CDE Detailed Report

Disease: content
Sub-Domain: Drugs
CRF: welcome

Displaying 1 - 15 of 15
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
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

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 known. 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

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;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

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. 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

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

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) log. 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 or concomitant drug or medication, such as extended release, liquid, sprinkle, etc. 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

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

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

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

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

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

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

CSV