ID

14767

Beschrijving

NINDS Common Data Elements Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

Link

https://www.commondataelements.ninds.nih.gov/

Trefwoorden

Versies (1)
  1. 27-04-16 27-04-16 -
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27 april 2016

DOI

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Creative Commons BY-NC 3.0
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NINDS CDE Adverse Event Tracking Log Epilepsy

Engels

Adverse Event Tracking Log

1 Formulieren  
Adverse Events
Beschrijving

Adverse Events

Adverse Event
Beschrijving

(Please use medical terminology)

Datatype

text

Alias
UMLS CUI [1]
C0877248
AE Start date
Beschrijving

AE Start date

Datatype

date

Alias
UMLS CUI [1]
C2697888
AE End date
Beschrijving

AE End date

Datatype

date

Alias
UMLS CUI [1]
C2697886
AE ongoing
Beschrijving

AE ongoing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0549178
AE Severity
Beschrijving

AE Severity

Datatype

integer

Alias
UMLS CUI [1]
C2985921
Relatedness
Beschrijving

AE causality

Datatype

integer

Alias
UMLS CUI [1]
C3641099
Action Taken with Study Intervention
Beschrijving

Action Taken

Datatype

integer

Alias
UMLS CUI [1]
C2826626
Action Taken with AED
Beschrijving

Action Taken

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0441472
Outcome
Beschrijving

Outcome

Datatype

integer

Alias
UMLS CUI [1]
C1705586
Serious Adverse Event
Beschrijving

SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
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Similar models

Adverse Event Tracking Log

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Adverse Events
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
AE Start date
Item
AE Start date
date
C2697888 (UMLS CUI [1])
AE End date
Item
AE End date
date
C2697886 (UMLS CUI [1])
AE ongoing
Item
AE ongoing
boolean
C0877248 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item
AE Severity
integer
C2985921 (UMLS CUI [1])
AE Severity
Code List
AE Severity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Life-threatening/Disabling (4)
CL Item
Death (5)
Item
Relatedness
integer
C3641099 (UMLS CUI [1])
AE causality
Code List
Relatedness
CL Item
Unrelated (1)
CL Item
Unlikely (2)
CL Item
Probable (3)
CL Item
Possible (4)
CL Item
Definite (5)
Item
Action Taken with Study Intervention
integer
C2826626 (UMLS CUI [1])
Action Taken
Code List
Action Taken with Study Intervention
CL Item
None (1)
CL Item
Study Intervention Interrupted (2)
CL Item
Study Intervention Discontinued (3)
CL Item
Study Intervention Modified (4)
Item
Action Taken with AED
integer
C0877248 (UMLS CUI [1,1])
C0441472 (UMLS CUI [1,2])
Action Taken
Code List
Action Taken with AED
CL Item
None (1)
CL Item
AED therapy temporarily interrupted (2)
CL Item
AED therapy permanently stopped (3)
CL Item
AED therapy modified (4)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovered/Resolved With Sequelae (2)
CL Item
Recovering/Resolving (3)
CL Item
Not Recovered/Not Resolved (4)
CL Item
Fatal (5)
CL Item
Unknown (6)
SAE
Item
Serious Adverse Event
boolean
C1519255 (UMLS CUI [1])
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