ID

19938

Beschreibung

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).

Stichworte

Versionen (2)
  1. 30.01.17 30.01.17 -
  2. 31.01.17 31.01.17 -
Hochgeladen am

31. Januar 2017

DOI

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Vital signs study drug infusion CRFs Multiple Sclerosis Tysabri NCT00027300

Englisch

Vital signs study drug infusion CRFs Multiple Sclerosis Tysabri NCT00027300

1 Formulare  
Vital signs within 1 hour pre-infusion
Beschreibung

Vital signs within 1 hour pre-infusion

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1289919
UMLS CUI-3
C0332152
Date
Beschreibung

Date

Datentyp

date

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

Time

Datentyp

time

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

Body temperature

Datentyp

float

Maßeinheiten
  • °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)
Beschreibung

Systolic Blood pressure

Datentyp

float

Maßeinheiten
  • 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)
Beschreibung

Diastolic Blood Pressure

Datentyp

float

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

Pulse

Datentyp

float

Maßeinheiten
  • beats/minute
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C1289919
UMLS CUI [1,3]
C0332152
beats/minute
Study drug infusion
Beschreibung

Study drug infusion

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

Infusion given

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1289919
UMLS CUI [1,2]
C0013227
If "No" provide reason:
Beschreibung

Reason

Datentyp

text

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

Date of infusion

Datentyp

date

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

Time infusion started

Datentyp

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
Beschreibung

Time infusion stopped

Datentyp

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
Beschreibung

Infusion volume prepared

Datentyp

float

Maßeinheiten
  • 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
Beschreibung

Infusion volume infused

Datentyp

float

Maßeinheiten
  • 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?
Beschreibung

Infusion interrupted

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1289919
UMLS CUI [1,2]
C1512900
UMLS CUI [1,3]
C0013227
If "yes", describe:
Beschreibung

Reason

Datentyp

text

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

Vital signs within 1 hour post-infusion

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1289919
UMLS CUI-3
C3272301
Date
Beschreibung

Date

Datentyp

date

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

Time

Datentyp

time

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

Body temperature

Datentyp

float

Maßeinheiten
  • °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)
Beschreibung

Systolic Blood pressure

Datentyp

float

Maßeinheiten
  • 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)
Beschreibung

Diastolic Blood Pressure

Datentyp

float

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

Pulse

Datentyp

float

Maßeinheiten
  • beats/minute
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C1289919
UMLS CUI [1,3]
C3272301
beats/minute
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Ähnliche Modelle

Vital signs study drug infusion CRFs Multiple Sclerosis Tysabri NCT00027300

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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