ID
44868
Beschreibung
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 17 (Week 168)
Stichworte
Versionen (2)
- 17.06.16 17.06.16 -
- 18.02.22 18.02.22 - Martin Dugas
Rechteinhaber
Biogen
Hochgeladen am
18. Februar 2022
DOI
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Lizenz
Creative Commons BY-NC 4.0
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Visit 17 (Week 168): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Visit 17 (Week 168): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Beschreibung
Vital Signs
Beschreibung
Date of examination
Datentyp
date
Alias
- UMLS CUI [1]
- C2826643
Beschreibung
Blood Pressure
Datentyp
text
Alias
- UMLS CUI [1]
- C0005823
Beschreibung
Pulse
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0232117
Beschreibung
Temperature
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Study Drug Accountability
Beschreibung
first dose date
Datentyp
date
Alias
- UMLS CUI [1]
- C3173309
Beschreibung
number of capsules not taken
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1705492
- UMLS CUI [1,2]
- C0178602
Beschreibung
If no, please specify on the appropriate adverse events form
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1707814
Ähnliche Modelle
Visit 17 (Week 168): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
C0178602 (UMLS CUI [1,2])