ID
44869
Beschrijving
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)
Trefwoorden
Versies (2)
- 10-06-16 10-06-16 -
- 18-02-22 18-02-22 - Martin Dugas
Houder van rechten
Biogen
Geüploaded op
18 februari 2022
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
Vital Signs
Beschrijving
Date of examination
Datatype
date
Alias
- UMLS CUI [1]
- C2826643
Beschrijving
Blood Pressure
Datatype
text
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Pulse
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
Temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Study Drug Accountability
Beschrijving
first dose date
Datatype
date
Alias
- UMLS CUI [1]
- C3173309
Beschrijving
number of capsules not taken
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1705492
- UMLS CUI [1,2]
- C0178602
Beschrijving
If no, please specify on the appropriate adverse events form
Datatype
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])