ID

44880

Descripción

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: Premature Study Withdrawal Visit

Palabras clave

Versiones (2)
  1. 16/6/16 16/6/16 -
  2. 19/2/22 19/2/22 - Martin Dugas
Titular de derechos de autor

Biogen

Subido en

19 de febrero de 2022

DOI

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Licencia

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

Inglés

Premature Study Withdrawal Visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 formularios  
Subject Identification
Descripción

Subject Identification

Number of Facility
Descripción

Site number

Tipo de datos

integer

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

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Descripción

Subject Initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Vital Signs
Descripción

Vital Signs

Date of examination
Descripción

Date of examination

Tipo de datos

date

Alias
UMLS CUI [1]
C2826643
Blood Pressure
Descripción

Blood Pressure

Tipo de datos

text

Alias
UMLS CUI [1]
C0005823
Pulse
Descripción

Pulse

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temperature
Descripción

Temperature

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Physical examination
Descripción

Physical examination

Body System
Descripción

Body System

Tipo de datos

integer

Alias
UMLS CUI [1]
C0460002
Examination Status
Descripción

Examination Status

Tipo de datos

integer

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

physical examination findings

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
EDSS Evaluation
Descripción

EDSS Evaluation

Alias
UMLS CUI [1]
C0451246
Date of Evaluation
Descripción

EDSS Date

Tipo de datos

date

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

Functional System Scores

Visual
Descripción

Visual System EDSS

Tipo de datos

text

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

Brainstem System EDSS

Tipo de datos

text

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

Pyramidal System EDSS

Tipo de datos

text

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

Cerebellar System EDSS

Tipo de datos

text

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

Sensory System EDSS

Tipo de datos

text

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

Bowel or Bladder System EDSS

Tipo de datos

text

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

Cerebral System EDSS

Tipo de datos

text

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

Additional and Results

Actual Distance Walked
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C0429886
Actual Distance Walked
Descripción

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

Tipo de datos

integer

Alias
UMLS CUI [1]
C0429886
EDSS Score
Descripción

EDSS score

Tipo de datos

float

Alias
UMLS CUI [1]
C0451246
Name of Neurologist
Descripción

Name of Neurologist

Tipo de datos

text

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

Visual Function Test

Date of Evaluation
Descripción

Visual Function test, date

Tipo de datos

date

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

Contrast Sensitivity Evaluation Binocular

100% Chart, Total # Correct
Descripción

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

Tipo de datos

float

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

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

Tipo de datos

float

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

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

Tipo de datos

float

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

Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent

Tipo de datos

text

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

Study Drug Accountability

date of first dose
Descripción

first dose date

Tipo de datos

date

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

number of capsules not taken

Tipo de datos

integer

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

If no, please specify on the appropriate adverse events form

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707814
Additional Surveys
Descripción

Additional Surveys

EQ5D Questionnaire
Descripción

EQ5D

Tipo de datos

text

Alias
UMLS CUI [1]
C2733251
SF-36 Questionaire
Descripción

SF-36

Tipo de datos

text

Alias
UMLS CUI [1]
C1519136
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Similar models

Premature Study Withdrawal Visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
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
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Item Group
EDSS Evaluation
C0451246 (UMLS CUI [1])
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])
dose reduction or 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
C2733251 (UMLS CUI [1])
SF-36
Item
SF-36 Questionaire
text
C1519136 (UMLS CUI [1])
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