ID

15223

Beschreibung

Study documentation part: Visit 5 (Core Study), Study week 24 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.

Stichworte

Versionen (3)
  1. 17.11.15 17.11.15 - Julian Varghese
  2. 23.05.16 23.05.16 -
  3. 23.05.16 23.05.16 -
Hochgeladen am

23. Mai 2016

DOI

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Lab and Medical Examination Visit 5 (Core Study), DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069

Englisch

Lab and Medical Examination

1 Formulare  
Visit Details
Beschreibung

Visit Details

Date of visit
Beschreibung

Visit date

Datentyp

date

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

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

Datentyp

boolean

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
Further Visit Information
Beschreibung

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.).

Datentyp

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.)
Beschreibung

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

Test done, specify: Test Date:
Beschreibung

Urine pregnancy test done, specify: Test Date:

Datentyp

date

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

Urinary Pregnancy Test Result

Datentyp

text

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

Urine pregnancy test not done, reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C1272696
UMLS CUI [1,3]
C0392360
Date of blood sampling
Beschreibung

Date of blood sampling

Date of blood sampling
Beschreibung

Date of blood sampling

Datentyp

date

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

Hematology

Leucocytes
Beschreibung

Leucocytes

Datentyp

float

Alias
UMLS CUI [1]
C0023516
Leucocytes measurement unit
Beschreibung

Leucocytes measurement unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1519795
Leucocytes Count not done
Beschreibung

Leucocytes Count Procesdure not done

Datentyp

boolean

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

Lymphocytes

Datentyp

float

Alias
UMLS CUI [1]
C0024264
Lymphocytes measurement unit
Beschreibung

Lymphocytes measurement unit

Datentyp

text

Alias
UMLS CUI [1]
C0024264
Lymphocytes Count Procedure not done
Beschreibung

Lymphocytes Count Procedure not done

Datentyp

boolean

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

Liver Function

Aspartate transaminase (AST) (SGOT)
Beschreibung

AST

Datentyp

float

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
AST Measurement Unit
Beschreibung

AST Measurement Unit

Datentyp

text

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

AST measurement not done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1272696
Alanine transaminase (ALT) (SGPT)
Beschreibung

ALT

Datentyp

float

Alias
UMLS CUI [1]
C0201836
ALT Measurement Unit
Beschreibung

ALT measurement unit

Datentyp

text

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

ALT measurement not done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1272696
Gamma Glutamyl Transpeptidase Measurement
Beschreibung

GGT

Datentyp

float

Alias
UMLS CUI [1]
C0202035
GGT Measurement Unit
Beschreibung

GGT Measurement Unit

Datentyp

text

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

GGT Measurement not done

Datentyp

boolean

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

Renal function

Creatinine
Beschreibung

Creatinine, Serum

Datentyp

float

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

Creatinine, Serum Measurment Unit

Datentyp

text

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

Serum Creatinine Measurment not done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1272696
Blood Urea Nitrogen (BUN)
Beschreibung

Blood Urea Nitrogen

Datentyp

float

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

Blood urea nitrogen measurement unit

Datentyp

text

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

Blood urea nitrogen measurement not done

Datentyp

boolean

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

Medical Examination

Medical Examination performed at:
Beschreibung

Medical Examination performed at:

Datentyp

date

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

HEART RATE

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Systolic blood pressure
Beschreibung

Systolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Beschreibung

Diastolic blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Body weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Expanded disability status scale (EDSS)
Beschreibung

Expanded disability status scale (EDSS)

EDSS performed at
Beschreibung

EDSS performed at

Datentyp

date

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

Converted FS Score

Datentyp

integer

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

Brianstem testing

Datentyp

integer

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

Pyramidal testing

Datentyp

text

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

Cerebellar testing

Datentyp

text

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

Bowel/Bladder

Datentyp

integer

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

Cerebral testing

Datentyp

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0006104
Ambulation Score
Beschreibung

Ambulation Score

Datentyp

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0080331
EDSS step
Beschreibung

EDSS score

Datentyp

float

Alias
UMLS CUI [1]
C0451246
Treatment after the core study phase
Beschreibung

Treatment after the core study phase

How will the patient be treated after the core study phase (Visit 5)?
Beschreibung

How will the patient be treated after the core study phase (Visit 5)?

Datentyp

text

Alias
UMLS CUI [1]
C0087111
If "other treatment", specify:
Beschreibung

If other treatment, specify:

Datentyp

text

Alias
UMLS CUI [1]
C2015819
If "other treatment", please give a reason for discontinuation of dimethyl fumarate:
Beschreibung

If "other treatment", please give a reason for discontinuation of dimethyl fumarate:

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0087111
Signature
Beschreibung

Signature

Date
Beschreibung

Investigator Signature Date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Name/Signature Investigator
Beschreibung

Name/Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
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Ähnliche Modelle

Lab and Medical Examination

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Visit Details
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])
Item Group
Laboratory Urine Pregnancy Test (Please perform the test only on suspicion of pregnancy.)
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])
Urinary Pregnancy Test Result
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])
Urine pregnancy test not done, reason
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)
CL Item
other (other)
Item Group
Date of blood sampling
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
Leucocytes
float
C0023516 (UMLS CUI [1])
Item
Leucocytes measurement unit
text
C0023508 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Leucocytes measurement unit
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 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])
Lymphocytes
Code List
Lymphocytes measurement unit
CL Item
other (other)
CL Item
10^3 /µL  (10^3 /µL )
CL Item
/mm^3 (/µL )
Lymphocytes Count Procedure not done
Item
Lymphocytes Count Procedure not done
boolean
C0024264 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item Group
Liver Function
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])
AST Measurement Unit
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])
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])
ALT measurement unit
Code List
ALT Measurement Unit
CL Item
U/L (U/L)
CL Item
nkat/L (nmol/s*L )
CL Item
other (other)
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])
GGT Measurement Unit
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
Creatinine
float
C0201976 (UMLS CUI [1])
Item
Serum Creatinine Measurment Unit
text
C0201976 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Creatinine, Serum Measurment Unit
Code List
Serum Creatinine Measurment Unit
CL Item
mg/dL (mg/dL)
CL Item
µmol/L (µmol/L)
CL Item
other (other)
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 (BUN)
float
C0005845 (UMLS CUI [1])
Item
Blood urea nitrogen measurement unit
text
C0005845 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Blood urea nitrogen measurement unit
Code List
Blood urea nitrogen measurement unit
CL Item
mg/dL (mg/dL)
CL Item
µmol/L (µmol/L)
CL Item
other (other)
Blood urea nitrogen measurement not done
Item
Blood urea nitrogen measurement not done
boolean
C0005845 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Item Group
Medical Examination
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])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Item Group
Expanded disability status scale (EDSS)
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])
Visual testing
Code List
Visual testing
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
CL Item
5 (6)
CL Item
6 (7)
Item
Brianstem testing
integer
C0451246 (UMLS CUI [1,1])
C0006121 (UMLS CUI [1,2])
Brianstem testing
Code List
Brianstem testing
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
CL Item
5 (6)
Item
Pyramidal testing
text
C0451246 (UMLS CUI [1,1])
C0228060 (UMLS CUI [1,2])
Pyramidal testing
Code List
Pyramidal testing
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
Item
Cerebellar testing
text
C0451246 (UMLS CUI [1,1])
C0742034 (UMLS CUI [1,2])
Cerebellar testing
Code List
Cerebellar testing
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
X (X)
Item
Bowel/Bladder
integer
C0451246 (UMLS CUI [1,1])
C2707247 (UMLS CUI [1,2])
Bowel/Bladder
Code List
Bowel/Bladder
CL Item
Cerebellar testing (1)
Item
Cerebral testing
text
C0451246 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
Cerebral testing
Code List
Cerebral testing
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
Item
Ambulation Score
text
C0451246 (UMLS CUI [1,1])
C0080331 (UMLS CUI [1,2])
Ambulation Score
Code List
Ambulation Score
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
EDSS score
Item
EDSS step
float
C0451246 (UMLS CUI [1])
Item Group
Treatment after the core study phase
Item
How will the patient be treated after the core study phase (Visit 5)?
text
C0087111 (UMLS CUI [1])
How will the patient be treated after the core study phase (Visit 5)?
Code List
How will the patient be treated after the core study phase (Visit 5)?
CL Item
Further treatment with dimethyl fumarate (1)
CL Item
Other treatment (2)
If other treatment, specify:
Item
If "other treatment", specify:
text
C2015819 (UMLS CUI [1])
If "other treatment", please give a reason for discontinuation of dimethyl fumarate:
Item
If "other treatment", please give a reason for discontinuation of dimethyl fumarate:
text
C0392360 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item Group
Signature
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])
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