ID

19938

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 31, 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
UMLS CUI-2
C1289919
UMLS CUI-3
C0332152
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1289919
UMLS CUI [1,3]
C0332152
Time
Description

Time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1289919
UMLS CUI [1,3]
C0332152
Temperature
Description

Body temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1289919
UMLS CUI [1,3]
C0332152
°C
Systolic Blood pressure (sitting quietly for 5 minutes)
Description

Systolic Blood pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C1289919
UMLS CUI [1,3]
C3272301
mmHg
Diastolic Blood Pressure (Sitting quietly for 5 minutes)
Description

Diastolic Blood Pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C1289919
UMLS CUI [1,3]
C3272301
mmHg
Pulse (sitting quietly for 5 minutes)
Description

Pulse

Data type

float

Measurement units
  • beats/minute
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C1289919
UMLS CUI [1,3]
C0332152
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 [1,1]
C1289919
UMLS CUI [1,2]
C0013227
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
UMLS CUI [1,4]
C0013227
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
UMLS CUI [1,4]
C0013227
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
UMLS CUI [1,4]
C0013227
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
UMLS CUI [1,4]
C0013227
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
UMLS CUI [1,3]
C0013227
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
UMLS CUI-2
C1289919
UMLS CUI-3
C3272301
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1289919
UMLS CUI [1,3]
C3272301
Time
Description

Time

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C1289919
UMLS CUI [1,3]
C3272301
Temperature
Description

Body temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1289919
UMLS CUI [1,3]
C3272301
°C
Systolic Blood pressure (sitting quietly for 5 minutes)
Description

Systolic Blood pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C1289919
UMLS CUI [1,3]
C3272301
mmHg
Diastolic Blood Pressure (Sitting quietly for 5 minutes)
Description

Diastolic Blood Pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C1289919
UMLS CUI [1,3]
C3272301
mmHg
Pulse (sitting quietly for 5 minutes)
Description

Pulse

Data type

float

Measurement units
  • beats/minute
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C1289919
UMLS CUI [1,3]
C3272301
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)
C1289919 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
Date
Item
Date
date
C0518766 (UMLS CUI [1,1])
C1289919 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Time
Item
Time
time
C0040223 (UMLS CUI [1,1])
C1289919 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Body temperature
Item
Temperature
float
C0005903 (UMLS CUI [1,1])
C1289919 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Systolic Blood pressure
Item
Systolic Blood pressure (sitting quietly for 5 minutes)
float
C0871470 (UMLS CUI [1,1])
C1289919 (UMLS CUI [1,2])
C3272301 (UMLS CUI [1,3])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure (Sitting quietly for 5 minutes)
float
C0428883 (UMLS CUI [1,1])
C1289919 (UMLS CUI [1,2])
C3272301 (UMLS CUI [1,3])
Pulse
Item
Pulse (sitting quietly for 5 minutes)
float
C0232117 (UMLS CUI [1,1])
C1289919 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
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 [1,1])
C0013227 (UMLS CUI [1,2])
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])
C0013227 (UMLS CUI [1,4])
Time infusion stopped
Item
Time infusion stopped
time
C1289919 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
Infusion volume prepared
Item
Total volume infusion prepared
float
C1289919 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])
C4082130 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
Infusion volume infused
Item
Volume infusion received
float
C1289919 (UMLS CUI [1,1])
C2700258 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
Infusion interrupted
Item
Was the infusion interrupted for any reason?
boolean
C1289919 (UMLS CUI [1,1])
C1512900 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
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)
C1289919 (UMLS CUI-2)
C3272301 (UMLS CUI-3)
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
C1289919 (UMLS CUI [1,2])
C3272301 (UMLS CUI [1,3])
Time
Item
Time
time
C0040223 (UMLS CUI [1,1])
C1289919 (UMLS CUI [1,2])
C3272301 (UMLS CUI [1,3])
Body temperature
Item
Temperature
float
C0005903 (UMLS CUI [1,1])
C1289919 (UMLS CUI [1,2])
C3272301 (UMLS CUI [1,3])
Systolic Blood pressure
Item
Systolic Blood pressure (sitting quietly for 5 minutes)
float
C0871470 (UMLS CUI [1,1])
C1289919 (UMLS CUI [1,2])
C3272301 (UMLS CUI [1,3])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure (Sitting quietly for 5 minutes)
float
C0428883 (UMLS CUI [1,1])
C1289919 (UMLS CUI [1,2])
C3272301 (UMLS CUI [1,3])
Pulse
Item
Pulse (sitting quietly for 5 minutes)
float
C0232117 (UMLS CUI [1,1])
C1289919 (UMLS CUI [1,2])
C3272301 (UMLS CUI [1,3])
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