ID

43094

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT01403376

Länk

http://clinicaltrials.gov/show/NCT01403376

Nyckelord

Versioner (3)
  1. 2013-04-17 2013-04-17 - Martin Dugas
  2. 2014-04-20 2014-04-20 - Julian Varghese
  3. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Creative Commons BY 4.0
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Eligibility NCT01403376 Multiple Sclerosis

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beskrivning

Inclusion Criteria

age 18 Years to 59 Years
Beskrivning

age 18 Years to 59 Years

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Male or female patients <60 years old with relapsing multiple sclerosis
Beskrivning

Male or female patients <60 years old with relapsing multiple sclerosis

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0751967
SNOMED CT 2011_0131
426373005
MedDRA 14.1
10063399
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
treated for at least 6 months with 7 or 14 mg teriflunomide in one of the studies LTS6048 or LTS6050 or
Beskrivning

treated for at least 6 months with 7 or 14 mg teriflunomide in one of the studies LTS6048 or LTS6050 or

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C1718383
LOINC Version 232
MTHU020205
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
treated with a stable dose of IFN-beta-1 for at least 6 months
Beskrivning

treated with a stable dose of IFN-beta-1 for at least 6 months

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0005148
Patient's Signature on Informed Consent Form
Beskrivning

Patients having signed the specific informed consent form for this study

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Having concomitant infectious pathology at the time of vaccination
Beskrivning

Having concomitant infectious pathology at the time of vaccination

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
40733004
MedDRA 14.1
10021881
LOINC Version 232
MTHU034915
ICD-9-CM Version 2011
136.9
UMLS CUI 2011AA
C0040223
SNOMED CT 2011_0131
410670007
LOINC Version 232
MTHU009151
UMLS CUI 2011AA
C0042196
SNOMED CT 2011_0131
33879002
MedDRA 14.1
10046859
LOINC Version 232
MTHU000146
MS relapse within 1 month before vaccination
Beskrivning

MS relapse within 1 month before vaccination

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0856120
MedDRA 14.1
10048393
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0042196
SNOMED CT 2011_0131
33879002
MedDRA 14.1
10046859
LOINC Version 232
MTHU000146
Systemic corticosteroids within 1 month before the vaccination
Beskrivning

Systemic corticosteroids within 1 month before the vaccination

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0042196
SNOMED CT 2011_0131
33879002
MedDRA 14.1
10046859
LOINC Version 232
MTHU000146
Any contraindication to influenza vaccine
Beskrivning

Any contraindication to influenza vaccine

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0770694
Any vaccination within the last 6 months.
Beskrivning

Any vaccination within the last 6 months.

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C0042196
SNOMED CT 2011_0131
33879002
MedDRA 14.1
10046859
LOINC Version 232
MTHU000146
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Prior use of any investigational drug or participation to a clinical trial within 1 year (only for patients under interferon Beta-1)
Beskrivning

Prior use of any investigational drug or participation to a clinical trial within 1 year (only for patients under interferon Beta-1)

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
Prior or concomitant use (for a minimum of 1 year before study entry) of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, natalizumab (Tysabri), leflunomide or fingolimod or other immunomodulator/immunosuppressant in development
Beskrivning

Prior or concomitant use (for a minimum of 1 year before study entry) of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, natalizumab (Tysabri), leflunomide or fingolimod or other immunomodulator/immunosuppressant in development

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0092801
SNOMED CT 2011_0131
386916009
UMLS CUI 2011AA
C0026259
SNOMED CT 2011_0131
386913001
UMLS CUI 2011AA
C0004482
SNOMED CT 2011_0131
372574004
LOINC Version 232
MTHU006794
UMLS CUI 2011AA
C0010583
SNOMED CT 2011_0131
387420009
LOINC Version 232
MTHU029970
UMLS CUI 2011AA
C0010592
SNOMED CT 2011_0131
387467008
LOINC Version 232
MTHU005140
UMLS CUI 2011AA
C0025677
SNOMED CT 2011_0131
387381009
LOINC Version 232
MTHU005020
UMLS CUI 2011AA
C0883242
LOINC Version 232
MTHU011568
UMLS CUI 2011AA
C0665297
SNOMED CT 2011_0131
414804006
UMLS CUI 2011AA
C0718644
SNOMED CT 2011_0131
386981009
LOINC Version 232
MTHU017708
UMLS CUI 2011AA
C1699926
SNOMED CT 2011_0131
449000008
UMLS CUI 2011AA
C0005525
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
Prior or concomitant use of Glatiramer acetate within 1 year before study entry
Beskrivning

Prior or concomitant use of Glatiramer acetate within 1 year before study entry

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0717787
SNOMED CT 2011_0131
108754007
Prior or concomitant use of intravenous immunoglobulins within 3 months before study entry
Beskrivning

Prior or concomitant use of intravenous immunoglobulins within 3 months before study entry

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0085297
SNOMED CT 2011_0131
350344000
HL7 V3 2006_05
87
Pregnant or breast feeding women
Beskrivning

Pregnant or breast feeding women

Datatyp

boolean

Alias
UMLS CUI 1
C0549206
MedDRA 1
10036586
UMLS CUI 2
C0006147
MedDRA 2
10006247
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
Women of childbearing potential without adequate contraception.
Beskrivning

Women of childbearing potential without adequate contraception.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0420844
SNOMED CT 2011_0131
169450001
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Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion Criteria
age 18 Years to 59 Years
Item
age 18 Years to 59 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Male or female patients <60 years old with relapsing multiple sclerosis
Item
Male or female patients <60 years old with relapsing multiple sclerosis
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0751967 (UMLS CUI 2011AA)
426373005 (SNOMED CT 2011_0131)
10063399 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
treated for at least 6 months with 7 or 14 mg teriflunomide in one of the studies LTS6048 or LTS6050 or
Item
treated for at least 6 months with 7 or 14 mg teriflunomide in one of the studies LTS6048 or LTS6050 or
boolean
CL415147 (UMLS CUI 2011AA)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C1718383 (UMLS CUI 2011AA)
MTHU020205 (LOINC Version 232)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
treated with a stable dose of IFN-beta-1 for at least 6 months
Item
treated with a stable dose of IFN-beta-1 for at least 6 months
boolean
CL415147 (UMLS CUI 2011AA)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0005148 (UMLS CUI 2011AA)
Patients having signed the specific informed consent form for this study
Item
Patient's Signature on Informed Consent Form
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
Having concomitant infectious pathology at the time of vaccination
Item
Having concomitant infectious pathology at the time of vaccination
boolean
CL415222 (UMLS CUI 2011AA)
C0009450 (UMLS CUI 2011AA)
40733004 (SNOMED CT 2011_0131)
10021881 (MedDRA 14.1)
MTHU034915 (LOINC Version 232)
136.9 (ICD-9-CM Version 2011)
C0040223 (UMLS CUI 2011AA)
410670007 (SNOMED CT 2011_0131)
MTHU009151 (LOINC Version 232)
C0042196 (UMLS CUI 2011AA)
33879002 (SNOMED CT 2011_0131)
10046859 (MedDRA 14.1)
MTHU000146 (LOINC Version 232)
MS relapse within 1 month before vaccination
Item
MS relapse within 1 month before vaccination
boolean
C0856120 (UMLS CUI 2011AA)
10048393 (MedDRA 14.1)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0042196 (UMLS CUI 2011AA)
33879002 (SNOMED CT 2011_0131)
10046859 (MedDRA 14.1)
MTHU000146 (LOINC Version 232)
Systemic corticosteroids within 1 month before the vaccination
Item
Systemic corticosteroids within 1 month before the vaccination
boolean
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0042196 (UMLS CUI 2011AA)
33879002 (SNOMED CT 2011_0131)
10046859 (MedDRA 14.1)
MTHU000146 (LOINC Version 232)
Any contraindication to influenza vaccine
Item
Any contraindication to influenza vaccine
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0770694 (UMLS CUI 2011AA)
Any vaccination within the last 6 months.
Item
Any vaccination within the last 6 months.
boolean
CL407060 (UMLS CUI 2011AA)
C0042196 (UMLS CUI 2011AA)
33879002 (SNOMED CT 2011_0131)
10046859 (MedDRA 14.1)
MTHU000146 (LOINC Version 232)
C1517741 (UMLS CUI 2011AA)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Prior use of any investigational drug or participation to a clinical trial within 1 year (only for patients under interferon Beta-1)
Item
Prior use of any investigational drug or participation to a clinical trial within 1 year (only for patients under interferon Beta-1)
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
Prior or concomitant use (for a minimum of 1 year before study entry) of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, natalizumab (Tysabri), leflunomide or fingolimod or other immunomodulator/immunosuppressant in development
Item
Prior or concomitant use (for a minimum of 1 year before study entry) of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, natalizumab (Tysabri), leflunomide or fingolimod or other immunomodulator/immunosuppressant in development
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0092801 (UMLS CUI 2011AA)
386916009 (SNOMED CT 2011_0131)
C0026259 (UMLS CUI 2011AA)
386913001 (SNOMED CT 2011_0131)
C0004482 (UMLS CUI 2011AA)
372574004 (SNOMED CT 2011_0131)
MTHU006794 (LOINC Version 232)
C0010583 (UMLS CUI 2011AA)
387420009 (SNOMED CT 2011_0131)
MTHU029970 (LOINC Version 232)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)
C0025677 (UMLS CUI 2011AA)
387381009 (SNOMED CT 2011_0131)
MTHU005020 (LOINC Version 232)
C0883242 (UMLS CUI 2011AA)
MTHU011568 (LOINC Version 232)
C0665297 (UMLS CUI 2011AA)
414804006 (SNOMED CT 2011_0131)
C0718644 (UMLS CUI 2011AA)
386981009 (SNOMED CT 2011_0131)
MTHU017708 (LOINC Version 232)
C1699926 (UMLS CUI 2011AA)
449000008 (SNOMED CT 2011_0131)
C0005525 (UMLS CUI 2011AA)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
Prior or concomitant use of Glatiramer acetate within 1 year before study entry
Item
Prior or concomitant use of Glatiramer acetate within 1 year before study entry
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0717787 (UMLS CUI 2011AA)
108754007 (SNOMED CT 2011_0131)
Prior or concomitant use of intravenous immunoglobulins within 3 months before study entry
Item
Prior or concomitant use of intravenous immunoglobulins within 3 months before study entry
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0085297 (UMLS CUI 2011AA)
350344000 (SNOMED CT 2011_0131)
87 (HL7 V3 2006_05)
Pregnant or breast feeding women
Item
Pregnant or breast feeding women
boolean
C0549206 (UMLS CUI 1)
10036586 (MedDRA 1)
C0006147 (UMLS CUI 2)
10006247 (MedDRA 2)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
Women of childbearing potential without adequate contraception.
Item
Women of childbearing potential without adequate contraception.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
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