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Adverse Event Psoriasis MIPSO EudraCT 2014-003022-40

1 Formulär  
Adverse Event
Beskrivning

Adverse Event

Alias
UMLS CUI-1
C0877248
AE: Sheet number
Beskrivning

AE: Sheet number

Datatyp

integer

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

AE: Signature date

Datatyp

date

Alias
UMLS CUI [1]
C0807937
Comment Adverse Event
Beskrivning

Comment Adverse Event

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Adverse Event Questionaire
Beskrivning

Adverse Event Questionaire

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

AE: Number

Datatyp

integer

Alias
UMLS CUI [1]
C0237753
AE: Term
Beskrivning

AE: Term

Datatyp

text

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

AE: Start date

Datatyp

date

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

AE: Start time, if relevant

Datatyp

time

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

AE: Serious event

Datatyp

boolean

Alias
UMLS CUI [1]
C2985919
AE: Severity
Beskrivning

AE: Severity

Datatyp

integer

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

AE: Related to study medication

Datatyp

integer

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

AE: Action taken with study treatment

Datatyp

integer

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

AE that caused study discontinuation

Datatyp

boolean

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

AE: End date

Datatyp

date

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

AE: End time, if relevant

Datatyp

time

Alias
UMLS CUI [1]
C1522314
AE: Ongoing
Beskrivning

AE: Ongoing

Datatyp

boolean

Alias
UMLS CUI [1]
C0549178
AE: Outcome
Beskrivning

AE: Outcome

Datatyp

integer

Alias
UMLS CUI [1]
C1705586
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Similar models

Adverse Event Psoriasis MIPSO EudraCT 2014-003022-40

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
AE: Severity
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])
AE: Related to study medication
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])
AE: Action taken with study treatment
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])
AE: Outcome
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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