ID
15816
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
Keywords
Versions (4)
- 6/14/16 6/14/16 -
- 6/18/16 6/18/16 -
- 6/18/16 6/18/16 -
- 2/18/22 2/18/22 - Martin Dugas
Uploaded on
June 14, 2016
DOI
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License
Creative Commons BY-NC 3.0
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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
Data type
date
Alias
- UMLS CUI [1]
- C2826643
Description
Blood Pressure
Data type
text
Alias
- UMLS CUI [1]
- C0005823
Description
Pulse
Data type
text
Alias
- UMLS CUI [1]
- C0232117
Description
Temperature
Data type
text
Alias
- UMLS CUI [1]
- C0039476
Description
Physical examination
Description
Body System
Data type
integer
Alias
- UMLS CUI [1]
- C0460002
Description
Examination Status
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0449438
Description
physical examination findings
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
Description
EDSS Evaluation
Description
Functional System Scores
Description
Visual System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0042789
- UMLS CUI [1,2]
- C0451246
Description
Brainstem System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0006121
Description
Pyramidal System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0228060
- UMLS CUI [1,2]
- C0451246
Description
Cerebellar System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0007765
- UMLS CUI [1,2]
- C0451246
Description
Sensory System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0682648
- UMLS CUI [1,2]
- C0451246
Description
Bowel or Bladder System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C2707247
Description
Cerebral System EDSS
Data type
text
Alias
- UMLS CUI [1,1]
- C0006104
- UMLS CUI [1,2]
- C0451246
Description
Relapse assessment
Description
Date neurologist contacted
Data type
date
Alias
- UMLS CUI [1,1]
- C3251708
- UMLS CUI [1,2]
- C0011008
Description
***treating neurologist to perform neurological exam including EDSS.***
Data type
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.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0277556
- UMLS CUI [1,2]
- C2348235
Description
MS relapse symptoms onset date
Data type
text
Alias
- UMLS CUI [1,1]
- C0856120
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0011008
Description
Onset date of MS relapse symptoms
Data type
date
Alias
- UMLS CUI [1,1]
- C0856120
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0011008
Description
If so, please record on concommitant medication form
Data type
boolean
Alias
- UMLS CUI [1]
- C0747791
Description
Subject Identification
Description
Visual Function Test
Description
Contrast Sensitivity Evaluation Binocular
Description
Contrast Sensitivity Evaluation Binocular: 100% Chart, Total # Correct
Data type
float
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Description
Contrast Sensitivity Evaluation Binocular: 2,5% Chart, Total # Correct
Data type
float
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Description
Contrast Sensitivity Evaluation Binocular: 1,25% Chart, Total # Correct
Data type
float
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Description
Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent
Data type
text
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Similar models
Unsceduled relapse assessment visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
C0600091 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C2348235 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])