ID

19907

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.

Keywords

Versions (1)
  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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Record of Death CRFs Multiple Sclerosis Tysabri NCT00027300

English

Record of Death CRFs Multiple Sclerosis Tysabri NCT00027300

1 forms  
Record of Death
Description

Record of Death

Alias
UMLS CUI-1
C0011065
Date of Death
Description

Date of death

Data type

date

Alias
UMLS CUI [1]
C1148348
Time of Death
Description

Time of death

Data type

time

Alias
UMLS CUI [1]
C1301931
Cause of Death
Description

Cause of death

Data type

text

Alias
UMLS CUI [1]
C0007465
Is the cause of death related to an adverse event which began during the dosing period?
Description

Death related to adverse event

Data type

boolean

Alias
UMLS CUI [1]
C1705232
If Yes, describe and fill in Adverse Event CRF Page No.:
Description

Description

Data type

text

Relationship of death to study drug(s):
Description

death related to study drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0013227
Autopsy
Description

Autopsy

Data type

text

Alias
UMLS CUI [1]
C0004398
Date of autopsy
Description

Please provide two copies of the autopsy report if available.

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0004398
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Similar models

Record of Death CRFs Multiple Sclerosis Tysabri NCT00027300

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Record of Death
C0011065 (UMLS CUI-1)
Date of death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Time of death
Item
Time of Death
time
C1301931 (UMLS CUI [1])
Cause of death
Item
Cause of Death
text
C0007465 (UMLS CUI [1])
Death related to adverse event
Item
Is the cause of death related to an adverse event which began during the dosing period?
boolean
C1705232 (UMLS CUI [1])
Description
Item
If Yes, describe and fill in Adverse Event CRF Page No.:
text
death related to study drug
Item
Relationship of death to study drug(s):
boolean
C0011065 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Item
Autopsy
text
C0004398 (UMLS CUI [1])
autopsy
Code List
Autopsy
CL Item
Not Done (1)
CL Item
Done (2)
Date of autopsy
Item
Date of autopsy
date
C0011008 (UMLS CUI [1,1])
C0004398 (UMLS CUI [1,2])
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