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Fel:
ID
15811
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: Visit 10 (Week 72)
Nyckelord
Versioner (2)
- 2016-06-14 2016-06-14 -
- 2022-02-17 2022-02-17 - Martin Dugas
Uppladdad den
14 juni 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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Visit 10 (Week 72): Vital Signs/Physical Examination BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Visit 10 (Week 72): Vital Signs/Physical Examination BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Similar models
Visit 10 (Week 72): Vital Signs/Physical Examination BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Site number
Item
Number of Facility
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Date of examination
Item
Date of examination
date
C2826643 (UMLS CUI [1])
Blood Pressure
Item
Blood Pressure
text
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
text
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
text
C0039476 (UMLS CUI [1])
Weight
Item
Weight
text
C0005910 (UMLS CUI [1])
CL Item
Skin (1)
CL Item
HEENT (2)
CL Item
Lymph nodes (3)
CL Item
Neck and Thyroid (4)
CL Item
Breasts (5)
CL Item
Chest/Lungs (6)
CL Item
Heart (7)
CL Item
Vascular (8)
CL Item
Abdomen (9)
CL Item
Rectal (10)
CL Item
Neurological (11)
CL Item
Extremities/Joints (12)
Item
Examination Status
integer
C0031809 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
CL Item
Not done (1)
CL Item
Normal (2)
CL Item
Abnormal (please specify) (3)
physical examination findings
Item
Abnormal examination findings
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
EDSS Date
Item
Date of Evaluation
date
C0451246 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Visual System EDSS
Item
Visual
text
C0042789 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
C0451246 (UMLS CUI [1,2])
Brainstem System EDSS
Item
Brinstem
text
C0451246 (UMLS CUI [1,1])
C0006121 (UMLS CUI [1,2])
C0006121 (UMLS CUI [1,2])
Pyramidal System EDSS
Item
Pyramidal
text
C0228060 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
C0451246 (UMLS CUI [1,2])
Cerebellar System EDSS
Item
Cerebellar
text
C0007765 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
C0451246 (UMLS CUI [1,2])
Sensory System EDSS
Item
Sensory
text
C0682648 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
C0451246 (UMLS CUI [1,2])
Bowel or Bladder System EDSS
Item
Bowel or Bladder
text
C0451246 (UMLS CUI [1,1])
C2707247 (UMLS CUI [1,2])
C2707247 (UMLS CUI [1,2])
Cerebral System EDSS
Item
Cerebral
text
C0006104 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
C0451246 (UMLS CUI [1,2])
CL Item
<100 metres (<100 metres)
CL Item
>100 metres and <200 metres (>100 metres and <200 metres)
CL Item
>200 metres and <300 metres (>200 metres and <300 metres)
CL Item
>300 metres and <500 metres (>300 metres and <500 metres)
CL Item
>500 metres (>500 metres)
CL Item
<100 metres (1)
CL Item
>100 metres and <200 metres (2)
CL Item
>200 metres and <300 metres (3)
CL Item
>300 metres and <500 metres (4)
CL Item
>500 metres (5)
EDSS score
Item
EDSS Score
float
C0451246 (UMLS CUI [1])
Name of Neurologist
Item
Name of Neurologist
text
C0237426 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
C0027365 (UMLS CUI [1,2])
Visual Function test, date
Item
Date of Evaluation
date
C0234621 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0392366 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Contrast Sensitivity Evaluation Binocular: 100% Chart, Total # Correct
Item
100% Chart, Total # Correct
float
C0009928 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
C0042794 (UMLS CUI [1,2])
Contrast Sensitivity Evaluation Binocular: 2,5% Chart, Total # Correct
Item
2,5% Chart, Total # Correct
float
C0009928 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
C0042794 (UMLS CUI [1,2])
Contrast Sensitivity Evaluation Binocular: 1,25% Chart, Total # Correct
Item
1,25% Chart, Total # Correct
float
C0009928 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
C0042794 (UMLS CUI [1,2])
Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent
Item
Snellen visual acuity equivalent
text
C0009928 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
C0042794 (UMLS CUI [1,2])
first dose date
Item
date of first dose
date
C3173309 (UMLS CUI [1])
number of capsules not taken
Item
Number of capsules not taken since previous visit to this visit
integer
C1705492 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
protocol-defined dose reduction/interruption
Item
Was there a protocol-defined dose reduction/interruption since the previous visit?
boolean
C3174092 (UMLS CUI [1,1])
C0441610 (UMLS CUI [1,2])
C1507394 (UMLS CUI [1,3])
C0441610 (UMLS CUI [1,2])
C1507394 (UMLS CUI [1,3])