ID

16550

Beschrijving

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

Trefwoorden

  1. 08-12-15 08-12-15 -
  2. 23-07-16 23-07-16 -
Geüploaded op

23 juli 2016

DOI

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Licentie

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

Adverse Event
Beschrijving

Adverse Event

Alias
UMLS CUI-1
C0877248
AE: Sheet number
Beschrijving

AE: Sheet number

Datatype

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0237753
AE: Signature date
Beschrijving

AE: Signature date

Datatype

date

Alias
UMLS CUI [1]
C0807937
Comment Adverse Event
Beschrijving

Comment Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C0947611
Adverse Event Questionaire
Beschrijving

Adverse Event Questionaire

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0034394
AE: Number
Beschrijving

AE: Number

Datatype

integer

Alias
UMLS CUI [1]
C0237753
AE: Term
Beschrijving

AE: Term

Datatype

text

Alias
UMLS CUI [1]
C2826302
AE: Start date
Beschrijving

AE: Start date

Datatype

date

Alias
UMLS CUI [1]
C0808070
AE: Start time
Beschrijving

AE: Start time, if relevant

Datatype

time

Alias
UMLS CUI [1]
C1301880
AE: Serious event
Beschrijving

AE: Serious event

Datatype

boolean

Alias
UMLS CUI [1]
C2985919
AE: Severity
Beschrijving

AE: Severity

Datatype

integer

Alias
UMLS CUI [1]
C1710066
AE: Related to study medication
Beschrijving

AE: Related to study medication

Datatype

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0877248
AE: Action taken with study treatment
Beschrijving

AE: Action taken with study treatment

Datatype

integer

Alias
UMLS CUI [1]
C1704758
AE that caused study discontinuation
Beschrijving

AE that caused study discontinuation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0877248
AE: End date
Beschrijving

AE: End date

Datatype

date

Alias
UMLS CUI [1]
C0806020
AE: End time
Beschrijving

AE: End time, if relevant

Datatype

time

Alias
UMLS CUI [1]
C1522314
AE: Ongoing
Beschrijving

AE: Ongoing

Datatype

boolean

Alias
UMLS CUI [1]
C0549178
AE: Outcome
Beschrijving

AE: Outcome

Datatype

integer

Alias
UMLS CUI [1]
C1705586

Similar models

Adverse Event Psoriasis MIPSO EudraCT 2014-003022-40

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
AE: Sheet number
Item
integer
C1704732 (UMLS CUI [1,1])
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)
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])
Item
integer
C1710066 (UMLS CUI [1])
Code List
AE: Severity
CL Item
easy (1)
CL Item
medium (2)
CL Item
heavy (3)
Item
integer
C0304229 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
AE: Related to study medication
CL Item
no causal link (0)
CL Item
not likely (1)
CL Item
possible (2)
CL Item
probably (3)
CL Item
very likely (4)
Item
integer
C1704758 (UMLS CUI [1])
Code List
AE: Action taken with study treatment
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])
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])
Item
integer
C1705586 (UMLS CUI [1])
Code List
AE: Outcome
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)

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