ID
44856
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: Visit 20 (Week 192)
Trefwoorden
Versies (3)
- 18-06-16 18-06-16 -
- 18-06-16 18-06-16 -
- 17-02-22 17-02-22 - Martin Dugas
Houder van rechten
Biogen
Geüploaded op
17 februari 2022
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
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Visit 20 (Week 192) BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Visit 20 (Week 192) 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
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
Temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0039476
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Physical examination
Beschrijving
Body System
Datatype
integer
Alias
- UMLS CUI [1]
- C0460002
Beschrijving
Examination Status
Datatype
integer
Alias
- UMLS CUI [1]
- C3267137
Beschrijving
physical examination findings
Datatype
text
Alias
- UMLS CUI [1]
- C2826636
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
Additional and Results
Beschrijving
type the number that indicates the furthest distance the subject is able to walk without aid or rest
Datatype
text
Alias
- UMLS CUI [1]
- C0429886
Beschrijving
type the number that indicates the furthest distance the subject is able to walk without aid or rest
Datatype
integer
Alias
- UMLS CUI [1]
- C0429886
Beschrijving
EDSS score
Datatype
float
Alias
- UMLS CUI [1]
- C0451246
Beschrijving
Name of Neurologist
Datatype
text
Alias
- UMLS CUI [1,1]
- C0237426
- UMLS CUI [1,2]
- C0027365
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
Study Drug Accountability
Beschrijving
first dose date
Datatype
date
Alias
- UMLS CUI [1]
- C3173309
Beschrijving
number of capsules not taken
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1705492
- UMLS CUI [1,2]
- C0178602
Beschrijving
If no, please specify on the appropriate adverse events form
Datatype
boolean
Alias
- UMLS CUI [1]
- C1707814
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
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C3890602 (UMLS CUI [1,2])
C2936631 (UMLS CUI [1,2])
C0516981 (UMLS CUI [1,2])
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