ID
15909
Beschrijving
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
Trefwoorden
Versies (4)
- 14-06-16 14-06-16 -
- 18-06-16 18-06-16 -
- 18-06-16 18-06-16 -
- 18-02-22 18-02-22 - Martin Dugas
Geüploaded op
18 juni 2016
DOI
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Licentie
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
Beschrijving
Vital Signs
Beschrijving
Date of examination
Datatype
date
Alias
- UMLS CUI [1]
- C2826643
Beschrijving
Blood Pressure
Datatype
text
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Pulse
Datatype
text
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
Temperature
Datatype
text
Alias
- UMLS CUI [1]
- C0039476
Beschrijving
Physical examination
Beschrijving
Body System
Datatype
integer
Alias
- UMLS CUI [1]
- C0460002
Beschrijving
Examination Status
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0449438
Beschrijving
physical examination findings
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0243095
Beschrijving
EDSS Evaluation
Beschrijving
Functional System Scores
Beschrijving
Visual System EDSS
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042789
- UMLS CUI [1,2]
- C0451246
Beschrijving
Brainstem System EDSS
Datatype
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0006121
Beschrijving
Pyramidal System EDSS
Datatype
text
Alias
- UMLS CUI [1,1]
- C0228060
- UMLS CUI [1,2]
- C0451246
Beschrijving
Cerebellar System EDSS
Datatype
text
Alias
- UMLS CUI [1,1]
- C0007765
- UMLS CUI [1,2]
- C0451246
Beschrijving
Sensory System EDSS
Datatype
text
Alias
- UMLS CUI [1,1]
- C0682648
- UMLS CUI [1,2]
- C0451246
Beschrijving
Bowel or Bladder System EDSS
Datatype
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C2707247
Beschrijving
Cerebral System EDSS
Datatype
text
Alias
- UMLS CUI [1,1]
- C0006104
- UMLS CUI [1,2]
- C0451246
Beschrijving
Relapse assessment
Beschrijving
Date neurologist contacted
Datatype
date
Alias
- UMLS CUI [1,1]
- C3251708
- UMLS CUI [1,2]
- C0011008
Beschrijving
***treating neurologist to perform neurological exam including EDSS.***
Datatype
date
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C0518766
- UMLS CUI [2,2]
- C0011008
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0277556
- UMLS CUI [1,2]
- C2348235
Beschrijving
MS relapse symptoms onset date
Datatype
text
Alias
- UMLS CUI [1,1]
- C0856120
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0011008
Beschrijving
Onset date of MS relapse symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0856120
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0011008
Beschrijving
If so, please record on concommitant medication form
Datatype
boolean
Alias
- UMLS CUI [1]
- C0747791
Beschrijving
Subject Identification
Beschrijving
Visual Function Test
Beschrijving
Contrast Sensitivity Evaluation Binocular
Beschrijving
Contrast Sensitivity Evaluation Binocular: 100% Chart, Total # Correct
Datatype
float
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Beschrijving
Contrast Sensitivity Evaluation Binocular: 2,5% Chart, Total # Correct
Datatype
float
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Beschrijving
Contrast Sensitivity Evaluation Binocular: 1,25% Chart, Total # Correct
Datatype
float
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Beschrijving
Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent
Datatype
text
Alias
- UMLS CUI [1,1]
- C0009928
- UMLS CUI [1,2]
- C0042794
Beschrijving
Additional Surveys
Beschrijving
Health survey
Datatype
text
Alias
- UMLS CUI [1]
- C0018762
Beschrijving
Health survey
Datatype
float
Alias
- UMLS CUI [1]
- C0018762
Beschrijving
SF-36
Datatype
text
Alias
- UMLS CUI [1]
- C0518214
Beschrijving
SF 36: vitality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C0424589
Beschrijving
SF-36: physical functioning
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C0516981
Beschrijving
SF-36: bodily pain
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C3890602
Beschrijving
SF-36: general health perceptions
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C2936631
Beschrijving
SF-36: physical function
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C0516981
Beschrijving
SF-36: emotional role functioning
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C2370883
Beschrijving
SF-36: social role functioning
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518214
- UMLS CUI [1,2]
- C0035820
Beschrijving
SF-36: Mental health
Datatype
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
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])
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])