ID
44863
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 11 (Week 84)
Palabras clave
Versiones (2)
- 14/6/16 14/6/16 -
- 17/2/22 17/2/22 - Martin Dugas
Titular de derechos de autor
Biogen
Subido en
17 de febrero de 2022
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 4.0
Comentarios del modelo :
Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.
Comentarios de grupo de elementos para :
Comentarios del elemento para :
Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.
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
Descripción
Vital Signs
Descripción
Date of examination
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2826643 (Physical Examination Date)
Descripción
Blood Pressure
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0005823 (Blood Pressure)
- SNOMED
- 75367002
Descripción
Pulse
Tipo de datos
integer
Unidades de medida
- bpm
Alias
- UMLS CUI [1]
- C0232117 (Pulse Rate)
- SNOMED
- 78564009
Descripción
Temperature
Tipo de datos
float
Unidades de medida
- °C
Alias
- UMLS CUI [1]
- C0005903 (Body Temperature)
- SNOMED
- 722490005
- LOINC
- LP36617-6
Descripción
Study Drug Accountability
Descripción
first dose date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C3173309 (Date treatment or therapy started)
- LOINC
- LP262646-5
Descripción
number of capsules not taken
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1705492 (Missing)
- LOINC
- LA14698-7
- UMLS CUI [1,2]
- C0178602 (Dosage)
- SNOMED
- 260911001
- LOINC
- LP7180-5
Descripción
If no, please specify on the appropriate adverse events form
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1707814 (Dose Reduced)
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])
Sin comentarios