ID

15280

Description

Study documentation part: Visits 1 (Screening), Study week -4 to 0 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. Principal Investigator PD Dr. Luisa Klotz, University Hospital Münster EudraCT - No.: 2014-003481-25. Clinical Trial No.r: NCT02461069.

Keywords

  1. 9/17/15 9/17/15 - Julian Varghese
  2. 9/22/15 9/22/15 - Julian Varghese
  3. 5/24/16 5/24/16 -
Uploaded on

May 24, 2016

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069

Blood samples for safety laboratory tests

Date of blood sampling
Description

Date of blood sampling

Date of blood sampling
Description

Date of blood sampling

Data type

date

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0011008
Hematology
Description

Hematology

Leukozyten
Description

Leucocytes

Data type

float

Alias
UMLS CUI [1]
C0023508
Leucocytes measurement unit
Description

10^3/L is equivalent to the following units: Tsd/L, 10^9/L, 1E9/L, /nL, G/L, Gpt/L, Giga/L

Data type

text

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1519795
Leucocytes Me
Description

Leucocytes Count Procesdure not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1272696
Lymphocytes
Description

Lymphocytes

Data type

float

Alias
UMLS CUI [1]
C0024264
Lymphocytes measurement unit
Description

Lymphocytes measurement unit

Data type

text

Alias
UMLS CUI [1,1]
C0024264
UMLS CUI [1,2]
C1519795
Lymphocytes Count Procesdure not done
Description

Lymphocytes Count Procesdure not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0024264
UMLS CUI [1,2]
C1272696
Liver Function
Description

Liver Function

Aspartate transaminase (AST) (SGOT)
Description

AST

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
AST Measurement Unit
Description

AST Measurement Unit

Data type

text

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1519795
AST measurement not done
Description

AST measurement not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1272696
Gamma Glutamyl Transpeptidase Measurement
Description

GGT

Data type

float

Alias
UMLS CUI [1]
C0202035
GGT Measurement Unit
Description

GGT Measurement Unit

Data type

text

Alias
UMLS CUI [1,1]
C0202035
UMLS CUI [1,2]
C1519795
GGT Measurement not done
Description

GGT Measurement not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0202035
UMLS CUI [1,2]
C1272696
Renal function
Description

Renal function

Serum creatinine
Description

Creatinine, Serum

Data type

float

Alias
UMLS CUI [1]
C0201976
Serum Creatinine Measurment Unit
Description

Creatinine, Serum Measurment Unit

Data type

text

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1519795
Serum Creatinine Measurment not done
Description

Serum Creatinine Measurment not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1272696

Similar models

Blood samples for safety laboratory tests

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Date of blood sampling
Item
Date of blood sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Hematology
Leucocytes
Item
Leukozyten
float
C0023508 (UMLS CUI [1])
Item
Leucocytes measurement unit
text
C0023508 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Leucocytes measurement unit
CL Item
10^3 /µL  (10^3 /µL )
CL Item
/mm^3 (/µL )
CL Item
other (other)
Leucocytes Count Procesdure not done
Item
Leucocytes Me
boolean
C0023508 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Lymphocytes
Item
Lymphocytes
float
C0024264 (UMLS CUI [1])
Item
Lymphocytes measurement unit
text
C0024264 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Lymphocytes measurement unit
CL Item
10^3 /µL  (10^3 /µL )
CL Item
/mm^3 (/µL )
CL Item
other (other)
Lymphocytes Count Procesdure not done
Item
Lymphocytes Count Procesdure not done
boolean
C0024264 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item Group
AST
Item
Aspartate transaminase (AST) (SGOT)
float
C0201899 (UMLS CUI [1])
Item
AST Measurement Unit
text
C0201899 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
AST Measurement Unit
CL Item
U/L (U/L)
CL Item
nkat/L (nmol/s*L )
CL Item
other (other)
CL Item
µkat/L (µmol/s*L )
AST measurement not done
Item
AST measurement not done
boolean
C0201899 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
GGT
Item
Gamma Glutamyl Transpeptidase Measurement
float
C0202035 (UMLS CUI [1])
Item
GGT Measurement Unit
text
C0202035 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
GGT Measurement Unit
CL Item
U/L (U/L)
CL Item
nkat/L (nmol/s*L )
CL Item
other (other)
CL Item
µkat/L (µmol/s*L )
GGT Measurement not done
Item
GGT Measurement not done
boolean
C0202035 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item Group
Renal function
Creatinine, Serum
Item
Serum creatinine
float
C0201976 (UMLS CUI [1])
Item
Serum Creatinine Measurment Unit
text
C0201976 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Serum Creatinine Measurment Unit
CL Item
mg/dL (mg/dL)
CL Item
other (other)
CL Item
µmol/L (µmol/L)
Serum Creatinine Measurment not done
Item
Serum Creatinine Measurment not done
boolean
C0201976 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])

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