ID
44856
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: Visit 20 (Week 192)
Keywords
Versions (3)
- 6/18/16 6/18/16 -
- 6/18/16 6/18/16 -
- 2/17/22 2/17/22 - Martin Dugas
Copyright Holder
Biogen
Uploaded on
February 17, 2022
DOI
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License
Creative Commons BY-NC 4.0
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Visit 20 (Week 192) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Visit 20 (Week 192) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Description
Vital Signs
Description
Date of examination
Data type
date
Alias
- UMLS CUI [1]
- C2826643
Description
Blood Pressure
Data type
text
Alias
- UMLS CUI [1]
- C0005823
Description
Pulse
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0232117
Description
Temperature
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0039476
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Physical examination
Description
Body System
Data type
integer
Alias
- UMLS CUI [1]
- C0460002
Description
Examination Status
Data type
integer
Alias
- UMLS CUI [1]
- C3267137
Description
physical examination findings
Data type
text
Alias
- UMLS CUI [1]
- C2826636
Description
EDSS Evaluation
Description
Functional System Scores
Description
Visual System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0042789
- UMLS CUI [1,2]
- C0451246
Description
Brainstem System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0006121
Description
Pyramidal System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0228060
- UMLS CUI [1,2]
- C0451246
Description
Cerebellar System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0007765
- UMLS CUI [1,2]
- C0451246
Description
Sensory System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0682648
- UMLS CUI [1,2]
- C0451246
Description
Bowel or Bladder System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C2707247
Description
Cerebral System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0006104
- UMLS CUI [1,2]
- C0451246
Description
Additional and Results
Description
type the number that indicates the furthest distance the subject is able to walk without aid or rest
Data type
text
Alias
- UMLS CUI [1]
- C0429886
Description
type the number that indicates the furthest distance the subject is able to walk without aid or rest
Data type
integer
Alias
- UMLS CUI [1]
- C0429886
Description
EDSS score
Data type
float
Alias
- UMLS CUI [1]
- C0451246
Description
Name of Neurologist
Data type
text
Alias
- UMLS CUI [1,1]
- C0237426
- UMLS CUI [1,2]
- C0027365
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
Study Drug Accountability
Description
first dose date
Data type
date
Alias
- UMLS CUI [1]
- C3173309
Description
number of capsules not taken
Data type
integer
Alias
- UMLS CUI [1,1]
- C1705492
- UMLS CUI [1,2]
- C0178602
Description
If no, please specify on the appropriate adverse events form
Data type
boolean
Alias
- UMLS CUI [1]
- C1707814
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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C0042794 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
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C0516981 (UMLS CUI [1,2])
C3890602 (UMLS CUI [1,2])
C2936631 (UMLS CUI [1,2])
C0516981 (UMLS CUI [1,2])
C2370883 (UMLS CUI [1,2])
C0035820 (UMLS CUI [1,2])
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