ID
44865
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: Unsceduled relapse assessment visit
Mots-clés
Versions (4)
- 14/06/2016 14/06/2016 -
- 18/06/2016 18/06/2016 -
- 18/06/2016 18/06/2016 -
- 18/02/2022 18/02/2022 - Martin Dugas
Détendeur de droits
Biogen
Téléchargé le
18 février 2022
DOI
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Licence
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
Unsceduled relapse assessment visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Description
Vital Signs
Description
Date of examination
Type de données
date
Alias
- UMLS CUI [1]
- C2826643
Description
Blood Pressure
Type de données
text
Alias
- UMLS CUI [1]
- C0005823
Description
Pulse
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0232117
Description
Temperature
Type de données
float
Unités de mesure
- °C
Alias
- UMLS CUI [1]
- C0039476
Description
Physical examination
Description
Body System
Type de données
integer
Alias
- UMLS CUI [1]
- C0460002
Description
Examination Status
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0449438
Description
physical examination findings
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
Description
EDSS Evaluation
Description
Functional System Scores
Description
Visual System EDSS
Type de données
text
Alias
- UMLS CUI [1,1]
- C0042789
- UMLS CUI [1,2]
- C0451246
Description
Brainstem System EDSS
Type de données
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0006121
Description
Pyramidal System EDSS
Type de données
text
Alias
- UMLS CUI [1,1]
- C0228060
- UMLS CUI [1,2]
- C0451246
Description
Cerebellar System EDSS
Type de données
text
Alias
- UMLS CUI [1,1]
- C0007765
- UMLS CUI [1,2]
- C0451246
Description
Sensory System EDSS
Type de données
text
Alias
- UMLS CUI [1,1]
- C0682648
- UMLS CUI [1,2]
- C0451246
Description
Bowel or Bladder System EDSS
Type de données
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C2707247
Description
Cerebral System EDSS
Type de données
text
Alias
- UMLS CUI [1,1]
- C0006104
- UMLS CUI [1,2]
- C0451246
Description
Relapse assessment
Alias
- UMLS CUI [1,1]
- C0035020
- UMLS CUI [1,2]
- C1516048
Description
Date neurologist contacted
Type de données
date
Alias
- UMLS CUI [1,1]
- C3251708
- UMLS CUI [1,2]
- C0011008
Description
***treating neurologist to perform neurological exam including EDSS.***
Type de données
date
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C0518766
- UMLS CUI [2,2]
- C0011008
Description
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.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0277556
Description
MS relapse symptoms onset date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0856120
- UMLS CUI [1,2]
- C0011008
Description
If so, please record on concommitant medication form
Type de données
boolean
Alias
- UMLS CUI [1]
- C0747791
Description
Subject Identification
Description
Site number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0018704
- UMLS CUI [1,2]
- C0600091
Description
Subject number
Type de données
integer
Alias
- UMLS CUI [1]
- C2348585
Description
Subject Initials
Type de données
text
Alias
- UMLS CUI [1]
- C2986440
Description
Visual Function Test
Description
Contrast Sensitivity Evaluation Binocular
Description
Contrast Sensitivity Evaluation Binocular: 100% Chart, Total # Correct
Type de données
float
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Description
Contrast Sensitivity Evaluation Binocular: 2,5% Chart, Total # Correct
Type de données
float
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Description
Contrast Sensitivity Evaluation Binocular: 1,25% Chart, Total # Correct
Type de données
float
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Description
Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent
Type de données
text
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Description
Additional Surveys
Description
EQ5D
Type de données
text
Alias
- UMLS CUI [1]
- C2733251
Description
SF-36
Type de données
text
Alias
- UMLS CUI [1]
- C1519136
Description
SF 36: vitality
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C0424589
Description
SF-36: physical functioning
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C0516981
Description
SF-36: bodily pain
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C3890602
Description
SF-36: general health perceptions
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C2936631
Description
SF-36: physical function
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C0516981
Description
SF-36: emotional role functioning
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C2370883
Description
SF-36: social role functioning
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C0035820
Description
SF-36: Mental health
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C0025353
Similar models
Unsceduled relapse assessment visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
C0449438 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0451246 (UMLS CUI [1,2])
C0006121 (UMLS CUI [1,2])
C0451246 (UMLS CUI [1,2])
C0451246 (UMLS CUI [1,2])
C0451246 (UMLS CUI [1,2])
C2707247 (UMLS CUI [1,2])
C0451246 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0011008 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0392366 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0042794 (UMLS CUI [1,2])
C0042794 (UMLS CUI [1,2])
C0042794 (UMLS CUI [1,2])
C0042794 (UMLS CUI [1,2])
C0424589 (UMLS CUI [1,2])
C0516981 (UMLS CUI [1,2])
C3890602 (UMLS CUI [1,2])
C2936631 (UMLS CUI [1,2])
C0516981 (UMLS CUI [1,2])
C2370883 (UMLS CUI [1,2])
C0035820 (UMLS CUI [1,2])
C0025353 (UMLS CUI [1,2])