ID

15908

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

Versions (3)
  1. 6/9/16 6/9/16 -
  2. 6/18/16 6/18/16 -
  3. 6/18/16 6/18/16 -
Uploaded on

June 18, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Baseline Visit (Day 1): Visual Function Test BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

English

Baseline Visit (Day 1): Visual Function Test BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 forms  
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
Visual Function Test
Description

Visual Function Test

Date of Evaluation
Description

Visual Function test, date

Data type

date

Alias
UMLS CUI [1,1]
C0234621
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C0011008
Contrast Sensitivity Evaluation Binocular
Description

Contrast Sensitivity Evaluation Binocular

100% Chart, Total # Correct
Description

Contrast Sensitivity Evaluation Binocular: 100% Chart, Total # Correct

Data type

float

Alias
UMLS CUI [1,1]
C0009928
UMLS CUI [1,2]
C0042794
2,5% Chart, Total # Correct
Description

Contrast Sensitivity Evaluation Binocular: 2,5% Chart, Total # Correct

Data type

float

Alias
UMLS CUI [1,1]
C0009928
UMLS CUI [1,2]
C0042794
1,25% Chart, Total # Correct
Description

Contrast Sensitivity Evaluation Binocular: 1,25% Chart, Total # Correct

Data type

float

Alias
UMLS CUI [1,1]
C0009928
UMLS CUI [1,2]
C0042794
Snellen visual acuity equivalent
Description

Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent

Data type

text

Alias
UMLS CUI [1,1]
C0009928
UMLS CUI [1,2]
C0042794
Additional Surveys
Description

Additional Surveys

EQ5D Questionnaire
Description

Health survey

Data type

text

Alias
UMLS CUI [1]
C0018762
EQ5D Questionnaire
Description

Health survey

Data type

float

Alias
UMLS CUI [1]
C0018762
SF-36 Questionaire
Description

SF-36

Data type

text

Alias
UMLS CUI [1]
C0518214
SF 36: vitality
Description

SF 36: vitality

Data type

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C0424589
SF-36: physical functioning
Description

SF-36: physical functioning

Data type

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C0516981
SF-36: bodily pain
Description

SF-36: bodily pain

Data type

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C3890602
SF-36: general health perceptions
Description

SF-36: general health perceptions

Data type

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C2936631
SF-36 physical function
Description

SF-36: physical function

Data type

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C0516981
SF-36: emotional role functioning
Description

SF-36: emotional role functioning

Data type

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C2370883
SF-36: social role functioning
Description

SF-36: social role functioning

Data type

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C0035820
SF-36: Mental health
Description

SF-36: Mental health

Data type

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C0025353
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Similar models

Baseline Visit (Day 1): Visual Function Test BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 forms
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
Visual Function Test
Visual Function test, date
Item
Date of Evaluation
date
C0234621 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Contrast Sensitivity Evaluation Binocular
Contrast Sensitivity Evaluation Binocular: 100% Chart, Total # Correct
Item
100% Chart, Total # Correct
float
C0009928 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
Contrast Sensitivity Evaluation Binocular: 2,5% Chart, Total # Correct
Item
2,5% Chart, Total # Correct
float
C0009928 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
Contrast Sensitivity Evaluation Binocular: 1,25% Chart, Total # Correct
Item
1,25% Chart, Total # Correct
float
C0009928 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent
Item
Snellen visual acuity equivalent
text
C0009928 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
Item Group
Additional Surveys
Health survey
Item
EQ5D Questionnaire
text
C0018762 (UMLS CUI [1])
Health survey
Item
EQ5D Questionnaire
float
C0018762 (UMLS CUI [1])
SF-36
Item
SF-36 Questionaire
text
C0518214 (UMLS CUI [1])
SF 36: vitality
Item
SF 36: vitality
integer
C0518214 (UMLS CUI [1,1])
C0424589 (UMLS CUI [1,2])
SF-36: physical functioning
Item
SF-36: physical functioning
integer
C0518214 (UMLS CUI [1,1])
C0516981 (UMLS CUI [1,2])
SF-36: bodily pain
Item
SF-36: bodily pain
integer
C0518214 (UMLS CUI [1,1])
C3890602 (UMLS CUI [1,2])
SF-36: general health perceptions
Item
SF-36: general health perceptions
integer
C0518214 (UMLS CUI [1,1])
C2936631 (UMLS CUI [1,2])
SF-36: physical function
Item
SF-36 physical function
integer
C0518214 (UMLS CUI [1,1])
C0516981 (UMLS CUI [1,2])
SF-36: emotional role functioning
Item
SF-36: emotional role functioning
integer
C0518214 (UMLS CUI [1,1])
C2370883 (UMLS CUI [1,2])
SF-36: social role functioning
Item
SF-36: social role functioning
integer
C0518214 (UMLS CUI [1,1])
C0035820 (UMLS CUI [1,2])
SF-36: Mental health
Item
SF-36: Mental health
integer
C0518214 (UMLS CUI [1,1])
C0025353 (UMLS CUI [1,2])
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