ID
15816
Beskrivning
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
Nyckelord
Versioner (4)
- 2016-06-14 2016-06-14 -
- 2016-06-18 2016-06-18 -
- 2016-06-18 2016-06-18 -
- 2022-02-18 2022-02-18 - Martin Dugas
Uppladdad den
14 juni 2016
DOI
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Licens
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
Beskrivning
Vital Signs
Beskrivning
Date of examination
Datatyp
date
Alias
- UMLS CUI [1]
- C2826643
Beskrivning
Blood Pressure
Datatyp
text
Alias
- UMLS CUI [1]
- C0005823
Beskrivning
Pulse
Datatyp
text
Alias
- UMLS CUI [1]
- C0232117
Beskrivning
Temperature
Datatyp
text
Alias
- UMLS CUI [1]
- C0039476
Beskrivning
Physical examination
Beskrivning
Body System
Datatyp
integer
Alias
- UMLS CUI [1]
- C0460002
Beskrivning
Examination Status
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0449438
Beskrivning
physical examination findings
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
Beskrivning
EDSS Evaluation
Beskrivning
Functional System Scores
Beskrivning
Visual System EDSS
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042789
- UMLS CUI [1,2]
- C0451246
Beskrivning
Brainstem System EDSS
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0006121
Beskrivning
Pyramidal System EDSS
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0228060
- UMLS CUI [1,2]
- C0451246
Beskrivning
Cerebellar System EDSS
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0007765
- UMLS CUI [1,2]
- C0451246
Beskrivning
Sensory System EDSS
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0682648
- UMLS CUI [1,2]
- C0451246
Beskrivning
Bowel or Bladder System EDSS
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C2707247
Beskrivning
Cerebral System EDSS
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0006104
- UMLS CUI [1,2]
- C0451246
Beskrivning
Relapse assessment
Beskrivning
Date neurologist contacted
Datatyp
date
Alias
- UMLS CUI [1,1]
- C3251708
- UMLS CUI [1,2]
- C0011008
Beskrivning
***treating neurologist to perform neurological exam including EDSS.***
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C0518766
- UMLS CUI [2,2]
- C0011008
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0277556
- UMLS CUI [1,2]
- C2348235
Beskrivning
MS relapse symptoms onset date
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0856120
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0011008
Beskrivning
Onset date of MS relapse symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0856120
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0011008
Beskrivning
If so, please record on concommitant medication form
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0747791
Beskrivning
Subject Identification
Beskrivning
Visual Function Test
Beskrivning
Contrast Sensitivity Evaluation Binocular
Beskrivning
Contrast Sensitivity Evaluation Binocular: 100% Chart, Total # Correct
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Beskrivning
Contrast Sensitivity Evaluation Binocular: 2,5% Chart, Total # Correct
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Beskrivning
Contrast Sensitivity Evaluation Binocular: 1,25% Chart, Total # Correct
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Beskrivning
Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent
Datatyp
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])