CDE Detailed Report
Subdomain Name: Drugs
CRF: AED Resistance 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | 3.00 | 2013-08-28 16:08:00.453 | AED Resistance Log | Drugs | Treatment/Intervention Data | 4000 |
Free-Form Entry |
3162728 | |||||||||
| C18544 | Medication anti-epileptic drug formulation indicator | MedctnAEDFormInd | The yes/no indicator for formulation of the prior/concomitant anti-epileptic drug (AED) | The yes/no indicator for formulation of the prior/concomitant anti-epileptic drug (AED | AED Formulation Known? | Yes;No | Yes;No | Alphanumeric | No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-30 14:29:49.047 | AED Resistance Log | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| 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 | 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 | 3.00 | 2013-08-28 16:08:00.453 | AED Resistance Log | Drugs | Treatment/Intervention Data |
Multiple Pre-Defined Values Selected |
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| 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 Resistance Log | Drugs | Treatment/Intervention Data |
Free-Form Entry |
0 | 20 | |||||||||
| 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/concomitant medication, such as extended release, liquid, sprinkle, et | 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 | 3.00 | 2013-08-28 16:08:00.453 | AED Resistance Log | Drugs | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| 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. 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 | 1.00 | 2014-05-27 13:34:46.0 | AED Resistance Log | Drugs | Treatment/Intervention Data | 4000 |
Free-Form Entry |
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| 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 | 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 | 3.00 | 2013-08-28 16:08:00.453 | AED Resistance Log | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| 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 | 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 | 3.00 | 2013-08-28 16:08:00.453 | AED Resistance Log | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| 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 | 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 | 3.00 | 2013-08-28 16:08:00.453 | AED Resistance Log | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| 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 | 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 | 3.00 | 2013-08-28 16:08:00.453 | AED Resistance Log | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C18540 | Medication dosing schedule administration time | MedctnDoseScheduleAdminTime | Medication administration time schedule | 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 | 3.00 | 2013-07-30 14:29:49.047 | AED Resistance Log | Drugs | Treatment/Intervention Data |
Free-Form Entry |
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| C18541 | Medication anti-epileptic drug name | MedctnAEDName | Name of the prior or concomitant anti-epileptic drug (AED) | Name of the prior or concomitant anti-epileptic drug (AED) | Name of AED | Alphanumeric | RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) | Adult;Pediatric | Supplemental | 3.00 | 2013-07-30 14:29:49.047 | AED Resistance Log | Drugs | Treatment/Intervention Data | 255 |
Free-Form Entry |
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| C18542 | Responses all known indicator | ResponsAllKnownInd | The yes/no indicator where all the answers on the form were known | The yes/no indicator where all the answers on the form were know | Are the answers to all the previous questions known? | Yes;No | Yes;No | Alphanumeric |
(check only one) |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-30 14:29:49.047 | AED Resistance Log | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
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| C02011 | Medication prior or concomitant dose frequency | MedctnPriorConcmtntDoseFreq | Frequency of use of a prior/concomitant medication | Frequency of use of a prior/concomitant medicatio | 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 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 | 3.00 | 2013-07-24 21:00:23.88 | AED Resistance Log | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
3162733 | ||||||||
| C18543 | Responses all positive indicator | ResponsAllPositiveInd | The yes/no indicator where all the answers on the form were "Yes" | 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 | 3.00 | 2013-07-30 14:29:49.047 | AED Resistance Log | Drugs | Treatment/Intervention Data |
Single Pre-Defined Value Selected |
