CDE Detailed Report

Disease: Epilepsy
Sub-Domain: Drugs
CRF: Anti Epileptic Drug (AED) Log

Displaying 1 - 22 of 22
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C02014 Medication prior or concomitant name MedctnPriorConcomName Name of the prior/concomitant agent or drug administered. 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 3.00 2013-08-28 16:08:00.453 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data 4000

Free-Form Entry

3162728
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 The free-text field to specify the idiosyncratic side effect that resulted in a discontinuation of medication Idiosyncratic Side Effect(s), specify Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data 255

Free-Form Entry

C02015 Medication prior or concomitant route type MedctnPriorConcomRteTy Type of access route for the administration of the prior/concomitant medication. 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 3.00 2013-08-28 16:08:00.453 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

3162743
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. Medication labeled as brand name or generic Generic or Brand Used? Generic;Brand;Unknown Generic;Brand;Unknown Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

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. 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 3.00 2013-08-28 16:08:00.453 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data

Free-Form Entry

3162752
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 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 1.00 2014-05-27 13:34:46.0 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data 4000

Free-Form Entry

C02022 Medication prior or concomitant dose unit of measure MedctnPriorConcomDoseUo Dosage unit of measure of the prior or concomitant medication administered. 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 3.00 2013-08-28 16:08:00.453 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

3162730
C18736 Medication prior or concomitant dose unit of measure other text MedctnPriorConcomDoseUoMOTH 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. 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 2.00 2018-03-13 16:27:22.0 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data 4000

Free-Form Entry

3162730
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. 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 3.00 2013-08-28 16:08:00.453 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data 4000

Free-Form Entry

3158920
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. 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 1.00 2014-05-27 13:34:46.0 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data 4000

Free-Form Entry

3162743
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 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 3.00 2013-07-22 16:57:17.79 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

2220500
C02025 Medication prior or concomitant RXNorm code MedctnPriorConcomRxNormCode Code for name of the prior/concomitant agent or drug administered. 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 3.00 2013-08-28 16:08:00.453 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data 255

Free-Form Entry

3162728
C02003 Medication prior or concomitant ongoing indicator MedctPrConcomOngoingInd Indicator of or description that the prior/concomitant medication usage is ongoing. 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 3.00 2013-08-28 16:08:00.453 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

2321822
C08223 Medication prior or concomitant discontinuation reason MedPriorConcDiscontRsn Reason the participant/subject discontinued taking the prior or concomitant medication Reason the participant/subject discontinued taking the prior or concomitant medication If Applicable, Reason for Discontinuation Other, specify;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 Alphanumeric

Choose all that apply. Core for all prospective intervention and observation studies

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data

Multiple Pre-Defined Values Selected

C02006 Medication prior or concomitant dose MedctnPriorConcomDose Dose of prior/concomitant medication taken per administration. 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 3.00 2013-08-28 16:08:00.453 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data

Free-Form Entry

3162729
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 per month for the non-anti-epileptic drugs (NAED) 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 3.00 2013-08-28 16:08:00.453 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data

Free-Form Entry

1 99
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. 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 3.00 2013-08-28 16:08:00.453 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data

Free-Form Entry

3162753
C14142 Medication prior or concomitant formulation text MedctnPriorConcomFormTxt Text describing the formulation of the prior/concomitant medication, such as extended release, liquid, sprinkle, etc. Text describing the formulation of the prior or concomitant drug or 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 3.00 2013-08-28 16:08:00.453 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data 255

Free-Form Entry

C02011 Medication prior or concomitant dose frequency MedctnPriorConcmtntDoseFreq Frequency of use of a prior/concomitant medication. 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 3.00 2013-07-24 21:00:23.88 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

3162733
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). Identifier that describes the frequency of use of a prior/concomitant medication Dose Frequency N/A - taken PRN N/A - taken PRN Alphanumeric CDISC SDTM Frequency Terminology (Code C71113) - http://evs.nci.nih.gov/ftp1/CDISC/SDTM/ Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

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). 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 3.00 2013-08-28 16:08:00.453 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 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 references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 Anti Epileptic Drug (AED) Log Drugs Treatment/Intervention Data 255

Free-Form Entry

CSV