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Relapse Assessment CRFs Multiple Sklerosis Tysabri NCT00027300

1 forms  
Relapse Assessment
Description

Relapse Assessment

Alias
UMLS CUI-1
C0035020
UMLS CUI-2
C1516048
Date treating neurologist contacted by subject
Description

Date neurologist contacted

Data type

date

Alias
UMLS CUI [1,1]
C3251708
UMLS CUI [1,2]
C0011008
Date subject evaluated by treating neurologist
Description

Date subject evaluated by neurologist

Data type

date

Alias
UMLS CUI [1,1]
C0583578
UMLS CUI [1,2]
C0011008
Does the treating neurologist suspect that the subject has experienced a relapse?
Description

Suspected relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C0522483
UMLS CUI [1,2]
C0035020
If "Yes", examining neurologist to perform EDSS
Description

Reason for EDSS performance

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0451246
EDSS
Description

EDSS

Alias
UMLS CUI-1
C0451246
Evalutation date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0011008
EDSS visual
Description

EDSS visual

Data type

float

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C1321512
EDSS brainstem
Description

EDSS brainstem

Data type

float

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0006121
EDSS pyramidal
Description

EDSS pyramidal

Data type

float

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0228060
EDSS cerebellar
Description

EDSS cerebellar

Data type

float

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0007765
EDSS sensory
Description

EDSS sonsory

Data type

float

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0445254
EDSS bowel or bladder
Description

EDSS bowel or bladder

Data type

float

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0021853
UMLS CUI [2,1]
C0451246
UMLS CUI [2,2]
C0005682
EDSS cerebral
Description

EDSS cerebral

Data type

float

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C3829397
Check the box that indicates the furthest distance the subject is able to walk without aid or rest:
Description

actual distance walked

Data type

integer

Alias
UMLS CUI [1]
C0429888
EDSS score: __ * _
Description

EDSS Score

Data type

float

Alias
UMLS CUI [1]
C0451246
UMLS CUI [2]
C0429888
Treating neurologist evaluation
Description

Treating neurologist evaluation

Alias
UMLS CUI-1
C0237426
UMLS CUI-2
C0220825
Has the subject experienced a relapse (i.e. having new or recurrent symptoms, lasting more than 48 hours with corresponding objective findings documented on the examining neurologist's exam)?
Description

Relapse

Data type

boolean

Alias
UMLS CUI [1]
C0856120
Onset date of MS relapse (Record relapse on Adverse Event page)
Description

Onset date of MS relapse

Data type

date

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C0011008
Was the subject treated with IV methylprednisolone per protocol? (Record on Concomitant Medication form)
Description

Treatment with iv methylprednisolone

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0025815
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Similar models

Relapse Assessment CRFs Multiple Sklerosis Tysabri NCT00027300

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Relapse Assessment
C0035020 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
Date neurologist contacted
Item
Date treating neurologist contacted by subject
date
C3251708 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date subject evaluated by neurologist
Item
Date subject evaluated by treating neurologist
date
C0583578 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Suspected relapse
Item
Does the treating neurologist suspect that the subject has experienced a relapse?
boolean
C0522483 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
Reason for EDSS performance
Item
If "Yes", examining neurologist to perform EDSS
text
C0392360 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Item Group
EDSS
C0451246 (UMLS CUI-1)
Date
Item
Evalutation date
date
C0451246 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
EDSS visual
Item
EDSS visual
float
C0451246 (UMLS CUI [1,1])
C1321512 (UMLS CUI [1,2])
EDSS brainstem
Item
EDSS brainstem
float
C0451246 (UMLS CUI [1,1])
C0006121 (UMLS CUI [1,2])
EDSS pyramidal
Item
EDSS pyramidal
float
C0451246 (UMLS CUI [1,1])
C0228060 (UMLS CUI [1,2])
EDSS cerebellar
Item
EDSS cerebellar
float
C0451246 (UMLS CUI [1,1])
C0007765 (UMLS CUI [1,2])
EDSS sonsory
Item
EDSS sensory
float
C0451246 (UMLS CUI [1,1])
C0445254 (UMLS CUI [1,2])
EDSS bowel or bladder
Item
EDSS bowel or bladder
float
C0451246 (UMLS CUI [1,1])
C0021853 (UMLS CUI [1,2])
C0451246 (UMLS CUI [2,1])
C0005682 (UMLS CUI [2,2])
EDSS cerebral
Item
EDSS cerebral
float
C0451246 (UMLS CUI [1,1])
C3829397 (UMLS CUI [1,2])
Item
Check the box that indicates the furthest distance the subject is able to walk without aid or rest:
integer
C0429888 (UMLS CUI [1])
actual distance walked
Code List
Check the box that indicates the furthest distance the subject is able to walk without aid or rest:
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])
C0429888 (UMLS CUI [2])
Item Group
Treating neurologist evaluation
C0237426 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Relapse
Item
Has the subject experienced a relapse (i.e. having new or recurrent symptoms, lasting more than 48 hours with corresponding objective findings documented on the examining neurologist's exam)?
boolean
C0856120 (UMLS CUI [1])
Onset date of MS relapse
Item
Onset date of MS relapse (Record relapse on Adverse Event page)
date
C0856120 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Treatment with iv methylprednisolone
Item
Was the subject treated with IV methylprednisolone per protocol? (Record on Concomitant Medication form)
boolean
C0013216 (UMLS CUI [1,1])
C0025815 (UMLS CUI [1,2])
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