ID

15528

Description

Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential (ALAIN01) https://clinicaltrials.gov/ct2/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany Please document clinically significant findings as Adverse Events. Clinical Significance is defined as any variation in physical findings that has medical relevance and may result in an alteration in medical care. Safety Blood and Urine Examinations: Please document the results for Serum Creatinine, Platelets and TSH on CRF-Pages "Safety Laboratory Assessments". Part: Month 3

Link

https://clinicaltrials.gov/ct2/show/NCT02419378

Keywords

Versions (1)
  1. 6/2/16 6/2/16 -
Uploaded on

June 2, 2016

DOI

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License

Creative Commons BY 4.0
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Month 3: Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

English

Month 3: Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

1 forms  
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Patient ID (derived)
Description

Patient ID (derived)

Data type

text

Alias
UMLS CUI [1]
C1269815
Vital Signs and Physical Examination: Date
Description

Vital Signs and Physical Examination: Date

Data type

date

Alias
UMLS CUI [1]
C2826644
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Respiratory Rate
Description

Respiratory Rate

Data type

integer

Measurement units
  • /min
Alias
UMLS CUI [1]
C0231832
/min
Height
Description

Height

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Systolic blood pressure
Description

Systolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Description

Diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Body weight
Description

Body weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Physical Examination: General Appearance
Description

Physical Examination: General Appearance

Data type

text

Alias
UMLS CUI [1,1]
C1148438
Physical Examination: General Appearance, Text
Description

Physical Examination: General Appearance, Text

Data type

text

Alias
UMLS CUI [1]
C1148438
Physical Examination: Skin
Description

Physical Examination: Skin

Data type

text

Alias
UMLS CUI [1]
C0437750
Physical Examination: Skin, Text
Description

Physical Examination: Skin, Text

Data type

text

Alias
UMLS CUI [1]
C0437750
Physical Examination: HEENT
Description

Physical Examination: HEENT

Data type

text

Alias
UMLS CUI [1]
C3494720
Physical Examination: HEENT, Text
Description

Physical Examination: HEENT, Text

Data type

text

Alias
UMLS CUI [1]
C3494720
Physical Examination: Lymph Nodes
Description

Lymph Nodes Status

Data type

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0449438
Physical Examination: Lymph Nodes, Text
Description

Physical Examination: Lymph Nodes, Text

Data type

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0449438
Physical Examination: Heart
Description

Heart rate, Auscultation of the heart

Data type

text

Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0018793
Physical Examination: Heart, Text
Description

Physical Examination: Heart, Text

Data type

text

Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0018793
Physical Examination: Lungs
Description

Physical Examination: Lungs

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024109
Physical Examination: Lungs, Text
Description

Physical Examination: Lungs, Text

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024109
Physical Examination: Abdomen
Description

Physical Examination: Abdomen

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
Physical Examination: Abdomen, Text
Description

Physical Examination: Abdomen, Text

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
Physical Examination: Extremeties/Joints
Description

Physical Examination: Extremeties/Joints

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278454
UMLS CUI [1,3]
C0022417
Physical Examination: Extremeties/Joints, Text
Description

Physical Examination: Extremeties/Joints, Text

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0022417
Physical Examination: Mental Status
Description

Physical Examination: Mental Status

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278060
Physical Examination: Mental Status, Text
Description

Physical Examination: Mental Status, Text

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278060
Vital Signs and Physical Examination: ND
Description

Vital Signs and Physical Examination: ND

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C1705848
Name of the Investigator
Description

Name of the Investigator

Data type

text

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0027365
Physical Examination: Date of Signature
Description

Physical Examination: Date of Signature

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1519316
UMLS CUI [1,3]
C0011008
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Similar models

Month 3: Vital Signs Multiple Sclerosis ALAIN01 NCT02419378

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Patient ID
Item
Patient ID (derived)
text
C1269815 (UMLS CUI [1])
Vital Signs date
Item
Vital Signs and Physical Examination: Date
date
C2826644 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Respiratory Rate
Item
Respiratory Rate
integer
C0231832 (UMLS CUI [1])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Item
Physical Examination: General Appearance
text
C1148438 (UMLS CUI [1,1])
Physical Examination: General Appearance
Code List
Physical Examination: General Appearance
CL Item
yes (1)
CL Item
no (0)
General Appearance
Item
Physical Examination: General Appearance, Text
text
C1148438 (UMLS CUI [1])
Item
Physical Examination: Skin
text
C0437750 (UMLS CUI [1])
Physical Examination: Skin
Code List
Physical Examination: Skin
CL Item
yes (1)
CL Item
no (0)
Skin examination
Item
Physical Examination: Skin, Text
text
C0437750 (UMLS CUI [1])
Item
Physical Examination: HEENT
text
C3494720 (UMLS CUI [1])
Physical Examination: HEENT
Code List
Physical Examination: HEENT
CL Item
yes (1)
CL Item
no (0)
HEENT Examination
Item
Physical Examination: HEENT, Text
text
C3494720 (UMLS CUI [1])
Item
Physical Examination: Lymph Nodes
text
C0024204 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Physical Examination: Lymph Nodes
Code List
Physical Examination: Lymph Nodes
CL Item
yes (1)
CL Item
no (0)
Physical Examination: Lymph Nodes, Text
Item
Physical Examination: Lymph Nodes, Text
text
C0024204 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Item
Physical Examination: Heart
text
C0018810 (UMLS CUI [1,1])
C0018793 (UMLS CUI [1,2])
Physical Examination: Heart
Code List
Physical Examination: Heart
CL Item
yes (1)
CL Item
no (0)
Physical Examination: Heart, Text
Item
Physical Examination: Heart, Text
text
C0018810 (UMLS CUI [1,1])
C0018793 (UMLS CUI [1,2])
Item
Physical Examination: Lungs
text
C0031809 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
Physical Examination: Lungs
Code List
Physical Examination: Lungs
CL Item
yes (1)
CL Item
no (0)
Physical Examination: Lungs, Text
Item
Physical Examination: Lungs, Text
text
C0031809 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
Item
Physical Examination: Abdomen
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Physical Examination: Abdomen
Code List
Physical Examination: Abdomen
CL Item
yes (1)
CL Item
no (0)
Physical Examination: Abdomen, Text
Item
Physical Examination: Abdomen, Text
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Item
Physical Examination: Extremeties/Joints
text
C0031809 (UMLS CUI [1,1])
C0278454 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
Physical Examination: Extremeties/Joints
Code List
Physical Examination: Extremeties/Joints
CL Item
yes (1)
CL Item
no (0)
Physical Examination: Extremeties/Joints, Text
Item
Physical Examination: Extremeties/Joints, Text
text
C0031809 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
Item
Physical Examination: Mental Status
text
C0031809 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
Physical Examination: Mental Status
Code List
Physical Examination: Mental Status
CL Item
yes (1)
CL Item
no (0)
Physical Examination: Mental Status, Text
Item
Physical Examination: Mental Status, Text
text
C0031809 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
Item
Vital Signs and Physical Examination: ND
text
C0518766 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1705848 (UMLS CUI [1,3])
Vital Signs and Physical Examination: ND
Code List
Vital Signs and Physical Examination: ND
CL Item
Not performed (0)
Name of the Investigator
Item
Name of the Investigator
text
C2346576 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Physical Examination: Date of Signature
Item
Physical Examination: Date of Signature
text
C0031809 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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