ID

15815

Beschreibung

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: End of Study

Stichworte

Versionen (2)
  1. 14.06.16 14.06.16 -
  2. 17.02.22 17.02.22 - Martin Dugas
Hochgeladen am

14. Juni 2016

DOI

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Creative Commons BY-NC 3.0
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End of Study: Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Englisch

End of Study: Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 Formulare  
Subject Identification
Beschreibung

Subject Identification

Number of Facility
Beschreibung

Site number

Datentyp

integer

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

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Beschreibung

Subject Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Vital Signs
Beschreibung

Vital Signs

Date of examination
Beschreibung

Date of examination

Datentyp

date

Alias
UMLS CUI [1]
C2826643
Blood Pressure
Beschreibung

Blood Pressure

Datentyp

text

Alias
UMLS CUI [1]
C0005823
Pulse
Beschreibung

Pulse

Datentyp

text

Alias
UMLS CUI [1]
C0232117
Temperature
Beschreibung

Temperature

Datentyp

text

Alias
UMLS CUI [1]
C0039476
End of Study Survey
Beschreibung

End of Study Survey

Date of last dose
Beschreibung

Last Dose Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0011008
End of Study Date
Beschreibung

End of Study Date

Datentyp

date

Alias
UMLS CUI [1]
C2983670
Did the subject complete the study?
Beschreibung

If no, please specify below

Datentyp

boolean

Alias
UMLS CUI [1]
C2348577
Primary reason for not completing treatment (mark one)
Beschreibung

if other than MS, please describe below if Adverse Event, complete Adverse Events Form If Death, please complete Record of death form

Datentyp

integer

Alias
UMLS CUI [1]
C1709849
Primary reason for not completing treatment, description
Beschreibung

Reason for non-completion, Description

Datentyp

text

Alias
UMLS CUI [1]
C1709849
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Ähnliche Modelle

End of Study: Vital Signs BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
End of Study Survey
Last Dose Date
Item
Date of last dose
date
C0178602 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
End of Study Date
Item
End of Study Date
date
C2983670 (UMLS CUI [1])
Study completed
Item
Did the subject complete the study?
boolean
C2348577 (UMLS CUI [1])
Item
Primary reason for not completing treatment (mark one)
integer
C1709849 (UMLS CUI [1])
Reason for non-completion
Code List
Primary reason for not completing treatment (mark one)
CL Item
MS Relapse (1)
CL Item
MS Progression (2)
CL Item
Adverse Event (3)
CL Item
Lost to follow up (4)
CL Item
Consent withdrawn (5)
CL Item
Investigator decision (6)
CL Item
Subject non-compliance (7)
CL Item
Death (8)
CL Item
Other (9)
Reason for non-completion, Description
Item
Primary reason for not completing treatment, description
text
C1709849 (UMLS CUI [1])
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