Informações:
Falhas:
ID
14646
Descrição
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/
Palavras-chave
Versões (1)
- 25/04/2016 25/04/2016 -
Transferido a
25 de abril de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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NINDS CDE Drugs Epilepsy
Similar models
Drugs
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Anti Epileptic Drug (AED) Plasma Concentration Log
Study ID
Item
Study ID
text
C2826693 (UMLS CUI [1])
Study site
Item
Study site name
text
C2825164 (UMLS CUI [1])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Line
Item
Line Number
integer
C0750480 (UMLS CUI [1])
Generic Name of AED
Item
Generic Name of AED
text
C0003299 (UMLS CUI [1,1])
C0592502 (UMLS CUI [1,2])
C0592502 (UMLS CUI [1,2])
Line on AED Log
Item
Number of line on AED Log
integer
C0750480 (UMLS CUI [1])
Date and Time
Item
Date and Time of Blood Draw (mm/dd/yyyy hh:mm)
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Amount of Last Dose
Item
Amount of Last Dose Before Blood Draw (Specify Units)
integer
C0178602 (UMLS CUI [1])
Units used
Item
Please specify unit of medication dosage
text
C1519795 (UMLS CUI [1])
Date and Time of Last Dose Before Blood Draw
Item
Date and Time of Last Dose Before Blood Draw
datetime
C0945146 (UMLS CUI [1])
Plasma Concentration
Item
Plasma Concentration Result
float
C0683150 (UMLS CUI [1])
Plasma concentration
Item
Plasma concentration please specify unit
text
C0683150 (UMLS CUI [1])
Plasma concentration
Item
Plasma concentration:Not Done
boolean
C0683150 (UMLS CUI [1])
Non Adherence
Item
Clinically Significant Non Adherence Expected/ Confirmed?
boolean
C0376405 (UMLS CUI [1])
Further comments
Item
Further comments
text
C1830770 (UMLS CUI [1])
Line
Item
Line number
integer
C0750480 (UMLS CUI [1])
Antiepileptic drug
Item
Antiepileptic drug name
text
C0003299 (UMLS CUI [1])
Antiepileptic drug
Item
Antiepileptic drug formulation known?
boolean
C0003299 (UMLS CUI [1,1])
C1705957 (UMLS CUI [1,2])
C1705957 (UMLS CUI [1,2])
Antiepileptic drug
Item
Antiepileptic drug: if formulation is known, please specify
text
C0003299 (UMLS CUI [1,1])
C1705957 (UMLS CUI [1,2])
C1705957 (UMLS CUI [1,2])
Antiepileptic drug schedule
Item
AED Schedule Known?
boolean
C0003299 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
C0040808 (UMLS CUI [1,2])
Antiepileptic drug schedule
Item
Antiepileptic drug schedule is known, please specify
text
C0003299 (UMLS CUI [1,1])
C0040808 (UMLS CUI [1,2])
C0040808 (UMLS CUI [1,2])
CL Item
Idiosyncratic Side Effect(s), specify (1)
CL Item
Dose Related Side Effect(s), specify (2)
CL Item
Chronic Side Effects (3)
CL Item
Inadequate Seizure Control (4)
CL Item
Other, specify (5)
Reason for discontinuation
Item
Reason for discontinuation: please specify
text
C0457454 (UMLS CUI [1])
Was antiepileptic drug appropriate for the epilepsy syndrome?
Item
Was antiepileptic drug appropriate for the epilepsy syndrome?
boolean
C0003299 (UMLS CUI [1,1])
C3640049 (UMLS CUI [1,2])
C3640049 (UMLS CUI [1,2])
Item
Was 3 months of therapy achieved without discontinuation due to adverse events?
integer
C0580352 (UMLS CUI [1])
Code List
Was 3 months of therapy achieved without discontinuation due to adverse events?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Were attempts made to adjust dose? (not titration)
integer
C1299575 (UMLS CUI [1])
Code List
Were attempts made to adjust dose? (not titration)
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Seizures
Item
Did the subject continue to have seizures on this AED despite dose adjustment?
boolean
C0036572 (UMLS CUI [1])
Answers known
Item
Are the answers to all the previous questions known?
boolean
C1822117 (UMLS CUI [1])
Positive
Item
Are the answers to all the previous questions “Yes”?
boolean
C1446409 (UMLS CUI [1])
Non-study antiepileptic drugs
Item
Did the subject take any non-study antiepileptic drugs during the study?
boolean
C0003299 (UMLS CUI [1])
Antiepileptic Drug
Item
Name of Antiepileptic Drug
text
C0003299 (UMLS CUI [1,1])
C0592503 (UMLS CUI [1,2])
C0592503 (UMLS CUI [1,2])
Item
Generic or Brand used?
integer
C0085155 (UMLS CUI [1,1])
C0590772 (UMLS CUI [1,2])
C0590772 (UMLS CUI [1,2])
CL Item
Generic (1)
CL Item
Brand (2)
CL Item
Unknown (3)
Formulation
Item
Formulation
text
C1705957 (UMLS CUI [1])
Dosing Schedule -Times of Administration
Item
Dosing Schedule -Times of Administration
time
C0040808 (UMLS CUI [1])
Dosing Schedule -Times of Administration
Item
Dosing Schedule -Times of Administration: N/A - taken PRN
boolean
C0040808 (UMLS CUI [1])
Dosing Schedule -Times of Administration
Item
Dosing Schedule -Times of Administration: Average frequency = times per month
integer
C0040808 (UMLS CUI [1])
Medication Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
CL Item
gram (g )
CL Item
grain (gr )
CL Item
drop (gtt )
CL Item
microgram (mcg )
CL Item
microliter (mcL )
CL Item
milligram (mg )
CL Item
milliliter (mL )
CL Item
ounce (oz )
CL Item
spray/squirt (SPY )
CL Item
suppository (supp )
CL Item
tablespoon (TBSP )
CL Item
teaspoon (Sp )
CL Item
other, specify (OTH )
CL Item
Unknown (UNK)
Route of administration
Item
Route of administration
text
C0013153 (UMLS CUI [1])
Treatment Start Date
Item
Start Date
date
C3173309 (UMLS CUI [1])
Treatment End Date
Item
End Date
date
C1531784 (UMLS CUI [1])
ongoing
Item
ongoing
boolean
C0549178 (UMLS CUI [1])
Item
If Applicable, Reason for Discontinuation
integer
C0457454 (UMLS CUI [1])
CL Item
Idiosyncratic Side Effect(s), specify (1)
CL Item
Dose Related Side Effect(s), specify (2)
CL Item
Chronic Side Effects (3)
CL Item
Inadequate Seizure Control (4)
CL Item
Other, specify (5)
Reason for Discontinuation
Item
Reason for Discontinuation:please specify
text
C0457454 (UMLS CUI [1])
Further comments
Item
Further comments
text
C1830770 (UMLS CUI [1])
Concomitant medication
Item
Did the participant/subject take any medications days before or during the study?
boolean
C2347852 (UMLS CUI [1])
Line
Item
Line number
integer
C0750480 (UMLS CUI [1])
Generic Name
Item
Generic Name of Medication
text
C0592502 (UMLS CUI [1])
Dose Frequency
Item
Dose Frequency
text
C2826654 (UMLS CUI [1])
Dose frequency
Item
Dose frequency N/A-taken PRN
boolean
C2826654 (UMLS CUI [1])
Dose frequency
Item
Dose frequency Average frequency= times per month
integer
C2826654 (UMLS CUI [1])
Total Daily Dose or PRN Dose
Item
Total Daily Dose or PRN Dose
integer
C2348070 (UMLS CUI [1])
C0558288 (UMLS CUI [2])
C0558288 (UMLS CUI [2])
CL Item
gram (g )
CL Item
grain (gr )
CL Item
drop (gtt )
CL Item
microgram (mcg )
CL Item
microliter (mcL )
CL Item
milligram (mg )
CL Item
milliliter (mL )
CL Item
ounce (oz )
CL Item
spray/squirt (SPY )
CL Item
suppository (supp )
CL Item
tablespoon (TBSP )
CL Item
teaspoon (Sp )
CL Item
other, specify (OTH )
CL Item
Unknown (UNK)
unit
Item
Dosage unit: if other please specify
text
C2348328 (UMLS CUI [1])
Concomitant Medication Start Date
Item
Start date
date
C2826734 (UMLS CUI [1])
Concomitant Medication End Date
Item
Concomitant Medication: End Date
date
C2826744 (UMLS CUI [1])
Ongoing
Item
Ongoing
boolean
C0549178 (UMLS CUI [1])
Indication
Item
Indication
text
C2826696 (UMLS CUI [1])