ID

43780

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: Adverse Event

Stichworte

Versionen (2)
  1. 16.06.16 16.06.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Creative Commons BY-NC 3.0
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Adverse Event BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Englisch

Adverse Event 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
Adverse Event
Beschreibung

Adverse Event

Adverse Event: List Diagnosis if possible
Beschreibung

diagnosis

Datentyp

text

Alias
UMLS CUI [1]
C0011900
Serious adverse event
Beschreibung

If yes, List SAE Tracking number

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
SAE Tracking number
Beschreibung

SAE Tracking number

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1300638
Start Date
Beschreibung

Adverse Event Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2697888
Adverse Event Stop Date
Beschreibung

Adverse Event Stop Date

Datentyp

date

Alias
UMLS CUI [1]
C2697886
not resolved
Beschreibung

Adverse Event not resolved

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1709863
Severity
Beschreibung

Adverse Event Severity

Datentyp

integer

Action taken with study treatment
Beschreibung

Study treatment

Datentyp

integer

Alias
UMLS CUI [1]
C0949266
Relationship to blinded study treatment
Beschreibung

AE Relationship to blinded study treatment

Datentyp

integer

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2347038
Concomitant treatment given
Beschreibung

if yes, record on the appropriate concomitant therapy form

Datentyp

boolean

Alias
UMLS CUI [1]
C1707479
Resulted in withdrawal from study?
Beschreibung

withdrawal from study due to Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0877248
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Ähnliche Modelle

Adverse Event 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
diagnosis
Item
Adverse Event: List Diagnosis if possible
text
C0011900 (UMLS CUI [1])
SAE
Item
Serious adverse event
boolean
C1519255 (UMLS CUI [1])
SAE Tracking number
Item
SAE Tracking number
text
C1519255 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Adverse Event Start Date
Item
Start Date
date
C2697888 (UMLS CUI [1])
Adverse Event Stop Date
Item
Adverse Event Stop Date
date
C2697886 (UMLS CUI [1])
Adverse Event not resolved
Item
not resolved
boolean
C0877248 (UMLS CUI [1,1])
C1709863 (UMLS CUI [1,2])
Item
Severity
integer
Adverse Event Severity
Code List
Severity
CL Item
Mild  (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Action taken with study treatment
integer
C0949266 (UMLS CUI [1])
Study treatment
Code List
Action taken with study treatment
CL Item
None  (1)
CL Item
Interrupdet  (2)
CL Item
Reduced  (3)
CL Item
Discontinued (4)
Item
Relationship to blinded study treatment
integer
C0439849 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2347038 (UMLS CUI [1,3])
AE Relationship to blinded study treatment
Code List
Relationship to blinded study treatment
CL Item
unrelated  (1)
CL Item
unlikely  (2)
CL Item
possible  (3)
CL Item
related (4)
Concomitant treatment
Item
Concomitant treatment given
boolean
C1707479 (UMLS CUI [1])
withdrawal from study due to Adverse Event
Item
Resulted in withdrawal from study?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
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