ID

15914

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: Visit 8 (Week 32)

Stichworte

Versionen (3)
  1. 10.06.16 10.06.16 -
  2. 18.06.16 18.06.16 -
  3. 17.02.22 17.02.22 - Martin Dugas
Hochgeladen am

18. Juni 2016

DOI

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Visit 8 (Week 32) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Englisch

Visit 8 (Week 32) 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
Weight
Beschreibung

Weight

Datentyp

text

Alias
UMLS CUI [1]
C0005910
Physical examination
Beschreibung

Physical examination

Body System
Beschreibung

Body System

Datentyp

integer

Alias
UMLS CUI [1]
C0460002
Examination Status
Beschreibung

Examination Status

Datentyp

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0449438
Abnormal examination findings
Beschreibung

physical examination findings

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
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
Visual Function Test
Beschreibung

Visual Function Test

Date of Evaluation
Beschreibung

Visual Function test, date

Datentyp

date

Alias
UMLS CUI [1,1]
C0234621
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C0011008
Contrast Sensitivity Evaluation Binocular
Beschreibung

Contrast Sensitivity Evaluation Binocular

100% Chart, Total # Correct
Beschreibung

Contrast Sensitivity Evaluation Binocular: 100% Chart, Total # Correct

Datentyp

float

Alias
UMLS CUI [1,1]
C0009928
UMLS CUI [1,2]
C0042794
2,5% Chart, Total # Correct
Beschreibung

Contrast Sensitivity Evaluation Binocular: 2,5% Chart, Total # Correct

Datentyp

float

Alias
UMLS CUI [1,1]
C0009928
UMLS CUI [1,2]
C0042794
1,25% Chart, Total # Correct
Beschreibung

Contrast Sensitivity Evaluation Binocular: 1,25% Chart, Total # Correct

Datentyp

float

Alias
UMLS CUI [1,1]
C0009928
UMLS CUI [1,2]
C0042794
Snellen visual acuity equivalent
Beschreibung

Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent

Datentyp

text

Alias
UMLS CUI [1,1]
C0009928
UMLS CUI [1,2]
C0042794
Study Drug Accountability
Beschreibung

Study Drug Accountability

date of first dose
Beschreibung

first dose date

Datentyp

date

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

number of capsules not taken

Datentyp

integer

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

If no, please specify on the appropriate adverse events form

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0441610
UMLS CUI [1,3]
C1507394
Additional Surveys
Beschreibung

Additional Surveys

EQ5D Questionnaire
Beschreibung

Health survey

Datentyp

text

Alias
UMLS CUI [1]
C0018762
EQ5D Questionnaire
Beschreibung

Health survey

Datentyp

float

Alias
UMLS CUI [1]
C0018762
SF-36 Questionaire
Beschreibung

SF-36

Datentyp

text

Alias
UMLS CUI [1]
C0518214
SF 36: vitality
Beschreibung

SF 36: vitality

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C0424589
SF-36: physical functioning
Beschreibung

SF-36: physical functioning

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C0516981
SF-36: bodily pain
Beschreibung

SF-36: bodily pain

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C3890602
SF-36: general health perceptions
Beschreibung

SF-36: general health perceptions

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C2936631
SF-36 physical function
Beschreibung

SF-36: physical function

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C0516981
SF-36: emotional role functioning
Beschreibung

SF-36: emotional role functioning

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C2370883
SF-36: social role functioning
Beschreibung

SF-36: social role functioning

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C0035820
SF-36: Mental health
Beschreibung

SF-36: Mental health

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C0025353
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Ähnliche Modelle

Visit 8 (Week 32) 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])
Weight
Item
Weight
text
C0005910 (UMLS CUI [1])
Item Group
Physical examination
Item
Body System
integer
C0460002 (UMLS CUI [1])
Body System
Code List
Body System
CL Item
Skin (1)
CL Item
HEENT  (2)
CL Item
Lymph nodes (3)
CL Item
Neck and Thyroid  (4)
CL Item
Breasts (5)
CL Item
Chest/Lungs (6)
CL Item
Heart  (7)
CL Item
Vascular (8)
CL Item
Abdomen (9)
CL Item
Rectal  (10)
CL Item
Neurological  (11)
CL Item
Extremities/Joints (12)
Item
Examination Status
integer
C0031809 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Examination Status
Code List
Examination Status
CL Item
Not done (1)
CL Item
Normal (2)
CL Item
Abnormal (please specify) (3)
physical examination findings
Item
Abnormal examination findings
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
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])
Item Group
Visual Function Test
Visual Function test, date
Item
Date of Evaluation
date
C0234621 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Contrast Sensitivity Evaluation Binocular
Contrast Sensitivity Evaluation Binocular: 100% Chart, Total # Correct
Item
100% Chart, Total # Correct
float
C0009928 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
Contrast Sensitivity Evaluation Binocular: 2,5% Chart, Total # Correct
Item
2,5% Chart, Total # Correct
float
C0009928 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
Contrast Sensitivity Evaluation Binocular: 1,25% Chart, Total # Correct
Item
1,25% Chart, Total # Correct
float
C0009928 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent
Item
Snellen visual acuity equivalent
text
C0009928 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
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])
Item Group
Additional Surveys
Health survey
Item
EQ5D Questionnaire
text
C0018762 (UMLS CUI [1])
Health survey
Item
EQ5D Questionnaire
float
C0018762 (UMLS CUI [1])
SF-36
Item
SF-36 Questionaire
text
C0518214 (UMLS CUI [1])
SF 36: vitality
Item
SF 36: vitality
integer
C0518214 (UMLS CUI [1,1])
C0424589 (UMLS CUI [1,2])
SF-36: physical functioning
Item
SF-36: physical functioning
integer
C0518214 (UMLS CUI [1,1])
C0516981 (UMLS CUI [1,2])
SF-36: bodily pain
Item
SF-36: bodily pain
integer
C0518214 (UMLS CUI [1,1])
C3890602 (UMLS CUI [1,2])
SF-36: general health perceptions
Item
SF-36: general health perceptions
integer
C0518214 (UMLS CUI [1,1])
C2936631 (UMLS CUI [1,2])
SF-36: physical function
Item
SF-36 physical function
integer
C0518214 (UMLS CUI [1,1])
C0516981 (UMLS CUI [1,2])
SF-36: emotional role functioning
Item
SF-36: emotional role functioning
integer
C0518214 (UMLS CUI [1,1])
C2370883 (UMLS CUI [1,2])
SF-36: social role functioning
Item
SF-36: social role functioning
integer
C0518214 (UMLS CUI [1,1])
C0035820 (UMLS CUI [1,2])
SF-36: Mental health
Item
SF-36: Mental health
integer
C0518214 (UMLS CUI [1,1])
C0025353 (UMLS CUI [1,2])
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