ID

19884

Description

The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS. Documentation process: This form ist to be obtained in week 24, week 52, week 104, week, 120, week, 128 and Premature Study Withdrawl.

Keywords

  1. 1/30/17 1/30/17 -
Uploaded on

January 30, 2017

DOI

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License

Creative Commons BY-NC 3.0

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Modified Fatigue Impact Scale CRFs Multiple Sklerosis Tysabri NCT00027300

Modified Fatigue Impact Scale CRFs Multiple Sklerosis Tysabri NCT00027300

Modified Fatigue Impact Scale
Description

Modified Fatigue Impact Scale

Alias
UMLS CUI-1
C3810705
Because of my fatigue during the past 4 weeks I have been less alert.
Description

Have been less alert

Data type

integer

Alias
UMLS CUI [1]
C3829104
Because of my fatigue during the past 4 weeks I have had difficulty paying attention for long periods of time.
Description

Have had difficulty paying attention for long periods of time

Data type

integer

Alias
UMLS CUI [1]
C3829102
Because of my fatigue during the past 4 weeks I have been unable to think clearly.
Description

Been unable to think clearly

Data type

integer

Alias
UMLS CUI [1]
C3829088
Because of my fatigue during the past 4 weeks I have been clumsy and uncoordinated.
Description

Been clumsy and uncoordinated

Data type

integer

Alias
UMLS CUI [1]
C3829106
Because of my fatigue during the past 4 weeks I have been forgetful.
Description

Been forgetful

Data type

integer

Alias
UMLS CUI [1]
C3829105
Because of my fatigue during the past 4 weeks I had to pace myself in my physical activities.
Description

Had to pace myself in my physical activities

Data type

integer

Alias
UMLS CUI [1]
C3829090
Because of my fatigue during the past 4 weeks I have been less motivated to do anything that requires physical effort.
Description

Been less motivated to do anything that requires physical effort

Data type

integer

Alias
UMLS CUI [1]
C3829097
Because of my fatigue during the past 4 weeks I have been less motivated to participate in social activities.
Description

Been less motivated to participate in social activities

Data type

integer

Alias
UMLS CUI [1]
C3829095
Because of my fatigue during the past 4 weeks I have been limited in my ability to do things away from home.
Description

Been limited in my ability to do things away from home

Data type

integer

Alias
UMLS CUI [1]
C3829094
Because of my fatigue during the past 4 weeks I have had trouble maintaining physical effort for long periods.
Description

Had trouble maintaining physical effort for long periods

Data type

integer

Alias
UMLS CUI [1]
C3827236
Because of my fatigue during the past 4 weeks I have had difficulty making decisions.
Description

Had difficulty making decisions

Data type

integer

Alias
UMLS CUI [1]
C3829103
Because of my fatigue during the past 4 weeks I have been less motivated to do anything that requires thinking.
Description

Been less motivated to do anything that requires thinking

Data type

integer

Alias
UMLS CUI [1]
C3829096
Because of my fatigue during the past 4 weeks my muscles have felt weak.
Description

Muscles have felt weak

Data type

integer

Alias
UMLS CUI [1]
C3829093
Because of my fatigue during the past 4 weeks I have been physically uncomfortable.
Description

Been physically uncomfortable

Data type

integer

Alias
UMLS CUI [1]
C3829108
Because of my fatigue during the past 4 weeks I have had trouble finishing tasks that require thinking.
Description

Had trouble finishing tasks that require thinking

Data type

integer

Alias
UMLS CUI [1]
C3829099
Because of my fatigue during the past 4 weeks I have had difficulty organizing my thoughts when doing things at home or at work.
Description

Had difficulty organizing my thoughts when doing things at home or at work

Data type

integer

Alias
UMLS CUI [1]
C3829107
Because of my fatigue during the past 4 weeks I have been less able to comlete tasks that require physical effort.
Description

Been less able to complete tasks that require physical effort

Data type

integer

Alias
UMLS CUI [1]
C3829098
Because of my fatigue during the past 4 weeks my thinking has been slowed down.
Description

My thinking has been slowed down

Data type

integer

Alias
UMLS CUI [1]
C3829092
Because of my fatigue during the past 4 weeks I have had trouble concentrating.
Description

Had trouble concentrating

Data type

integer

Alias
UMLS CUI [1]
C3829100
Because of my fatigue during the past 4 weeks I have limited my physical activities.
Description

Have limited my physical activities

Data type

integer

Alias
UMLS CUI [1]
C3829101
Because of my fatigue during the past 4 weeks I have needed to rest more often or for longer periods.
Description

Needed to rest more often or for longer

Data type

integer

Alias
UMLS CUI [1]
C3829091

Similar models

Modified Fatigue Impact Scale CRFs Multiple Sklerosis Tysabri NCT00027300

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Modified Fatigue Impact Scale
C3810705 (UMLS CUI-1)
Item
Because of my fatigue during the past 4 weeks I have been less alert.
integer
C3829104 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have been less alert.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I have had difficulty paying attention for long periods of time.
integer
C3829102 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have had difficulty paying attention for long periods of time.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I have been unable to think clearly.
integer
C3829088 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have been unable to think clearly.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I have been clumsy and uncoordinated.
integer
C3829106 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have been clumsy and uncoordinated.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I have been forgetful.
integer
C3829105 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have been forgetful.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I had to pace myself in my physical activities.
integer
C3829090 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I had to pace myself in my physical activities.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I have been less motivated to do anything that requires physical effort.
integer
C3829097 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have been less motivated to do anything that requires physical effort.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I have been less motivated to participate in social activities.
integer
C3829095 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have been less motivated to participate in social activities.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I have been limited in my ability to do things away from home.
integer
C3829094 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have been limited in my ability to do things away from home.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I have had trouble maintaining physical effort for long periods.
integer
C3827236 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have had trouble maintaining physical effort for long periods.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I have had difficulty making decisions.
integer
C3829103 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have had difficulty making decisions.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I have been less motivated to do anything that requires thinking.
integer
C3829096 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have been less motivated to do anything that requires thinking.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks my muscles have felt weak.
integer
C3829093 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks my muscles have felt weak.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I have been physically uncomfortable.
integer
C3829108 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have been physically uncomfortable.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I have had trouble finishing tasks that require thinking.
integer
C3829099 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have had trouble finishing tasks that require thinking.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I have had difficulty organizing my thoughts when doing things at home or at work.
integer
C3829107 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have had difficulty organizing my thoughts when doing things at home or at work.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I have been less able to comlete tasks that require physical effort.
integer
C3829098 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have been less able to comlete tasks that require physical effort.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks my thinking has been slowed down.
integer
C3829092 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks my thinking has been slowed down.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I have had trouble concentrating.
integer
C3829100 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have had trouble concentrating.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I have limited my physical activities.
integer
C3829101 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have limited my physical activities.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)
Item
Because of my fatigue during the past 4 weeks I have needed to rest more often or for longer periods.
integer
C3829091 (UMLS CUI [1])
Code List
Because of my fatigue during the past 4 weeks I have needed to rest more often or for longer periods.
CL Item
Never (1)
CL Item
Rarely (2)
CL Item
Sometimes (3)
CL Item
Often (4)
CL Item
Almost always (5)

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