ID

15717

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: Baseline Visit (Day 1)

Stichworte

Versionen (1)
  1. 09.06.16 09.06.16 -
Hochgeladen am

9. Juni 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Baseline Visit (Day 1): EDSS evaluation BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Englisch

Baseline Visit (Day 1): EDSS evaluation 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
EDSS Evaluation
Beschreibung

EDSS Evaluation

Date of Evaluation
Beschreibung

EDSS Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0011008
Functional System Scores
Beschreibung

Functional System Scores

Visual
Beschreibung

Visual System EDSS

Datentyp

text

Alias
UMLS CUI [1,1]
C0042789
UMLS CUI [1,2]
C0451246
Brinstem
Beschreibung

Brainstem System EDSS

Datentyp

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0006121
Pyramidal
Beschreibung

Pyramidal System EDSS

Datentyp

text

Alias
UMLS CUI [1,1]
C0228060
UMLS CUI [1,2]
C0451246
Cerebellar
Beschreibung

Cerebellar System EDSS

Datentyp

text

Alias
UMLS CUI [1,1]
C0007765
UMLS CUI [1,2]
C0451246
Sensory
Beschreibung

Sensory System EDSS

Datentyp

text

Alias
UMLS CUI [1,1]
C0682648
UMLS CUI [1,2]
C0451246
Bowel or Bladder
Beschreibung

Bowel or Bladder System EDSS

Datentyp

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C2707247
Cerebral
Beschreibung

Cerebral System EDSS

Datentyp

text

Alias
UMLS CUI [1,1]
C0006104
UMLS CUI [1,2]
C0451246
Additional and Results
Beschreibung

Additional and Results

Actual Distance Walked
Beschreibung

type the number that indicates the furthest distance the subject is able to walk without aid or rest

Datentyp

text

Alias
UMLS CUI [1]
C0429886
Actual Distance Walked
Beschreibung

type the number that indicates the furthest distance the subject is able to walk without aid or rest

Datentyp

integer

Alias
UMLS CUI [1]
C0429886
EDSS Score
Beschreibung

EDSS score

Datentyp

float

Alias
UMLS CUI [1]
C0451246
Name of Neurologist
Beschreibung

Name of Neurologist

Datentyp

text

Alias
UMLS CUI [1,1]
C0237426
UMLS CUI [1,2]
C0027365
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Baseline Visit (Day 1): EDSS evaluation 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
EDSS Evaluation
EDSS Date
Item
Date of Evaluation
date
C0451246 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Functional System Scores
Visual System EDSS
Item
Visual
text
C0042789 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Brainstem System EDSS
Item
Brinstem
text
C0451246 (UMLS CUI [1,1])
C0006121 (UMLS CUI [1,2])
Pyramidal System EDSS
Item
Pyramidal
text
C0228060 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Cerebellar System EDSS
Item
Cerebellar
text
C0007765 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Sensory System EDSS
Item
Sensory
text
C0682648 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Bowel or Bladder System EDSS
Item
Bowel or Bladder
text
C0451246 (UMLS CUI [1,1])
C2707247 (UMLS CUI [1,2])
Cerebral System EDSS
Item
Cerebral
text
C0006104 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Item Group
Additional and Results
Item
Actual Distance Walked
text
C0429886 (UMLS CUI [1])
walking distance
Code List
Actual Distance Walked
CL Item
<100 metres (<100 metres)
CL Item
>100 metres and <200 metres (>100 metres and <200 metres)
CL Item
>200 metres and <300 metres (>200 metres and <300 metres)
CL Item
>300 metres and <500 metres (>300 metres and <500 metres)
CL Item
>500 metres (>500 metres)
Item
Actual Distance Walked
integer
C0429886 (UMLS CUI [1])
walking distance
Code List
Actual Distance Walked
CL Item
<100 metres (1)
CL Item
>100 metres and <200 metres (2)
CL Item
>200 metres and <300 metres (3)
CL Item
>300 metres and <500 metres (4)
CL Item
>500 metres (5)
EDSS score
Item
EDSS Score
float
C0451246 (UMLS CUI [1])
Name of Neurologist
Item
Name of Neurologist
text
C0237426 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video