ID

15224

Description

Study documentation part: Visit 3 (Core Study), Study week 16 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 (3)
  1. 11/17/15 11/17/15 - Julian Varghese
  2. 5/23/16 5/23/16 -
  3. 5/23/16 5/23/16 -
Uploaded on

May 23, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Lab and Medical Examination Visit 4 (Core Study), DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069

English

Lab and Medical Examination

1 forms  
Visit Details
Description

Visit Details

Date of visit
Description

Visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Did the patient experience a relapse since screening? If yes, please document p. 29
Description

Did the patient experience a relapse since screening? � if yes, please document p. 29

Data type

boolean

Alias
UMLS CUI [1]
C0856120
Did the patient have an infection since screening? If yes, please document on Adverse Event form
Description

Did the patient have an infection since screening? If yes, please document on Adverse Event form

Data type

boolean

Alias
UMLS CUI [1]
C0009450
Further Visit Information
Description

1) Please document any Adverse Event occurring after signing the informed consent on the Adverse Events Form (p. 35 ff.). An Adverse Event is the appearance or worsening of any undesirable sign, symptom, or medical condition even if the event is not considered to be related to study drug. Medical conditions/diseases that are present before study entry are only considered Adverse Events if they worsen after study entry. 2) Please list all concomitant medications and significant non-drug therapies on the Concomi- tant Medication Form (p. 32). 3) Please document the date of the first Tecfidera® administration on the Study Medication Form (p. 30 f.).

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0920316
UMLS CUI [1,3]
C1442085
Laboratory Urine Pregnancy Test (Please perform the test only on suspicion of pregnancy.)
Description

Laboratory Urine Pregnancy Test (Please perform the test only on suspicion of pregnancy.)

Test done, specify: Test Date:
Description

Urine pregnancy test done, specify: Test Date:

Data type

date

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0011008
Urinary Pregnancy Test Result
Description

Urinary Pregnancy Test Result

Data type

text

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0456984
Urine pregnancy test not done, reason
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
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

Leucocytes
Description

Leucocytes

Data type

float

Alias
UMLS CUI [1]
C0023516
Leucocytes measurement unit
Description

Leucocytes measurement unit

Data type

text

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1519795
Leucocytes Count not done
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]
C0024264
Lymphocytes Count Procedure not done
Description

Lymphocytes Count Procedure 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
Alanine transaminase (ALT) (SGPT)
Description

ALT

Data type

float

Alias
UMLS CUI [1]
C0201836
ALT Measurement Unit
Description

ALT measurement unit

Data type

text

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1519795
ALT measurement not done
Description

ALT measurement not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0201836
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

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
Blood Urea Nitrogen (BUN)
Description

Blood Urea Nitrogen

Data type

float

Alias
UMLS CUI [1]
C0005845
Blood urea nitrogen measurement unit
Description

Blood urea nitrogen measurement unit

Data type

text

Alias
UMLS CUI [1,1]
C0005845
UMLS CUI [1,2]
C1519795
Blood urea nitrogen measurement not done
Description

Blood urea nitrogen measurement not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0005845
UMLS CUI [1,2]
C1272696
Medical Examination
Description

Medical Examination

Medical Examination performed at:
Description

Medical Examination performed at:

Data type

date

Alias
UMLS CUI [1,1]
C0582103
UMLS CUI [1,2]
C0011008
Heart rate (in bpm):
Description

HEART RATE

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Systolic blood pressure
Description

Systolic blood pressure

Data type

integer

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

Diastolic blood pressure

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
Expanded disability status scale (EDSS)
Description

Expanded disability status scale (EDSS)

EDSS performed at
Description

EDSS performed at

Data type

date

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0011008
Visual testing
Description

Converted FS Score

Data type

integer

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0042789
Brianstem testing
Description

Brianstem testing

Data type

integer

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0006121
Pyramidal testing
Description

Pyramidal testing

Data type

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0228060
Cerebellar testing
Description

Cerebellar testing

Data type

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0742034
Bowel/Bladder
Description

Bowel/Bladder

Data type

integer

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C2707247
Cerebral testing
Description

Cerebral testing

Data type

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0006104