ID

15736

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: Visit 4 (Week 16)

Trefwoorden

Versies (2)
  1. 10-06-16 10-06-16 -
  2. 17-02-22 17-02-22 - Martin Dugas
Geüploaded op

10 juni 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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Visit 4 (Week 16): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Engels

Visit 4 (Week 16): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 Formulieren  
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
Vital Signs
Beschrijving

Vital Signs

Date of examination
Beschrijving

Date of examination

Datatype

date

Alias
UMLS CUI [1]
C2826643
Blood Pressure
Beschrijving

Blood Pressure

Datatype

text

Alias
UMLS CUI [1]
C0005823
Pulse
Beschrijving

Pulse

Datatype

text

Alias
UMLS CUI [1]
C0232117
Temperature
Beschrijving

Temperature

Datatype

text

Alias
UMLS CUI [1]
C0039476
Study Drug Accountability
Beschrijving

Study Drug Accountability

date of first dose
Beschrijving

first dose date

Datatype

date

Alias
UMLS CUI [1]
C3173309
Number of capsules not taken since previous visit to this visit
Beschrijving

number of capsules not taken

Datatype

integer

Alias
UMLS CUI [1,1]
C1705492
UMLS CUI [1,2]
C0178602
Was there a protocol-defined dose reduction/interruption since the previous visit?
Beschrijving

If no, please specify on the appropriate adverse events form

Datatype

boolean

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0441610
UMLS CUI [1,3]
C1507394
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Similar models

Visit 4 (Week 16): Vital Signs, Study Drug accountability BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 Formulieren
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
Vital Signs
Date of examination
Item
Date of examination
date
C2826643 (UMLS CUI [1])
Blood Pressure
Item
Blood Pressure
text
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
text
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
text
C0039476 (UMLS CUI [1])
Item Group
Study Drug Accountability
first dose date
Item
date of first dose
date
C3173309 (UMLS CUI [1])
number of capsules not taken
Item
Number of capsules not taken since previous visit to this visit
integer
C1705492 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
protocol-defined dose reduction/interruption
Item
Was there a protocol-defined dose reduction/interruption since the previous visit?
boolean
C3174092 (UMLS CUI [1,1])
C0441610 (UMLS CUI [1,2])
C1507394 (UMLS CUI [1,3])
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