ID

13553

Beschreibung

The primary purpose is to investigate the autonomic nervous system using positron emission tomography (PET) in genotyped longQT syndrome patients and corresponding mouse model and compare the results with the genetic subtype, the phenotype and the role of the autonomic nervous system in the onset of tachyarrhythmias. See https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-002767-41/DE#E

Link

https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-002767-41/DE#E

Stichworte

Versionen (1)
  1. 15.02.16 15.02.16 -
Hochgeladen am

15. Februar 2016

DOI

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Creative Commons BY-NC 3.0
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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

Englisch

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

1 Formulare  
Adverse Events
Beschreibung

Adverse Events

Alias
UMLS CUI-1
C0877248
Did Adverse Events occur
Beschreibung

AE occured

Datentyp

text

Alias
UMLS CUI [1]
C0877248
Study termination
Beschreibung

Study termination

Datentyp

text

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

Study termination specification

Datentyp

text

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

List of Adverse Events

Adverse event
Beschreibung

Adverse event

Datentyp

text

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

Start date of Adverse Event

Datentyp

date

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

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

Datentyp

text

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

AE leads to termination of study

Datentyp

text

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

AE Correlation to Protocol Agent

Datentyp

text

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

CTCAE-Grading

Datentyp

text

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

AE End date

Datentyp

date

Alias
UMLS CUI [1]
C0877248
AE ongoing
Beschreibung

AE ongoing

Datentyp

text

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

Final consequence of AE

Datentyp

text

Alias
UMLS CUI [1]
C0877248
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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