ID

15388

Beschreibung

Study documentation part: End of Study/Discontinuation 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.: NCT02461069.

Stichworte

Versionen (2)
  1. 29.05.16 29.05.16 -
  2. 29.05.16 29.05.16 -
Hochgeladen am

29. Mai 2016

DOI

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Creative Commons BY-NC 3.0
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End of Study/Discontinuation, DIMAT-MS Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069

Englisch

End of Study/Discontinuation, DIMAT-MS Relapsing Remitting Multiple Sclerosis NCT02461069

1 Formulare  
End of Study / Discontinuation
Beschreibung

End of Study / Discontinuation

Date
Beschreibung

Date

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C0011008
dd/mm/yy
Regular end of study
Beschreibung

Regular end of study

after week 24 (Core study phase)
Beschreibung

after week 24 (Core study phase)

Datentyp

boolean

Alias
UMLS CUI [1]
C2983670
after week 48 (Follow up phase)
Beschreibung

after week 48 (Follow up phase)

Datentyp

boolean

Alias
UMLS CUI [1]
C2983670
Early discontinuation
Beschreibung

Early discontinuation

during the Screening phase (Screening failure)
Beschreibung

during the Screening phase (Screening failure)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1710477
UMLS CUI [1,2]
C0231175
If screening failure, please specify:
Beschreibung

If screening failure, please specify:

Datentyp

text

Alias
UMLS CUI [1,1]
C1710477
UMLS CUI [1,2]
C0231175
during the Core study phase
Beschreibung

during the Core study phase

Datentyp

boolean

during Follow up phase
Beschreibung

during Follow up phase

Datentyp

text

Alias
UMLS CUI [1]
C1522577
Reason for discontinuation of the Core study phase / Follow up phase:
Beschreibung

Reason for discontinuation of the Core study phase / Follow up phase:

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0008976
If "other reason", please specify:
Beschreibung

If "other reason", please specify:

Datentyp

text

Alias
UMLS CUI [1]
C3840932
Signature
Beschreibung

Signature

Date
Beschreibung

Investigator Signature Date

Datentyp

date

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

Signature Investigator

Datentyp

text

Alias
UMLS CUI [1]
C2346576
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Ähnliche Modelle

End of Study/Discontinuation, DIMAT-MS Relapsing Remitting Multiple Sclerosis NCT02461069

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
End of Study / Discontinuation
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Regular end of study
after week 24 (Core study phase)
Item
after week 24 (Core study phase)
boolean
C2983670 (UMLS CUI [1])
after week 48 (Follow up phase)
Item
after week 48 (Follow up phase)
boolean
C2983670 (UMLS CUI [1])
Item Group
Early discontinuation
during the Screening phase (Screening failure)
Item
during the Screening phase (Screening failure)
boolean
C1710477 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
If screening failure, please specify:
Item
If screening failure, please specify:
text
C1710477 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
during the Core study phase
Item
during the Core study phase
boolean
during Follow up phase
Item
during Follow up phase
text
C1522577 (UMLS CUI [1])
Item
Reason for discontinuation of the Core study phase / Follow up phase:
text
C0392360 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Reason for discontinuation of the Core study phase / Follow up phase:
Code List
Reason for discontinuation of the Core study phase / Follow up phase:
CL Item
Patient withdraws informed consent (1)
CL Item
Lack of efficacy (2)
CL Item
Other medical, cognitive, or other conditions, in the Investigator’s opinion, com- promise the patient’s ability to understand the nature, signi cance, implications and risks of the study, to comply with the protocol or to complete the study (3)
CL Item
Adverse Event (4)
CL Item
Serious Adverse Event (5)
CL Item
Lost to Follow up (6)
CL Item
Other reason (7)
If "other reason", please specify:
Item
If "other reason", please specify:
text
C3840932 (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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