ID

19898

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.

Mots-clés

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

30 janvier 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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End of study CRFs Multiple Sklerosis Tysabri NCT00027300

Anglais

End of study CRFs Multiple Sklerosis Tysabri NCT00027300

1 Formulaires  
End of study
Description

End of study

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C0444930
Did the subject complete the study?
Description

Completion of study

Type de données

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1444661
If "yes", mark the primary reason below
Description

Reason

Type de données

text

Alias
UMLS CUI [1]
C0392360
Reason, why subject did not complete the study:
Description

Reason study not completed

Type de données

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205257
Description:
Description

Reason description

Type de données

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C0392360
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Similar models

End of study CRFs Multiple Sklerosis Tysabri NCT00027300

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
End of study
C0008976 (UMLS CUI-1)
C0444930 (UMLS CUI-2)
Completion of study
Item
Did the subject complete the study?
boolean
C0008976 (UMLS CUI [1,1])
C1444661 (UMLS CUI [1,2])
Reason
Item
If "yes", mark the primary reason below
text
C0392360 (UMLS CUI [1])
Item
Reason, why subject did not complete the study:
integer
C0392360 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
reason study drug discontinued
Code List
Reason, why subject did not complete the study:
CL Item
Lost to follow-up (describe below) (1 )
CL Item
Adverse event(s) (complete Adverse Event form) (2 )
CL Item
Voluntary withdrawal for reasons other than Adverse Event (describe below) (3 )
CL Item
Subject was non-compliant (4 )
CL Item
Death (complete Record of Death form) (5 )
CL Item
Other (describe below) (6 )
Reason description
Item
Description:
text
C0678257 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
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