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CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease: Epilepsy
Sub-Domain: Drugs
CRF: AED Resistance Log
Item count: 15 (15 distinct CDEs)
CDE ID
CDE Name
Variable Name
Definition / Description
Question Text
Permissible Value
Description
Data Type
Instructions
References
Population
Classification (e.g., Core)
Version #
Version Date
Aliases for Variable Name
CRF Module / Guideline
© or TM
Sub-Domain
Domain
Previous Title
Size
Input Restrictions
Min Value
Max Value
Measurement Type
LOINC ID
SNOMED
caDSR ID
CDISC ID
C02014
Medication prior or concomitant name
MedctnPriorConcomName
Name of the prior/concomitant agent or drug administered.
   
Alphanumeric
Indicate Name of Anti Epileptic Drug
This form is intended for chronic AED therapies only. Do not list PRN and rescue medications.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
AED Resistance Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant name
4000
Free-Form Entry
     
3162728
 
C18545
Medication anti-epileptic drug log line number
MedctnAEDLogLineNum
The referenced line number of an entry on the anti-epileptic drug (AED) log.
Line number
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
AED Resistance Log
Drugs
Treatment/Intervention Data
  
Free-Form Entry
0
20
     
C18541
Medication anti-epileptic drug name
MedctnAEDName
Name of the prior or concomitant anti-epileptic drug (AED)
Name of AED
  
Alphanumeric
No instructions available
RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/)
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
AED Resistance Log
Drugs
Treatment/Intervention Data
 
255
Free-Form Entry
       
C14142
Medication prior or concomitant formulation text
MedctnPriorConcomFormTxt
Text describing the formulation of the prior/concomitant medication, such as extended release, liquid, sprinkle, etc.
AED Formulation Known?
  
Alphanumeric
Record the formulation for the AED (e.g., extended release, liquid, sprinkle); (e.g., IR, ER, liquid). Possible formulations include immediate release (IR), extended release (ER), or liquid. This form is intended for chronic AED therapies only. Do not list PRN and rescue medications.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
AED Resistance Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant formulation text
255
Free-Form Entry
       
C02011
Medication prior or concomitant dose frequency
MedctnPriorConcmtntDoseFreq
Frequency of use of a prior/concomitant medication.
 
BID;TID;QID;q2h;q4h;q6h;q8h;QAM;QPM;QD;AD;HS;PRN;OTH;UNK;NA;
twice daily;three times a day;four times a day;every 2 hours;every 4 hours;every 6 hours;every 8 hours;one dose in morning;one dose in evening;once daily;alternating day (every other day);at bedtime;as needed;Other, specify;unknown;Not applicable;
Alphanumeric
Record the AED schedule/dosing frequency. Possible schedules include 3 times a day (TID), or twice a day (BID).
This form is intended for chronic AED therapies only. Do not list PRN and rescue medications.
CDISC SDTM Frequency Terminology (Code C71113) (http://www.cancer.gov/cancertopics/cancerlibrary/terminologyresources/cdisc) - http://evs.nci.nih.gov/ftp1/CDISC/SDTM/
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
AED Resistance Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose frequency
 
Single Pre-Defined Value Selected
     
3162733
 
C18544
Medication anti-epileptic drug formulation indicator
MedctnAEDFormInd
The yes/no indicator for formulation of the prior/concomitant anti-epileptic drug (AED).
AED Formulation Known?
Yes;No;
Yes;No;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
AED Resistance Log
Drugs
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
C08223
Medication prior or concomitant discontinuation reason
MedPriorConcDiscontRsn
Reason the participant/subject discontinued taking the prior or concomitant medication
Reason for discontinuation known?
Side effects - idiosyncratic, specify;Dose Related Side Effect(s), specify;Lack of efficacy;Side effects - chronic;Other, specify;
Side effects - idiosyncratic, specify;Dose Related Side Effect(s), specify;Lack of efficacy;Side effects - chronic;Other, specify;
Alphanumeric
Choose all that apply. Specify reason for discontinuation, if known. This form is intended for chronic AED therapies only. Do not list PRN and rescue medications.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
AED Resistance Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant discontinuation reason
 
Multiple Pre-Defined Values Selected
       
C18735
Medication prior or concomitant discontinuation other text
MedPriorConcDiscontOTH
The free-text field related to 'Medication prior or concomitant discontinuation reason' specifying other text. Reason the participant/subject discontinued taking the prior or concomitant medication
Other, specify
  
Alphanumeric
Choose all that apply. Specify reason for discontinuation, if known. This form is intended for chronic AED therapies only. Do not list PRN and rescue medications.
No references available
Adult;Pediatric
Supplemental
1.0
5/27/2014
Aliases for variable name not defined
AED Resistance Log
Drugs
Treatment/Intervention Data
 
4000
Free-Form Entry
       
C18540
Medication dosing schedule administration time
MedctnDoseScheduleAdminTime
Medication administration time schedule
Dosing Schedule - Times of Administration
  
Date or Date & Time
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.). (00:00-24:00;99:99=Unknown, 88:88=N/A)
CDISC SDTM Frequency Terminology (Code C71113) - http://evs.nci.nih.gov/ftp1/CDISC/SDTM/
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
AED Resistance Log
Drugs
Treatment/Intervention Data
  
Free-Form Entry
       
C14495
Medication anti-epileptic drug appropriate indicator
MedctnAEDAppropInd
Indicator as to whether the anti-epileptic drug (AED) provided sufficient control for the participant's/subject's epilepsy syndrome
Was AED appropriate for the epilepsy syndrome
Yes;No;
Yes;No;
Alphanumeric
Choose one only. This form is intended for chronic AED therapies only. Do not list PRN and rescue medications.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
AED Resistance Log
Drugs
Treatment/Intervention Data
AED appropriate indicator
 
Single Pre-Defined Value Selected
       
C14496
Medication anti-epileptic drug three months therapy without discontinuation indicator
MedAED3MoTxWoDiscontInd
Indicator as to whether the duration of therapy exceeded 3 months without discontinuation due to adverse events
Was 3 months of therapy achieved without discontinuation due to adverse events
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Indicate whether the duration of therapy is greater than 3 months only if discontinuation did not occur to due adverse events. This form is intended for chronic AED therapies only. Do not list PRN and rescue medications.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
AED Resistance Log
Drugs
Treatment/Intervention Data
AED three months of therapy achieved indicator
 
Single Pre-Defined Value Selected
       
C14497
Medication anti-epileptic drug dose adjustment attempt indicator
MedAEDDoseAdjustmentAttemptInd
Indicator as to whether attempts were made to adjust the dose of the anti-epileptic drug (AED) prior to discontinuation
Were attempts made to adjust dose
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Report only those dose adjustments that are not related to titration This form is intended for chronic AED therapies only. Do not list PRN and rescue medications.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
AED Resistance Log
Drugs
Treatment/Intervention Data
AED dose adjustment attempt indicator
 
Single Pre-Defined Value Selected
       
C14498
Medication anti-epileptic drug seizure despite adjustment indicator
MedAEDSeizDespDoseAdjustInd
Indicator as to whether, after adjusting dose of anti-epileptic drug (AED), the subject continued to experienced seizures
Did the subject continue to have seizures on this AED despite dose adjustment
Yes;No;
Yes;No;
Alphanumeric
Choose one only. This form is intended for chronic AED therapies only. Do not list PRN and rescue medications.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
AED Resistance Log
Drugs
Treatment/Intervention Data
AED seizures persist despite dose adjustment indicator
 
Single Pre-Defined Value Selected
       
C18542
Responses all known indicator
ResponsAllKnownInd
The yes/no indicator where all the answers on the form were known.
Are the answers to all the previous questions known?
Yes;No;
Yes;No;
Alphanumeric
(check only one)
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
AED Resistance Log
Drugs
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
C18543
Responses all positive indicator
ResponsAllPositiveInd
The yes/no indicator where all the answers on the form were "Yes".
Are the answers to all the previous questions “Yes”?
Yes;No;
Yes;No;
Alphanumeric
(check only one)
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
AED Resistance Log
Drugs
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
02-24-2017
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