ID

15388

Description

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.

Mots-clés

Versions (2)
  1. 29/05/2016 29/05/2016 -
  2. 29/05/2016 29/05/2016 -
Téléchargé le

29 mai 2016

DOI

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Licence

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

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

1 Formulaires  
End of Study / Discontinuation
Description

End of Study / Discontinuation

Date
Description

Date

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C0011008
dd/mm/yy
Regular end of study
Description

Regular end of study

after week 24 (Core study phase)
Description

after week 24 (Core study phase)

Type de données

boolean

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

after week 48 (Follow up phase)

Type de données

boolean

Alias
UMLS CUI [1]
C2983670
Early discontinuation
Description

Early discontinuation

during the Screening phase (Screening failure)
Description

during the Screening phase (Screening failure)

Type de données

boolean

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

If screening failure, please specify:

Type de données

text

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

during the Core study phase

Type de données

boolean

during Follow up phase
Description

during Follow up phase

Type de données

text

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

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

Type de données

text

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

If "other reason", please specify:

Type de données

text

Alias
UMLS CUI [1]
C3840932
Signature
Description

Signature

Date
Description

Investigator Signature Date

Type de données

date

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

Signature Investigator

Type de données

text

Alias
UMLS CUI [1]
C2346576
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Similar models

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

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

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