ID

15387

Beschreibung

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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Versionen (1)
  1. 29.05.16 29.05.16 -
Hochgeladen am

29. Mai 2016

DOI

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Adverse Events, DIMAT-MS Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069

Englisch

Adverse Events, DIMAT-MS Relapsing Remitting Multiple Sclerosis NCT02461069

1 Formulare  
Adverse Events
Beschreibung

Adverse Events

Adverse Events Sheet No.
Beschreibung

Adverse Events Sheet No.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
Consecutive AE-No.
Beschreibung

Consecutive AE-No.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0877248
Adverse Event (AE)
Beschreibung

Adverse Event

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Date of onset of AE
Beschreibung

Date of onset of AE

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985916
dd/mm/yy
Seriousness
Beschreibung

Seriousness

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0871902
UMLS CUI [1,2]
C0877248
Intensity/Severity
Beschreibung

Intensity/Severity

Datentyp

text

Alias
UMLS CUI [1]
C1710066
Relationship to invest. medicinal product
Beschreibung

Relationship to invest. medicinal product

Datentyp

text

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C3854006
Action taken with invest. medicinal product
Beschreibung

Action taken with invest. medicinal product

Datentyp

text

Alias
UMLS CUI [1]
C0420247
Withdrawal from trial due to this event
Beschreibung

Withdrawal from trial due to this event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680260
UMLS CUI [1,2]
C0008976
Date of end of AE
Beschreibung

Documentation up to the final study visit (48 weeks from ignition of treatment at week 0)

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C2697886
dd/mm/yy
or ongoing
Beschreibung

or ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C0549178
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
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

Adverse Events, DIMAT-MS Relapsing Remitting Multiple Sclerosis NCT02461069

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Adverse Events
Adverse Events Sheet No.
Item
Adverse Events Sheet No.
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Consecutive AE-No.
Item
Consecutive AE-No.
integer
C0449788 (UMLS CUI [1,1])
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])
Item
Intensity/Severity
text
C1710066 (UMLS CUI [1])
Intensity/Severity
Code List
Intensity/Severity
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])
Relationship to invest. medicinal product
Code List
Relationship to invest. medicinal product
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])
Action taken with invest. medicinal product
Code List
Action taken with invest. medicinal product
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])
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])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
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)
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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