CDE Detailed Report

Disease: Parkinson's Disease
Subdomain Name: 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 / 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
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 Continuing Medication is answered No. Conversely, Stop Date should remain blank if Continuing Medication is answered Yes.

ISO 8601 - https://www.iso.org/iso-8601-date-and-time-format.html Adult Supplemental 3.10 2022-08-02 16:59:51.0 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data

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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

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).

Unified Code for Units of Measure (UCUM): https://ucum.org/trac Adult Supplemental 3.10 2022-08-02 14:42:09.0 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data 255

Free-Form Entry

C59040 Medication prior use report duration MedctnPriorUseRprtDur Duration in days prior to the study that participant/subject should report taking any medications, specified by the study protocol Duration in days prior to the study that participant/subject should report taking any medications, specified by the study protocol Did the subject take any medications before or during the study? (days) Numeric Values

No instructions available

No references available Adult Supplemental 1.00 2022-07-19 12:44:45.0 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data

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 administere Medication Name (Trade or generic name) Alphanumeric

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

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

Free-Form Entry

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C59041 Medication prior or concomitant as needed dose average frequency MedctnPriorCnmAsNdDoseAvgFreq The frequency of use on average of the prior/concomitant medication taken by the participant/subject on an as needed basis (PRN). The frequency of use on average of the prior/concomitant medication taken by the participant/subject on an as needed basis (PRN). If PRN, Average Frequency (with units e.g., times per month) Numeric Values

Only answer if the medication is taken PRN.

No references available Adult Supplemental 1.00 2022-07-19 13:14:28.0 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data

Free-Form Entry

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. 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 - https://www.iso.org/iso-8601-date-and-time-format.html Adult Supplemental 3.10 2022-08-02 16:58:56.0 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data

Free-Form Entry

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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 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 or was taking.

Unified Code for Units of Measure (UCUM): https://ucum.org/trac Adult Supplemental 3.10 2022-08-02 14:36:00.0 Non-Parkinson's Disease 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 AE, enter exact term from Adverse Event CRF.

No references available Adult Supplemental 3.00 2013-08-28 16:08:00.453 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data 4000

Free-Form Entry

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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 Medication Name Alphanumeric

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

RXNorm (https://www.nlm.nih.gov/research/umls/rxnorm/index.html) Adult Supplemental 3.00 2013-08-28 16:08:00.453 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data 255

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C08216 Medication prior or concomitant total daily as needed dose measurement MedctnPrrCnmTotDalyPRNDosMeasr 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 (https://www.nlm.nih.gov/research/umls/rxnorm/index.html) Adult Supplemental 3.00 2013-07-22 09:34:41.527 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data

Free-Form Entry

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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 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

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 before or during the study? (days) Yes;No;Unknown Yes;No;Unknown Alphanumeric

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

No references available Adult 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
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 Supplemental 3.00 2013-06-21 00:00:00.0 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data 255

Free-Form Entry

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 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 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
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 units for the dosage of medication the participant/subject is taking or was taking.

Unified Code for Units of Measure (UCUM): https://ucum.org/trac Adult Supplemental 2.10 2022-08-02 14:27:44.0 Non-Parkinson's Disease Medication Log Drugs Treatment/Intervention Data 4000

Free-Form Entry

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