ID
44869
Beskrivning
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 5 (Week 20)
Nyckelord
Versioner (2)
- 2016-06-10 2016-06-10 -
- 2022-02-18 2022-02-18 - Martin Dugas
Rättsinnehavare
Biogen
Uppladdad den
18 februari 2022
DOI
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Licens
Creative Commons BY-NC 4.0
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Visit 5 (Week 20): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Visit 5 (Week 20): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Beskrivning
Vital Signs
Beskrivning
Date of examination
Datatyp
date
Alias
- UMLS CUI [1]
- C2826643
Beskrivning
Blood Pressure
Datatyp
text
Alias
- UMLS CUI [1]
- C0005823
Beskrivning
Pulse
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0232117
Beskrivning
Temperature
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Study Drug Accountability
Beskrivning
first dose date
Datatyp
date
Alias
- UMLS CUI [1]
- C3173309
Beskrivning
number of capsules not taken
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1705492
- UMLS CUI [1,2]
- C0178602
Beskrivning
If no, please specify on the appropriate adverse events form
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1707814
Similar models
Visit 5 (Week 20): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
C0178602 (UMLS CUI [1,2])