ID

19880

Beschrijving

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 Baseline week 0 and every 4 weeks (week 4 to week 116).

Trefwoorden

Versies (2)
  1. 30-01-17 30-01-17 -
  2. 31-01-17 31-01-17 -
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30 januari 2017

DOI

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Creative Commons BY-NC 3.0
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Vital signs study drug infusion CRFs Multiple Sclerosis Tysabri NCT00027300

Engels

Vital signs study drug infusion CRFs Multiple Sclerosis Tysabri NCT00027300

1 Formulieren  
Vital signs within 1 hour pre-infusion
Beschrijving

Vital signs within 1 hour pre-infusion

Alias
UMLS CUI-1
C0518766
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Time
Beschrijving

Time

Datatype

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Temperature
Beschrijving

Body temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Blood pressure (sitting quietly for 5 minutes)
Beschrijving

Blood pressure

Datatype

text

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse (sitting quietly for 5 minutes)
Beschrijving

Pulse

Datatype

float

Maateenheden
  • beats/minute
Alias
UMLS CUI [1]
C0232117
beats/minute
Study drug infusion
Beschrijving

Study drug infusion

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0008972
UMLS CUI-3
C1289919
Was the infusion given?
Beschrijving

Infusion given

Datatype

boolean

Alias
UMLS CUI [1]
C1289919
If "No" provide reason:
Beschrijving

Reason

Datatype

text

Alias
UMLS CUI [1,1]
C1289919
UMLS CUI [1,2]
C0392360
Date of infusion
Beschrijving

Date of infusion

Datatype

date

Alias
UMLS CUI [1,1]
C1289919
UMLS CUI [1,2]
C0011008
Time infusion started
Beschrijving

Time infusion started

Datatype

time

Alias
UMLS CUI [1,1]
C1289919
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0439659
Time infusion stopped
Beschrijving

Time infusion stopped

Datatype

time

Alias
UMLS CUI [1,1]
C1289919
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C1522314
Total volume infusion prepared
Beschrijving

Infusion volume prepared

Datatype

float

Maateenheden
  • mL
Alias
UMLS CUI [1,1]
C1289919
UMLS CUI [1,2]
C2700258
UMLS CUI [1,3]
C4082130
mL
Volume infusion received
Beschrijving

Infusion volume infused

Datatype

float

Maateenheden
  • mL
Alias
UMLS CUI [1,1]
C1289919
UMLS CUI [1,2]
C2700258
UMLS CUI [1,3]
C1514756
mL
Was the infusion interrupted for any reason?
Beschrijving

Infusion interrupted

Datatype

boolean

Alias
UMLS CUI [1,1]
C1289919
UMLS CUI [1,2]
C1512900
If "yes", describe:
Beschrijving

Reason

Datatype

text

Alias
UMLS CUI [1,1]
C1289919
UMLS CUI [1,2]
C0392360
Vital signs within 1 hour post-infusion
Beschrijving

Vital signs within 1 hour post-infusion

Alias
UMLS CUI-1
C0518766
Date
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Time
Beschrijving

Time

Datatype

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Temperature
Beschrijving

Vody temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Blood pressure (sitting quietly for 5 minutes)
Beschrijving

Blood pressure

Datatype

text

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse (sitting quietly for 5 minutes)
Beschrijving

Pulse

Datatype

float

Maateenheden
  • beats/minute
Alias
UMLS CUI [1]
C0232117
beats/minute
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Similar models

Vital signs study drug infusion CRFs Multiple Sclerosis Tysabri NCT00027300

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Vital signs within 1 hour pre-infusion
C0518766 (UMLS CUI-1)
Date
Item
Date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time
Item
Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Body temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Blood pressure
Item
Blood pressure (sitting quietly for 5 minutes)
text
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse (sitting quietly for 5 minutes)
float
C0232117 (UMLS CUI [1])
Item Group
Study drug infusion
C0013227 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
C1289919 (UMLS CUI-3)
Infusion given
Item
Was the infusion given?
boolean
C1289919 (UMLS CUI [1])
Reason
Item
If "No" provide reason:
text
C1289919 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Date of infusion
Item
Date of infusion
date
C1289919 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time infusion started
Item
Time infusion started
time
C1289919 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
Time infusion stopped
Item
Time infusion stopped
time
C1289919 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Infusion volume prepared
Item
Total volume infusion prepared
float
C1289919 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])
C4082130 (UMLS CUI [1,3])
Infusion volume infused
Item
Volume infusion received
float
C1289919 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
Infusion interrupted
Item
Was the infusion interrupted for any reason?
boolean
C1289919 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
Reason
Item
If "yes", describe:
text
C1289919 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Item Group
Vital signs within 1 hour post-infusion
C0518766 (UMLS CUI-1)
Date
Item
Date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time
Item
Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Vody temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Blood pressure
Item
Blood pressure (sitting quietly for 5 minutes)
text
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse (sitting quietly for 5 minutes)
float
C0232117 (UMLS CUI [1])
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