ID

4775

Beschrijving

translated and modified from CDASH Adverse Event 2011-10-24 http://www.cdisc.org/

Link

http://www.cdisc.org/

Trefwoorden

Versies (4)
  1. 28-03-14 28-03-14 - Martin Dugas
  2. 29-03-14 29-03-14 - Martin Dugas
  3. 20-06-18 20-06-18 - Julian Varghese
  4. 09-03-20 09-03-20 - Sarah Riepenhausen
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29 maart 2014

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy
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CDASH Adverse Event

Duits Engels

Adverse Event

1 Formulieren  
  1. StudyEvent: Adverse Event
    1. Adverse Event
General information section
Beschrijving

General information section

Alias
UMLS CUI-1
C1508263
Any AE?
Beschrijving

General prompt question regarding whether or not any AEs were experienced during the study. This provides verification that all other fields on the CRF were deliberately left blank.

Datatype

text

Alias
CDASH
AEYN
UMLS CUI-1
C2826937
Details
Beschrijving

Details

Alias
UMLS CUI-1
C1522508
Adverse Event
Beschrijving

Verbatim (i.e., investigator-reported term) description of the adverse event.

Datatype

text

Alias
CDASH
AETERM
CDASH/SDTM
AETERM
UMLS CUI-1
C2699044
Start Date
Beschrijving

Date when the adverse event started.

Datatype

partialDate

Alias
CDASH
AESTDAT
UMLS CUI-1
C2697888
Ongoing?
Beschrijving

Indicates AE is ongoing when no End Date is provided.

Datatype

text

Alias
CDASH
AEONGO
UMLS CUI-1
C2826663
End Date
Beschrijving

Date when the adverse event resolved.

Datatype

partialDate

Alias
CDASH
AEENDAT
UMLS CUI-1
C2697886
Severity
Beschrijving

Description of the severity of the adverse event.

Datatype

text

Alias
CDASH
AESEV
CDASH/SDTM
AESEV
UMLS CUI-1
C1710066
Serious
Beschrijving

Indicates whether or not the adverse event is determined to be “serious” based on what is defined in the protocol.

Datatype

text

Alias
CDASH
AESER
CDASH/SDTM
AESER
UMLS CUI-1
C2985919
Congenital Anomaly or Birth Defect
Beschrijving

Indicates if a “serious” adverse event was associated with a congenital anomaly or birth defect.

Datatype

text

Alias
CDASH
AESCONG
CDASH/SDTM
AESCONG
UMLS CUI-1
C2826727
Significant Disability
Beschrijving

Indicates if a “serious” adverse event was associated with a persistent or significant disability or incapacity.

Datatype

text

Alias
CDASH
AESDISAB
CDASH/SDTM
AESDISAB
UMLS CUI-1
CL427997
Death
Beschrijving

Indicates if a “serious” adverse event resulted in death.

Datatype

text

Alias
CDASH
AESDTH
CDASH/SDTM
AESDTH
UMLS CUI-1
C1705232
Hospitalization
Beschrijving

Indicates if a “serious” adverse event resulted in an initial or prolonged hospitalization for the subject.

Datatype

text

Alias
CDASH
AESHOSP
CDASH/SDTM
AESHOSP
UMLS CUI-1
C2826664
Life threatening
Beschrijving

Indicates if a “serious” adverse event was life threatening.

Datatype

text

Alias
CDASH
AESLIFE
CDASH/SDTM
AESLIFE
UMLS CUI-1
C1517874
Other Medically Important Event
Beschrijving

Indicates if a “serious” adverse event is associated with other serious or important medical events.

Datatype

text

Alias
CDASH
AESMIE
CDASH/SDTM
AESMIE
UMLS CUI-1
C2826307
Relationship to Study Treatment
Beschrijving

Indication of whether the study treatment had a causal effect on the adverse event, as reported by the clinician/investigator.

Datatype

text

Alias
CDASH
AEREL
CDASH/SDTM
AEREL
UMLS CUI-1
C1510821
Action Taken with Study Treatment
Beschrijving

Changes made to the study treatment in response to the adverse event.

Datatype

text

Alias
CDASH
AEACN
CDASH/SDTM
AEACN
UMLS CUI-1
C2826626
Other Action Taken
Beschrijving

Describes Other Action(s) taken in response to the adverse event that are unrelated to study treatment dose changes.

Datatype

text

Alias
CDASH
AEACNOTH
CDASH/SDTM
AEACNOTH
UMLS CUI-1
C2826719
Outcome
Beschrijving

Description of the subject’s status associated with an event.

Datatype

text

Alias
CDASH
AEOUT
CDASH/SDTM
AEOUT
UMLS CUI-1
C1705586
Caused Study Discontinuation
Beschrijving

Indication of whether the adverse event caused the subject to discontinue from the study.

Datatype

text

Alias
CDASH
AEDIS
UMLS CUI-1
C2826233
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Similar models

Adverse Event

1 Formulieren
  1. StudyEvent: Adverse Event
    1. Adverse Event
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
General information section
C1508263 (UMLS CUI-1)
Item
Any AE?
text
AEYN (CDASH)
C2826937 (UMLS CUI-1)
No Yes Response
Code List
Any AE?
CL Item
NO (N)
CL Item
YES (Y)
Item Group
Details
C1522508 (UMLS CUI-1)
Adverse Event Verbatim Description
Item
Adverse Event
text
AETERM (CDASH)
AETERM (CDASH/SDTM)
C2699044 (UMLS CUI-1)
Adverse Event Start Date
Item
Start Date
partialDate
AESTDAT (CDASH)
C2697888 (UMLS CUI-1)
Item
Ongoing?
text
AEONGO (CDASH)
C2826663 (UMLS CUI-1)
No Yes Response
Code List
Ongoing?
CL Item
NO (N)
CL Item
YES (Y)
Adverse Event End Date
Item
End Date
partialDate
AEENDAT (CDASH)
C2697886 (UMLS CUI-1)
Item
Severity
text
AESEV (CDASH)
AESEV (CDASH/SDTM)
C1710066 (UMLS CUI-1)
Severity/Intensity Scale for Adverse Events
Code List
Severity
CL Item
MILD (MILD)
CL Item
MODERATE (MODERATE)
CL Item
SEVERE (SEVERE)
Item
Serious
text
AESER (CDASH)
AESER (CDASH/SDTM)
C2985919 (UMLS CUI-1)
No Yes Response
Code List
Serious
CL Item
NO (N)
CL Item
YES (Y)
Item
Congenital Anomaly or Birth Defect
text
AESCONG (CDASH)
AESCONG (CDASH/SDTM)
C2826727 (UMLS CUI-1)
No Yes Response
Code List
Congenital Anomaly or Birth Defect
CL Item
NO (N)
CL Item
YES (Y)
Item
Significant Disability
text
AESDISAB (CDASH)
AESDISAB (CDASH/SDTM)
CL427997 (UMLS CUI-1)
No Yes Response
Code List
Significant Disability
CL Item
NO (N)
CL Item
YES (Y)
Item
Death
text
AESDTH (CDASH)
AESDTH (CDASH/SDTM)
C1705232 (UMLS CUI-1)
No Yes Response
Code List
Death
CL Item
NO (N)
CL Item
YES (Y)
Item
Hospitalization
text
AESHOSP (CDASH)
AESHOSP (CDASH/SDTM)
C2826664 (UMLS CUI-1)
No Yes Response
Code List
Hospitalization
CL Item
NO (N)
CL Item
YES (Y)
Item
Life threatening
text
AESLIFE (CDASH)
AESLIFE (CDASH/SDTM)
C1517874 (UMLS CUI-1)
No Yes Response
Code List
Life threatening
CL Item
NO (N)
CL Item
YES (Y)
Item
Other Medically Important Event
text
AESMIE (CDASH)
AESMIE (CDASH/SDTM)
C2826307 (UMLS CUI-1)
No Yes Response
Code List
Other Medically Important Event
CL Item
NO (N)
CL Item
YES (Y)
Item
Relationship to Study Treatment
text
AEREL (CDASH)
AEREL (CDASH/SDTM)
C1510821 (UMLS CUI-1)
Relationship to Study Treatment
Code List
Relationship to Study Treatment
CL Item
NOT RELATED (NOT RELATED)
CL Item
UNLIKELY RELATED (UNLIKELY)
CL Item
POSSIBLY RELATED (POSSIBLY)
CL Item
RELATED (RELATED)
Item
Action Taken with Study Treatment
text
AEACN (CDASH)
AEACN (CDASH/SDTM)
C2826626 (UMLS CUI-1)
Action Taken with Study Treatment
Code List
Action Taken with Study Treatment
CL Item
DOSE INCREASED (DOSE INCREASED)
CL Item
DOSE NOT CHANGED (DOSE NOT CHANGED)
CL Item
DOSE REDUCED (DOSE REDUCED)
CL Item
DRUG INTERRUPTED (DRUG INTERRUPTED)
CL Item
DRUG WITHDRAWN (DRUG WITHDRAWN)
CL Item
NOT APPLICABLE (NOT APPLICABLE)
CL Item
UNKNOWN (UNKNOWN)
Other Actions taken in Response to Adverse Event
Item
Other Action Taken
text
AEACNOTH (CDASH)
AEACNOTH (CDASH/SDTM)
C2826719 (UMLS CUI-1)
Item
Outcome
text
AEOUT (CDASH)
AEOUT (CDASH/SDTM)
C1705586 (UMLS CUI-1)
Outcome of Event
Code List
Outcome
CL Item
FATAL (FATAL)
CL Item
NOT RECOVERED/NOT RESOLVED (NOT RECOVERED/NOT RESOLVED)
CL Item
RECOVERED/RESOLVED (RECOVERED/RESOLVED)
CL Item
RECOVERED/RESOLVED WITH SEQUELAE (RECOVERED/RESOLVED WITH SEQUELAE)
CL Item
RECOVERING/RESOLVING (RECOVERING/RESOLVING)
CL Item
UNKNOWN (UNKNOWN)
Item
Caused Study Discontinuation
text
AEDIS (CDASH)
C2826233 (UMLS CUI-1)
No Yes Response
Code List
Caused Study Discontinuation
CL Item
NO (N)
CL Item
YES (Y)
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