ID

19716

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 and Premature Study Withdrawl.

Mots-clés

Versions (2)
  1. 23/01/2017 23/01/2017 -
  2. 30/01/2017 30/01/2017 -
Téléchargé le

23 janvier 2017

DOI

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Licence

Creative Commons BY-NC 3.0
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Nine Hole Peg Test CRFs Multiple Sclerosis Tysabri NCT00027300

Anglais

Nine Hole Peg Test CRFs Multiple Sclerosis Tysabri NCT00027300

1 Formulaires  
Nine Hole Peg Test Dominant Hand Trial One
Description

Nine Hole Peg Test Dominant Hand Trial One

Alias
UMLS CUI-1
C0451335
UMLS CUI-2
C0449722
time
Description

time

Type de données

float

Unités de mesure
  • seconds
Alias
UMLS CUI [1]
C0040223
seconds
For a completed trial, record any circumstances that affected the patient's performance
Description

circumstances

Type de données

text

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

not completed

Type de données

text

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

reason

Type de données

text

Alias
UMLS CUI [1]
C2348235
Nine Hole Peg Test Dominant Hand Trial Two
Description

Nine Hole Peg Test Dominant Hand Trial Two

Alias
UMLS CUI-1
C0451335
UMLS CUI-2
C0449722
time
Description

time

Type de données

float

Unités de mesure
  • seconds
Alias
UMLS CUI [1]
C0040223
seconds
For a completed trial, record any circumstances that affected the patient's performance:
Description

circumstances

Type de données

text

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

not completed

Type de données

text

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

reason

Type de données

text

Alias
UMLS CUI [1]
C2348235
If two trials were completed, did it take more than two attempts to get the two successful trials?
Description

number of attempts

Type de données

boolean

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

reason

Type de données

text

Alias
UMLS CUI [1]
C2348235
Nine Hole Peg Test Non-dominant Hand Trial One
Description

Nine Hole Peg Test Non-dominant Hand Trial One

Alias
UMLS CUI-1
C0451335
UMLS CUI-2
C0449722
time
Description

time

Type de données

float

Unités de mesure
  • seconds
Alias
UMLS CUI [1]
C0040223
seconds
For a completed trial, record any circumstances that affected the patient's performance:
Description

circumstances

Type de données

text

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

not completed

Type de données

text

Alias
UMLS CUI [1]
C0205197
Specify reason if a, b or c is marked
Description

reason

Type de données

text

Alias
UMLS CUI [1]
C2348235
Nine Hole Peg Test Non-dominant Hand Trial Two
Description

Nine Hole Peg Test Non-dominant Hand Trial Two

Alias
UMLS CUI-1
C0451335
UMLS CUI-2
C0449722
time
Description

time

Type de données

float

Unités de mesure
  • seconds
Alias
UMLS CUI [1]
C0040223
seconds
For a completed trial, record any circumstances that affected the patient's performance:
Description

circumstances

Type de données

text

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

not completed

Type de données

text

Alias
UMLS CUI [1]
C0205197
Specify reason ist a, b or c is marked:
Description

reason

Type de données

text

Alias
UMLS CUI [1]
C2348235
If two trials were completed, did it take more than two attempts to get the two successful trials?
Description

number of attempts

Type de données

boolean

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

reason

Type de données

text

Alias
UMLS CUI [1]
C2348235
Retour au début de la page

Similar models

Nine Hole Peg Test CRFs Multiple Sclerosis Tysabri NCT00027300

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Nine Hole Peg Test Dominant Hand Trial One
C0451335 (UMLS CUI-1)
C0449722 (UMLS CUI-2)
time
Item
float
C0040223 (UMLS CUI [1])
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
C0205197 (UMLS CUI [1])
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)
reason
Item
Specify reason if a, b or c is marked:
text
C2348235 (UMLS CUI [1])
Item Group
Nine Hole Peg Test Dominant Hand Trial Two
C0451335 (UMLS CUI-1)
C0449722 (UMLS CUI-2)
time
Item
time
float
C0040223 (UMLS CUI [1])
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
C0205197 (UMLS CUI [1])
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)
reason
Item
Specify reason if a, b or c is marked:
text
C2348235 (UMLS CUI [1])
number of attempts
Item
If two trials were completed, did it take more than two attempts to get the two successful trials?
boolean
C3163850 (UMLS CUI [1])
reason
Item
If "Yes", specify reason(s) for more than two attempted trials:
text
C2348235 (UMLS CUI [1])
Item Group
Nine Hole Peg Test Non-dominant Hand Trial One
C0451335 (UMLS CUI-1)
C0449722 (UMLS CUI-2)
time
Item
time
float
C0040223 (UMLS CUI [1])
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
C0205197 (UMLS CUI [1])
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)
reason
Item
Specify reason if a, b or c is marked
text
C2348235 (UMLS CUI [1])
Item Group
Nine Hole Peg Test Non-dominant Hand Trial Two
C0451335 (UMLS CUI-1)
C0449722 (UMLS CUI-2)
time
Item
time
float
C0040223 (UMLS CUI [1])
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
C0205197 (UMLS CUI [1])
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)
reason
Item
Specify reason ist a, b or c is marked:
text
C2348235 (UMLS CUI [1])
number of attempts
Item
If two trials were completed, did it take more than two attempts to get the two successful trials?
boolean
C3163850 (UMLS CUI [1])
reason
Item
If "Yes", specify reason(s) for more than two attempted trials:
text
C2348235 (UMLS CUI [1])
Retour au début de la page 

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