ID

12662

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

  1. 12/8/15 12/8/15 -
  2. 7/23/16 7/23/16 -
Uploaded on

December 8, 2015

DOI

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License

Creative Commons BY-NC 3.0

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Adverse Event Psoriasis MIPSO EudraCT 2014-003022-40

Adverse Event Psoriasis MIPSO EudraCT 2014-003022-40

Adverse Event
Description

Adverse Event

AE: Sheet number
Description

AE: Sheet number

Data type

integer

AE: Signature date
Description

AE: Signature date

Data type

date

Comment Adverse Event
Description

Comment Adverse Event

Data type

text

Adverse Event Questionaire
Description

Adverse Event Questionaire

AE: Number
Description

AE: Number

Data type

integer

AE: Term
Description

AE: Term

Data type

text

AE: Start date
Description

AE: Start date

Data type

date

AE: Start time
Description

AE: Start time, if relevant

Data type

time

AE: Serious event
Description

AE: Serious event

Data type

boolean

AE: Severity
Description

AE: Severity

Data type

integer

AE: Related to study medication
Description

AE: Related to study medication

Data type

integer

AE: Action taken with study treatment
Description

AE: Action taken with study treatment

Data type

integer

AE that caused study discontinuation
Description

AE that caused study discontinuation

Data type

boolean

AE: End date
Description

AE: End date

Data type

date

AE: End time
Description

AE: End time, if relevant

Data type

time

AE: Ongoing
Description

AE: Ongoing

Data type

boolean

AE: Outcome
Description

AE: Outcome

Data type

integer

Similar models

Adverse Event Psoriasis MIPSO EudraCT 2014-003022-40

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse Event
AE: Sheet number
Item
integer
AE: Signature date
Item
date
Comment Adverse Event
Item
text
Item Group
Adverse Event Questionaire
AE: Number
Item
integer
AE: Term
Item
text
AE: Start date
Item
date
AE: Start time
Item
time
AE: Serious event
Item
boolean
Item
integer
Code List
AE: Severity
CL Item
easy (1)
CL Item
medium (2)
CL Item
heavy (3)
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)
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
AE: End date
Item
date
AE: End time
Item
time
AE: Ongoing
Item
boolean
Item
integer
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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