ID

19900

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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Adverse Event CRFs Multiple Sklerosis Tysabri NCT00027300

English

Adverse Event CRFs Multiple Sklerosis Tysabri NCT00027300

1 forms  
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
Adverse Event
Description

Adverse Event

Data type

text

Alias
UMLS CUI [1]
C0877248
Date and time of onset (Record time only on day of infusion)
Description

Date and time of onset

Data type

datetime

Alias
UMLS CUI [1,1]
C0332162
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1264639
Date and time of resolution (if resolved, record time only on day of infusion)
Description

Date and time of resolution

Data type

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C2699488
Relationship to study drug
Description

Relationship to study drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0439849
Severity
Description

Severity

Data type

text

Alias
UMLS CUI [1]
C1710066
Action take with study drug
Description

Action take with study drug

Data type

text

Alias
UMLS CUI [1]
C3819139
Treatment required (If Yes, record on the appropriate Concomitant Therapy form)
Description

Treatment required

Data type

boolean

Alias
UMLS CUI [1]
C2981656
Mark ONLY if this is a SERIOUS ADVERSE EVENT (complete an SAE form)
Description

Serious adverse event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Mark ONLY if this adverse event is the reason for the subject's withdrawal from study
Description

Adverse event reason for withdrawal

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C2349954
Mark ONLY if this is an infection
Description

Infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
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Similar models

Adverse Event CRFs Multiple Sklerosis Tysabri NCT00027300

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Date and time of onset
Item
Date and time of onset (Record time only on day of infusion)
datetime
C0332162 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Date and time of resolution
Item
Date and time of resolution (if resolved, record time only on day of infusion)
datetime
C1264639 (UMLS CUI [1,1])
C2699488 (UMLS CUI [1,2])
Relationship to study drug
Item
Relationship to study drug
boolean
C0013227 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Item
Severity
text
C1710066 (UMLS CUI [1])
severity
Code List
Severity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Action take with study drug
text
C3819139 (UMLS CUI [1])
action take with study drug
Code List
Action take with study drug
CL Item
None (1)
CL Item
Interrupted (2)
CL Item
Discontinued (3)
Treatment required
Item
Treatment required (If Yes, record on the appropriate Concomitant Therapy form)
boolean
C2981656 (UMLS CUI [1])
Serious adverse event
Item
Mark ONLY if this is a SERIOUS ADVERSE EVENT (complete an SAE form)
boolean
C1519255 (UMLS CUI [1])
Adverse event reason for withdrawal
Item
Mark ONLY if this adverse event is the reason for the subject's withdrawal from study
boolean
C0877248 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Infection
Item
Mark ONLY if this is an infection
boolean
C0009450 (UMLS CUI [1])
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