ID

44851

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: End of Study

Keywords

Versions (2)
  1. 6/14/16 6/14/16 -
  2. 2/17/22 2/17/22 - Martin Dugas
Copyright Holder

Biogen

Uploaded on

February 17, 2022

DOI

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License

Creative Commons BY-NC 4.0
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End of Study: Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

English

End of Study: Vital Signs 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
Vital Signs
Description

Vital Signs

Date of examination
Description

Date of examination

Data type

date

Alias
UMLS CUI [1]
C2826643
Blood Pressure
Description

Blood Pressure

Data type

text

Alias
UMLS CUI [1]
C0005823
Pulse
Description

Pulse

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
End of Study Survey
Description

End of Study Survey

Date of last dose
Description

Last Dose Date

Data type

date

Alias
UMLS CUI [1]
C1762893
End of Study Date
Description

End of Study Date

Data type

date

Alias
UMLS CUI [1]
C2983670
Did the subject complete the study?
Description

If no, please specify below

Data type

boolean

Alias
UMLS CUI [1]
C2348577
Primary reason for not completing treatment (mark one)
Description

if other than MS, please describe below if Adverse Event, complete Adverse Events Form If Death, please complete Record of death form

Data type

integer

Alias
UMLS CUI [1]
C1709849
Primary reason for not completing treatment, description
Description

Reason for non-completion, Description

Data type

text

Alias
UMLS CUI [1]
C1709849
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Similar models

End of Study: Vital Signs 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
Vital Signs
Date of examination
Item
Date of examination
date
C2826643 (UMLS CUI [1])
Blood Pressure
Item
Blood Pressure
text
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
End of Study Survey
Last Dose Date
Item
Date of last dose
date
C1762893 (UMLS CUI [1])
End of Study Date
Item
End of Study Date
date
C2983670 (UMLS CUI [1])
Study completed
Item
Did the subject complete the study?
boolean
C2348577 (UMLS CUI [1])
Item
Primary reason for not completing treatment (mark one)
integer
C1709849 (UMLS CUI [1])
Reason for non-completion
Code List
Primary reason for not completing treatment (mark one)
CL Item
MS Relapse (1)
C0856120 (UMLS CUI-1)
(Comment:en)
CL Item
MS Progression (2)
C1536149 (UMLS CUI-1)
(Comment:en)
CL Item
Adverse Event (3)
C0877248 (UMLS CUI-1)
(Comment:en)
CL Item
Lost to follow up (4)
C1302313 (UMLS CUI-1)
(Comment:en)
CL Item
Consent withdrawn (5)
C1707492 (UMLS CUI-1)
(Comment:en)
CL Item
Investigator decision (6)
C1709536 (UMLS CUI-1)
(Comment:en)
CL Item
Subject non-compliance (7)
C0376405 (UMLS CUI-1)
(Comment:en)
CL Item
Death (8)
C0011065 (UMLS CUI-1)
(Comment:en)
CL Item
Other (9)
C3840932 (UMLS CUI-1)
(Comment:en)
Reason for non-completion, Description
Item
Primary reason for not completing treatment, description
text
C1709849 (UMLS CUI [1])
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