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ID
16550
Description
MIPSO Vergleichende Untersuchung der bakteriellen Mikrobiota in der Haut sowie dem Darm von Psoriasis-Patienten vor und nach systemischer Behandlung mit Adalimumab bzw. Ustekinumab oder Ciclosporin (EudraCT 2014-003022-40) Principal Investigator: Prof. Dr. Dr. h.c. Thomas A. Luger
Keywords
Versions (2)
- 12/8/15 12/8/15 -
- 7/23/16 7/23/16 -
Uploaded on
July 23, 2016
DOI
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License
Creative Commons BY-NC 3.0
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Adverse Event Psoriasis MIPSO EudraCT 2014-003022-40 DRKS00007147
Adverse Event Psoriasis MIPSO EudraCT 2014-003022-40
- StudyEvent: ODM
Similar models
Adverse Event Psoriasis MIPSO EudraCT 2014-003022-40
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
AE: Sheet number
Item
integer
C1704732 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
AE: Signature date
Item
date
C0807937 (UMLS CUI [1])
Comment Adverse Event
Item
text
C0947611 (UMLS CUI [1])
Item Group
Adverse Event Questionaire
C0877248 (UMLS CUI-1)
C0034394 (UMLS CUI-2)
C0034394 (UMLS CUI-2)
AE: Number
Item
integer
C0237753 (UMLS CUI [1])
AE: Term
Item
text
C2826302 (UMLS CUI [1])
AE: Start date
Item
date
C0808070 (UMLS CUI [1])
AE: Start time
Item
time
C1301880 (UMLS CUI [1])
AE: Serious event
Item
boolean
C2985919 (UMLS CUI [1])
CL Item
easy (1)
CL Item
medium (2)
CL Item
heavy (3)
CL Item
no causal link (0)
CL Item
not likely (1)
CL Item
possible (2)
CL Item
probably (3)
CL Item
very likely (4)
CL Item
dose unchanged (0)
CL Item
discontinued temporarily (1)
CL Item
permanently discontinued (2)
CL Item
dose reduced (3)
CL Item
dose increases (4)
CL Item
unknown (5)
CL Item
not applicable (6)
AE that caused study discontinuation
Item
boolean
C0457454 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
AE: End date
Item
date
C0806020 (UMLS CUI [1])
AE: End time
Item
time
C1522314 (UMLS CUI [1])
AE: Ongoing
Item
boolean
C0549178 (UMLS CUI [1])
CL Item
restored (0)
CL Item
improved (1)
CL Item
not yet improved (2)
CL Item
recovered with permanent damage (3)
CL Item
death (4)
CL Item
unknown (5)