ID
12437
Description
Study documentation part: Unscheduled Visit Study Details: A 24-week, multicenter, exploratory, two arm study to assess the effect of Dimethyl fumarate on ImmuneModulatory Action on T cells in patients with relapsing remitting Multiple Sclerosis. EudraCT - No.: 2014-003481-25. Clinical Trial No.r: NCT02461069.
Keywords
Versions (4)
- 11/17/15 11/17/15 - Julian Varghese
- 11/17/15 11/17/15 - Julian Varghese
- 5/24/16 5/24/16 -
- 5/28/16 5/28/16 -
Uploaded on
November 17, 2015
DOI
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License
Creative Commons BY-NC 3.0 Legacy
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Lab and Medical Examination Unscheduled Visit Relapsing Remitting Multiple Sclerosis NCT02461069
Lab and Medical Examination
- StudyEvent: ODM
Description
Laboratory Urine Pregnancy Test (Please perform the test only on suspicion of pregnancy.)
Description
Urine pregnancy test done, specify: Test Date:
Data type
date
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C0011008
Description
Urinary Pregnancy Test Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C0456984
Description
Urine pregnancy test not done, reason
Data type
text
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C1272696
- UMLS CUI [1,3]
- C0392360
Description
Date of blood sampling
Description
Hematology
Description
Leucocytes
Data type
float
Alias
- UMLS CUI [1]
- C0023516
Description
Leucocytes measurement unit
Data type
text
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C1519795
Description
Leucocytes Count Procesdure not done
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C1272696
Description
Lymphocytes
Data type
text
Alias
- UMLS CUI [1]
- C0024264
Description
Lymphocytes Count Procesdure not done
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0024264
- UMLS CUI [1,2]
- C1272696
Description
Liver Function
Description
AST
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201899
Description
AST Measurement Unit
Data type
text
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C1519795
Description
AST measurement not done
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C1272696
Description
GGT
Data type
float
Alias
- UMLS CUI [1]
- C0202035
Description
GGT Measurement Unit
Data type
text
Alias
- UMLS CUI [1,1]
- C0202035
- UMLS CUI [1,2]
- C1519795
Description
GGT Measurement not done
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0202035
- UMLS CUI [1,2]
- C1272696
Description
Renal function
Description
Creatinine, Serum
Data type
float
Alias
- UMLS CUI [1]
- C0201976
Description
Creatinine, Serum Measurment Unit
Data type
text
Alias
- UMLS CUI [1,1]
- C0201976
- UMLS CUI [1,2]
- C1519795
Description
Serum Creatinine Measurment not done
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0201976
- UMLS CUI [1,2]
- C1272696
Description
Medical Examination
Description
Medical Examination performed at:
Data type
date
Alias
- UMLS CUI [1,1]
- C0582103
- UMLS CUI [1,2]
- C0011008
Description
HEART RATE
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Systolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0428883
Description
Temperature
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0039476
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Height
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Expanded disability status scale (EDSS)
Description
EDSS performed at
Data type
date
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0011008
Description
Converted FS Score
Data type
integer
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0042789
Description
Brianstem testing
Data type
integer
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0006121
Description
Pyramidal testing
Data type
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0228060
Description
Cerebellar testing
Data type
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0742034
Description
Bowel/Bladder
Data type
integer
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C2707247
Description
Cerebral testing
Data type
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0006104
Description
Ambulation Score
Data type
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0080331
Description
EDSS score
Data type
float
Alias
- UMLS CUI [1]
- C0451246
Description
Signature
Description
Please hand out a prescription for the study drug to the patient and document the amount of prescribed study medication on the Drug Accountability Form (Investigator Site File).
Data type
text
Alias
- UMLS CUI [1]
- C2239117
Description
Investigator Signature Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Name/Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
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Lab and Medical Examination
- StudyEvent: ODM
C0920316 (UMLS CUI [1,2])
C1442085 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0006121 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])