Information:
Error:
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.
Keywords
Versions (2)
- 5/29/16 5/29/16 -
- 5/29/16 5/29/16 -
Uploaded on
May 29, 2016
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
End of Study/Discontinuation, DIMAT-MS Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069
End of Study/Discontinuation, DIMAT-MS Relapsing Remitting Multiple Sclerosis NCT02461069
Similar models
End of Study/Discontinuation, DIMAT-MS Relapsing Remitting Multiple Sclerosis NCT02461069
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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])
during the Screening phase (Screening failure)
Item
during the Screening phase (Screening failure)
boolean
C1710477 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
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])
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])
C1444662 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
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])
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Signature Investigator
Item
Signature Investigator
text
C2346576 (UMLS CUI [1])