ID
4775
Description
translated and modified from CDASH Adverse Event 2011-10-24 http://www.cdisc.org/
Link
Keywords
Versions (4)
- 3/28/14 3/28/14 - Martin Dugas
- 3/29/14 3/29/14 - Martin Dugas
- 6/20/18 6/20/18 - Julian Varghese
- 3/9/20 3/9/20 - Sarah Riepenhausen
Uploaded on
March 29, 2014
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0 Legacy
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
CDASH Adverse Event
Adverse Event
- StudyEvent: Adverse Event
Description
Details
Alias
- UMLS CUI-1
- C1522508
Description
Verbatim (i.e., investigator-reported term) description of the adverse event.
Data type
text
Alias
- CDASH
- AETERM
- CDASH/SDTM
- AETERM
- UMLS CUI-1
- C2699044
Description
Date when the adverse event started.
Data type
partialDate
Alias
- CDASH
- AESTDAT
- UMLS CUI-1
- C2697888
Description
Indicates AE is ongoing when no End Date is provided.
Data type
text
Alias
- CDASH
- AEONGO
- UMLS CUI-1
- C2826663
Description
Date when the adverse event resolved.
Data type
partialDate
Alias
- CDASH
- AEENDAT
- UMLS CUI-1
- C2697886
Description
Description of the severity of the adverse event.
Data type
text
Alias
- CDASH
- AESEV
- CDASH/SDTM
- AESEV
- UMLS CUI-1
- C1710066
Description
Indicates whether or not the adverse event is determined to be “serious” based on what is defined in the protocol.
Data type
text
Alias
- CDASH
- AESER
- CDASH/SDTM
- AESER
- UMLS CUI-1
- C2985919
Description
Indicates if a “serious” adverse event was associated with a congenital anomaly or birth defect.
Data type
text
Alias
- CDASH
- AESCONG
- CDASH/SDTM
- AESCONG
- UMLS CUI-1
- C2826727
Description
Indicates if a “serious” adverse event was associated with a persistent or significant disability or incapacity.
Data type
text
Alias
- CDASH
- AESDISAB
- CDASH/SDTM
- AESDISAB
- UMLS CUI-1
- CL427997
Description
Indicates if a “serious” adverse event resulted in death.
Data type
text
Alias
- CDASH
- AESDTH
- CDASH/SDTM
- AESDTH
- UMLS CUI-1
- C1705232
Description
Indicates if a “serious” adverse event resulted in an initial or prolonged hospitalization for the subject.
Data type
text
Alias
- CDASH
- AESHOSP
- CDASH/SDTM
- AESHOSP
- UMLS CUI-1
- C2826664
Description
Indicates if a “serious” adverse event was life threatening.
Data type
text
Alias
- CDASH
- AESLIFE
- CDASH/SDTM
- AESLIFE
- UMLS CUI-1
- C1517874
Description
Indicates if a “serious” adverse event is associated with other serious or important medical events.
Data type
text
Alias
- CDASH
- AESMIE
- CDASH/SDTM
- AESMIE
- UMLS CUI-1
- C2826307
Description
Indication of whether the study treatment had a causal effect on the adverse event, as reported by the clinician/investigator.
Data type
text
Alias
- CDASH
- AEREL
- CDASH/SDTM
- AEREL
- UMLS CUI-1
- C1510821
Description
Changes made to the study treatment in response to the adverse event.
Data type
text
Alias
- CDASH
- AEACN
- CDASH/SDTM
- AEACN
- UMLS CUI-1
- C2826626
Description
Describes Other Action(s) taken in response to the adverse event that are unrelated to study treatment dose changes.
Data type
text
Alias
- CDASH
- AEACNOTH
- CDASH/SDTM
- AEACNOTH
- UMLS CUI-1
- C2826719
Description
Description of the subject’s status associated with an event.
Data type
text
Alias
- CDASH
- AEOUT
- CDASH/SDTM
- AEOUT
- UMLS CUI-1
- C1705586
Description
Indication of whether the adverse event caused the subject to discontinue from the study.
Data type
text
Alias
- CDASH
- AEDIS
- UMLS CUI-1
- C2826233
Similar models
Adverse Event
- StudyEvent: Adverse Event
AETERM (CDASH/SDTM)
C2699044 (UMLS CUI-1)
C2697888 (UMLS CUI-1)
C2697886 (UMLS CUI-1)
AESER (CDASH/SDTM)
C2985919 (UMLS CUI-1)
AESCONG (CDASH/SDTM)
C2826727 (UMLS CUI-1)
AESDISAB (CDASH/SDTM)
CL427997 (UMLS CUI-1)
AESDTH (CDASH/SDTM)
C1705232 (UMLS CUI-1)
AESHOSP (CDASH/SDTM)
C2826664 (UMLS CUI-1)
AESLIFE (CDASH/SDTM)
C1517874 (UMLS CUI-1)
AESMIE (CDASH/SDTM)
C2826307 (UMLS CUI-1)
AEREL (CDASH/SDTM)
C1510821 (UMLS CUI-1)
AEACN (CDASH/SDTM)
C2826626 (UMLS CUI-1)
AEACNOTH (CDASH/SDTM)
C2826719 (UMLS CUI-1)
C2826233 (UMLS CUI-1)
No comments