CDE Detailed Report

Disease: Headache
Sub-Domain: Drugs
CRF: Concomitant Medications

Displaying 1 - 14 of 14
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
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/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 Concomitant Medications Drugs Treatment/Intervention Data

Free-Form Entry

3162752
C02022 Medication prior or concomitant dose unit of measure MedctnPriorConcomDoseUOM Dosage unit of measure of the prior or concomitant medication administered. Dosage unit of measure of the prior or concomitant medication administered. Units of Dose g;mcg;mcL;mg;mL;oz;Other, specify;Unknown;NA gram;microgram;microliter;milligram;milliliter;ounce;Other, specify;Unknown;Not applicable Alphanumeric

Record the units of the medication the participant/subject is taking. The code list displays the most common dose unit options.

Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Concomitant Medications 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/subject. Indication Alphanumeric

If given for AE, enter exact term from AE CRF Record the reason the participant/subject gives for taking the medication.

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Concomitant Medications Drugs Treatment/Intervention Data 4000

Free-Form Entry

3158920
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 within days prior study participation or during the study? Yes;No Yes;No Alphanumeric

If Yes, please complete below table for each concomitant medication. Including all prescription medications, vitamins, herbal supplements, and over the counter (OTCs).

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 16:57:17.79 Concomitant Medications 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. Medication Name Alphanumeric

Code the verbatim name (generic or trade name) of the medication using RXNorm.

RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Concomitant Medications 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;Unknown Yes;No;Unknown Alphanumeric

Answer Yes if the participant/subject is still taking the medication or No if the participant/subject has stopped taking the medication

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

Single Pre-Defined Value Selected

2321822
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 units of the medication the participant/subject is taking. The code list displays the most common dose unit options.

Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/ Adult;Pediatric Supplemental 2.00 2018-03-13 16:27:22.0 Concomitant Medications Drugs Treatment/Intervention Data 4000

Free-Form Entry

3162730
C02006 Medication prior or concomitant dose MedctnPriorConcomDose Dose of prior/concomitant medication taken per administration. Dose of prior/concomitant medication taken per administration. Dose per Administration Numeric Values

Record the strength of the medication the participant/subject is taking.

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

Free-Form Entry

3162729
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

Record the route of administration. The code list displays the most common options.

No references available Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Concomitant Medications Drugs Treatment/Intervention Data 4000

Free-Form Entry

3162743
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 day, month, and year the participant/subject stopped taking the medication. Stop Date should be recorded if Ongoing? is answered No. Conversely, Stop Date should remain blank if Ongoing? is answered Yes. This field should be completed to the best of the Investigator's knowledge.

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

Free-Form Entry

3162753
C02011 Medication prior or concomitant dose frequency MedctnPriorConcmtntDoseFreq Frequency of use of a prior/concomitant medication. Frequency of use of a prior/concomitant medication. 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 how often the medication is being taken. The code list displays the most common options.

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 Concomitant Medications Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

3162733
C02013 Medication prior or concomitant dose unit of measure UCUM code MedctnPriorConcmDseUOMUCUMCode 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). Dose per Administration 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 Concomitant Medications Drugs Treatment/Intervention Data 255

Free-Form Entry

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. Medication Name Alphanumeric

Verbatim name (generic or trade name) of the medication, including vitamins and herbal supplements the participant/subject reports taking.;Verbatim name (generic or trade name) of the rescue medication or treatment the participant/subject has received.

RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Concomitant Medications Drugs Treatment/Intervention Data 4000

Free-Form Entry

3162728
C02015 Medication prior or concomitant route type MedctnPriorConcomRteTyp 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

Record the route of administration. The code list displays the most common options.

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

Single Pre-Defined Value Selected

3162743
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