ID

14767

Description

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/

Keywords

Versions (1)
  1. 4/27/16 4/27/16 -
Uploaded on

April 27, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
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.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

NINDS CDE Adverse Event Tracking Log Epilepsy

English

Adverse Event Tracking Log

1 forms  
Adverse Events
Description

Adverse Events

Adverse Event
Description

(Please use medical terminology)

Data type

text

Alias
UMLS CUI [1]
C0877248
AE Start date
Description

AE Start date

Data type

date

Alias
UMLS CUI [1]
C2697888
AE End date
Description

AE End date

Data type

date

Alias
UMLS CUI [1]
C2697886
AE ongoing
Description

AE ongoing

Data type

boolean

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

AE Severity

Data type

integer

Alias
UMLS CUI [1]
C2985921
Relatedness
Description

AE causality

Data type

integer

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

Action Taken

Data type

integer

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

Action Taken

Data type

integer

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

Outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
Serious Adverse Event
Description

SAE

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Back to the top of the page

Similar models

Adverse Event Tracking Log

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial