CDE Detailed Report
Subdomain Name: Drugs
CRF: Non Anti Epileptic Medication Log
Displaying 1 - 15 of 15
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C02016 | Medication prior or concomitant start date and time | MedctnPriorOrConcmStrtDateTime | 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 | 3.10 | 2022-08-02 16:58:56.0 | Non Anti Epileptic Medication Log | Drugs | Treatment/Intervention Data |
Free-Form Entry |
3162752 | |||||||||
| C02022 | Medication prior or concomitant dose unit of measure | MedctnPriorOrConcomDoseUOM | 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 observacation 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 | 3.10 | 2022-08-02 14:36:00.0 | Non Anti Epileptic Medication Log | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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/subjec | Indication | 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 | Non Anti Epileptic Medication Log | Drugs | Treatment/Intervention Data | 4000 |
Free-Form Entry |
3158920 | ||||||||
| 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 administere | Generic Name of Medication | 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 | Non Anti Epileptic Medication Log | Drugs | Treatment/Intervention Data | 255 |
Free-Form Entry |
3162728 | ||||||||
| 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 participant/subject take any medications _ days before or 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 | Non Anti Epileptic Medication Log | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
2220500 | |||||||
| 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 |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Non Anti Epileptic Medication Log | Drugs | Treatment/Intervention Data |
Free-Form Entry |
1 | 99 | ||||||||
| 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 ongoin | N/A - Ongoing? | Yes;No;Unknown | Yes;No;Unknown | 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 |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Non Anti Epileptic Medication Log | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
2321822 | |||||||
| C18552 | Medication non-anti-epileptic drug log line number | MedctnNAEDLogLineNum | The referenced line number of an entry on the non-anti-epileptic drug (NAED) plasma concentration log | The referenced line number of an entry on the non-anti-epileptic drug (NAED) plasma concentration lo | Line number | Numeric Values | No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-30 14:29:49.047 | Non Anti Epileptic Medication Log | Drugs | Treatment/Intervention Data |
Free-Form Entry |
0 | 20 | |||||||||
| C02006 | Medication prior or concomitant dose | MedctnPriorOrConcomDose | Dose of prior/concomitant medication taken per administration | Dose of prior/concomitant medication taken per administration | Total Daily Dose or PRN 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 | 3.10 | 2022-08-02 14:33:32.0 | Non Anti Epileptic Medication Log | Drugs | Treatment/Intervention Data |
Free-Form Entry |
3162729 | |||||||||
| C18553 | Medication non-anti-epileptic drug prior or concomitant use day count | MedNAEDPriorOrConcomUseDayCt | The numeric count of days a non-anti-epileptic drug (NAED) was taken before or during a study | The numeric count of days a non-anti-epileptic drug (NAED) was taken before or during a stud | Number of days before or during the study | Numeric Values | No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-30 14:29:49.047 | Non Anti Epileptic Medication Log | Drugs | Treatment/Intervention Data |
Free-Form Entry |
0 | 200 | day | ||||||||
| C02008 | Medication prior or concomitant end date and time | MedctnPriorOrConcomEndDateTime | 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. 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.) and in the format acceptable to the study database. 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 |
No references available | Adult;Pediatric | Supplemental | 3.10 | 2022-08-02 16:59:51.0 | Non Anti Epileptic Medication Log | Drugs | Treatment/Intervention Data |
Free-Form Entry |
3162753 | |||||||||
| C18736 | Medication prior or concomitant dose unit of measure other text | MedctnPriorOrConcomDoseUoMOTH | 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 administere | Other, specify | Alphanumeric |
Record the unit for dose of AED the participant/subject was prescribed to take. Core for all prospective intervention and observacation 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 | 2.10 | 2022-08-02 14:27:44.0 | Non Anti Epileptic Medication Log | Drugs | Treatment/Intervention Data | 4000 |
Free-Form Entry |
3162730 | ||||||||
| C02011 | Medication prior or concomitant dose frequency | MedctnPriorConcmtntDoseFreq | Frequency of use of a prior/concomitant medication | Frequency of use of a prior/concomitant medicatio | Dose Frequency | BID;TID;QID;q2h;q4h;q6h;q8h;QAM;QPM;QD;alt. d.;HS;PRN;OTH;UNK;NA | twice a day;three times a day;four times a day;every 2 hours;every 4 hours;every 6 hours;every 8 hours;every morning;every evening;one a day;every other day (on alternate days);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 | Non Anti Epileptic Medication Log | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
3162733 | |||||||
| C02013 | Medication prior or concomitant dose unit of measure UCUM code | MedctnPriorOrConDseUOMUCUMCode | 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 | 3.10 | 2022-08-02 14:42:09.0 | Non Anti Epileptic Medication Log | Drugs | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C02014 | Medication prior or concomitant name | MedctnPriorConcomName | Name of the prior/concomitant agent or drug administered | Name of the prior/concomitant agent or drug administere | Generic Name of Medication | 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 | Non Anti Epileptic Medication Log | Drugs | Treatment/Intervention Data | 4000 |
Free-Form Entry |
3162728 |
