ID

15868

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: Concomitat Non-Drug Treatment

Keywords

  1. 6/17/16 6/17/16 -
Uploaded on

June 17, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Concomitat Non-Drug Treatment BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Concomitat Non-Drug Treatment BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

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
Concomitant Medication list
Description

Concomitant Medication list

Treatment Number
Description

Treatment Number

Data type

text

Treatment/Procedure
Description

Treatment

Data type

text

Alias
UMLS CUI [1]
C0087111
Indication
Description

Indication

Data type

text

Alias
UMLS CUI [1]
C3146298
Dose
Description

Dose

Data type

text

Alias
UMLS CUI [1]
C3174092
Units
Description

Units

Data type

text

Alias
UMLS CUI [1]
C1519795
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Frequency
Description

Frequency

Data type

text

Alias
UMLS CUI [1]
C3476109
Start date
Description

Concomitant Medication Start Date

Data type

date

Alias
UMLS CUI [1]
C2826734
Agent End Date
Description

Concomitant Medication End Date

Data type

date

Alias
UMLS CUI [1]
C2826744
Ongoing
Description

Concomitant Medication Ongoing

Data type

boolean

Alias
UMLS CUI [1]
C2826666

Similar models

Concomitat Non-Drug Treatment BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

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
Concomitant Medication list
Treatment Number
Item
Treatment Number
text
Treatment
Item
Treatment/Procedure
text
C0087111 (UMLS CUI [1])
Indication
Item
Indication
text
C3146298 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Concomitant Medication Start Date
Item
Start date
date
C2826734 (UMLS CUI [1])
Concomitant Medication End Date
Item
Agent End Date
date
C2826744 (UMLS CUI [1])
Concomitant Medication Ongoing
Item
Ongoing
boolean
C2826666 (UMLS CUI [1])

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