ID

19936

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 Screening, week 52, week 104, week 120, week 128 and in Premature Study Withdrawl.

Stichworte

Versionen (2)
  1. 27.01.17 27.01.17 -
  2. 31.01.17 31.01.17 -
Hochgeladen am

31. Januar 2017

DOI

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Physical examination CRFs Multiple Sclerosis Tysabri NCT00027300

Englisch

Physical examination CRFs Multiple Sclerosis Tysabri NCT00027300

1 Formulare  
Physical examination
Beschreibung

Physical examination

Alias
UMLS CUI-1
C0031809
date of examination
Beschreibung

date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0031809
Body weight
Beschreibung

Body weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0031809
kg
Body Height
Beschreibung

Body Height

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1,1]
C0005890
UMLS CUI [1,2]
C0031809
cm
temperature
Beschreibung

body temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0031809
°C
Systolic blood pressure (sitting quietly for 5 minutes)
Beschreibung

Systolic blood pressure

Datentyp

text

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0031809
mmHg
Diastolic blood pressure (sitting quietly for 5 minutes):
Beschreibung

Diastolic blood pressure

Datentyp

text

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0031809
mmHg
pulse (sitting quietly for 5 minutes)
Beschreibung

pulse

Datentyp

float

Maßeinheiten
  • beats/minute
Alias
UMLS CUI [1,1]
C0232117
UMLS CUI [1,2]
C0031809
beats/minute
skin
Beschreibung

skin

Datentyp

text

Alias
UMLS CUI [1,1]
C1123023
UMLS CUI [1,2]
C0031809
If skin Abnormal, provide details
Beschreibung

skin abnormal

Datentyp

text

Alias
UMLS CUI [1,1]
C1123023
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0205161
HEENT
Beschreibung

HEENT

Datentyp

text

Alias
UMLS CUI [1,1]
C1512338
UMLS CUI [1,2]
C0031809
If HEENT Abnormal, provide details
Beschreibung

HEENT abnormal

Datentyp

text

Alias
UMLS CUI [1,1]
C1512338
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0205161
respiratory
Beschreibung

respiratory

Datentyp

text

Alias
UMLS CUI [1,1]
C0035237
UMLS CUI [1,2]
C0031809
If respiratory Abnormal, provide details
Beschreibung

respiratory abnormal

Datentyp

text

Alias
UMLS CUI [1,1]
C0035237
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0205161
cardiovascular
Beschreibung

cardiovascular

Datentyp

text

Alias
UMLS CUI [1,1]
C0007226
UMLS CUI [1,2]
C0031809
If cardiovascular Abnormal, provide details
Beschreibung

cardiovascular abnormal

Datentyp

text

Alias
UMLS CUI [1,1]
C0007226
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0205161
abdomen
Beschreibung

abdomen

Datentyp

text

Alias
UMLS CUI [1,1]
C0000726
UMLS CUI [1,2]
C0031809
If abdomen Abnormal, provide details
Beschreibung

abdomen abnormal

Datentyp

text

Alias
UMLS CUI [1,1]
C0000726
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0205161
lymph nodes
Beschreibung

lymph nodes

Datentyp

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0031809
If lymph nodes Abnormal, provide details
Beschreibung

lymph nodes abnormal

Datentyp

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0205161
musculoskeletal
Beschreibung

musculoskeletal

Datentyp

text

Alias
UMLS CUI [1,1]
C0026860
UMLS CUI [1,2]
C0031809
If musculoskeletal Abnormal, provide details
Beschreibung

musculoskeletal abnormal

Datentyp

text

Alias
UMLS CUI [1,1]
C0026860
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0205161
neurological (not MS related)
Beschreibung

neurological

Datentyp

text

Alias
UMLS CUI [1,1]
C0027763
UMLS CUI [1,2]
C0031809
If neurological Abnormal, provide details
Beschreibung

neurological abnormal

Datentyp

text

Alias
UMLS CUI [1,1]
C0027763
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0205161
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Ähnliche Modelle

Physical examination CRFs Multiple Sclerosis Tysabri NCT00027300

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Physical examination
C0031809 (UMLS CUI-1)
date
Item
date of examination
date
C0011008 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Body weight
Item
Body weight
float
C0005910 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Body Height
Item
Body Height
float
C0005890 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
body temperature
Item
temperature
float
C0005903 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Systolic blood pressure
Item
Systolic blood pressure (sitting quietly for 5 minutes)
text
C0871470 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Diastolic blood pressure
Item
Diastolic blood pressure (sitting quietly for 5 minutes):
text
C0428883 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
pulse
Item
pulse (sitting quietly for 5 minutes)
float
C0232117 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Item
skin
text
C1123023 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
skin
Code List
skin
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
skin abnormal
Item
If skin Abnormal, provide details
text
C1123023 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Item
HEENT
text
C1512338 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
skin
Code List
HEENT
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
HEENT abnormal
Item
If HEENT Abnormal, provide details
text
C1512338 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Item
respiratory
text
C0035237 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
skin
Code List
respiratory
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
respiratory abnormal
Item
If respiratory Abnormal, provide details
text
C0035237 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Item
cardiovascular
text
C0007226 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
skin
Code List
cardiovascular
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
cardiovascular abnormal
Item
If cardiovascular Abnormal, provide details
text
C0007226 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Item
abdomen
text
C0000726 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
skin
Code List
abdomen
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
abdomen abnormal
Item
If abdomen Abnormal, provide details
text
C0000726 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Item
lymph nodes
text
C0024204 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
skin
Code List
lymph nodes
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
lymph nodes abnormal
Item
If lymph nodes Abnormal, provide details
text
C0024204 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Item
musculoskeletal
text
C0026860 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
skin
Code List
musculoskeletal
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
musculoskeletal abnormal
Item
If musculoskeletal Abnormal, provide details
text
C0026860 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Item
neurological (not MS related)
text
C0027763 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
skin
Code List
neurological (not MS related)
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
neurological abnormal
Item
If neurological Abnormal, provide details
text
C0027763 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
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