ID

15373

Beskrivning

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.

Nyckelord

Versioner (1)
  1. 2016-05-28 2016-05-28 -
Uppladdad den

28 maj 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Study medication, DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069

Engelsk

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

1 Formulär  
Study Medication dose adjustments and interruptions
Beskrivning

Study Medication dose adjustments and interruptions

Date of first Tecfidera® administration:
Beskrivning

Date of first Tecfidera® administration:

Datatyp

date

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

Date of last Tecfidera® administration:

Datatyp

date

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

No. of dose adjustment

Datatyp

integer

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

Adjusted daily dose

Datatyp

integer

Måttenheter
  • mg
Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0456081
mg
or interruption
Beskrivning

or interruption

Datatyp

boolean

Alias
UMLS CUI [1]
C1512900
Start date
Beskrivning

Start date

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI [1]
C0808070
dd/mm/yy
End date
Beskrivning

End date

Datatyp

date

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

Reason for adjustment/interruption

Datatyp

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
Beskrivning

Other

Datatyp

text

Alias
UMLS CUI [1]
C0205394
Signature
Beskrivning

Signature

Date
Beskrivning

Investigator Signature Date

Datatyp

date

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

Signature Investigator

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Tillbaka till toppen

Similar models

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

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial