ID
40000
Beskrivning
translated and modified from CDASH Adverse Event 2011-10-24 http://www.cdisc.org/
Länk
Nyckelord
Versioner (4)
- 2014-03-28 2014-03-28 - Martin Dugas
- 2014-03-29 2014-03-29 - Martin Dugas
- 2018-06-20 2018-06-20 - Julian Varghese
- 2020-03-09 2020-03-09 - Sarah Riepenhausen
Rättsinnehavare
CDISC
Uppladdad den
9 mars 2020
DOI
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Licens
Creative Commons BY-NC 4.0
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CDASH Adverse Event
Adverse Event
- StudyEvent: Adverse Event
Beskrivning
Details
Alias
- UMLS CUI-1
- C1522508
- UMLS CUI-2
- C0877248
Beskrivning
Verbatim (i.e., investigator-reported term) description of the adverse event.
Datatyp
text
Alias
- UMLS CUI [1]
- C2699044
- CDASH
- AETERM
- CDASH/SDTM
- AETERM
Beskrivning
Date when the adverse event started.
Datatyp
partialDate
Alias
- UMLS CUI [1]
- C2697888
- CDASH
- AESTDAT
Beskrivning
Indicates AE is ongoing when no End Date is provided.
Datatyp
text
Alias
- UMLS CUI [1]
- C2826663
- CDASH
- AEONGO
Beskrivning
Date when the adverse event resolved.
Datatyp
partialDate
Alias
- UMLS CUI [1]
- C2697886
- CDASH
- AEENDAT
Beskrivning
Description of the severity of the adverse event.
Datatyp
text
Alias
- CDASH
- AESEV
- CDASH/SDTM
- AESEV
- UMLS CUI-1
- C1710066
Beskrivning
Indicates whether or not the adverse event is determined to be “serious” based on what is defined in the protocol.
Datatyp
text
Alias
- UMLS CUI [1]
- C2985919
- CDASH
- AESER
- CDASH/SDTM
- AESER
Beskrivning
Indicates if a “serious” adverse event was associated with a congenital anomaly or birth defect.
Datatyp
text
Alias
- UMLS CUI [1]
- C2826727
- CDASH
- AESCONG
- CDASH/SDTM
- AESCONG
Beskrivning
Indicates if a “serious” adverse event was associated with a persistent or significant disability or incapacity.
Datatyp
text
Alias
- UMLS CUI [1]
- C3830477
- CDASH
- AESDISAB
- CDASH/SDTM
- AESDISAB
Beskrivning
Indicates if a “serious” adverse event resulted in death.
Datatyp
text
Alias
- UMLS CUI [1]
- C1705232
- CDASH
- AESDTH
- CDASH/SDTM
- AESDTH
Beskrivning
Indicates if a “serious” adverse event resulted in an initial or prolonged hospitalization for the subject.
Datatyp
text
Alias
- UMLS CUI [1]
- C2826664
- CDASH
- AESHOSP
- CDASH/SDTM
- AESHOSP
Beskrivning
Indicates if a “serious” adverse event was life threatening.
Datatyp
text
Alias
- UMLS CUI [1]
- C1517874
- CDASH
- AESLIFE
- CDASH/SDTM
- AESLIFE
Beskrivning
Indicates if a “serious” adverse event is associated with other serious or important medical events.
Datatyp
text
Alias
- UMLS CUI [1]
- C2826665
- CDASH
- AESMIE
- CDASH/SDTM
- AESMIE
Beskrivning
Indication of whether the study treatment had a causal effect on the adverse event, as reported by the clinician/investigator.
Datatyp
text
Alias
- UMLS CUI [1]
- C1510821
- CDASH
- AEREL
- CDASH/SDTM
- AEREL
Beskrivning
Changes made to the study treatment in response to the adverse event.
Datatyp
text
Alias
- UMLS CUI [1]
- C2826626
- CDASH
- AEACN
- CDASH/SDTM
- AEACN
Beskrivning
Describes Other Action(s) taken in response to the adverse event that are unrelated to study treatment dose changes.
Datatyp
text
Alias
- UMLS CUI [1]
- C2826719
- CDASH
- AEACNOTH
- CDASH/SDTM
- AEACNOTH
Beskrivning
Description of the subject’s status associated with an event.
Datatyp
text
Alias
- CDASH
- AEOUT
- CDASH/SDTM
- AEOUT
- UMLS CUI-1
- C1705586
Beskrivning
Indication of whether the adverse event caused the subject to discontinue from the study.
Datatyp
text
Alias
- UMLS CUI [1]
- C2826233
- CDASH
- AEDIS
Similar models
Adverse Event
- StudyEvent: Adverse Event
AETERM (CDASH)
AETERM (CDASH/SDTM)
AESTDAT (CDASH)
AEENDAT (CDASH)
AESER (CDASH)
AESER (CDASH/SDTM)
AESCONG (CDASH)
AESCONG (CDASH/SDTM)
AESDISAB (CDASH)
AESDISAB (CDASH/SDTM)
AESDTH (CDASH)
AESDTH (CDASH/SDTM)
AESHOSP (CDASH)
AESHOSP (CDASH/SDTM)
AESLIFE (CDASH)
AESLIFE (CDASH/SDTM)
AESMIE (CDASH)
AESMIE (CDASH/SDTM)
AEREL (CDASH)
AEREL (CDASH/SDTM)
AEACN (CDASH)
AEACN (CDASH/SDTM)
AEACNOTH (CDASH)
AEACNOTH (CDASH/SDTM)
AEDIS (CDASH)