Visit date
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Multiple sclerosis relapse
Item
Did the patient experience a relapse since screening? If yes, please document p. 29
boolean
C0856120 (UMLS CUI [1])
Infection
Item
Did the patient have an infection since screening? If yes, please document on Adverse Event form
boolean
C0009450 (UMLS CUI [1])
Further Visit Information
Item
Further Visit Information
text
C0545082 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C1442085 (UMLS CUI [1,3])
Urine pregnancy test done, specify: Test Date:
Item
Test done, specify: Test Date:
date
C0430056 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Urinary Pregnancy Test Result
text
C0430056 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
Urinary Pregnancy Test Result
CL Item
positive (positive)
CL Item
negative (negative)
Item
Urine pregnancy test not done, reason
text
C0430056 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Code List
Urine pregnancy test not done, reason
CL Item
male participant (male participant)
CL Item
female participant with no childbearing potential (female participant with no childbearing potential)
CL Item
no suspicion of pregnancy (no suspicion of pregnancy)
Date of blood sampling
Item
Date of blood sampling
date
C0178913 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Leucocytes
Item
Leucocytes
float
C0023516 (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 )
Leucocytes Count Procesdure not done
Item
Leucocytes Count not done
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 )
Lymphocytes Count Procesdure not done
Item
Lymphocytes Count Procesdure not done
boolean
C0024264 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
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
nkat/L (nmol/s*L )
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])
ALT
Item
Alanine transaminase (ALT) (SGPT)
float
C0201836 (UMLS CUI [1])
Item
ALT Measurement Unit
text
C0201836 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
ALT Measurement Unit
CL Item
nkat/L (nmol/s*L )
ALT measurement not done
Item
ALT measurement not done
boolean
C0201836 (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
nkat/L (nmol/s*L )
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])
Creatinine, Serum
Item
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
Serum Creatinine Measurment not done
Item
Serum Creatinine Measurment not done
boolean
C0201976 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Blood Urea Nitrogen
Item
Blood Urea Nitrogen
float
C0005845 (UMLS CUI [1])
Item
Blood urea nitrogen measurement unit
text
C0005845 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Blood urea nitrogen measurement unit
Blood urea nitrogen measurement not done
Item
Blood urea nitrogen measurement not done
boolean
C0005845 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Medical Examination performed at:
Item
Medical Examination performed at:
date
C0582103 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
HEART RATE
Item
Heart rate (in bpm):
integer
C0018810 (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])
Body Temperature
Item
Body temperature
float
C0005903 (UMLS CUI [1])
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
EDSS performed at
Item
EDSS performed at
date
C0451246 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Visual testing
integer
C0451246 (UMLS CUI [1,1])
C0042789 (UMLS CUI [1,2])
Item
Brianstem testing
integer
C0451246 (UMLS CUI [1,1])
C0006121 (UMLS CUI [1,2])
Code List
Brianstem testing
Item
Pyramidal testing
text
C0451246 (UMLS CUI [1,1])
C0228060 (UMLS CUI [1,2])
Code List
Pyramidal testing
Item
Cerebellar testing
text
C0451246 (UMLS CUI [1,1])
C0742034 (UMLS CUI [1,2])
Code List
Cerebellar testing
Item
Bowel/Bladder
integer
C0451246 (UMLS CUI [1,1])
C2707247 (UMLS CUI [1,2])
CL Item
Cerebellar testing (1)
Item
Cerebral testing
text
C0451246 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
Code List
Cerebral testing
Item
Ambulation Score
text
C0451246 (UMLS CUI [1,1])
C0080331 (UMLS CUI [1,2])
Code List
Ambulation Score
EDSS score
Item
EDSS step
float
C0451246 (UMLS CUI [1])
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Name/Signature Investigator
Item
Name/Signature Investigator
text
C2346576 (UMLS CUI [1])