ID

40000

Descripción

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

Link

http://www.cdisc.org/

Palabras clave

Versiones (4)
  1. 28/3/14 28/3/14 - Martin Dugas
  2. 29/3/14 29/3/14 - Martin Dugas
  3. 20/6/18 20/6/18 - Julian Varghese
  4. 9/3/20 9/3/20 - Sarah Riepenhausen
Titular de derechos de autor

CDISC

Subido en

9 de marzo de 2020

DOI

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Licencia

Creative Commons BY-NC 4.0
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CDASH Adverse Event

Alemán Inglés

Adverse Event

1 formularios  
  1. StudyEvent: Adverse Event
    1. Adverse Event
General information section
Descripción

General information section

Alias
UMLS CUI-1
C1508263
Any AE?
Descripción

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.

Tipo de datos

text

Alias
UMLS CUI [1]
C2826937
CDASH
AEYN
Details
Descripción

Details

Alias
UMLS CUI-1
C1522508
UMLS CUI-2
C0877248
Adverse Event
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C2699044
CDASH
AETERM
CDASH/SDTM
AETERM
Start Date
Descripción

Date when the adverse event started.

Tipo de datos

partialDate

Alias
UMLS CUI [1]
C2697888
CDASH
AESTDAT
Ongoing?
Descripción

Indicates AE is ongoing when no End Date is provided.

Tipo de datos

text

Alias
UMLS CUI [1]
C2826663
CDASH
AEONGO
End Date
Descripción

Date when the adverse event resolved.

Tipo de datos

partialDate

Alias
UMLS CUI [1]
C2697886
CDASH
AEENDAT
Severity
Descripción

Description of the severity of the adverse event.

Tipo de datos

text

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

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

Tipo de datos

text

Alias
UMLS CUI [1]
C2985919
CDASH
AESER
CDASH/SDTM
AESER
Congenital Anomaly or Birth Defect
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C2826727
CDASH
AESCONG
CDASH/SDTM
AESCONG
Significant Disability
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C3830477
CDASH
AESDISAB
CDASH/SDTM
AESDISAB
Death
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C1705232
CDASH
AESDTH
CDASH/SDTM
AESDTH
Hospitalization
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C2826664
CDASH
AESHOSP
CDASH/SDTM
AESHOSP
Life threatening
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C1517874
CDASH
AESLIFE
CDASH/SDTM
AESLIFE
Other Medically Important Event
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C2826665
CDASH
AESMIE
CDASH/SDTM
AESMIE
Relationship to Study Treatment
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C1510821
CDASH
AEREL
CDASH/SDTM
AEREL
Action Taken with Study Treatment
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C2826626
CDASH
AEACN
CDASH/SDTM
AEACN
Other Action Taken
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C2826719
CDASH
AEACNOTH
CDASH/SDTM
AEACNOTH
Outcome
Descripción

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

Tipo de datos

text

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

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

Tipo de datos

text

Alias
UMLS CUI [1]
C2826233
CDASH
AEDIS
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Similar models

Adverse Event

1 formularios
  1. StudyEvent: Adverse Event
    1. Adverse Event
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
General information section
C1508263 (UMLS CUI-1)
Item
Any AE?
text
C2826937 (UMLS CUI [1])
AEYN (CDASH)
No Yes Response
Code List
Any AE?
CL Item
NO (N)
CL Item
YES (Y)
Item Group
Details
C1522508 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Adverse Event Verbatim Description
Item
Adverse Event
text
C2699044 (UMLS CUI [1])
AETERM (CDASH)
AETERM (CDASH/SDTM)
Adverse Event Start Date
Item
Start Date
partialDate
C2697888 (UMLS CUI [1])
AESTDAT (CDASH)
Item
Ongoing?
text
C2826663 (UMLS CUI [1])
AEONGO (CDASH)
No Yes Response
Code List
Ongoing?
CL Item
NO (N)
CL Item
YES (Y)
Adverse Event End Date
Item
End Date
partialDate
C2697886 (UMLS CUI [1])
AEENDAT (CDASH)
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
C2985919 (UMLS CUI [1])
AESER (CDASH)
AESER (CDASH/SDTM)
No Yes Response
Code List
Serious
CL Item
NO (N)
CL Item
YES (Y)
Item
Congenital Anomaly or Birth Defect
text
C2826727 (UMLS CUI [1])
AESCONG (CDASH)
AESCONG (CDASH/SDTM)
No Yes Response
Code List
Congenital Anomaly or Birth Defect
CL Item
NO (N)
CL Item
YES (Y)
Item
Significant Disability
text
C3830477 (UMLS CUI [1])
AESDISAB (CDASH)
AESDISAB (CDASH/SDTM)
No Yes Response
Code List
Significant Disability
CL Item
NO (N)
CL Item
YES (Y)
Item
Death
text
C1705232 (UMLS CUI [1])
AESDTH (CDASH)
AESDTH (CDASH/SDTM)
No Yes Response
Code List
Death
CL Item
NO (N)
CL Item
YES (Y)
Item
Hospitalization
text
C2826664 (UMLS CUI [1])
AESHOSP (CDASH)
AESHOSP (CDASH/SDTM)
No Yes Response
Code List
Hospitalization
CL Item
NO (N)
CL Item
YES (Y)
Item
Life threatening
text
C1517874 (UMLS CUI [1])
AESLIFE (CDASH)
AESLIFE (CDASH/SDTM)
No Yes Response
Code List
Life threatening
CL Item
NO (N)
CL Item
YES (Y)
Item
Other Medically Important Event
text
C2826665 (UMLS CUI [1])
AESMIE (CDASH)
AESMIE (CDASH/SDTM)
No Yes Response
Code List
Other Medically Important Event
CL Item
NO (N)
CL Item
YES (Y)
Item
Relationship to Study Treatment
text
C1510821 (UMLS CUI [1])
AEREL (CDASH)
AEREL (CDASH/SDTM)
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
C2826626 (UMLS CUI [1])
AEACN (CDASH)
AEACN (CDASH/SDTM)
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
C2826719 (UMLS CUI [1])
AEACNOTH (CDASH)
AEACNOTH (CDASH/SDTM)
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
C2826233 (UMLS CUI [1])
AEDIS (CDASH)
No Yes Response
Code List
Caused Study Discontinuation
CL Item
NO (N)
CL Item
YES (Y)
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