ID
44857
Descripción
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 7 (Week 28)
Palabras clave
Versiones (2)
- 10/6/16 10/6/16 -
- 17/2/22 17/2/22 - Martin Dugas
Titular de derechos de autor
Biogen
Subido en
17 de febrero de 2022
DOI
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Licencia
Creative Commons BY-NC 4.0
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Visit 7 (Week 28): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Visit 7 (Week 28): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Descripción
Vital Signs
Descripción
Date of examination
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826643
Descripción
Blood Pressure
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0005823
Descripción
Pulse
Tipo de datos
integer
Unidades de medida
- bpm
Alias
- UMLS CUI [1]
- C0232117
Descripción
Temperature
Tipo de datos
float
Unidades de medida
- °C
Alias
- UMLS CUI [1]
- C0005903
Descripción
Study Drug Accountability
Descripción
first dose date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C3173309
Descripción
number of capsules not taken
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1705492
- UMLS CUI [1,2]
- C0178602
Descripción
If no, please specify on the appropriate adverse events form
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1707814
Similar models
Visit 7 (Week 28): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
C0178602 (UMLS CUI [1,2])