ID

15868

Beschrijving

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

Trefwoorden

  1. 17-06-16 17-06-16 -
Geüploaded op

17 juni 2016

DOI

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Licentie

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
Beschrijving

Subject Identification

Number of Facility
Beschrijving

Site number

Datatype

integer

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

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Beschrijving

Subject Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Concomitant Medication list
Beschrijving

Concomitant Medication list

Treatment Number
Beschrijving

Treatment Number

Datatype

text

Treatment/Procedure
Beschrijving

Treatment

Datatype

text

Alias
UMLS CUI [1]
C0087111
Indication
Beschrijving

Indication

Datatype

text

Alias
UMLS CUI [1]
C3146298
Dose
Beschrijving

Dose

Datatype

text

Alias
UMLS CUI [1]
C3174092
Units
Beschrijving

Units

Datatype

text

Alias
UMLS CUI [1]
C1519795
Route
Beschrijving

Route

Datatype

text

Alias
UMLS CUI [1]
C0013153
Frequency
Beschrijving

Frequency

Datatype

text

Alias
UMLS CUI [1]
C3476109
Start date
Beschrijving

Concomitant Medication Start Date

Datatype

date

Alias
UMLS CUI [1]
C2826734
Agent End Date
Beschrijving

Concomitant Medication End Date

Datatype

date

Alias
UMLS CUI [1]
C2826744
Ongoing
Beschrijving

Concomitant Medication Ongoing

Datatype

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)
Datatype
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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