versions (2)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00683930 Pemphigus Vulgaris (PV)

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 70 Years
Description

age 18 Years to 70 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Adulthood (qualifier value)
Description

Adult patients

Data type

boolean

Alias
UMLS CUI 2011AA
C0700597
SNOMED CT 2011_0131
41847000
Diagnosis of mild to moderate pemphigus vulgaris within the past 12 months, requiring high dose corticosteroids
Description

Diagnosis of mild to moderate pemphigus vulgaris within the past 12 months, requiring high dose corticosteroids

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C2945599
SNOMED CT 2011_0131
255604002
UMLS CUI 2011AA
C1881878
UMLS CUI 2011AA
C0030809
SNOMED CT 2011_0131
49420001
MedDRA 14.1
10052802
ICD-10-CM Version 2010
L10.0
UMLS CUI 2011AA
C1444637
SNOMED CT 2011_0131
410513005
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0444956
SNOMED CT 2011_0131
261829003
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Female patients who are pregnant, breastfeeding, or lactating
Description

Female patients who are pregnant, breastfeeding, or lactating

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 8 weeks prior to randomization
Description

Regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 8 weeks prior to randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C0205272
SNOMED CT 2011_0131
17854005
UMLS CUI 2011AA
C0086960
UMLS CUI 2011AA
C0032113
SNOMED CT 2011_0131
19647005
UMLS CUI 2011AA
C0085297
SNOMED CT 2011_0131
350344000
HL7 V3 2006_05
87
UMLS CUI 2011AA
C0039798
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
C0034656
CellCept or other immunosuppressive therapy, except corticosteroids, exceeding 2 weeks total duration and within 8 weeks prior to randomization
Description

CellCept or other immunosuppressive therapy, except corticosteroids, exceeding 2 weeks total duration and within 8 weeks prior to randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C0209368
SNOMED CT 2011_0131
386976000
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0439810
SNOMED CT 2011_0131
255619001
UMLS CUI 2011AA
C0449238
SNOMED CT 2011_0131
103335007
LOINC Version 232
MTHU001938
UMLS CUI 2011AA
CL384738
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
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
C0034656
Use of PV therapies other than those noted above, within 4 weeks prior to randomization
Description

Use of PV therapies other than those noted above, within 4 weeks prior to randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C0030809
SNOMED CT 2011_0131
49420001
MedDRA 14.1
10052802
ICD-10-CM Version 2010
L10.0
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1552738
HL7 V3 2006_05
KIND
UMLS CUI 2011AA
CL384738
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
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
C0034656
Use of topical corticosteroids within 2 weeks prior to randomization
Description

Use of topical corticosteroids within 2 weeks prior to randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0304604
SNOMED CT 2011_0131
331645009
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
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
C0034656
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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 18 Years to 70 Years
Item
age 18 Years to 70 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Adult patients
Item
Adulthood (qualifier value)
boolean
C0700597 (UMLS CUI 2011AA)
41847000 (SNOMED CT 2011_0131)
Diagnosis of mild to moderate pemphigus vulgaris within the past 12 months, requiring high dose corticosteroids
Item
Diagnosis of mild to moderate pemphigus vulgaris within the past 12 months, requiring high dose corticosteroids
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C2945599 (UMLS CUI 2011AA)
255604002 (SNOMED CT 2011_0131)
C1881878 (UMLS CUI 2011AA)
C0030809 (UMLS CUI 2011AA)
49420001 (SNOMED CT 2011_0131)
10052802 (MedDRA 14.1)
L10.0 (ICD-10-CM Version 2010)
C1444637 (UMLS CUI 2011AA)
410513005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1514873 (UMLS CUI 2011AA)
C0444956 (UMLS CUI 2011AA)
261829003 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Female patients who are pregnant, breastfeeding, or lactating
Item
Female patients who are pregnant, breastfeeding, or lactating
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 8 weeks prior to randomization
Item
Regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 8 weeks prior to randomization
boolean
C0205272 (UMLS CUI 2011AA)
17854005 (SNOMED CT 2011_0131)
C0086960 (UMLS CUI 2011AA)
C0032113 (UMLS CUI 2011AA)
19647005 (SNOMED CT 2011_0131)
C0085297 (UMLS CUI 2011AA)
350344000 (SNOMED CT 2011_0131)
87 (HL7 V3 2006_05)
C0039798 (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)
C0034656 (UMLS CUI 2011AA)
CellCept or other immunosuppressive therapy, except corticosteroids, exceeding 2 weeks total duration and within 8 weeks prior to randomization
Item
CellCept or other immunosuppressive therapy, except corticosteroids, exceeding 2 weeks total duration and within 8 weeks prior to randomization
boolean
C0209368 (UMLS CUI 2011AA)
386976000 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0439810 (UMLS CUI 2011AA)
255619001 (SNOMED CT 2011_0131)
C0449238 (UMLS CUI 2011AA)
103335007 (SNOMED CT 2011_0131)
MTHU001938 (LOINC Version 232)
CL384738 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
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)
C0034656 (UMLS CUI 2011AA)
Use of PV therapies other than those noted above, within 4 weeks prior to randomization
Item
Use of PV therapies other than those noted above, within 4 weeks prior to randomization
boolean
C0030809 (UMLS CUI 2011AA)
49420001 (SNOMED CT 2011_0131)
10052802 (MedDRA 14.1)
L10.0 (ICD-10-CM Version 2010)
C0039798 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1552738 (UMLS CUI 2011AA)
KIND (HL7 V3 2006_05)
CL384738 (UMLS CUI 2011AA)
C0205450 (UMLS CUI 2011AA)
9362000 (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)
C0034656 (UMLS CUI 2011AA)
Use of topical corticosteroids within 2 weeks prior to randomization
Item
Use of topical corticosteroids within 2 weeks prior to randomization
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0304604 (UMLS CUI 2011AA)
331645009 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (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)
C0034656 (UMLS CUI 2011AA)
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