ID

19900

Descripción

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.

Palabras clave

Versiones (1)
  1. 30/1/17 30/1/17 -
Subido en

30 de enero de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Adverse Event CRFs Multiple Sklerosis Tysabri NCT00027300

Inglés

Adverse Event CRFs Multiple Sklerosis Tysabri NCT00027300

1 formularios  
Adverse Event
Descripción

Adverse Event

Alias
UMLS CUI-1
C0877248
Adverse Event
Descripción

Adverse Event

Tipo de datos

text

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

Date and time of onset

Tipo de datos

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)
Descripción

Date and time of resolution

Tipo de datos

datetime

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

Relationship to study drug

Tipo de datos

boolean

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

Severity

Tipo de datos

text

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

Action take with study drug

Tipo de datos

text

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

Treatment required

Tipo de datos

boolean

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

Serious adverse event

Tipo de datos

boolean

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

Adverse event reason for withdrawal

Tipo de datos

boolean

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

Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009450
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Similar models

Adverse Event CRFs Multiple Sklerosis Tysabri NCT00027300

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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