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Informações:
Falhas:
ID
37364
Descrição
Formblatt für die Meldung von schwerwiegenden unerwünschten Ereignissen (SAE) im Rahmen einer klinischen Prüfung oder Leistungsbewertungsprüfung durch Sponsoren nach § 3 Abs. 5 der MPSV Die Vorlage dieser Meldung stellt an sich keine Schlussfolgerung des Herstellers und / oder seines Bevollmächtigten bzw. der zuständigen Behörde dar, dass der Inhalt dieser Meldung vollständig oder zutreffend ist, dass das (die) aufgeführte(n) Medizinprodukt(e) in irgendeiner Weise versagt und/oder zum angegebenen Tod bzw. zur angegebenen Verschlechterung des Gesundheitszustandes einer Person geführt oder beigetragen hat (haben). Report form for reporting of serious adverse events (SAE) in clinical trials or performance evaluations for use by sponsors according to section 3 (5) of the Ordinance on the Medical Device Safety Plan Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorised representative or the National Competent Authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person
Palavras-chave
Versões (2)
- 20/07/2019 20/07/2019 -
- 17/09/2021 17/09/2021 -
Titular dos direitos
Bundesinstitut für Arzneimittel und Medizinprodukte
Transferido a
20 de julho de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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Bfarm SAE
Serious Adverse Event Report Form
- StudyEvent: ODM
Similar models
Serious Adverse Event Report Form
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item
National Competent Authority
integer
C0086035 (UMLS CUI [1,1])
C1273803 (UMLS CUI [1,2])
C0681788 (UMLS CUI [1,3])
C1273803 (UMLS CUI [1,2])
C0681788 (UMLS CUI [1,3])
CL Item
Bfarm, Bonn (1)
CL Item
PEI, Langen (2)
CL Item
Andere (3)
Title of Clinical Investigation
Item
Title of Clinical Investigation
text
C1705824 (UMLS CUI [1,1])
C4553154 (UMLS CUI [1,2])
C4553154 (UMLS CUI [1,2])
Clinical investigation identifier
Item
Clinical investigation identifier
text
C4553154 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Date of this report
Item
Date of this report
date
C0011008 (UMLS CUI [1,1])
C3897642 (UMLS CUI [1,2])
C3897642 (UMLS CUI [1,2])
Reference number assigned by the sponsor
Item
Reference number assigned by the sponsor
text
C0237753 (UMLS CUI [1,1])
C0586393 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
C0586393 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
NCA's reference #
Item
NCA's reference #
text
C0086035 (UMLS CUI [1,1])
C1273803 (UMLS CUI [1,2])
C0681788 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
C0586393 (UMLS CUI [1,5])
C1273803 (UMLS CUI [1,2])
C0681788 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
C0586393 (UMLS CUI [1,5])
Identify to which other NCAs this report was also submitted
Item
Identify to which other NCAs this report was also submitted
text
C0086035 (UMLS CUI [1,1])
C1273803 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C3897642 (UMLS CUI [1,4])
C1515023 (UMLS CUI [1,5])
C1273803 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C3897642 (UMLS CUI [1,4])
C1515023 (UMLS CUI [1,5])
CL Item
Initial report by the sponsor (1)
CL Item
Follow-up report by the sponsor (2)
CL Item
Final report by the sponsor (3)
CL Item
Combined initial and final report by the sponsor (4)
This SAE also meets the incident definition according to Section 2 number 1 MPSV
Item
This SAE also meets the incident definition according to Section 2 number 1 MPSV
boolean
C1519255 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1301860 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C1550543 (UMLS CUI [1,2])
C1301860 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Expected date of next report
Item
Expected date of next report
date
C1517001 (UMLS CUI [1,1])
C4724350 (UMLS CUI [1,2])
C4724350 (UMLS CUI [1,2])
Name
Item
Name
text
C0027365 (UMLS CUI [1])
Contact Person
Item
Contact Person
text
C0337611 (UMLS CUI [1])
Street, house number
Item
Street, house number
text
C1301826 (UMLS CUI [1])
Postal Code
Item
Postal Code
float
C1514254 (UMLS CUI [1])
City
Item
City
text
C0008848 (UMLS CUI [1])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
Telephone
Item
Telephone
float
C1515258 (UMLS CUI [1])
Fax
Item
Fax
float
C1549619 (UMLS CUI [1])
E-Mail
Item
E-Mail
text
C1705961 (UMLS CUI [1])
Name
Item
Name
text
C0027365 (UMLS CUI [1])
Contact Person
Item
Contact Person
text
C0337611 (UMLS CUI [1])
Street, house number
Item
Street, house number
text
C1301826 (UMLS CUI [1])
Postal Code
Item
Postal Code
float
C1514254 (UMLS CUI [1])
City
Item
City
text
C0008848 (UMLS CUI [1])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
Telephone
Item
Telephone
float
C1515258 (UMLS CUI [1])
Fax
Item
Fax
float
C1549619 (UMLS CUI [1])
E-Mail
Item
E-Mail
text
C1705961 (UMLS CUI [1])
Device Name
Item
Device Name
text
C3242369 (UMLS CUI [1])
Model number
Item
Model number
text
C3274659 (UMLS CUI [1])
Explant date
Item
Explant date
date
C0561946 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Duration of Implantation
Item
Duration of Implantation
time
C0021107 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
Accessories and / or associated devices
Item
Accessories and / or associated devices
text
C2963249 (UMLS CUI [1,1])
C0025080 (UMLS CUI [1,2])
C0699733 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0025080 (UMLS CUI [2,3])
C0025080 (UMLS CUI [1,2])
C0699733 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0025080 (UMLS CUI [2,3])
Product identifier in the clinical investigation
Item
Product identifier in the clinical investigation
text
C3272556 (UMLS CUI [1,1])
C4553154 (UMLS CUI [1,2])
C4553154 (UMLS CUI [1,2])
Subject
Item
Subject
boolean
C0681850 (UMLS CUI [1])
User
Item
User
boolean
C1706077 (UMLS CUI [1])
Other Person
Item
Other Person
boolean
C0027361 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Other Person Further Information
Item
Other Person Further Information
text
C0027361 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C1533716 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C1533716 (UMLS CUI [1,4])
CL Item
unknown (1)
CL Item
male (2)
CL Item
male (2)
CL Item
female (3)
Year of birth
Item
Year of birth
partialDate
C2826771 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Subject ID according to investigation protocol
Item
Subject ID according to investigation protocol
text
C2348578 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
Date of the study procedure
Item
Date of the study procedure
date
C0008972 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Date of event
Item
Date of event
date
C0011008 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,2])
Doctor / Investigation site awareness date
Item
Doctor / Investigation site awareness date
date
C0011008 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
C1522154 (UMLS CUI [1,3])
C0011008 (UMLS CUI [2,1])
C2347790 (UMLS CUI [2,2])
C1522154 (UMLS CUI [2,3])
C0031831 (UMLS CUI [1,2])
C1522154 (UMLS CUI [1,3])
C0011008 (UMLS CUI [2,1])
C2347790 (UMLS CUI [2,2])
C1522154 (UMLS CUI [2,3])
Date the report was received by the sponsor
Item
Date the report was received by the sponsor
date
C0011008 (UMLS CUI [1,1])
C3897642 (UMLS CUI [1,2])
C1709850 (UMLS CUI [1,3])
C1711305 (UMLS CUI [1,4])
C3897642 (UMLS CUI [1,2])
C1709850 (UMLS CUI [1,3])
C1711305 (UMLS CUI [1,4])
Outcome Death
Item
Outcome Death
boolean
C1274040 (UMLS CUI [1,1])
C1306577 (UMLS CUI [1,2])
C1306577 (UMLS CUI [1,2])
Outcome Life-threatening illness or injury
Item
Outcome Life-threatening illness or injury
boolean
C1274040 (UMLS CUI [1,1])
C3846017 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C3263722 (UMLS CUI [2,3])
C3846017 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C3263722 (UMLS CUI [2,3])
Outcome Permanent impairment of body structure or body function
Item
Outcome Permanent impairment of body structure or body function
boolean
C1274040 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
C1268086 (UMLS CUI [1,4])
C1274040 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0205355 (UMLS CUI [2,3])
C0242821 (UMLS CUI [2,4])
C0542341 (UMLS CUI [2,5])
C0221099 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
C1268086 (UMLS CUI [1,4])
C1274040 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0205355 (UMLS CUI [2,3])
C0242821 (UMLS CUI [2,4])
C0542341 (UMLS CUI [2,5])
Outcome In-patient hospitalisation or prolongation of existing hospitalisation
Item
Outcome In-patient hospitalisation or prolongation of existing hospitalisation
boolean
C1274040 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
C0439590 (UMLS CUI [2,3])
C0019993 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
C0439590 (UMLS CUI [2,3])
Outcome Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or body function
Item
Outcome Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or body function
boolean
C1274040 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
C0205355 (UMLS CUI [1,4])
C1268086 (UMLS CUI [1,5])
C1274040 (UMLS CUI [2,1])
C0549433 (UMLS CUI [2,2])
C0221099 (UMLS CUI [2,3])
C0205355 (UMLS CUI [2,4])
C1268086 (UMLS CUI [2,5])
C1274040 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C0221099 (UMLS CUI [3,3])
C0205355 (UMLS CUI [3,4])
C0242821 (UMLS CUI [3,5])
C0542341 (UMLS CUI [3,6])
C1274040 (UMLS CUI [4,1])
C0549433 (UMLS CUI [4,2])
C0221099 (UMLS CUI [4,3])
C0205355 (UMLS CUI [4,4])
C0242821 (UMLS CUI [4,5])
C0542341 (UMLS CUI [4,6])
C0184661 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
C0205355 (UMLS CUI [1,4])
C1268086 (UMLS CUI [1,5])
C1274040 (UMLS CUI [2,1])
C0549433 (UMLS CUI [2,2])
C0221099 (UMLS CUI [2,3])
C0205355 (UMLS CUI [2,4])
C1268086 (UMLS CUI [2,5])
C1274040 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C0221099 (UMLS CUI [3,3])
C0205355 (UMLS CUI [3,4])
C0242821 (UMLS CUI [3,5])
C0542341 (UMLS CUI [3,6])
C1274040 (UMLS CUI [4,1])
C0549433 (UMLS CUI [4,2])
C0221099 (UMLS CUI [4,3])
C0205355 (UMLS CUI [4,4])
C0242821 (UMLS CUI [4,5])
C0542341 (UMLS CUI [4,6])
Outcome Foetal distress, foetal death, congenital abnormality or birth defect
Item
Outcome Foetal distress, foetal death, congenital abnormality or birth defect
boolean
C1274040 (UMLS CUI [1,1])
C0015930 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2,1])
C0015927 (UMLS CUI [2,2])
C1274040 (UMLS CUI [3,1])
C0000768 (UMLS CUI [3,2])
C1274040 (UMLS CUI [4,1])
C2112165 (UMLS CUI [4,2])
C0015930 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2,1])
C0015927 (UMLS CUI [2,2])
C1274040 (UMLS CUI [3,1])
C0000768 (UMLS CUI [3,2])
C1274040 (UMLS CUI [4,1])
C2112165 (UMLS CUI [4,2])
Detailed description of the event by the investigation site
Item
Detailed description of the event by the investigation site
text
C2348319 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
C0441471 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
Additional description by the sponsor
Item
Additional description by the sponsor
text
C1524062 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
Remedial action taken by the investigation site relevant to the care of the subject
Item
Remedial action taken by the investigation site relevant to the care of the subject
text
C1709895 (UMLS CUI [1,1])
C2825164 (UMLS CUI [1,2])
C1947933 (UMLS CUI [1,3])
C0681850 (UMLS CUI [1,4])
C2825164 (UMLS CUI [1,2])
C1947933 (UMLS CUI [1,3])
C0681850 (UMLS CUI [1,4])
CL Item
expected event (1)
CL Item
unexpected event (2)
Rationale for the classification as expected or unexpected
Item
Rationale for the classification as expected or unexpected
text
C2699007 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
C2699007 (UMLS CUI [2,1])
C0008902 (UMLS CUI [2,2])
C4055646 (UMLS CUI [2,3])
C0008902 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
C2699007 (UMLS CUI [2,1])
C0008902 (UMLS CUI [2,2])
C4055646 (UMLS CUI [2,3])
Initial actions taken by the sponsor
Item
Initial actions taken by the sponsor
text
C0205265 (UMLS CUI [1,1])
C3266814 (UMLS CUI [1,2])
C1711305 (UMLS CUI [1,3])
C3266814 (UMLS CUI [1,2])
C1711305 (UMLS CUI [1,3])
Item Group
Related to investigation
C0869014 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0220825 (UMLS CUI-2)
Item
Relation to investigation Medical procedure
integer
C0869014 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0199171 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,2])
C0199171 (UMLS CUI [1,3])
CL Item
yes (1)
CL Item
possible (2)
CL Item
no (3)
Item
Relation to investigation Medical device
integer
C0869014 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,2])
C0025080 (UMLS CUI [1,3])
CL Item
yes (1)
CL Item
possible (2)
CL Item
no (3)
No relation
Item
No relation
boolean
C0869014 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
C1705492 (UMLS CUI [1,2])
Rationale for rating the relation
Item
Rationale for rating the relation
text
C2699007 (UMLS CUI [1,1])
C0871208 (UMLS CUI [1,2])
C0869014 (UMLS CUI [1,3])
C0871208 (UMLS CUI [1,2])
C0869014 (UMLS CUI [1,3])
Number of patients currently enrolled At the investigation site
Item
Number of patients currently enrolled At the investigation site
float
C2360800 (UMLS CUI [1,1])
C4727055 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
C4727055 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
Number of patients currently enrolled All investigation sites
Item
Number of patients currently enrolled All investigation sites
float
C2360800 (UMLS CUI [1,1])
C4727055 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
C0444868 (UMLS CUI [1,4])
C4727055 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
C0444868 (UMLS CUI [1,4])
Item Group
Final report by the sponsor
C0460114 (UMLS CUI-1)
C2347796 (UMLS CUI-2)
C2347796 (UMLS CUI-2)
Item
Root cause of the SAE is
text
C3179036 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
CL Item
Medical procedure (1)
CL Item
Medical device (2)
CL Item
Other (3)
Root Cause SAE Other further information
Item
Root Cause SAE Other further information
text
C3179036 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1517331 (UMLS CUI [1,4])
C1533716 (UMLS CUI [1,5])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1517331 (UMLS CUI [1,4])
C1533716 (UMLS CUI [1,5])
Investigation results and rationale for the above root cause classification
Item
Investigation results and rationale for the above root cause classification
text
C1274040 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C2699007 (UMLS CUI [2,1])
C3179036 (UMLS CUI [2,2])
C0008902 (UMLS CUI [2,3])
C0220825 (UMLS CUI [1,2])
C2699007 (UMLS CUI [2,1])
C3179036 (UMLS CUI [2,2])
C0008902 (UMLS CUI [2,3])
Corrective action taken or planned including time schedule:
Item
Corrective action taken or planned including time schedule:
text
C0719519 (UMLS CUI [1,1])
C3266814 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1549502 (UMLS CUI [1,4])
C0719519 (UMLS CUI [2,1])
C3266814 (UMLS CUI [2,2])
C1272695 (UMLS CUI [2,3])
C1549502 (UMLS CUI [2,4])
C3266814 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1549502 (UMLS CUI [1,4])
C0719519 (UMLS CUI [2,1])
C3266814 (UMLS CUI [2,2])
C1272695 (UMLS CUI [2,3])
C1549502 (UMLS CUI [2,4])