ID

19764

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

Keywords

Versions (2)
  1. 1/27/17 1/27/17 -
  2. 1/31/17 1/31/17 -
Uploaded on

January 27, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Physical examination CRFs Multiple Sclerosis Tysabri NCT00027300

English

Physical examination CRFs Multiple Sclerosis Tysabri NCT00027300

1 forms  
Physical examination
Description

Physical examination

Alias
UMLS CUI-1
C0031809
date of examination
Description

date

Data type

date

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0011008
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
skin
Description

skin

Data type

text

Alias
UMLS CUI [1]
C1123023
If skin Abnormal, provide details
Description

skin abnormal

Data type

text

Alias
UMLS CUI [1,1]
C1123023
UMLS CUI [1,2]
C0205161
HEENT
Description

HEENT

Data type

text

Alias
UMLS CUI [1]
C1512338
If HEENT Abnormal, provide details
Description

HEENT abnormal

Data type

text

Alias
UMLS CUI [1,1]
C1512338
UMLS CUI [1,2]
C0205161
respiratory
Description

respiratory

Data type

text

Alias
UMLS CUI [1]
C0035237
If respiratory Abnormal, provide details
Description

respiratory abnormal

Data type

text

Alias
UMLS CUI [1,1]
C0035237
UMLS CUI [1,2]
C0205161
cardiovascular
Description

cardiovascular

Data type

text

Alias
UMLS CUI [1]
C0007226
If cardiovascular Abnormal, provide details
Description

cardiovascular abnormal

Data type

text

Alias
UMLS CUI [1,1]
C0007226
UMLS CUI [1,2]
C0205161
abdomen
Description

abdomen

Data type

text

Alias
UMLS CUI [1]
C0000726
If abdomen Abnormal, provide details
Description

abdomen abnormal

Data type

text

Alias
UMLS CUI [1,1]
C0000726
UMLS CUI [1,2]
C0205161
lymph nodes
Description

lymph nodes

Data type

text

Alias
UMLS CUI [1]
C0024204
If lymph nodes Abnormal, provide details
Description

lymph nodes abnormal

Data type

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0205161
musculoskeletal
Description

musculoskeletal

Data type

text

Alias
UMLS CUI [1]
C0026860
If musculoskeletal Abnormal, provide details
Description

musculoskeletal abnormal

Data type

text

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

neurological

Data type

text

Alias
UMLS CUI [1]
C0027763
If neurological Abnormal, provide details
Description

neurological abnormal

Data type

text

Alias
UMLS CUI [1,1]
C0027763
UMLS CUI [1,2]
C0205161
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Similar models

Physical examination CRFs Multiple Sclerosis Tysabri NCT00027300

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Physical examination
C0031809 (UMLS CUI-1)
date
Item
date of examination
date
C0031809 (UMLS CUI [1,1])
C0011008 (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
skin
text
C1123023 (UMLS CUI [1])
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])
C0205161 (UMLS CUI [1,2])
Item
HEENT
text
C1512338 (UMLS CUI [1])
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])
C0205161 (UMLS CUI [1,2])
Item
respiratory
text
C0035237 (UMLS CUI [1])
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])
C0205161 (UMLS CUI [1,2])
Item
cardiovascular
text
C0007226 (UMLS CUI [1])
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])
C0205161 (UMLS CUI [1,2])
Item
abdomen
text
C0000726 (UMLS CUI [1])
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])
C0205161 (UMLS CUI [1,2])
Item
lymph nodes
text
C0024204 (UMLS CUI [1])
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])
C0205161 (UMLS CUI [1,2])
Item
musculoskeletal
text
C0026860 (UMLS CUI [1])
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])
C0205161 (UMLS CUI [1,2])
Item
neurological (not MS related)
text
C0027763 (UMLS CUI [1])
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])
C0205161 (UMLS CUI [1,2])
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