ID

44855

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 10 (Week 72)

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Versies (2)
  1. 14-06-16 14-06-16 -
  2. 17-02-22 17-02-22 - Martin Dugas
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17 februari 2022

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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

Engels

Visit 10 (Week 72): Vital Signs/Physical Examination BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 Formulieren  
Subject Identification
Beschrijving

Subject Identification

Number of Facility
Beschrijving

Site number

Datatype

integer

Alias
UMLS CUI [1]
C2826711
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Beschrijving

Subject Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Vital Signs
Beschrijving

Vital Signs

Date of examination
Beschrijving

Date of examination

Datatype

date

Alias
UMLS CUI [1]
C2826643
Blood Pressure
Beschrijving

Blood Pressure

Datatype

text

Alias
UMLS CUI [1]
C0005823
Pulse
Beschrijving

Pulse

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temperature
Beschrijving

Temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Physical examination
Beschrijving

Physical examination

Body System
Beschrijving

Body System

Datatype

integer

Alias
UMLS CUI [1]
C0460002
Examination Status
Beschrijving

Examination Status

Datatype

integer

Alias
UMLS CUI [1]
C3267137
Abnormal examination findings
Beschrijving

physical examination findings

Datatype

text

Alias
UMLS CUI [1]
C2826636
EDSS Evaluation
Beschrijving

EDSS Evaluation

Date of Evaluation
Beschrijving

EDSS Date

Datatype

date

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0011008
Functional System Scores
Beschrijving

Functional System Scores

Visual
Beschrijving

Visual System EDSS

Datatype

text

Alias
UMLS CUI [1,1]
C0042789
UMLS CUI [1,2]
C0451246
Brinstem
Beschrijving

Brainstem System EDSS

Datatype

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0006121
Pyramidal
Beschrijving

Pyramidal System EDSS

Datatype

text

Alias
UMLS CUI [1,1]
C0228060
UMLS CUI [1,2]
C0451246
Cerebellar
Beschrijving

Cerebellar System EDSS

Datatype

text

Alias
UMLS CUI [1,1]
C0007765
UMLS CUI [1,2]
C0451246
Sensory
Beschrijving

Sensory System EDSS

Datatype

text

Alias
UMLS CUI [1,1]
C0682648
UMLS CUI [1,2]
C0451246
Bowel or Bladder
Beschrijving

Bowel or Bladder System EDSS

Datatype

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C2707247
Cerebral
Beschrijving

Cerebral System EDSS

Datatype

text

Alias
UMLS CUI [1,1]
C0006104
UMLS CUI [1,2]
C0451246
Additional and Results
Beschrijving

Additional and Results

Actual Distance Walked
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
Actual Distance Walked
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
EDSS Score
Beschrijving

EDSS score

Datatype

float

Alias
UMLS CUI [1]
C0451246
Name of Neurologist
Beschrijving

Name of Neurologist

Datatype

text

Alias
UMLS CUI [1,1]
C0237426
UMLS CUI [1,2]
C0027365
Visual Function Test
Beschrijving

Visual Function Test

Date of Evaluation
Beschrijving

Visual Function test, date

Datatype

date

Alias
UMLS CUI [1,1]
C0234621
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C0011008
Contrast Sensitivity Evaluation Binocular
Beschrijving

Contrast Sensitivity Evaluation Binocular

100% Chart, Total # Correct
Beschrijving

Contrast Sensitivity Evaluation Binocular: 100% Chart, Total # Correct

Datatype

float

Alias
UMLS CUI [1,1]
C0009928
UMLS CUI [1,2]
C0042794
2,5% Chart, Total # Correct
Beschrijving

Contrast Sensitivity Evaluation Binocular: 2,5% Chart, Total # Correct

Datatype

float

Alias
UMLS CUI [1,1]
C0009928
UMLS CUI [1,2]
C0042794
1,25% Chart, Total # Correct
Beschrijving

Contrast Sensitivity Evaluation Binocular: 1,25% Chart, Total # Correct

Datatype

float

Alias
UMLS CUI [1,1]
C0009928
UMLS CUI [1,2]
C0042794
Snellen visual acuity equivalent
Beschrijving

Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent

Datatype

text

Alias
UMLS CUI [1,1]
C0009928
UMLS CUI [1,2]
C0042794
Study Drug Accountability
Beschrijving

Study Drug Accountability

date of first dose
Beschrijving

first dose date

Datatype

date

Alias
UMLS CUI [1]
C3173309
Number of capsules not taken since previous visit to this visit
Beschrijving

number of capsules not taken

Datatype

integer

Alias
UMLS CUI [1,1]
C1705492
UMLS CUI [1,2]
C0178602
Was there a protocol-defined dose reduction/interruption since the previous visit?
Beschrijving

If no, please specify on the appropriate adverse events form

Datatype

boolean

Alias
UMLS CUI [1]
C1707814
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Similar models

Visit 10 (Week 72): Vital Signs/Physical Examination BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Subject Identification
Site number
Item
Number of Facility
integer
C2826711 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Item Group
Vital Signs
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
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Physical examination
Item
Body System
integer
C0460002 (UMLS CUI [1])
Body System
Code List
Body System
CL Item
Skin (1)
C1123023 (UMLS CUI-1)
(Comment:en)
CL Item
HEENT  (2)
C1512338 (UMLS CUI-1)
(Comment:en)
CL Item
Lymph nodes (3)
C0024204 (UMLS CUI-1)
(Comment:en)
CL Item
Neck and Thyroid  (4)
C0027530 (UMLS CUI-1)
C0040132 (UMLS CUI-2)
(Comment:en)
CL Item
Breasts (5)
C0006141 (UMLS CUI-1)
(Comment:en)
CL Item
Chest/Lungs (6)
C0817096 (UMLS CUI-1)
C0024109 (UMLS CUI-2)
(Comment:en)
CL Item
Heart  (7)
C0018787 (UMLS CUI-1)
(Comment:en)
CL Item
Vascular (8)
C1801960 (UMLS CUI-1)
(Comment:en)
CL Item
Abdomen (9)
C0000726 (UMLS CUI-1)
(Comment:en)
CL Item
Rectal  (10)
C0205052 (UMLS CUI-1)
(Comment:en)
CL Item
Neurological  (11)
CL Item
Extremities/Joints (12)
Item
Examination Status
integer
C3267137 (UMLS CUI [1])
Examination Status
Code List
Examination Status
CL Item
Not done (1)
C1272696 (UMLS CUI-1)
(Comment:en)
CL Item
Normal (2)
C0205307 (UMLS CUI-1)
(Comment:en)
CL Item
Abnormal (please specify) (3)
C0205161 (UMLS CUI-1)
(Comment:en)
physical examination findings
Item
Abnormal examination findings
text
C2826636 (UMLS CUI [1])
Item Group
EDSS Evaluation
EDSS Date
Item
Date of Evaluation
date
C0451246 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Functional System Scores
Visual System EDSS
Item
Visual
text
C0042789 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Brainstem System EDSS
Item
Brinstem
text
C0451246 (UMLS CUI [1,1])
C0006121 (UMLS CUI [1,2])
Pyramidal System EDSS
Item
Pyramidal
text
C0228060 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Cerebellar System EDSS
Item
Cerebellar
text
C0007765 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Sensory System EDSS
Item
Sensory
text
C0682648 (UMLS CUI [1,1])
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])
Cerebral System EDSS
Item
Cerebral
text
C0006104 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Item Group
Additional and Results
Item
Actual Distance Walked
text
C0429886 (UMLS CUI [1])
walking distance
Code List
Actual Distance Walked
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)
Item
Actual Distance Walked
integer
C0429886 (UMLS CUI [1])
walking distance
Code List
Actual Distance Walked
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])
Item Group
Visual Function Test
Visual Function test, date
Item
Date of Evaluation
date
C0234621 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Contrast Sensitivity Evaluation Binocular
Contrast Sensitivity Evaluation Binocular: 100% Chart, Total # Correct
Item
100% Chart, Total # Correct
float
C0009928 (UMLS CUI [1,1])
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])
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])
Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent
Item
Snellen visual acuity equivalent
text
C0009928 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
Item Group
Study Drug Accountability
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])
protocol-defined dose reduction/interruption
Item
Was there a protocol-defined dose reduction/interruption since the previous visit?
boolean
C1707814 (UMLS CUI [1])
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