ID

15903

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: Hospitalization

Palabras clave

  1. 18/6/16 18/6/16 -
Subido en

18 de junio de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0

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Hospitalization BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Hospitalization BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Subject Identification
Descripción

Subject Identification

Number of Facility
Descripción

Site number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Descripción

Subject Initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Hospitalization List
Descripción

Hospitalization List

Event number
Descripción

Event number

Tipo de datos

integer

Event Term for Hospitalization
Descripción

Reason for Hospitalization

Tipo de datos

text

Alias
UMLS CUI [1]
C1830395
Date of Admission
Descripción

Date of Admission

Tipo de datos

date

Alias
UMLS CUI [1]
C1302393
Date of Discharge
Descripción

Date of Discharge

Tipo de datos

date

Alias
UMLS CUI [1]
C2361123
Primary reason for Hospitalization
Descripción

Select one reason for each hospitalization

Tipo de datos

integer

Alias
UMLS CUI [1]
C1830395

Similar models

Hospitalization BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Subject Identification
Site number
Item
Number of Facility
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Item Group
Hospitalization List
Event number
Item
Event number
integer
Reason for Hospitalization
Item
Event Term for Hospitalization
text
C1830395 (UMLS CUI [1])
Date of Admission
Item
Date of Admission
date
C1302393 (UMLS CUI [1])
Date of Discharge
Item
Date of Discharge
date
C2361123 (UMLS CUI [1])
Item
Primary reason for Hospitalization
integer
C1830395 (UMLS CUI [1])
Code List
Primary reason for Hospitalization
CL Item
MS Relapse (1)
CL Item
Other MS related complicaton (2)
CL Item
Other (3)

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