ID

19763

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 is to be obtained in Screening #1, Screening #2, Screening #3, Baseline Week 0, week 12, week 24, week 36, week 48, week 60, week 72, week 84, week 96, week 108, week 120, week 128, week and Premature Study Withdrawl.

Keywords

Versions (1)
  1. 1/27/17 1/27/17 -
Uploaded on

January 27, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Timed 25-foot walk test CRFs Multiple Sclerosis Tysabri NCT00027300

English

Timed 25-foot walk test CRFs Multiple Sclerosis Tysabri NCT00027300

1 forms  
Timed 25-foot walk test
Description

Timed 25-foot walk test

Alias
UMLS CUI-1
C3897356
date of evaluation
Description

date

Data type

date

Alias
UMLS CUI [1,1]
C3897356
UMLS CUI [1,2]
C0011008
Did subject wear an AFO?
Description

AFO

Data type

boolean

Alias
UMLS CUI [1]
C3843016
Was assistive device used?
Description

assistive device

Data type

boolean

Alias
UMLS CUI [1]
C0036605
assistive device used
Description

assistive device used

Data type

text

Alias
UMLS CUI [1,1]
C0205092
UMLS CUI [1,2]
C0036605
UMLS CUI [1,3]
C0683312
UMLS CUI [2,1]
C0238767
UMLS CUI [2,2]
C0036605
UMLS CUI [2,3]
C0683312
trial one
Description

trial one

time for a 25-foot walk
Description

time

Data type

float

Measurement units
  • seconds
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C3897356
seconds
For a completed trial, record any circumstances that affected the patient's performance
Description

circumstances

Data type

text

Alias
UMLS CUI [1]
C1821459
If trial was not completed:
Description

not completed

Data type

text

Alias
UMLS CUI [1,1]
C1272696
UMLS CUI [1,2]
C0205197
specify reason if a, b or c is marked:
Description

Specify reason

Data type

text

Alias
UMLS CUI [1]
C1521902
trial two
Description

trial two

time for a 25-foot walk
Description

time

Data type

float

Measurement units
  • seconds
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C3897356
seconds
For a completed trial, record any circumstances that affected the patient's performance
Description

circumstances

Data type

text

Alias
UMLS CUI [1]
C1821459
If trial was not completed:
Description

not completed

Data type

text

Alias
UMLS CUI [1,1]
C1272696
UMLS CUI [1,2]
C0205197
specify reason if a, b or c is marked:
Description

Specify reason

Data type

text

Alias
UMLS CUI [1]
C1521902
If two trials were completed, did it take more than two attemptsto get the two successful trials?
Description

number of attempts

Data type

boolean

Alias
UMLS CUI [1]
C3163850
If "Yes", specify reason(s) for more than two attempted trials:
Description

Specify reason

Data type

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C3163850
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Similar models

Timed 25-foot walk test CRFs Multiple Sclerosis Tysabri NCT00027300

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Timed 25-foot walk test
C3897356 (UMLS CUI-1)
date
Item
date of evaluation
date
C3897356 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
AFO
Item
Did subject wear an AFO?
boolean
C3843016 (UMLS CUI [1])
assistive device
Item
Was assistive device used?
boolean
C0036605 (UMLS CUI [1])
Item
assistive device used
text
C0205092 (UMLS CUI [1,1])
C0036605 (UMLS CUI [1,2])
C0683312 (UMLS CUI [1,3])
C0238767 (UMLS CUI [2,1])
C0036605 (UMLS CUI [2,2])
C0683312 (UMLS CUI [2,3])
assistive device used
Code List
assistive device used
CL Item
unilateral cane (unilateral cane)
CL Item
unilateral crutch (unilateral crutch)
CL Item
bilateral cane (bilateral cane)
CL Item
bilateral crutch (bilateral crutch)
CL Item
walker/ rollator (walker/ rollator)
Item Group
trial one
time
Item
time for a 25-foot walk
float
C0040223 (UMLS CUI [1,1])
C3897356 (UMLS CUI [1,2])
circumstances
Item
For a completed trial, record any circumstances that affected the patient's performance
text
C1821459 (UMLS CUI [1])
Item
If trial was not completed:
text
C1272696 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
completed
Code List
If trial was not completed:
CL Item
unable to complete trial due to MS-related physical limitation (a)
CL Item
unable to complete trial due to other physical limitations (b)
CL Item
other (c)
Specify reason
Item
specify reason if a, b or c is marked:
text
C1521902 (UMLS CUI [1])
Item Group
trial two
time
Item
time for a 25-foot walk
float
C0040223 (UMLS CUI [1,1])
C3897356 (UMLS CUI [1,2])
circumstances
Item
For a completed trial, record any circumstances that affected the patient's performance
text
C1821459 (UMLS CUI [1])
Item
If trial was not completed:
text
C1272696 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
completed
Code List
If trial was not completed:
CL Item
unable to complete trial due to MS-related physical limitation (a)
CL Item
unable to complete trial due to other physical limitations (b)
CL Item
other (c)
Specify reason
Item
specify reason if a, b or c is marked:
text
C1521902 (UMLS CUI [1])
number of attempts
Item
If two trials were completed, did it take more than two attemptsto get the two successful trials?
boolean
C3163850 (UMLS CUI [1])
Specify reason
Item
If "Yes", specify reason(s) for more than two attempted trials:
text
C1521902 (UMLS CUI [1,1])
C3163850 (UMLS CUI [1,2])
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