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)
- 6/9/16 6/9/16 -
- 6/18/16 6/18/16 -
- 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
Baseline Visit (Day 1): Visual Function Test BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Description
Visual Function Test
Description
Contrast Sensitivity Evaluation Binocular
Description
Contrast Sensitivity Evaluation Binocular: 100% Chart, Total # Correct
Data type
float
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Description
Contrast Sensitivity Evaluation Binocular: 2,5% Chart, Total # Correct
Data type
float
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Description
Contrast Sensitivity Evaluation Binocular: 1,25% Chart, Total # Correct
Data type
float
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Description
Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent
Data type
text
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Description
Additional Surveys
Description
Health survey
Data type
text
Alias
- UMLS CUI [1]
- C0018762
Description
Health survey
Data type
float
Alias
- UMLS CUI [1]
- C0018762
Description
SF-36
Data type
text
Alias
- UMLS CUI [1]
- C0518214
Description
SF 36: vitality
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C0424589
Description
SF-36: physical functioning
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C0516981
Description
SF-36: bodily pain
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C3890602
Description
SF-36: general health perceptions
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C2936631
Description
SF-36: physical function
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C0516981
Description
SF-36: emotional role functioning
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C2370883
Description
SF-36: social role functioning
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C0035820
Description
SF-36: Mental health
Data type
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C0025353
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