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ID
15387
Beschrijving
Study documentation part: Discontinuation of 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.: NCT02461069.
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- 29-05-16 29-05-16 -
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29 mei 2016
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Creative Commons BY-NC 3.0
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Adverse Events, DIMAT-MS Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069
Adverse Events, DIMAT-MS Relapsing Remitting Multiple Sclerosis NCT02461069
Similar models
Adverse Events, DIMAT-MS Relapsing Remitting Multiple Sclerosis NCT02461069
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Adverse Events Sheet No.
Item
Adverse Events Sheet No.
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Consecutive AE-No.
Item
Consecutive AE-No.
integer
C0449788 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
Adverse Event
Item
Adverse Event (AE)
text
C0877248 (UMLS CUI [1])
Date of onset of AE
Item
Date of onset of AE
date
C2985916 (UMLS CUI [1])
Seriousness
Item
Seriousness
boolean
C0871902 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
mild: usually transient in nature and generally not interfering with normal activities (1)
CL Item
moderate: sufficiently discomforting to interfere with normal activities (2)
CL Item
severe: prevents normal activities (3)
Item
Relationship to invest. medicinal product
text
C0439849 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
CL Item
no reasonable possibility: time relationship is improbable, and/or another explanation is more likely (e.g. disease or other drugs provide plausible explanation) (0)
CL Item
reasonable possibility: there are facts or arguments to suggest a causal relationship (1)
Item
Action taken with invest. medicinal product
text
C0420247 (UMLS CUI [1])
CL Item
dose not changed (0 )
CL Item
dose reduced (1)
CL Item
dose increased (2)
CL Item
drug withdrawn temporarily (3)
CL Item
drug withdrawn permanently (4)
CL Item
unknown (5)
CL Item
not applicable (6)
Withdrawal from trial due to this event
Item
Withdrawal from trial due to this event
boolean
C0680260 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
Date of end of AE
Item
Date of end of AE
date
C2697886 (UMLS CUI [1])
or ongoing
Item
or ongoing
boolean
C0549178 (UMLS CUI [1])
CL Item
recovered/resolved (0)
CL Item
recovering/resolving (1)
CL Item
not recovered/not resolved (2)
CL Item
recovered/resolved with sequelae (3)
CL Item
fatal (4)
CL Item
unknown (5)
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])