ID

15858

Descrizione

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

  1. 16/06/16 16/06/16 -
Caricato su

16 giugno 2016

DOI

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Licenza

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

Telephone Visit Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Subject Identification
Descrizione

Subject Identification

Number of Facility
Descrizione

Site number

Tipo di dati

integer

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

Subject number

Tipo di dati

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Descrizione

Subject Initials

Tipo di dati

text

Alias
UMLS CUI [1]
C2986440
Telepone Visit Details
Descrizione

Telepone Visit Details

Date of telephone call
Descrizione

Date of telephone call

Tipo di dati

date

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

if other please specify

Tipo di dati

integer

Alias
UMLS CUI [1]
C0337611
Other person
Descrizione

Other person

Tipo di dati

text

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

if yes please specify in the CRF

Tipo di dati

boolean

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

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

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2347852

Similar models

Telephone Visit Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
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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