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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 forms  
Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
Did Adverse Events occur
Description

AE occured

Data type

text

Alias
UMLS CUI [1]
C0877248
Study termination
Description

Study termination

Data type

text

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

Study termination specification

Data type

text

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

List of Adverse Events

Adverse event
Description

Adverse event

Data type

text

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

Start date of Adverse Event

Data type

date

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

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

Data type

text

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

AE leads to termination of study

Data type

text

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

AE Correlation to Protocol Agent

Data type

text

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

CTCAE-Grading

Data type

text

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

AE End date

Data type

date

Alias
UMLS CUI [1]
C0877248
AE ongoing
Description

AE ongoing

Data type

text

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

Final consequence of AE

Data type

text

Alias
UMLS CUI [1]
C0877248
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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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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