ID

15867

Beskrivning

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: Concomitant Medication

Nyckelord

  1. 2016-06-17 2016-06-17 -
Uppladdad den

17 juni 2016

DOI

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Licens

Creative Commons BY-NC 3.0

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Concomitant Medication BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Concomitant Medication BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Subject Identification
Beskrivning

Subject Identification

Number of Facility
Beskrivning

Site number

Datatyp

integer

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

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Beskrivning

Subject Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Any new or changed medication
Beskrivning

if yes, please specify below

Datatyp

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant Medication list
Beskrivning

Concomitant Medication list

Medication No.
Beskrivning

Medication Number

Datatyp

integer

Medication name:
Beskrivning

MEDICATION NAME

Datatyp

text

Alias
UMLS CUI [1]
C2360065
Indication
Beskrivning

Indication

Datatyp

text

Alias
UMLS CUI [1]
C3146298
Dose
Beskrivning

Dose

Datatyp

text

Alias
UMLS CUI [1]
C3174092
Units
Beskrivning

Units

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Route
Beskrivning

Route

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Frequency
Beskrivning

Frequency

Datatyp

text

Alias
UMLS CUI [1]
C3476109
Start date
Beskrivning

Concomitant Medication Start Date

Datatyp

date

Alias
UMLS CUI [1]
C2826734
Agent End Date
Beskrivning

Concomitant Medication End Date

Datatyp

date

Alias
UMLS CUI [1]
C2826744
Ongoing
Beskrivning

Concomitant Medication Ongoing

Datatyp

boolean

Alias
UMLS CUI [1]
C2826666

Similar models

Concomitant Medication BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
concomitant medication
Item
Any new or changed medication
boolean
C2347852 (UMLS CUI [1])
Item Group
Concomitant Medication list
Medication Number
Item
Medication No.
integer
MEDICATION NAME
Item
Medication name:
text
C2360065 (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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