ID

15280

Beskrivning

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.

Nyckelord

  1. 2015-09-17 2015-09-17 - Julian Varghese
  2. 2015-09-22 2015-09-22 - Julian Varghese
  3. 2016-05-24 2016-05-24 -
Uppladdad den

24 maj 2016

DOI

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Licens

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

NON-MS Treatment and symptomatic MS Treatment

General Instructions
Beskrivning

General Instructions

Instructions
Beskrivning

Please document medications which are taken within 30 days prior to Screening on the Concomitant Medication Form. Please document significant non-drug therapies which are performed after signing the informed consent on the Concomitant Medication Form.

Datatyp

text

Medical Examination
Beskrivning

Medical Examination

Medical Examination performed at:
Beskrivning

Medical Examination performed at:

Datatyp

date

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

HEART RATE

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Systolic blood pressure
Beskrivning

Systolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic
Beskrivning

Diastolic blood pressure

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Body weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Beskrivning

Height

Datatyp

float

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Expanded disability status scale (EDSS)
Beskrivning

Expanded disability status scale (EDSS)

EDSS performed at
Beskrivning

EDSS performed at

Datatyp

date

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

Converted FS Score

Datatyp

integer

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

Brianstem testing

Datatyp

integer

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

Pyramidal testing

Datatyp

text

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

Cerebellar testing

Datatyp

text

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

Bowel/Bladder

Datatyp

integer

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

Cerebral testing

Datatyp

text

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

Ambulation Score

Datatyp

text

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

EDSS score

Datatyp

float

Alias
UMLS CUI [1]
C0451246
Signature
Beskrivning

Signature

Date
Beskrivning

Investigator Signature Date

Datatyp

date

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

Name/Signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576

Similar models

NON-MS Treatment and symptomatic MS Treatment

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
General Instructions
Instructions
Item
Instructions
text
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
integer
C0428883 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
float
C0005890 (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])
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])
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])
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])
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])
Code List
Bowel/Bladder
CL Item
Cerebellar testing (1)
Item
Cerebral testing
text
C0451246 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
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])
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
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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