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Adverse Events and Study Termination Mobil-c1 Items Cardiac Innervation In Genetic Models Of Arrhythmia In Humans And Mice EudraCT 2006-002767-41

1 Formulär  
Adverse Events
Beskrivning

Adverse Events

Alias
UMLS CUI-1
C0877248
Did Adverse Events occur
Beskrivning

AE occured

Datatyp

text

Alias
UMLS CUI [1]
C0877248
Study termination
Beskrivning

Study termination

Datatyp

text

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0013135
If study was terminated, please specify reason
Beskrivning

Study termination specification

Datatyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0008972
UMLS CUI [1,3]
C0013135
List of Adverse Events
Beskrivning

List of Adverse Events

Adverse event
Beskrivning

Adverse event

Datatyp

text

Alias
UMLS CUI [1]
C0877248
Start date of Adverse Event
Beskrivning

Start date of Adverse Event

Datatyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0011008
Was the AE serious
Beskrivning

serious AE include: Patient died, life-threatening event, inpatient treatment required or extendend, permanent damages or disabilities, congenital abnormalties / birth defects, other important medical events

Datatyp

text

Alias
UMLS CUI [1]
C1519255
AE leads to termination of study
Beskrivning

AE leads to termination of study

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0013135
AE Correlation to Protocol Agent
Beskrivning

AE Correlation to Protocol Agent

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1521826
CTCAE-Grading of Adverse Event
Beskrivning

CTCAE-Grading

Datatyp

text

Alias
UMLS CUI [1]
C1516728
AE End date, if ended
Beskrivning

AE End date

Datatyp

date

Alias
UMLS CUI [1]
C0877248
AE ongoing
Beskrivning

AE ongoing

Datatyp

text

Alias
UMLS CUI [1]
C0877248
Final consequence of AE
Beskrivning

Final consequence of AE

Datatyp

text

Alias
UMLS CUI [1]
C0877248
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Similar models

Adverse Events and Study Termination Mobil-c1 Items Cardiac Innervation In Genetic Models Of Arrhythmia In Humans And Mice EudraCT 2006-002767-41

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Item
Did Adverse Events occur
text
C0877248 (UMLS CUI [1])
AE occured
Code List
Did Adverse Events occur
CL Item
No (1)
CL Item
yes (2)
Item
Study termination
text
C0008972 (UMLS CUI [1,1])
C0013135 (UMLS CUI [1,2])
Study termination
Code List
Study termination
CL Item
No (1)
CL Item
yes (2)
Item
If study was terminated, please specify reason
text
C0392360 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
C0013135 (UMLS CUI [1,3])
Study termination specification
Code List
If study was terminated, please specify reason
CL Item
Adverse events (1)
CL Item
Wish of patient prescan (2)
CL Item
Wish of patient postscan (3)
CL Item
other reason, specifiy: (4)
Item Group
List of Adverse Events
Adverse event
Item
Adverse event
text
C0877248 (UMLS CUI [1])
Start date of Adverse Event
Item
Start date of Adverse Event
date
C0877248 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Was the AE serious
text
C1519255 (UMLS CUI [1])
Serious Adverse Event
Code List
Was the AE serious
CL Item
No  (1)
CL Item
yes (2)
Item
AE leads to termination of study
text
C0877248 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0013135 (UMLS CUI [1,3])
AE leads to termination of study
Code List
AE leads to termination of study
CL Item
No (1)
CL Item
Yes (2)
Item
AE Correlation to Protocol Agent
text
C0877248 (UMLS CUI [1,1])
C1521826 (UMLS CUI [1,2])
AE Correlation to Protocol Agent
Code List
AE Correlation to Protocol Agent
CL Item
reasonable correlation to protocol agent (1)
CL Item
no correlation (0)
CTCAE-Grading
Item
CTCAE-Grading of Adverse Event
text
C1516728 (UMLS CUI [1])
AE End date
Item
AE End date, if ended
date
C0877248 (UMLS CUI [1])
Item
AE ongoing
text
C0877248 (UMLS CUI [1])
AE ongoing
Code List
AE ongoing
CL Item
No (1)
CL Item
Yes (2)
Item
Final consequence of AE
text
C0877248 (UMLS CUI [1])
Final consequence of AE
Code List
Final consequence of AE
CL Item
recovered (0)
CL Item
improved (1)
CL Item
not yet improved (2)
CL Item
recovered with defect (3)
CL Item
unknown (4)
CL Item
death (5)
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