ID

15858

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: Telephone Visit

Keywords

Versions (1)
  1. 6/16/16 6/16/16 -
Uploaded on

June 16, 2016

DOI

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License

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

English

Telephone Visit 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
Telepone Visit Details
Description

Telepone Visit Details

Date of telephone call
Description

Date of telephone call

Data type

date

Alias
UMLS CUI [1,1]
C0302186
UMLS CUI [1,2]
C0011008
Person contacted
Description

if other please specify

Data type

integer

Alias
UMLS CUI [1]
C0337611
Other person
Description

Other person

Data type

text

Alias
UMLS CUI [1]
C0337611
Since the subject was last contacted, has the subject experienced any new or continuing adverse events?
Description

if yes please specify in the CRF

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Since the subject was last contacted, has the subject received any concomitant medications?*
Description

*Includes IV Steroid therapy and alternate MS therapy. If yes please record concomitant medications in the CRF.

Data type

boolean

Alias
UMLS CUI [1]
C2347852
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Similar models

Telephone Visit 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])
Date of telephone call
Item
Date of telephone call
date
C0302186 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Person contacted
integer
C0337611 (UMLS CUI [1])
contact person
Code List
Person contacted
CL Item
subject (1)
CL Item
other  (2)
CL Item
unable to make contact (3)
Other person
Item
Other person
text
C0337611 (UMLS CUI [1])
adverse events
Item
Since the subject was last contacted, has the subject experienced any new or continuing adverse events?
boolean
C0877248 (UMLS CUI [1])
concomitant medication
Item
Since the subject was last contacted, has the subject received any concomitant medications?*
boolean
C2347852 (UMLS CUI [1])
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