ID

15373

Beschrijving

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.

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Versies (1)
  1. 28-05-16 28-05-16 -
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28 mei 2016

DOI

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

Engels

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

1 Formulieren  
Study Medication dose adjustments and interruptions
Beschrijving

Study Medication dose adjustments and interruptions

Date of first Tecfidera® administration:
Beschrijving

Date of first Tecfidera® administration:

Datatype

date

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

Date of last Tecfidera® administration:

Datatype

date

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

No. of dose adjustment

Datatype

integer

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

Adjusted daily dose

Datatype

integer

Maateenheden
  • mg
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0456081
mg
or interruption
Beschrijving

or interruption

Datatype

boolean

Alias
UMLS CUI [1]
C1512900
Start date
Beschrijving

Start date

Datatype

date

Maateenheden
  • dd/mm/yy
Alias
UMLS CUI [1]
C0808070
dd/mm/yy
End date
Beschrijving

End date

Datatype

date

Maateenheden
  • dd/mm/yy
Alias
UMLS CUI [1]
C0806020
dd/mm/yy
Reason for adjustment/interruption
Beschrijving

Reason for adjustment/interruption

Datatype

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
Beschrijving

Other

Datatype

text

Alias
UMLS CUI [1]
C0205394
Signature
Beschrijving

Signature

Date
Beschrijving

Investigator Signature Date

Datatype

date

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

Signature Investigator

Datatype

text

Alias
UMLS CUI [1]
C2346576
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Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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