ID
44863
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 11 (Week 84)
Keywords
Versions (2)
- 6/14/16 6/14/16 -
- 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 11 (Week 84): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Visit 11 (Week 84): Vital Signs, Study Drug accountability 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]
- C0005903
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
Similar models
Visit 11 (Week 84): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
C0178602 (UMLS CUI [1,2])