ID

15859

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: Adverse Event

Keywords

Versions (2)
  1. 6/16/16 6/16/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

June 16, 2016

DOI

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License

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

English

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

1 forms  
Subject Identification
Description

Subject Identification

Number of Facility
Description

Site number

Data type

integer

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

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Adverse Event
Description

Adverse Event

Adverse Event: List Diagnosis if possible
Description

diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Serious adverse event
Description

If yes, List SAE Tracking number

Data type

boolean

Alias
UMLS CUI [1]
C1519255
SAE Tracking number
Description

SAE Tracking number

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1300638
Start Date
Description

Adverse Event Start Date

Data type

date

Alias
UMLS CUI [1]
C2697888
Adverse Event Stop Date
Description

Adverse Event Stop Date

Data type

date

Alias
UMLS CUI [1]
C2697886
not resolved
Description

Adverse Event not resolved

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1709863
Severity
Description

Adverse Event Severity

Data type

integer

Action taken with study treatment
Description

Study treatment

Data type

integer

Alias
UMLS CUI [1]
C0949266
Relationship to blinded study treatment
Description

AE Relationship to blinded study treatment

Data type

integer

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0681870
Concomitant treatment given
Description

if yes, record on the appropriate concomitant therapy form

Data type

boolean

Alias
UMLS CUI [1]
C1707479
Resulted in withdrawal from study?
Description

withdrawal from study due to Adverse Event

Data type

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0877248
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
diagnosis
Item
Adverse Event: List Diagnosis if possible
text
C0011900 (UMLS CUI [1])
SAE
Item
Serious adverse event
boolean
C1519255 (UMLS CUI [1])
SAE Tracking number
Item
SAE Tracking number
text
C1519255 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Adverse Event Start Date
Item
Start Date
date
C2697888 (UMLS CUI [1])
Adverse Event Stop Date
Item
Adverse Event Stop Date
date
C2697886 (UMLS CUI [1])
Adverse Event not resolved
Item
not resolved
boolean
C0877248 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
Item
Severity
integer
Adverse Event Severity
Code List
Severity
CL Item
Mild  (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Action taken with study treatment
integer
C0949266 (UMLS CUI [1])
Study treatment
Code List
Action taken with study treatment
CL Item
None  (1)
CL Item
Interrupdet  (2)
CL Item
Reduced  (3)
CL Item
Discontinued (4)
Item
Relationship to blinded study treatment
integer
C0439849 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0681870 (UMLS CUI [1,3])
AE Relationship to blinded study treatment
Code List
Relationship to blinded study treatment
CL Item
unrelated  (1)
CL Item
unlikely  (2)
CL Item
possible  (3)
CL Item
related (4)
Concomitant treatment
Item
Concomitant treatment given
boolean
C1707479 (UMLS CUI [1])
withdrawal from study due to Adverse Event
Item
Resulted in withdrawal from study?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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