ID

15869

Description

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: Record of Death

Mots-clés

Versions (1)
  1. 17/06/2016 17/06/2016 -
Téléchargé le

17 juin 2016

DOI

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Licence

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

Anglais

Record of Death BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 Formulaires  
Subject Identification
Description

Subject Identification

Number of Facility
Description

Site number

Type de données

integer

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

Subject number

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Description

Subject Initials

Type de données

text

Alias
UMLS CUI [1]
C2986440
Record of Death
Description

Record of Death

Date of death
Description

Date of death

Type de données

date

Alias
UMLS CUI [1]
C1148348
Cause of death
Description

Cause of death

Type de données

text

Alias
UMLS CUI [1]
C0007465
Is the cause of death related to an adverse event?
Description

If yes, please indicate the adverse event CRF page number.

Type de données

boolean

Alias
UMLS CUI [1]
C1705232
Adverse Event CRF page number
Description

Adverse Event page number

Type de données

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1704732
Relationship of death to study treatment
Description

death due to study treatment

Type de données

integer

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0949266
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Similar models

Record of Death BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
Record of Death
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Cause of death
Item
Cause of death
text
C0007465 (UMLS CUI [1])
Death Related to Adverse Event
Item
Is the cause of death related to an adverse event?
boolean
C1705232 (UMLS CUI [1])
Adverse Event page number
Item
Adverse Event CRF page number
integer
C0877248 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
Item
Relationship of death to study treatment
integer
C0007465 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
death due to study treatment
Code List
Relationship of death to study treatment
CL Item
not related  (0)
CL Item
unlikely  (1)
CL Item
possible  (2)
CL Item
related (3)
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