ID
4775
Descrizione
translated and modified from CDASH Adverse Event 2011-10-24 http://www.cdisc.org/
collegamento
Keywords
versioni (4)
- 28/03/14 28/03/14 - Martin Dugas
- 29/03/14 29/03/14 - Martin Dugas
- 20/06/18 20/06/18 - Julian Varghese
- 09/03/20 09/03/20 - Sarah Riepenhausen
Caricato su
29 marzo 2014
DOI
Per favore, per richiedere un accesso.
Licenza
Creative Commons BY-NC 3.0 Legacy
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CDASH Adverse Event
Adverse Event
- StudyEvent: Adverse Event
Descrizione
Details
Alias
- UMLS CUI-1
- C1522508
Descrizione
Verbatim (i.e., investigator-reported term) description of the adverse event.
Tipo di dati
text
Alias
- CDASH
- AETERM
- CDASH/SDTM
- AETERM
- UMLS CUI-1
- C2699044
Descrizione
Date when the adverse event started.
Tipo di dati
partialDate
Alias
- CDASH
- AESTDAT
- UMLS CUI-1
- C2697888
Descrizione
Indicates AE is ongoing when no End Date is provided.
Tipo di dati
text
Alias
- CDASH
- AEONGO
- UMLS CUI-1
- C2826663
Descrizione
Date when the adverse event resolved.
Tipo di dati
partialDate
Alias
- CDASH
- AEENDAT
- UMLS CUI-1
- C2697886
Descrizione
Description of the severity of the adverse event.
Tipo di dati
text
Alias
- CDASH
- AESEV
- CDASH/SDTM
- AESEV
- UMLS CUI-1
- C1710066
Descrizione
Indicates whether or not the adverse event is determined to be “serious” based on what is defined in the protocol.
Tipo di dati
text
Alias
- CDASH
- AESER
- CDASH/SDTM
- AESER
- UMLS CUI-1
- C2985919
Descrizione
Indicates if a “serious” adverse event was associated with a congenital anomaly or birth defect.
Tipo di dati
text
Alias
- CDASH
- AESCONG
- CDASH/SDTM
- AESCONG
- UMLS CUI-1
- C2826727
Descrizione
Indicates if a “serious” adverse event was associated with a persistent or significant disability or incapacity.
Tipo di dati
text
Alias
- CDASH
- AESDISAB
- CDASH/SDTM
- AESDISAB
- UMLS CUI-1
- CL427997
Descrizione
Indicates if a “serious” adverse event resulted in death.
Tipo di dati
text
Alias
- CDASH
- AESDTH
- CDASH/SDTM
- AESDTH
- UMLS CUI-1
- C1705232
Descrizione
Indicates if a “serious” adverse event resulted in an initial or prolonged hospitalization for the subject.
Tipo di dati
text
Alias
- CDASH
- AESHOSP
- CDASH/SDTM
- AESHOSP
- UMLS CUI-1
- C2826664
Descrizione
Indicates if a “serious” adverse event was life threatening.
Tipo di dati
text
Alias
- CDASH
- AESLIFE
- CDASH/SDTM
- AESLIFE
- UMLS CUI-1
- C1517874
Descrizione
Indicates if a “serious” adverse event is associated with other serious or important medical events.
Tipo di dati
text
Alias
- CDASH
- AESMIE
- CDASH/SDTM
- AESMIE
- UMLS CUI-1
- C2826307
Descrizione
Indication of whether the study treatment had a causal effect on the adverse event, as reported by the clinician/investigator.
Tipo di dati
text
Alias
- CDASH
- AEREL
- CDASH/SDTM
- AEREL
- UMLS CUI-1
- C1510821
Descrizione
Changes made to the study treatment in response to the adverse event.
Tipo di dati
text
Alias
- CDASH
- AEACN
- CDASH/SDTM
- AEACN
- UMLS CUI-1
- C2826626
Descrizione
Describes Other Action(s) taken in response to the adverse event that are unrelated to study treatment dose changes.
Tipo di dati
text
Alias
- CDASH
- AEACNOTH
- CDASH/SDTM
- AEACNOTH
- UMLS CUI-1
- C2826719
Descrizione
Description of the subject’s status associated with an event.
Tipo di dati
text
Alias
- CDASH
- AEOUT
- CDASH/SDTM
- AEOUT
- UMLS CUI-1
- C1705586
Descrizione
Indication of whether the adverse event caused the subject to discontinue from the study.
Tipo di dati
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)