CDE Detailed Report

Disease: Parkinson's Disease
Sub-Domain: Drugs
CRF: Non-Parkinson's Disease Medication Log

Displaying 1 - 16 of 16
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 / 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
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

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

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Non-Parkinson's Disease 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 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 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data 255

Free-Form Entry

3162728
C08216 Medication prior total daily as needed dose measure MedctnPrrTotDalyPRNDosMeasr Total daily dose or PRN (as needed) dose of the non-Parkinson's disease (PD) medication taken by the participant/subject Total daily dose or PRN (as needed) dose of the prior or concomitant medication taken by the participant/subject Total Daily Dose or PRN Dose (with units) Numeric Values

Record the total strength of the medication the participant/subject is taking or was taking on a daily basis or on an as needed basis.

RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data

Free-Form Entry

3162729
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 subject take any medications days before or during the study? Yes;No;Unknown Yes;No;Unknown Alphanumeric

If YES is answered then at least one medication should be recorded.

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 16:57:17.79 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

2220500
C08217 Medication prior taken as needed indicator MedctnPrrTknPRNInd Indicator of whether the medication is being taken PRN (as needed) Indicator of whether the medication is being taken PRN (as needed) PRN Med? Yes;No;Unknown Yes;No;Unknown Alphanumeric

No should be answered for chronic medications that are taken on a regular basis

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

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. Medication Use 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.

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

2321822
C17402 Site name SiteName The name of the site for the study The name of the site for the study Site Name Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data 255

Free-Form Entry

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 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 Continuing Medication is answered No. Conversely, Stop Date should remain blank if Continuing Medication is answered Yes.

ISO 8601 - http://www.iso.org/iso/iso_catalogue.htm Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data

Free-Form Entry

3162753
C18035 Medication prior name MedctnPrrNm Name of the prior/concomitant agent or drug administered Name of the prior/concomitant agent or drug administered Medication Name Alphanumeric RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) Adult Supplemental 3.00 2013-07-20 10:46:24.96 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data 255

Free-Form Entry

3162728
C02011 Medication prior or concomitant dose frequency MedctnPriorConcmtntDoseFreq Frequency of use of a prior/concomitant medication. Frequency of use of a prior/concomitant medication. If PRN, Average Frequency (with units e.g., times per month) 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

Only answer if the medication is taken PRN.

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 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

3162733
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 for the dosage of medication the participant/subject is taking.

Unified Code for Units of Measure (UCUM): http://unitsofmeasure.org/ Adult;Pediatric Supplemental 2.00 2018-03-13 16:27:22.0 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data 4000

Free-Form Entry

3162730
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). 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 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data 255

Free-Form Entry

C19247 Subject ID SubIDNam Subject identification ID Subject identification ID SubjectID Alphanumeric No references available Adult Supplemental 1.00 2014-06-05 13:10:49.0 Non-Parkinson's Disease Medication Log 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 (Trade or generic name) Alphanumeric

Record the verbatim name (generic or trade name) of the medication the participant/subject reports taking.

RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/) Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data 4000

Free-Form Entry

3162728
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 (and time) the participant/subject started 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. Start Date can be used to distinguish between prior medications and concomitant medications.

ISO 8601 - http://www.iso.org/iso/iso_catalogue.htm Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Non-Parkinson's Disease Medication Log 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. Unit of Measure 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 for the dosage of medication the participant/subject is taking.

Unified Code for Units of Measure (UCUM): http://unitsofmeasure.org/ Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

3162730
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