ID

15696

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): Demography BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Baseline Visit (Day 1): Demography 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
Demography
Description

Demography

Sex
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
Other Race, specified
Description

Other Race

Data type

text

Alias
UMLS CUI [1]
C0034510

Similar models

Baseline Visit (Day 1): Demography 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
Demography
Item
Sex
integer
C0079399 (UMLS CUI [1])
Code List
Sex
CL Item
male (1)
CL Item
female (2)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Race
integer
C0034510 (UMLS CUI [1])
Code List
Race
CL Item
American Indian or Alaska Native (1)
CL Item
Asian (2)
CL Item
Black or African American (3)
CL Item
Native Hawaiian or other pacific Islander (4)
CL Item
White (5)
CL Item
Other, specify (6)
Other Race
Item
Other Race, specified
text
C0034510 (UMLS CUI [1])

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