ID

15388

Descripción

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.

Palabras clave

Versiones (2)
  1. 29/5/16 29/5/16 -
  2. 29/5/16 29/5/16 -
Subido en

29 de mayo de 2016

DOI

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Licencia

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

Inglés

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

1 formularios  
End of Study / Discontinuation
Descripción

End of Study / Discontinuation

Date
Descripción

Date

Tipo de datos

date

Unidades de medida
  • dd/mm/yy
Alias
UMLS CUI [1]
C0011008
dd/mm/yy
Regular end of study
Descripción

Regular end of study

after week 24 (Core study phase)
Descripción

after week 24 (Core study phase)

Tipo de datos

boolean

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

after week 48 (Follow up phase)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2983670
Early discontinuation
Descripción

Early discontinuation

during the Screening phase (Screening failure)
Descripción

during the Screening phase (Screening failure)

Tipo de datos

boolean

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

If screening failure, please specify:

Tipo de datos

text

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

during the Core study phase

Tipo de datos

boolean

during Follow up phase
Descripción

during Follow up phase

Tipo de datos

text

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

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

Tipo de datos

text

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

If "other reason", please specify:

Tipo de datos

text

Alias
UMLS CUI [1]
C3840932
Signature
Descripción

Signature

Date
Descripción

Investigator Signature Date

Tipo de datos

date

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

Signature Investigator

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
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Similar models

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

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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