ID

44860

Description

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)

Keywords

Versions (3)
  1. 6/10/16 6/10/16 -
  2. 6/18/16 6/18/16 -
  3. 2/17/22 2/17/22 - Martin Dugas
Copyright Holder

Biogen

Uploaded on

February 17, 2022

DOI

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License

Creative Commons BY-NC 4.0
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Visit 8 (Week 32) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

English

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

1 forms  
Subject Identification
Description

Subject Identification

Number of Facility
Description

Site number

Data type

integer

Alias
UMLS CUI [1]
C2826711
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Vital Signs
Description

Vital Signs

Date of examination
Description

Date of examination

Data type

date

Alias
UMLS CUI [1]
C2826643
Blood Pressure
Description

Blood Pressure

Data type

text

Alias
UMLS CUI [1]
C0005823
Pulse
Description

Pulse

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Physical examination
Description

Physical examination

Body System
Description

Body System

Data type

integer

Alias
UMLS CUI [1]
C0460002
Examination Status
Description

Examination Status

Data type

integer

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

physical examination findings

Data type

text

Alias
UMLS CUI [1]
C2826636
EDSS Evaluation
Description

EDSS Evaluation

Date of Evaluation
Description

EDSS Date

Data type

date

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

Functional System Scores

Visual
Description

Visual System EDSS

Data type

text

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

Brainstem System EDSS

Data type

text

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

Pyramidal System EDSS

Data type

text

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

Cerebellar System EDSS

Data type

text

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

Sensory System EDSS

Data type

text

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

Bowel or Bladder System EDSS

Data type

text

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

Cerebral System EDSS

Data type

text

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

Additional and Results

Actual Distance Walked
Description

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

Data type

text

Alias
UMLS CUI [1]
C0429886
Actual Distance Walked
Description

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

Data type

integer

Alias
UMLS CUI [1]
C0429886
EDSS Score
Description

EDSS score

Data type

float

Alias
UMLS CUI [1]
C0451246
Name of Neurologist
Description

Name of Neurologist

Data type

text

Alias
UMLS CUI [1,1]
C0237426
UMLS CUI [1,2]
C0027365
Visual Function Test
Description

Visual Function Test

Date of Evaluation
Description

Visual Function test, date

Data type

date

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

Contrast Sensitivity Evaluation Binocular

100% Chart, Total # Correct
Description

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

Data type

float

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

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

Data type

float

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

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

Data type

float

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

Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent

Data type

text

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

Study Drug Accountability

date of first dose
Description

first dose date

Data type

date

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

number of capsules not taken

Data type

integer

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

If no, please specify on the appropriate adverse events form

Data type

boolean

Alias
UMLS CUI [1]
C1707814
Additional Surveys
Description

Additional Surveys

EQ5D Questionnaire
Description

EQ5D

Data type

text

Alias
UMLS CUI [1]
C3640281
SF-36 Questionaire
Description

SF-36

Data type

text

Alias
UMLS CUI [1]
C1519136
SF 36: vitality
Description

SF 36: vitality

Data type

integer

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

SF-36: physical functioning

Data type

integer

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

SF-36: bodily pain

Data type

integer

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

SF-36: general health perceptions

Data type

integer

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

SF-36: physical function

Data type

integer

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

SF-36: emotional role functioning

Data type

integer

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

SF-36: social role functioning

Data type

integer

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

SF-36: Mental health

Data type

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C0025353
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Subject Identification
Site number
Item
Number of Facility
integer
C2826711 (UMLS CUI [1])
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
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Weight
Item
Weight
float
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
C2826636 (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])
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
C1707814 (UMLS CUI [1])
Item Group
Additional Surveys
EQ5D
Item
EQ5D Questionnaire
text
C3640281 (UMLS CUI [1])
SF-36
Item
SF-36 Questionaire
text
C1519136 (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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