ID

19880

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. Documentation process: This form is to be obtained in Baseline week 0 and every 4 weeks (week 4 to week 116).

Keywords

Versions (2)
  1. 1/30/17 1/30/17 -
  2. 1/31/17 1/31/17 -
Uploaded on

January 30, 2017

DOI

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License

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

English

Vital signs study drug infusion CRFs Multiple Sclerosis Tysabri NCT00027300

1 forms  
Vital signs within 1 hour pre-infusion
Description

Vital signs within 1 hour pre-infusion

Alias
UMLS CUI-1
C0518766
Date
Description

Date

Data type

date

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

Time

Data type

time

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

Body temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Blood pressure (sitting quietly for 5 minutes)
Description

Blood pressure

Data type

text

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse (sitting quietly for 5 minutes)
Description

Pulse

Data type

float

Measurement units
  • beats/minute
Alias
UMLS CUI [1]
C0232117
beats/minute
Study drug infusion
Description

Study drug infusion

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

Infusion given

Data type

boolean

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

Reason

Data type

text

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

Date of infusion

Data type

date

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

Time infusion started

Data type

time

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

Time infusion stopped

Data type

time

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

Infusion volume prepared

Data type

float

Measurement units
  • mL
Alias
UMLS CUI [1,1]
C1289919
UMLS CUI [1,2]
C2700258
UMLS CUI [1,3]
C4082130
mL
Volume infusion received
Description

Infusion volume infused

Data type

float

Measurement units
  • 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?
Description

Infusion interrupted

Data type

boolean

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

Reason

Data type

text

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

Vital signs within 1 hour post-infusion

Alias
UMLS CUI-1
C0518766
Date
Description

Date

Data type

date

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

Time

Data type

time

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

Vody temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Blood pressure (sitting quietly for 5 minutes)
Description

Blood pressure

Data type

text

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Pulse (sitting quietly for 5 minutes)
Description

Pulse

Data type

float

Measurement units
  • 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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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