ID

14646

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.

Lien

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

Mots-clés

Versions (1)
  1. 2016-04-25 2016-04-25 -
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25 april 2016

DOI

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Licence

Creative Commons BY-NC 3.0
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NINDS CDE Drugs Epilepsy

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Drugs

1 Formulaires  
  1. StudyEvent: ODM
    1. Drugs
Anti Epileptic Drug (AED) Plasma Concentration Log
Description

Anti Epileptic Drug (AED) Plasma Concentration Log

Study ID
Description

Study ID

Type de données

text

Alias
UMLS CUI [1]
C2826693
Study site name
Description

Study site

Type de données

text

Alias
UMLS CUI [1]
C2825164
Subject ID
Description

Subject ID

Type de données

text

Alias
UMLS CUI [1]
C2348585
Line Number
Description

Line

Type de données

integer

Alias
UMLS CUI [1]
C0750480
Generic Name of AED
Description

Generic Name of AED

Type de données

text

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0592502
Number of line on AED Log
Description

Line on AED Log

Type de données

integer

Alias
UMLS CUI [1]
C0750480
Date and Time of Blood Draw (mm/dd/yyyy hh:mm)
Description

Date and Time

Type de données

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
Amount of Last Dose Before Blood Draw (Specify Units)
Description

Amount of Last Dose

Type de données

integer

Alias
UMLS CUI [1]
C0178602
Please specify unit of medication dosage
Description

Units used

Type de données

text

Alias
UMLS CUI [1]
C1519795
Date and Time of Last Dose Before Blood Draw
Description

Date and Time of Last Dose Before Blood Draw

Type de données

datetime

Alias
UMLS CUI [1]
C0945146
Plasma Concentration Result
Description

Plasma Concentration

Type de données

float

Alias
UMLS CUI [1]
C0683150
Plasma concentration please specify unit
Description

Plasma concentration

Type de données

text

Alias
UMLS CUI [1]
C0683150
Plasma concentration:Not Done
Description

Plasma concentration

Type de données

boolean

Alias
UMLS CUI [1]
C0683150
Clinically Significant Non Adherence Expected/ Confirmed?
Description

Non Adherence

Type de données

boolean

Alias
UMLS CUI [1]
C0376405
Further comments
Description

Further comments

Type de données

text

Alias
UMLS CUI [1]
C1830770
Anti Epileptic Drug (AED) Resistance Log
Description

Anti Epileptic Drug (AED) Resistance Log

Line number
Description

Line

Type de données

integer

Alias
UMLS CUI [1]
C0750480
Antiepileptic drug name
Description

Please write in the information below for each AED that was taken by the subject in the past, including current AEDs. This form is intended for chronic AED therapies only. Do not list PRN and rescue medications.

Type de données

text

Alias
UMLS CUI [1]
C0003299
Antiepileptic drug formulation known?
Description

Antiepileptic drug

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C1705957
Antiepileptic drug: if formulation is known, please specify
Description

IR, ER, liquid...

Type de données

text

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C1705957
AED Schedule Known?
Description

(e.g., TID, BID)

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0040808
Antiepileptic drug schedule is known, please specify
Description

(TID; BID...)

Type de données

text

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0040808
Reason for discontinuation known?
Description

Reason for discontinuation

Type de données

integer

Alias
UMLS CUI [1]
C0457454
Reason for discontinuation: please specify
Description

Reason for discontinuation

Type de données

text

Alias
UMLS CUI [1]
C0457454
Was antiepileptic drug appropriate for the epilepsy syndrome?
Description

Was antiepileptic drug appropriate for the epilepsy syndrome?

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C3640049
Was 3 months of therapy achieved without discontinuation due to adverse events?
Description

3 months of therapy achieved without discontinuation

Type de données

integer

Alias
UMLS CUI [1]
C0580352
Were attempts made to adjust dose? (not titration)
Description

Dose adjustment

Type de données

integer

Alias
UMLS CUI [1]
C1299575
Did the subject continue to have seizures on this AED despite dose adjustment?
Description

Seizures

Type de données

boolean

Alias
UMLS CUI [1]
C0036572
Are the answers to all the previous questions known?
Description

Answers known

Type de données

boolean

Alias
UMLS CUI [1]
C1822117
Are the answers to all the previous questions “Yes”?
Description

Positive

Type de données

boolean

Alias
UMLS CUI [1]
C1446409
Anti Epileptic Drug (AED) Log
Description

Anti Epileptic Drug (AED) Log

Did the subject take any non-study antiepileptic drugs during the study?
Description

Please record all non-study AEDs the participant/subject took while participating in the study. Enter each dose change on a new line

Type de données

boolean

Alias
UMLS CUI [1]
C0003299
Name of Antiepileptic Drug
Description

Antiepileptic Drug

Type de données

text

Alias
UMLS CUI [1,1]
C0003299
UMLS CUI [1,2]
C0592503
Generic or Brand used?
Description

Generic or Brand Used?

Type de données

integer

Alias
UMLS CUI [1,1]
C0085155
UMLS CUI [1,2]
C0590772
Formulation
Description

(e.x., extended release, liquid, sprinkle, etc.)

Type de données

text

Alias
UMLS CUI [1]
C1705957
Dosing Schedule -Times of Administration
Description

(00:00-24:00; 99:99=Unknown, 88:88=N/A)

Type de données

time

Alias
UMLS CUI [1]
C0040808
Dosing Schedule -Times of Administration: N/A - taken PRN
Description

Dosing Schedule -Times of Administration

Type de données

boolean

Alias
UMLS CUI [1]
C0040808
Dosing Schedule -Times of Administration: Average frequency = times per month
Description

Dosing Schedule -Times of Administration

Type de données

integer

Alias
UMLS CUI [1]
C0040808
Dose
Description

Medication Dose

Type de données

float

Alias
UMLS CUI [1]
C3174092
Unit of dosage
Description

Unit

Type de données

integer

Alias
UMLS CUI [1]
C2348328
Route of administration
Description

Route of administration

Type de données

text

Alias
UMLS CUI [1]
C0013153
Start Date
Description

Treatment Start Date

Type de données

date

Alias
UMLS CUI [1]
C3173309
End Date
Description

Treatment End Date

Type de données

date

Alias
UMLS CUI [1]
C1531784
ongoing
Description

ongoing

Type de données

boolean

Alias
UMLS CUI [1]
C0549178
If Applicable, Reason for Discontinuation
Description

(Check all that apply)

Type de données

integer

Alias
UMLS CUI [1]
C0457454
Reason for Discontinuation:please specify
Description

Reason for Discontinuation

Type de données

text

Alias
UMLS CUI [1]
C0457454
Further comments
Description

Further comments

Type de données

text

Alias
UMLS CUI [1]
C1830770
Non Anti Epileptic Medication Log
Description

Non Anti Epileptic Medication Log

Did the participant/subject take any medications days before or during the study?
Description

Record all medications the participant/subject was taking at the time of study enrollment (and/or during a protocol-specified period prior to study participation) and all non-study medications the participant/subject took while participating in the study. These can include prescription medications, over the counter drugs, vitamins, supplements, minerals, complementary/alternative medications, etc.

Type de données

boolean

Alias
UMLS CUI [1]
C2347852
Line number
Description

Line

Type de données

integer

Alias
UMLS CUI [1]
C0750480
Generic Name of Medication
Description

Generic Name

Type de données

text

Alias
UMLS CUI [1]
C0592502
Dose Frequency
Description

Dose Frequency

Type de données

text

Alias
UMLS CUI [1]
C2826654
Dose frequency N/A-taken PRN
Description

Dose frequency

Type de données

boolean

Alias
UMLS CUI [1]
C2826654
Dose frequency Average frequency= times per month
Description

Dose frequency

Type de données

integer

Alias
UMLS CUI [1]
C2826654
Total Daily Dose or PRN Dose
Description

Total Daily Dose or PRN Dose

Type de données

integer

Alias
UMLS CUI [1]
C2348070
UMLS CUI [2]
C0558288
Dosage unit
Description

Unit

Type de données

integer

Alias
UMLS CUI [1]
C2348328
Dosage unit: if other please specify
Description

unit

Type de données

text

Alias
UMLS CUI [1]
C2348328
Start date
Description

Concomitant Medication Start Date

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C2826734
dd/mm/yy
Concomitant Medication: End Date
Description

Concomitant Medication End Date

Type de données

date

Alias
UMLS CUI [1]
C2826744
Ongoing
Description

Ongoing

Type de données

boolean

Alias
UMLS CUI [1]
C0549178
Indication
Description

Indication

Type de données

text

Alias
UMLS CUI [1]
C2826696
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Similar models

Drugs

1 Formulaires
  1. StudyEvent: ODM
    1. Drugs
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
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])
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])
Item Group
Anti Epileptic Drug (AED) Resistance Log
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])
Antiepileptic drug
Item
Antiepileptic drug: if formulation is known, please specify
text
C0003299 (UMLS CUI [1,1])
C1705957 (UMLS CUI [1,2])
Antiepileptic drug schedule
Item
AED Schedule Known?
boolean
C0003299 (UMLS CUI [1,1])
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])
Item
Reason for discontinuation known?
integer
C0457454 (UMLS CUI [1])
Reason for discontinuation
Code List
Reason for discontinuation known?
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])
Item
Was 3 months of therapy achieved without discontinuation due to adverse events?
integer
C0580352 (UMLS CUI [1])
3 months of therapy achieved without discontinuation
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])
3 months of therapy achieved without discontinuation
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])
Item Group
Anti Epileptic Drug (AED) Log
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])
Item
Generic or Brand used?
integer
C0085155 (UMLS CUI [1,1])
C0590772 (UMLS CUI [1,2])
Generic or Brand Used?
Code List
Generic or Brand used?
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])
Item
Unit of dosage
integer
C2348328 (UMLS CUI [1])
Unit
Code List
Unit of dosage
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])
Reason for discontinuation
Code List
If Applicable, Reason for Discontinuation
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])
Item Group
Non Anti Epileptic Medication Log
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])
Item
Dosage unit
integer
C2348328 (UMLS CUI [1])
Unit
Code List
Dosage unit
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])
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