ID

15906

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)
  1. 14.06.16 14.06.16 -
  2. 18.06.16 18.06.16 -
  3. 18.06.16 18.06.16 -
  4. 18.02.22 18.02.22 - Martin Dugas
Hochgeladen am

18. Juni 2016

DOI

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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

Englisch

Unsceduled relapse assessment visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 Formulare  
Subject Identification
Beschreibung

Subject Identification

Number of Facility
Beschreibung

Site number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Beschreibung

Subject Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Vital Signs
Beschreibung

Vital Signs

Date of examination
Beschreibung

Date of examination

Datentyp

date

Alias
UMLS CUI [1]
C2826643
Blood Pressure
Beschreibung

Blood Pressure

Datentyp

text

Alias
UMLS CUI [1]
C0005823
Pulse
Beschreibung

Pulse

Datentyp

text

Alias
UMLS CUI [1]
C0232117
Temperature
Beschreibung

Temperature

Datentyp

text

Alias
UMLS CUI [1]
C0039476
Physical examination
Beschreibung

Physical examination

Body System
Beschreibung

Body System

Datentyp

integer

Alias
UMLS CUI [1]
C0460002
Examination Status
Beschreibung

Examination Status

Datentyp

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0449438
Abnormal examination findings
Beschreibung

physical examination findings

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
EDSS Evaluation
Beschreibung

EDSS Evaluation

Date of Evaluation
Beschreibung

EDSS Date

Datentyp

date

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

Functional System Scores

Visual
Beschreibung

Visual System EDSS

Datentyp

text

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

Brainstem System EDSS

Datentyp

text

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

Pyramidal System EDSS

Datentyp

text

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

Cerebellar System EDSS

Datentyp

text

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

Sensory System EDSS

Datentyp

text

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

Bowel or Bladder System EDSS

Datentyp

text

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

Cerebral System EDSS

Datentyp

text

Alias
UMLS CUI [1,1]
C0006104
UMLS CUI [1,2]
C0451246
Relapse assessment
Beschreibung

Relapse assessment

Date treating neurologist contacted by subject
Beschreibung

Date neurologist contacted

Datentyp

date

Alias
UMLS CUI [1,1]
C3251708
UMLS CUI [1,2]
C0011008
Date treating neurologist performed neurological examination and collected vitals
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
Has the subject experienced a protocol-defined relapse ( having new or recurrent symptoms more than 24 hours not associated with fever or stress ans with new objective findings)?
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
Onset date of MS relapse symptoms?
Beschreibung

MS relapse symptoms onset date

Datentyp

text

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0011008
Onset date of MS relapse symptoms?
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
Was the subject treated with IV Methylprednisolon per protocol?
Beschreibung

If so, please record on concommitant medication form

Datentyp

boolean

Alias
UMLS CUI [1]
C0747791
Subject Identification
Beschreibung

Subject Identification

Number of Facility
Beschreibung

Site number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Beschreibung

Subject Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Visual Function Test
Beschreibung

Visual Function Test

Date of Evaluation
Beschreibung

Visual Function test, date

Datentyp

date

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

Contrast Sensitivity Evaluation Binocular

100% Chart, Total # Correct
Beschreibung

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

Datentyp

float

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

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

Datentyp

float

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

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

Datentyp

float

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

Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent

Datentyp

text

Alias
UMLS CUI [1,1]
C0009928
UMLS CUI [1,2]
C0042794
Additional Surveys
Beschreibung

Additional Surveys

EQ5D Questionnaire
Beschreibung

Health survey

Datentyp

text

Alias
UMLS CUI [1]
C0018762
SF-36 Questionaire
Beschreibung

SF-36

Datentyp

text

Alias
UMLS CUI [1]
C0518214
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Ähnliche Modelle

Unsceduled relapse assessment visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Subject Identification
Site number
Item
Number of Facility
integer
C0018704 (UMLS CUI [1,1])
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])
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
text
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
text
C0039476 (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)
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])
Examination Status
Code List
Examination Status
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])
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
Relapse assessment
Date neurologist contacted
Item
Date treating neurologist contacted by subject
date
C3251708 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
neurological examination date, vital signs date
Item
Date treating neurologist performed neurological examination and collected vitals
date
C0027853 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
relapse protocol defined
Item
Has the subject experienced a protocol-defined relapse ( having new or recurrent symptoms more than 24 hours not associated with fever or stress ans with new objective findings)?
boolean
C0277556 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
MS relapse symptoms onset date
Item
Onset date of MS relapse symptoms?
text
C0856120 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Onset date of MS relapse symptoms
Item
Onset date of MS relapse symptoms?
date
C0856120 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
prednisolone treatment
Item
Was the subject treated with IV Methylprednisolon per protocol?
boolean
C0747791 (UMLS CUI [1])
Item Group
Subject Identification
Site number
Item
Number of Facility
integer
C0018704 (UMLS CUI [1,1])
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])
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
Additional Surveys
Health survey
Item
EQ5D Questionnaire
text
C0018762 (UMLS CUI [1])
SF-36
Item
SF-36 Questionaire
text
C0518214 (UMLS CUI [1])
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