ID

44865

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: Unsceduled relapse assessment visit

Palabras clave

Versiones (4)
  1. 14/6/16 14/6/16 -
  2. 18/6/16 18/6/16 -
  3. 18/6/16 18/6/16 -
  4. 18/2/22 18/2/22 - Martin Dugas
Titular de derechos de autor

Biogen

Subido en

18 de febrero de 2022

DOI

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Licencia

Creative Commons BY-NC 4.0
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Unsceduled relapse assessment visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Inglés

Unsceduled relapse assessment 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]
C2826711
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]
C0039476
°C
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

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
Relapse assessment
Descripción

Relapse assessment

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1516048
Date treating neurologist contacted by subject
Descripción

Date neurologist contacted

Tipo de datos

date

Alias
UMLS CUI [1,1]
C3251708
UMLS CUI [1,2]
C0011008
Date treating neurologist performed neurological examination and collected vitals
Descripción

***treating neurologist to perform neurological exam including EDSS.***

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0518766
UMLS CUI [2,2]
C0011008
Has the subject experienced a protocol-defined relapse ( having new or recurrent symptoms more than 24 hours not associated with fever or stress ans with new objective findings)?
Descripción

After the Treating Neurologist has reviewed the results of the relapse assessments: No: Record the event on the Adverse Event CRF If the treating Neurologist still considers the event to be an MS relapse, record the event as "MS relaplse: non-protocol defined" and provide responses to questions 1 and 2. If Yes: Record the event on the Adverse Event CRF as "MS relapse" and provide responses to questions 1 and 2.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0277556
Onset date of MS relapse symptoms?
Descripción

MS relapse symptoms onset date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C0011008
Was the subject treated with IV Methylprednisolon per protocol?
Descripción

If so, please record on concommitant medication form

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0747791
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
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
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
SF 36: vitality
Descripción

SF 36: vitality

Tipo de datos

integer

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

SF-36: physical functioning

Tipo de datos

integer

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

SF-36: bodily pain

Tipo de datos

integer

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

SF-36: general health perceptions

Tipo de datos

integer

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

SF-36: physical function

Tipo de datos

integer

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

SF-36: emotional role functioning

Tipo de datos

integer

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

SF-36: social role functioning

Tipo de datos

integer

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

SF-36: Mental health

Tipo de datos

integer

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

Unsceduled relapse assessment 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
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
C0039476 (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
Relapse assessment
C0035020 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Date neurologist contacted
Item
Date treating neurologist contacted by subject
date
C3251708 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
neurological examination date, vital signs date
Item
Date treating neurologist performed neurological examination and collected vitals
date
C0027853 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
protocol defined relapse
Item
Has the subject experienced a protocol-defined relapse ( having new or recurrent symptoms more than 24 hours not associated with fever or stress ans with new objective findings)?
boolean
C0277556 (UMLS CUI [1])
MS relapse symptoms onset date
Item
Onset date of MS relapse symptoms?
date
C0856120 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
prednisolone treatment
Item
Was the subject treated with IV Methylprednisolon per protocol?
boolean
C0747791 (UMLS CUI [1])
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
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
Additional Surveys
EQ5D
Item
EQ5D Questionnaire
text
C2733251 (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])
Volver a la parte superior de la página 

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