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