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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: Anti Epileptic Drug (AED) Log
Item count: 22 (22 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
C02002
Medication prior or concomitant use indicator
MedctnPriorConcomUseInd
Indicator of whether the participant/subject reported taking any medications during the time period relevant to the study protocol
Did the subject take any non-study AEDs during the study?
Yes;No;
Yes;No;
Alphanumeric
Indicate whether the participant/subject took any non-study anti epileptic drugs (AEDs) during the study. Core for all prospective intervention and observation studies
No references available
Adult;Pediatric
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant use indicator
 
Single Pre-Defined Value Selected
     
2220500
 
C02014
Medication prior or concomitant name
MedctnPriorConcomName
Name of the prior/concomitant agent or drug administered.
Name of AED
  
Alphanumeric
Record the generic or brand name of the anti epileptic drug. Core for all prospective intervention and observation studies
RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/)
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant name
4000
Free-Form Entry
     
3162728
 
C02025
Medication prior or concomitant RXNorm code
MedctnPriorConcomRxNormCode
Code for name of the prior/concomitant agent or drug administered.
   
Alphanumeric
Code the verbatim name of the medication using RXNorm. Core for all prospective intervention and observation studies
RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/)
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant RXNorm code
255
Free-Form Entry
     
3162728
 
C18539
Medication generic or brand type
MedctnGenericOrBrandTyp
The identification of the medication label or manufacture as being either a brand name product or generic product.
Generic or Brand Used?
Generic;Brand;Unknown;
Generic;Brand;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
C02024
Medication prior or concomitant indication text
MedctnPriorConcomIndTxt
Text describing reason for administration of a prior/concomitant (nonstudy) agent or measure. This is not the pharmacologic classification of an agent (antibiotic, analgesic, etc.), but the reason for its administration to the participant/subject.
Comments
  
Alphanumeric
Record the reason the participant/subject gives for taking the medication. If given for an Adverse Event (AE), enter exact term from Adverse Event CRF. The indication for the AED medication should be recorded in the database as "epileptic seizure control" to distinguish the AEDs from other prior or concomitant medications taken during the study. The indication does NOT need to be recorded on the CRF. Core for all prospective intervention and observation studies.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant indication text
4000
Free-Form Entry
     
3158920
 
C14142
Medication prior or concomitant formulation text
MedctnPriorConcomFormTxt
Text describing the formulation of the prior/concomitant medication, such as extended release, liquid, sprinkle, etc.
Formulation
  
Alphanumeric
Indicate the type of formulation (e.g., extended release, liquid, sprinkle); (e.g., IR, ER, liquid). Core for all prospective intervention and observation studies
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant formulation text
255
Free-Form Entry
       
C18536
Medication non-anti-epileptic drug prior or concomitant dose frequency
MedNAEDPriorConcomDoseFreq
The frequency of use of a prior/concomitant non-anti-epileptic drug (NAED).
Dose Frequency
N/A - taken PRN;
N/A - taken PRN;
Alphanumeric
No instructions available
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
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
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 frequency based on the dosing schedule recorded on the CRF
CDISC SDTM Frequency Terminology (Code C71113) - http://evs.nci.nih.gov/ftp1/CDISC/SDTM/
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose frequency
 
Single Pre-Defined Value Selected
     
3162733
 
C10636
Medication prior or concomitant PRN average monthly frequency
MedctnPriorConTknPRNAvMnthFreq
Average frequency per month for medications that are taken on an as needed basis (PRN)
Average frequency
  
Numeric Values
Record the average number of times per month the PRN medication is taken. (N/A - taken PRN; times per month). Core for all prospective intervention and observation studies
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant PRN average monthly frequency
 
Free-Form Entry
1
99
     
C02006
Medication prior or concomitant dose
MedctnPriorConcomDose
Dose of prior/concomitant medication taken per administration.
Dose
  
Numeric Values
Record the dose of AED the participant/subject was prescribed to take. Core for all prospective intervention and observation studies. The following abbreviations are recommended to capture dose units: g = gram;gr = grain;gtt = drop;mcg = microgram;mcL = microliter;mg = milligram;mL = milliliter;oz = ounce;SPY = spray/squirt;supp = suppository;TBSP = tablespoon;Sp = teaspoon;OTH = other, specify;UNK= Unknown
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose
 
Free-Form Entry
     
3162729
 
C02022
Medication prior or concomitant dose unit of measure
MedctnPriorConcomDoseUo
Dosage unit of measure of the prior or concomitant medication administered.
Units
g;mcg;mcL;mg;mL;oz;Other, specify;Unknown;NA;
gram;microgram;microliter;milligram;milliliter;ounce;Other, specify;Unknown;Not applicable;
Alphanumeric
Record the unit for dose of AED the participant/subject was prescribed to take. Core for all prospective intervention and observation studies. Examples of dose units include: g = gram; gr = grain; gtt = drop; mcg = microgram; mcL = microliter; mg = milligram; mL = milliliter; oz = ounce; SPY = spray/squirt; supp = suppository; TBSP = Tablespoon; tsp = teaspoon; OTH = other, specify; UNK = unknown
Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose unit of measure
 
Single Pre-Defined Value Selected
     
3162730
 
C18736
Medication prior or concomitant dose other text
MedctnPriorConcomDoseOTH
The free-text field related to 'Medication prior or concomitant dose unit of measure' specifying other text. Dosage unit of measure of the prior or concomitant medication administered.
Other, specify
  
Alphanumeric
Record the unit for dose of AED the participant/subject was prescribed to take. Core for all prospective intervention and observation studies. Examples of dose units include: g = gram; gr = grain; gtt = drop; mcg = microgram; mcL = microliter; mg = milligram; mL = milliliter; oz = ounce; SPY = spray/squirt; supp = suppository; TBSP = Tablespoon; tsp = teaspoon; OTH = other, specify; UNK = unknown
Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/
Adult;Pediatric
Supplemental
1.0
5/27/2014
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
 
4000
Free-Form Entry
     
3162730
 
C02013
Medication prior or concomitant dose unit of measure UCUM code
MedctnPriorConcomDoseUOMUCUMCd
Code that represents the dosage unit of measure of the prior or concomitant medication administered. Unified Code for Units of Measure (UCUM).
   
Alphanumeric
Code the unit of measure of the medication dosage using Unified Code for Units of Measure (UCUM).
Core for all prospective intervention and observation studies
Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose unit of measure UCUM code
255
Free-Form Entry
       
C02015
Medication prior or concomitant route type
MedctnPriorConcomRteTy
Type of access route for the administration of the prior/concomitant medication.
Route
Buccal;Inhaled;Intramuscular;Intravenous;Nasal;Oral;Rectal;By ear;Topical;Subcutaneous;Sublingual;Transdermal;Unknown;Other, specify;
Buccal;Inhaled;Intramuscular;Intravenous;Nasal;Oral;Rectal;By Ear;Topical;Subcutaneous;Sublingual;Transdermal;Unknown;Other, specify;
Alphanumeric
Indicate the route of AED administration. Core for all prospective intervention and observation studies
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant route type
 
Single Pre-Defined Value Selected
     
3162743
 
C18737
Medication prior or concomitant route other text
MedctnPriorConcomRteOTH
The free-text field related to 'Medication prior or concomitant route type' specifying other text. Type of access route for the administration of the prior/concomitant medication.
Other, specify
  
Alphanumeric
Indicate the route of AED administration. Core for all prospective intervention and observation studies
No references available
Adult;Pediatric
Supplemental
1.0
5/27/2014
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
 
4000
Free-Form Entry
     
3162743
 
C02016
Medication prior or concomitant start date and time
MedctnPriorConcomStrtDateTime
The date (and time, if applicable and known) on which the prior/concomitant medication usage began.
Start Date
  
Date or Date & Time
Record the date (and time) the participant/subject started taking the medication. Start Date can be used to distinguish between prior medications and concomitant medications. Core for all prospective intervention and observation studies. 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.).
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant start date and time
 
Free-Form Entry
     
3162752
 
C02008
Medication prior or concomitant end date and time
MedctnPriorConcomEndDateTime
The date (and time, if applicable and known) the administration of the prior/concomitant medication ended.
End Date
  
Date or Date & Time
Record the date (and time) the participant/subject stopped taking the medication. Stop Date should be recorded if Ongoing Medication is answered No. Conversely, Stop Date should remain blank if Ongoing Medication is answered Yes. Core for all prospective intervention and observation studies. 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.).
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant end date and time
 
Free-Form Entry
     
3162753
 
C02003
Medication prior or concomitant ongoing indicator
MedctPrConcomOngoingInd
Indicator of or description that the prior/concomitant medication usage is ongoing.
Ongoing?
Yes;No;
Yes;No;
Alphanumeric
Choose one. Answer YES if the participant/subject is still taking the medication or NO if the participant/subject has stopped taking the medication. Core for all prospective intervention and observation studies. Value shown on CRF only as N/A - Continuing
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant ongoing indicator
 
Single Pre-Defined Value Selected
     
2321822
 
C18538
Medication discontinuation idiosyncratic side effect text
MedctnDiscntIdiosyncSidEffTxt
The free-text field to specify the idiosyncratic side effect that resulted in a discontinuation of medication
Idiosyncratic Side Effect(s), specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
 
255
Free-Form Entry
       
C18537
Medication discontinuation dose related side effect text
MedctnDiscntDoseSideEffTxt
The free-text field to specify the dose-related side effect that resulted in a discontinuation of medication
Dose Related Side Effect(s), specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
 
255
Free-Form Entry
       
C08223
Medication prior or concomitant discontinuation reason
MedPriorConcDiscontRsn
Reason the participant/subject discontinued taking the prior or concomitant medication
If Applicable, Reason for Discontinuation
Idiosyncratic Side Effect(s), specify;Dose Related Side Effect(s), specify;Chronic Side Effects;Inadequate Seizure Control;Other, specify;
Idiosyncratic Side Effect(s), specify;Dose Related Side Effect(s), specify;Chronic Side Effects;Inadequate Seizure Control;Other, specify;
Alphanumeric
Choose all that apply. Core for all prospective intervention and observation studies
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Anti Epileptic Drug (AED) 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. Core for all prospective intervention and observation studies
No references available
Adult;Pediatric
Supplemental
1.0
5/27/2014
Aliases for variable name not defined
Anti Epileptic Drug (AED) Log
Drugs
Treatment/Intervention Data
 
4000
Free-Form Entry
       
11-23-2017
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