CDE Detailed Report

Disease: Epilepsy
Subdomain Name: Drugs
CRF: AED Plasma Concentration

Displaying 1 - 13 of 13
CDE ID CDE Name Variable Name Definition Short Description 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 / Guidance) Subdomain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C14415 Medication plasma concentration last dose unit of measure MedPlasConcnLstDoseUOM Dosage unit of measure for the last dose taken before the blood draw for the plasma concentration measurement Dosage unit of measure for the last dose taken before the blood draw for the plasma concentration measurement Amount of Last Dose Before Blood Draw Alphanumeric

Indicate (specify) units of last dose of drug. Designed to be used in conjunction with the Anti Epileptic Drug Log. 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

Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 AED Plasma Concentration Drugs Treatment/Intervention Data 255

Free-Form Entry

3162730
C14416 Medication plasma concentration blood draw date and time MedPlasConcnBldDrawDateTime Date (and time if applicable and known) when the blood specimen was collected for the drug plasma concentration measurement Date (and time if applicable and known) when the blood specimen was collected for the drug plasma concentration measurement Date and Time of Blood Draw Date or Date & Time

Record the date and time of blood draw. Designed to be used in conjunction with the Anti Epileptic Drug Log. 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 AED Plasma Concentration Drugs Treatment/Intervention Data

Free-Form Entry

C14417 Medication plasma concentration last dose date and time MedPlasmConLstDsDateTime Date (and time if applicable and known) when the last dose was administered before the blood draw for the plasma concentration measurement Date (and time if applicable and known) when the last dose was administered before the blood draw for the plasma concentration measurement Date and Time of Last Dose Before Blood Draw Date or Date & Time

Record the date and time of last dose of drug before blood draw. Designed to be used in conjunction with the Anti Epileptic Drug Log. 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 AED Plasma Concentration Drugs Treatment/Intervention Data

Free-Form Entry

C14418 Medication plasma concentration result MedPlasmaConcnReslt Measurement of the concentration of the drug in the blood plasma Measurement of the concentration of the drug in the blood plasma Plasma Concentration Result Numeric Values

Record the plasma concentration for each blood draw along with the units. (Specify units). Designed to be used in conjunction with the Anti Epileptic Drug Log. 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 AED Plasma Concentration Drugs Treatment/Intervention Data

Free-Form Entry

C14419 Medication plasma concentration result unit of measure MedPlasmaConcnResltUOM Unit of measure used for the drug plasma concentration Unit of measure used for the drug plasma concentration Plasma Concentration Result Alphanumeric

Indicate units of plasma concentration from blood draw. Designed to be used in conjunction with the Anti Epileptic Drug Log.

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 AED Plasma Concentration Drugs Treatment/Intervention Data 255

Free-Form Entry

C14420 Medication plasma concentration last dose unit of measure UCUM code MedPlaConcLstDoseUOMUCUMCod The Unified Code for Units of Measure (UCUM) code that represents the dosage unit of measure for the last dose taken before the blood draw for the plasma concentration measurement UCUM code that represents the dosage unit of measure for the last dose taken before the blood draw for the plasma concentration measurement Amount of Last Dose Before Blood Draw Alphanumeric

Code the unit of measure of the medication dosage using Unified Code for Units of Measure (UCUM).

Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 AED Plasma Concentration Drugs Treatment/Intervention Data 255

Free-Form Entry

C14421 Medication plasma concentration no adherence clinically significant indicator MedPlasmConcNoAdherClinSignInd Whether the clinician expects or is able to confirm clinically significant non adherence to the prescribed drug dosing regimen based on the drug plasma concentration results Whether the clinician expects or is able to confirm clinically significant non adherence to the prescribed drug dosing regimen based on the drug plasma concentration results Clinically Significant Non Adherence Expected/Confirmed? No No Alphanumeric

Choose only one. Designed to be used in conjunction with the Anti Epileptic Drug Log

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 AED Plasma Concentration Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

C14628 Medication plasma concentration result unit of measure UCUM code MedPlasmaConcnResltUOMUCUMCode The Unified Code for Units of Measure (UCUM) code that represents the unit of measure for the drug plasma concentration measurement UCUM code that represents the unit of measure for the drug plasma concentration measurement Plasma Concentration Result Alphanumeric

Code the unit of measure of the medication dosage using Unified Code for Units of Measure (UCUM).

Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 AED Plasma Concentration Drugs Treatment/Intervention Data 255

Free-Form Entry

C18545 Medication anti-epileptic drug log line number MedctnAEDLogLineNum The referenced line number of an entry on the anti-epileptic drug (AED) log The referenced line number of an entry on the anti-epileptic drug (AED) lo Line number Numeric Values No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 AED Plasma Concentration Drugs Treatment/Intervention Data

Free-Form Entry

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C14413 Medication plasma concentration medication name MedPlasmaConcnMedctnName Generic or brand name of the medication for which the plasma concentration is measured Generic or brand name of the medication for which the plasma concentration is measured Generic Name of AED Alphanumeric

Record the generic name of the Anti Epileptic Drug administered. Designed to be used in conjunction with the Anti Epileptic Drug Log

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 AED Plasma Concentration Drugs Treatment/Intervention Data 255

Free-Form Entry

C18547 Medication anti-epileptic drug plasma concentration log comment text MedAEDPlasmConcLogCommTxt The free-text field to specify comments regarding the anti-epileptic drug (AED) plasma concentration log The free-text field to specify comments regarding the anti-epileptic drug (AED) plasma concentration lo Comments Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 AED Plasma Concentration Drugs Treatment/Intervention Data 255

Free-Form Entry

C14414 Medication plasma concentration last dose value MedPlasmaConcnLstDoseVal Amount of last dose taken before the blood draw for the plasma concentration measurement Amount of last dose taken before the blood draw for the plasma concentration measurement Amount of Last Dose Before Blood Draw Numeric Values

Record the dose amount of drug given before blood draw. (Specify units). Designed to be used in conjunction with the Anti Epileptic Drug Log.

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 AED Plasma Concentration Drugs Treatment/Intervention Data

Free-Form Entry

C18548 Medication anti-epileptic drug plasma concentration log line number MedAEDPlasmaConcnLogLineNum The reference line number of an entry on the anti-epileptic drug (AED) plasma concentration log The reference line number of an entry on the anti-epileptic drug (AED) plasma concentration lo Line number Numeric Values No references available Adult;Pediatric Supplemental 3.00 2013-07-30 14:29:49.047 AED Plasma Concentration Drugs Treatment/Intervention Data

Free-Form Entry

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CSV