ID

15373

Description

Study documentation part: Study medication Study short name: DIMAT MS 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. Please document below only temporary changes in the dosing schedule. If the Study Medication is permanently discontinued, please complete the Discontinuation of Study Medication Form on page 33.

Keywords

Versions (1)
  1. 5/28/16 5/28/16 -
Uploaded on

May 28, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Study medication, DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069

English

Study medication, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

1 forms  
Study Medication dose adjustments and interruptions
Description

Study Medication dose adjustments and interruptions

Date of first Tecfidera® administration:
Description

Date of first Tecfidera® administration:

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C3556178
Date of last Tecfidera® administration:
Description

Date of last Tecfidera® administration:

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C3556178
No. of dose adjustment
Description

No. of dose adjustment

Data type

integer

Alias
UMLS CUI [1,1]
C2826232
UMLS CUI [1,2]
C0449788
Adjusted daily dose
Description

Adjusted daily dose

Data type

integer

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0456081
mg
or interruption
Description

or interruption

Data type

boolean

Alias
UMLS CUI [1]
C1512900
Start date
Description

Start date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C0808070
dd/mm/yy
End date
Description

End date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C0806020
dd/mm/yy
Reason for adjustment/interruption
Description

Reason for adjustment/interruption

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C2826232
UMLS CUI [2,1]
C0392360
UMLS CUI [2,2]
C1512900
If other, please specify
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
Signature
Description

Signature

Date
Description

Investigator Signature Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Signature Investigator
Description

Signature Investigator

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Study medication, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study Medication dose adjustments and interruptions
Date of first Tecfidera® administration:
Item
Date of first Tecfidera® administration:
date
C0808070 (UMLS CUI [1,1])
C3556178 (UMLS CUI [1,2])
Date of last Tecfidera® administration:
Item
Date of last Tecfidera® administration:
date
C0806020 (UMLS CUI [1,1])
C3556178 (UMLS CUI [1,2])
No. of dose adjustment
Item
No. of dose adjustment
integer
C2826232 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Adjusted daily dose
Item
Adjusted daily dose
integer
C2348070 (UMLS CUI [1,1])
C0456081 (UMLS CUI [1,2])
or interruption
Item
or interruption
boolean
C1512900 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Item
Reason for adjustment/interruption
text
C0392360 (UMLS CUI [1,1])
C2826232 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2,1])
C1512900 (UMLS CUI [2,2])
Reason for adjustment/interruption
Code List
Reason for adjustment/interruption
CL Item
Adverse event (1)
C0877248 (UMLS CUI-1)
CL Item
Serious adverse event (2)
C1519255 (UMLS CUI-1)
CL Item
MS relapse (3)
C0856120 (UMLS CUI-1)
CL Item
Suspicion of pregnancy (4)
C0032961 (UMLS CUI-1)
CL Item
Use of prohibited concomitant medication (5)
C2347852 (UMLS CUI-1)
CL Item
Other (9)
C0205394 (UMLS CUI-1)
Other
Item
If other, please specify
text
C0205394 (UMLS CUI [1])
Item Group
Signature
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Signature Investigator
Item
Signature Investigator
text
C2346576 (UMLS CUI [1])
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