ID

15869

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: Record of Death

Palabras clave

Versiones (1)
  1. 17/6/16 17/6/16 -
Subido en

17 de junio de 2016

DOI

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Licencia

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

Inglés

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

1 formularios  
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
Record of Death
Descripción

Record of Death

Date of death
Descripción

Date of death

Tipo de datos

date

Alias
UMLS CUI [1]
C1148348
Cause of death
Descripción

Cause of death

Tipo de datos

text

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

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

Tipo de datos

boolean

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

Adverse Event page number

Tipo de datos

integer

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

death due to study treatment

Tipo de datos

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 formularios
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
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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