ID

15903

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: Hospitalization

Trefwoorden

Versies (1)
  1. 18-06-16 18-06-16 -
Geüploaded op

18 juni 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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Hospitalization BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Engels

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

1 Formulieren  
Subject Identification
Beschrijving

Subject Identification

Number of Facility
Beschrijving

Site number

Datatype

integer

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

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Beschrijving

Subject Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Hospitalization List
Beschrijving

Hospitalization List

Event number
Beschrijving

Event number

Datatype

integer

Event Term for Hospitalization
Beschrijving

Reason for Hospitalization

Datatype

text

Alias
UMLS CUI [1]
C1830395
Date of Admission
Beschrijving

Date of Admission

Datatype

date

Alias
UMLS CUI [1]
C1302393
Date of Discharge
Beschrijving

Date of Discharge

Datatype

date

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

Select one reason for each hospitalization

Datatype

integer

Alias
UMLS CUI [1]
C1830395
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Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
reason for Hospitalization
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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