ID

42876

Beschreibung

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

Stichworte

Versionen (2)
  1. 20.07.19 20.07.19 -
  2. 17.09.21 17.09.21 -
Rechteinhaber

Bundesinstitut für Arzneimittel und Medizinprodukte

Hochgeladen am

17. September 2021

DOI

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Lizenz

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Bfarm SAE

Deutsch Englisch

Serious Adverse Event Report Form

1 Formulare  
Basic Administrative Data
Beschreibung

Basic Administrative Data

Alias
UMLS CUI-1
C1320722
National Competent Authority
Beschreibung

National Competent Authority

Datentyp

integer

Alias
UMLS CUI [1,1]
C0086035
UMLS CUI [1,2]
C1273803
UMLS CUI [1,3]
C0681788
Title of Clinical Investigation
Beschreibung

Title of Clinical Investigation

Datentyp

text

Alias
UMLS CUI [1,1]
C1705824
UMLS CUI [1,2]
C4553154
Clinical investigation identifier
Beschreibung

Clinical investigation identifier

Datentyp

text

Alias
UMLS CUI [1,1]
C4553154
UMLS CUI [1,2]
C0600091
Date of this report
Beschreibung

Date of this report

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C3897642
Reference number assigned by the sponsor
Beschreibung

Reference number assigned by the sponsor

Datentyp

text

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0586393
UMLS CUI [1,3]
C2347796
NCA's reference #
Beschreibung

if known

Datentyp

text

Alias
UMLS CUI [1,1]
C0086035
UMLS CUI [1,2]
C1273803
UMLS CUI [1,3]
C0681788
UMLS CUI [1,4]
C0237753
UMLS CUI [1,5]
C0586393
Identify to which other NCAs this report was also submitted
Beschreibung

Identify to which other NCAs this report was also submitted

Datentyp

text

Alias
UMLS CUI [1,1]
C0086035
UMLS CUI [1,2]
C1273803
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C3897642
UMLS CUI [1,5]
C1515023
Type of report
Beschreibung

Type of report

Datentyp

integer

Alias
UMLS CUI [1,1]
C3897642
UMLS CUI [1,2]
C0332307
This SAE also meets the incident definition according to Section 2 number 1 MPSV
Beschreibung

This SAE also meets the incident definition according to Section 2 number 1 MPSV

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C1301860
UMLS CUI [1,4]
C0243161
Expected date of next report
Beschreibung

if applicable

Datentyp

date

Alias
UMLS CUI [1,1]
C1517001
UMLS CUI [1,2]
C4724350
Report submitted by
Beschreibung

Report submitted by

Alias
UMLS CUI-1
C3897642
UMLS CUI-2
C1710230
Name
Beschreibung

Name

Datentyp

text

Alias
UMLS CUI [1]
C0027365
Contact Person
Beschreibung

Contact Person

Datentyp

text

Alias
UMLS CUI [1]
C0337611
Street, house number
Beschreibung

Street, house number

Datentyp

text

Alias
UMLS CUI [1]
C1301826
Postal Code
Beschreibung

Postal Code

Datentyp

float

Alias
UMLS CUI [1]
C1514254
City
Beschreibung

City

Datentyp

text

Alias
UMLS CUI [1]
C0008848
Country
Beschreibung

Country

Datentyp

text

Alias
UMLS CUI [1]
C0454664
Telephone
Beschreibung

Telephone

Datentyp

float

Alias
UMLS CUI [1]
C1515258
Fax
Beschreibung

Fax

Datentyp

float

Alias
UMLS CUI [1]
C1549619
E-Mail
Beschreibung

E-Mail

Datentyp

text

Alias
UMLS CUI [1]
C1705961
Investigator
Beschreibung

Investigator

Alias
UMLS CUI-1
C0008961
Name
Beschreibung

Name

Datentyp

text

Alias
UMLS CUI [1]
C0027365
Contact Person
Beschreibung

Contact Person

Datentyp

text

Alias
UMLS CUI [1]
C0337611
Street, house number
Beschreibung

Street, house number

Datentyp

text

Alias
UMLS CUI [1]
C1301826
Postal Code
Beschreibung

Postal Code

Datentyp

float

Alias
UMLS CUI [1]
C1514254
City
Beschreibung

City

Datentyp

text

Alias
UMLS CUI [1]
C0008848
Country
Beschreibung

Country

Datentyp

text

Alias
UMLS CUI [1]
C0454664
Telephone
Beschreibung

Telephone

Datentyp

float

Alias
UMLS CUI [1]
C1515258
Fax
Beschreibung

Fax

Datentyp

float

Alias
UMLS CUI [1]
C1549619
E-Mail
Beschreibung

E-Mail

Datentyp

text

Alias
UMLS CUI [1]
C1705961
Medical Device Information
Beschreibung

Medical Device Information

Alias
UMLS CUI-1
C1533716
UMLS CUI-2
C0025080
Device Name
Beschreibung

Device Name

Datentyp

text

Alias
UMLS CUI [1]
C3242369
Model number
Beschreibung

if applicable

Datentyp

text

Alias
UMLS CUI [1]
C3274659
Explant date
Beschreibung

for implants only

Datentyp

date

Alias
UMLS CUI [1,1]
C0561946
UMLS CUI [1,2]
C0011008
Duration of Implantation
Beschreibung

For implants only. To be filled out if the exact implant and explant dates are unknown

Datentyp

time

Alias
UMLS CUI [1,1]
C0021107
UMLS CUI [1,2]
C0449238
Accessories and / or associated devices
Beschreibung

if applicable

Datentyp

text

Alias
UMLS CUI [1,1]
C2963249
UMLS CUI [1,2]
C0025080
UMLS CUI [2,1]
C0699733
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0025080
Product identifier in the clinical investigation
Beschreibung

Product identifier in the clinical investigation

Datentyp

text

Alias
UMLS CUI [1,1]
C3272556
UMLS CUI [1,2]
C4553154
Person(s) affected
Beschreibung

Person(s) affected

Alias
UMLS CUI-1
C0522476
Subject
Beschreibung

Subject

Datentyp

boolean

Alias
UMLS CUI [1]
C0681850
User
Beschreibung

User

Datentyp

boolean

Alias
UMLS CUI [1]
C1706077
Other Person
Beschreibung

Other Person

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027361
UMLS CUI [1,2]
C0205394
Other Person Further Information
Beschreibung

Other Person Further Information

Datentyp

text

Alias
UMLS CUI [1,1]
C0027361
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1517331
UMLS CUI [1,4]
C1533716
Sex
Beschreibung

Information on sex, year of birth and weight to be provided if necessary for the assessment of the SAE

Datentyp

integer

Alias
UMLS CUI [1]
C0079399
Year of birth
Beschreibung

Information on sex, year of birth and weight to be provided if necessary for the assessment of the SAE

Datentyp

partialDate

Alias
UMLS CUI [1]
C2826771
Weight
Beschreibung

Information on sex, year of birth and weight to be provided if necessary for the assessment of the SAE

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Subject ID according to investigation protocol
Beschreibung

Subject ID according to investigation protocol

Datentyp

text

Alias
UMLS CUI [1,1]
C2826694
UMLS CUI [1,2]
C2348563
Serious adverse event
Beschreibung

Serious adverse event

Alias
UMLS CUI-1
C1519255
Date of the study procedure
Beschreibung

Date of the study procedure

Datentyp

date

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0184661
UMLS CUI [1,3]
C0011008
Date of event
Beschreibung

Date of event

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0441471
Doctor / Investigation site awareness date
Beschreibung

Doctor / Investigation site awareness date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0031831
UMLS CUI [1,3]
C1522154
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C2347790
UMLS CUI [2,3]
C1522154
Date the report was received by the sponsor
Beschreibung

Date the report was received by the sponsor

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C3897642
UMLS CUI [1,3]
C1709850
UMLS CUI [1,4]
C1711305
Outcome Death
Beschreibung

actual or possible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C1306577
Outcome Life-threatening illness or injury
Beschreibung

actual or possible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C3846017
UMLS CUI [2,1]
C1274040
UMLS CUI [2,2]
C2826244
UMLS CUI [2,3]
C3263722
Outcome Permanent impairment of body structure or body function
Beschreibung

actual or possible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0205355
UMLS CUI [1,4]
C1268086
UMLS CUI [2,1]
C1274040
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0205355
UMLS CUI [2,4]
C0242821
UMLS CUI [2,5]
C0542341
Outcome In-patient hospitalisation or prolongation of existing hospitalisation
Beschreibung

actual or possible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0019993
UMLS CUI [2,1]
C1274040
UMLS CUI [2,2]
C0019993
UMLS CUI [2,3]
C0439590
Outcome Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or body function
Beschreibung

actual or possible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0184661
UMLS CUI [1,3]
C0221099
UMLS CUI [1,4]
C0205355
UMLS CUI [1,5]
C1268086
UMLS CUI [2,1]
C1274040
UMLS CUI [2,2]
C0549433
UMLS CUI [2,3]
C0221099
UMLS CUI [2,4]
C0205355
UMLS CUI [2,5]
C1268086
UMLS CUI [3,1]
C1274040
UMLS CUI [3,2]
C0184661
UMLS CUI [3,3]
C0221099
UMLS CUI [3,4]
C0205355
UMLS CUI [3,5]
C0242821
UMLS CUI [3,6]
C0542341
UMLS CUI [4,1]
C1274040
UMLS CUI [4,2]
C0549433
UMLS CUI [4,3]
C0221099
UMLS CUI [4,4]
C0205355
UMLS CUI [4,5]
C0242821
UMLS CUI [4,6]
C0542341
Outcome Foetal distress, foetal death, congenital abnormality or birth defect
Beschreibung

actual or possible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0015930
UMLS CUI [2,1]
C1274040
UMLS CUI [2,2]
C0015927
UMLS CUI [3,1]
C1274040
UMLS CUI [3,2]
C0000768
UMLS CUI [4,1]
C1274040
UMLS CUI [4,2]
C2112165
Detailed description of the event by the investigation site
Beschreibung

Detailed description of the event by the investigation site

Datentyp

text

Alias
UMLS CUI [1,1]
C2348319
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C2825164
Additional description by the sponsor
Beschreibung

Additional description by the sponsor

Datentyp

text

Alias
UMLS CUI [1,1]
C1524062
UMLS CUI [1,2]
C0678257
UMLS CUI [1,3]
C2347796
Remedial action taken by the investigation site relevant to the care of the subject
Beschreibung

Remedial action taken by the investigation site relevant to the care of the subject

Datentyp

text

Alias
UMLS CUI [1,1]
C1709895
UMLS CUI [1,2]
C2825164
UMLS CUI [1,3]
C1947933
UMLS CUI [1,4]
C0681850
The event is
Beschreibung

expected = addressed in the risk analysis of the sponsor or mentioned in the Investigators Brochure

Datentyp

integer

Alias
UMLS CUI [1,1]
C0679138
UMLS CUI [1,2]
C0441471
Rationale for the classification as expected or unexpected
Beschreibung

Rationale for the classification as expected or unexpected

Datentyp

text

Alias
UMLS CUI [1,1]
C2699007
UMLS CUI [1,2]
C0008902
UMLS CUI [1,3]
C1517001
UMLS CUI [2,1]
C2699007
UMLS CUI [2,2]
C0008902
UMLS CUI [2,3]
C4055646
Initial actions taken by the sponsor
Beschreibung

Initial actions taken by the sponsor

Datentyp

text

Alias
UMLS CUI [1,1]
C0205265
UMLS CUI [1,2]
C3266814
UMLS CUI [1,3]
C1711305
Related to investigation
Beschreibung

Related to investigation

Alias
UMLS CUI-1
C0869014
UMLS CUI-2
C0220825
Relation to investigation Medical procedure
Beschreibung

Relation to investigation Medical procedure

Datentyp

integer

Alias
UMLS CUI [1,1]
C0869014
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0199171
Relation to investigation Medical device
Beschreibung

Relation to investigation Medical device

Datentyp

integer

Alias
UMLS CUI [1,1]
C0869014
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0025080
No relation
Beschreibung

No relation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0869014
UMLS CUI [1,2]
C1705492
Rationale for rating the relation
Beschreibung

in case of changes in rating the relation compared to initial or follow-up reports please provide a rationale

Datentyp

text

Alias
UMLS CUI [1,1]
C2699007
UMLS CUI [1,2]
C0871208
UMLS CUI [1,3]
C0869014
Number of patients currently enrolled At the investigation site
Beschreibung

Number of patients currently enrolled At the investigation site

Datentyp

float

Alias
UMLS CUI [1,1]
C2360800
UMLS CUI [1,2]
C4727055
UMLS CUI [1,3]
C2825164
Number of patients currently enrolled All investigation sites
Beschreibung

Number of patients currently enrolled All investigation sites

Datentyp

float

Alias
UMLS CUI [1,1]
C2360800
UMLS CUI [1,2]
C4727055
UMLS CUI [1,3]
C2825164
UMLS CUI [1,4]
C0444868
Final report by the sponsor
Beschreibung

Final report by the sponsor

Alias
UMLS CUI-1
C0460114
UMLS CUI-2
C2347796
Root cause of the SAE is
Beschreibung

Root cause of the SAE is

Datentyp

text

Alias
UMLS CUI [1,1]
C3179036
UMLS CUI [1,2]
C1519255
Root Cause SAE Other further information
Beschreibung

Please provide information if other was picked on the previous item

Datentyp

text

Alias
UMLS CUI [1,1]
C3179036
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C1517331
UMLS CUI [1,5]
C1533716
Investigation results and rationale for the above root cause classification
Beschreibung

including a final risk-benefit assessment of the clinical investigation taking all SAEs into consideration

Datentyp

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0220825
UMLS CUI [2,1]
C2699007
UMLS CUI [2,2]
C3179036
UMLS CUI [2,3]
C0008902
Corrective action taken or planned including time schedule:
Beschreibung

Corrective action taken or planned including time schedule:

Datentyp

text

Alias
UMLS CUI [1,1]
C0719519
UMLS CUI [1,2]
C3266814
UMLS CUI [1,3]
C1301732
UMLS CUI [1,4]
C1549502
UMLS CUI [2,1]
C0719519
UMLS CUI [2,2]
C3266814
UMLS CUI [2,3]
C1272695
UMLS CUI [2,4]
C1549502
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Ähnliche Modelle

Serious Adverse Event Report Form

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Basic Administrative Data
C1320722 (UMLS CUI-1)
Item
National Competent Authority
integer
C0086035 (UMLS CUI [1,1])
C1273803 (UMLS CUI [1,2])
C0681788 (UMLS CUI [1,3])
National Competent Authority
Code List
National Competent Authority
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])
Clinical investigation identifier
Item
Clinical investigation identifier
text
C4553154 (UMLS CUI [1,1])
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])
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])
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])
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])
Item
Type of report
integer
C3897642 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of report
Code List
Type of report
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])
Expected date of next report
Item
Expected date of next report
date
C1517001 (UMLS CUI [1,1])
C4724350 (UMLS CUI [1,2])
Item Group
Report submitted by
C3897642 (UMLS CUI-1)
C1710230 (UMLS CUI-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])
Item Group
Investigator
C0008961 (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])
Item Group
C1533716 (UMLS CUI-1)
C0025080 (UMLS CUI-2)
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])
Duration of Implantation
Item
Duration of Implantation
time
C0021107 (UMLS CUI [1,1])
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])
Product identifier in the clinical investigation
Item
Product identifier in the clinical investigation
text
C3272556 (UMLS CUI [1,1])
C4553154 (UMLS CUI [1,2])
Item Group
Person(s) affected
C0522476 (UMLS CUI-1)
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])
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])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
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
C2826694 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
Serious adverse event
C1519255 (UMLS CUI-1)
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])
Date of event
Item
Date of event
date
C0011008 (UMLS CUI [1,1])
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])
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])
Outcome Death
Item
Outcome Death
boolean
C1274040 (UMLS CUI [1,1])
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])
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])
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])
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])
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])
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])
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])
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])
Item
The event is
integer
C0679138 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
The event is
Code List
The event is
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])
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])
Item Group
Related to investigation
C0869014 (UMLS CUI-1)
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])
Relation to investigation Medical procedure
Code List
Relation to investigation Medical procedure
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])
Relation to investigation Medical device
Code List
Relation to investigation Medical device
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])
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])
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])
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])
Item Group
Final report by the sponsor
C0460114 (UMLS CUI-1)
C2347796 (UMLS CUI-2)
Item
Root cause of the SAE is
text
C3179036 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Root cause of the SAE is
Code List
Root cause of the SAE is
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])
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])
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])
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