ID

43062

Description

ODM derived from http://clinicaltrials.gov/show/NCT01185821

Link

http://clinicaltrials.gov/show/NCT01185821

Keywords

Versions (3)
  1. 3/19/13 3/19/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01185821 Relapsing Remitting Multiple Sclerosis

German English

Eligibility

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

Inclusion Criteria

age 18 Years to 56 Years
Description

age 18 Years to 56 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Relapsing Remitting Multiple Sclerosis
Description

Relapsing Remitting Multiple Sclerosis

Data type

boolean

Alias
UMLS CUI 2011AA
C0751967
SNOMED CT 2011_0131
426373005
MedDRA 14.1
10063399
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Patients completed the core study BAF312A2201
Description

Patients completed the core study BAF312A2201

Data type

boolean

Alias
UMLS CUI 2011AA
C1556116
HL7 V3 2006_05
completed
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1542147
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Written informed consent provided before any assessment of the extension study
Description

Written informed consent provided before any assessment of the extension study

Data type

boolean

Alias
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception
Description

Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0427780
SNOMED CT 2011_0131
250425007
MedDRA 14.1
10036574
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0348078
SNOMED CT 2011_0131
246176004
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Exclusion Criteria
Description

Exclusion Criteria

Newly diagnosed systemic disease other than MS (which may require immunosuppressive treatment)
Description

Newly diagnosed systemic disease other than MS (which may require immunosuppressive treatment)

Data type

boolean

Alias
UMLS CUI 2011AA
C2585997
SNOMED CT 2011_0131
441308009
UMLS CUI 2011AA
C0442893
SNOMED CT 2011_0131
56019007, 264578000
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0026769
SNOMED CT 2011_0131
24700007
MedDRA 14.1
10028245
LOINC Version 232
MTHU020805
ICD-10-CM Version 2010
G35
ICD-9-CM Version 2011
340
Malignancies, diabetes, significant cardiovascular and pulmonary diseases and conditions
Description

Malignancies, diabetes, significant cardiovascular and pulmonary diseases and conditions

Data type

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
C0011849
SNOMED CT 2011_0131
191044006
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
UMLS CUI 2011AA
C0024115
SNOMED CT 2011_0131
19829001
MedDRA 14.1
10025082
ICD-10-CM Version 2010
J98.4
Active infections
Description

Active infections

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
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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
age 18 Years to 56 Years
Item
age 18 Years to 56 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Relapsing Remitting Multiple Sclerosis
Item
Relapsing Remitting Multiple Sclerosis
boolean
C0751967 (UMLS CUI 2011AA)
426373005 (SNOMED CT 2011_0131)
10063399 (MedDRA 14.1)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Patients completed the core study BAF312A2201
Item
Patients completed the core study BAF312A2201
boolean
C1556116 (UMLS CUI 2011AA)
completed (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1542147 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Written informed consent provided before any assessment of the extension study
Item
Written informed consent provided before any assessment of the extension study
boolean
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516048 (UMLS CUI 2011AA)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception
Item
Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0237399 (UMLS CUI 2011AA)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0348078 (UMLS CUI 2011AA)
246176004 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Item Group
Exclusion Criteria
Newly diagnosed systemic disease other than MS (which may require immunosuppressive treatment)
Item
Newly diagnosed systemic disease other than MS (which may require immunosuppressive treatment)
boolean
C2585997 (UMLS CUI 2011AA)
441308009 (SNOMED CT 2011_0131)
C0442893 (UMLS CUI 2011AA)
56019007, 264578000 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0026769 (UMLS CUI 2011AA)
24700007 (SNOMED CT 2011_0131)
10028245 (MedDRA 14.1)
MTHU020805 (LOINC Version 232)
G35 (ICD-10-CM Version 2010)
340 (ICD-9-CM Version 2011)
Malignancies, diabetes, significant cardiovascular and pulmonary diseases and conditions
Item
Malignancies, diabetes, significant cardiovascular and pulmonary diseases and conditions
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)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C0024115 (UMLS CUI 2011AA)
19829001 (SNOMED CT 2011_0131)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
Active infections
Item
Active infections
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
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