ID

15682

Description

The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Baseline Visit (Day 1)

Keywords

  1. 6/8/16 6/8/16 -
Uploaded on

June 8, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Baseline Visit (Day 1): Inclusion/Exclusion BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Baseline Visit (Day 1): Inclusion/Exclusion BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Subject Identification
Description

Subject Identification

Number of Facility
Description

Site number

Data type

integer

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Inclusion/Exclusion
Description

Inclusion/Exclusion

Protocol Version under which the subject is entered
Description

Protocol Version

Data type

text

Alias
UMLS CUI [1]
C2985700
informed consent date
Description

informed consent date

Data type

text

Alias
UMLS CUI [1]
C2985782
Did the subject meet the eligibility criteria for the study?
Description

If no, record the unmet criterion numbers as indicated in the protocol.

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria 1
Description

Inclusion Criteria

Data type

text

Alias
UMLS CUI [1]
C1512693
Inclusion Criteria 2
Description

Inclusion Criteria

Data type

text

Alias
UMLS CUI [1]
C1512693
Inclusion Criteria 3
Description

Inclusion Criteria

Data type

text

Alias
UMLS CUI [1]
C1512693
Inclusion Criteria 1
Description

Exclusion Criteria

Data type

text

Alias
UMLS CUI [1]
C0680251
Exclusion Criteria 2
Description

Exclusion Criteria

Data type

text

Alias
UMLS CUI [1]
C0680251
Exclusion Criteria 3
Description

Exclusion Criteria

Data type

text

Alias
UMLS CUI [1]
C0680251
Exclusion Criteria 4
Description

Exclusion Criteria

Data type

text

Alias
UMLS CUI [1]
C0680251

Similar models

Baseline Visit (Day 1): Inclusion/Exclusion BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Subject Identification
Site number
Item
Number of Facility
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Item Group
Inclusion/Exclusion
Protocol Version
Item
Protocol Version under which the subject is entered
text
C2985700 (UMLS CUI [1])
informed consent date
Item
text
C2985782 (UMLS CUI [1])
Eligibility criteria
Item
Did the subject meet the eligibility criteria for the study?
boolean
C1516637 (UMLS CUI [1])
Inclusion Criteria
Item
Inclusion Criteria 1
text
C1512693 (UMLS CUI [1])
Inclusion Criteria
Item
Inclusion Criteria 2
text
C1512693 (UMLS CUI [1])
Inclusion Criteria
Item
Inclusion Criteria 3
text
C1512693 (UMLS CUI [1])
Exclusion Criteria
Item
Inclusion Criteria 1
text
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Exclusion Criteria 2
text
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Exclusion Criteria 3
text
C0680251 (UMLS CUI [1])
Exclusion Criteria
Item
Exclusion Criteria 4
text
C0680251 (UMLS CUI [1])

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