ID
15222
Beschrijving
Study documentation part: Visit 3 (Core Study), Study week 8 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.
Trefwoorden
Versies (4)
- 17-11-15 17-11-15 - Julian Varghese
- 22-05-16 22-05-16 -
- 23-05-16 23-05-16 -
- 23-05-16 23-05-16 -
Geüploaded op
23 mei 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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Lab and Medical Examination Visit 3 (Core Study), DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069
Lab and Medical Examination
- StudyEvent: ODM
Beschrijving
Laboratory Urine Pregnancy Test (Please perform the test only on suspicion of pregnancy.)
Beschrijving
Urine pregnancy test done, specify: Test Date:
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C0011008
Beschrijving
Urinary Pregnancy Test Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C0456984
Beschrijving
Urine pregnancy test not done, reason
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C1272696
- UMLS CUI [1,3]
- C0392360
Beschrijving
Date of blood sampling
Beschrijving
Hematology
Beschrijving
Leucocytes
Datatype
float
Alias
- UMLS CUI [1]
- C0023516
Beschrijving
Leucocytes measurement unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C1519795
Beschrijving
Leucocytes Count Procesdure not done
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C1272696
Beschrijving
Lymphocytes
Datatype
float
Alias
- UMLS CUI [1]
- C0024264
Beschrijving
Lymphocytes measurement unit
Datatype
text
Alias
- UMLS CUI [1]
- C0024264
Beschrijving
Lymphocytes Count Procedure not done
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0024264
- UMLS CUI [1,2]
- C1272696
Beschrijving
Liver Function
Beschrijving
AST
Datatype
float
Maateenheden
- U/L
Alias
- UMLS CUI [1]
- C0201899
Beschrijving
AST Measurement Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C1519795
Beschrijving
AST measurement not done
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C1272696
Beschrijving
ALT
Datatype
float
Alias
- UMLS CUI [1]
- C0201836
Beschrijving
ALT measurement unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C1519795
Beschrijving
ALT measurement not done
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C1272696
Beschrijving
GGT
Datatype
float
Alias
- UMLS CUI [1]
- C0202035
Beschrijving
GGT Measurement Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0202035
- UMLS CUI [1,2]
- C1519795
Beschrijving
GGT Measurement not done
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0202035
- UMLS CUI [1,2]
- C1272696
Beschrijving
Renal function
Beschrijving
Creatinine, Serum
Datatype
float
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
Creatinine, Serum Measurment Unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201976
- UMLS CUI [1,2]
- C1519795
Beschrijving
Serum Creatinine Measurment not done
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201976
- UMLS CUI [1,2]
- C1272696
Beschrijving
Blood Urea Nitrogen
Datatype
float
Alias
- UMLS CUI [1]
- C0005845
Beschrijving
Blood urea nitrogen measurement unit
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005845
- UMLS CUI [1,2]
- C1519795
Beschrijving
Blood urea nitrogen measurement not done
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005845
- UMLS CUI [1,2]
- C1272696
Beschrijving
Medical Examination
Beschrijving
Medical Examination performed at:
Datatype
date
Alias
- UMLS CUI [1,1]
- C0582103
- UMLS CUI [1,2]
- C0011008
Beschrijving
HEART RATE
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Systolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0039476
Beschrijving
Expanded disability status scale (EDSS)
Beschrijving
EDSS performed at
Datatype
date
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0011008
Beschrijving
Converted FS Score
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0042789
Beschrijving
Brianstem testing
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0006121
Beschrijving
Pyramidal testing
Datatype
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0228060
Beschrijving
Cerebellar testing
Datatype
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0742034
Beschrijving
Bowel/Bladder
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C2707247
Beschrijving
Cerebral testing
Datatype
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0006104
Beschrijving
Ambulation Score
Datatype
text
Alias
- UMLS CUI [1,1]
- C0451246
- UMLS CUI [1,2]
- C0080331
Beschrijving
EDSS score
Datatype
float
Alias
- UMLS CUI [1]
- C0451246
Beschrijving
Signature
Beschrijving
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).
Datatype
text
Alias
- UMLS CUI [1]
- C2239117
Beschrijving
Please hand out a Patient's Diary to the patient.
Datatype
text
Alias
- UMLS CUI [1]
- C0018700
Beschrijving
Investigator Signature Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Name/Signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
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- StudyEvent: ODM
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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])
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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])
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])
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