CDE Detailed Report

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

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
C08221 Parkinson's Disease medication exposure duration PDMedExposDur Estimated total duration of exposure to the prior or concomitant medication Estimated total duration of exposure to the prior or concomitant medication Estimated Total Duration of Exposure Numeric Values No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Parkinson's Disease Medication Log Drugs Treatment/Intervention Data

Free-Form Entry

C08222 Parkinson's Disease medication exposure duration unit of measure PDMedExposDurUoM Unit of measure used to record the duration of exposure to the prior or concomitant medication Unit of measure used to record the duration of exposure to the prior or concomitant medication Unit of Measure Days;Weeks;Months;years Days;Weeks;Months;years Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Parkinson's Disease Medication 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 If Applicable, Reason for Discontinuation Lack of efficacy;Side effect;Other, specify;Idiosyncratic Side Effect(s), specify;Dose Related Side Effect(s), specify;Chronic Side Effects;Inadequate Seizure Control;Side effects - chronic;Side effects - dose related, specify;Side effects - idiosyncratic, specify Lack of efficacy;Side effect;Other, specify;Idiosyncratic Side Effect(s), specify;Dose Related Side Effect(s), specify;Chronic Side Effects;Inadequate Seizure Control;Side effects - chronic;Side effects - dose related, specify;Side effects - idiosyncratic, specify Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Parkinson's Disease Medication Log Drugs Treatment/Intervention Data

Multiple Pre-Defined Values 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 ever take any non-study PD medications? Yes;No;Unknown Yes;No;Unknown Alphanumeric

If "Yes", follow instructions below: Please record all PD medications the subject has ever taken (including PD medications the subject has taken while participating in the study). Enter each dose change on a new line. All other medications (i.e., non-PD medications) should be recorded on the Non-PD Medications Log.

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

Single Pre-Defined Value Selected

2220500
C08224 Parkinson's Disease medication side effect text PDMedSidEffctTxt Type(s) of side effect experienced by participant/subject from the prior or concomitant anti-Parkinson's Disease medication Type(s) of side effect experienced by participant/subject from the prior or concomitant anti-Parkinson's Disease medication Side Effects Alphanumeric

Please refer to the Common Side Effects chart for the codes of the possible side effects experienced from PD medications. Only capture the side effects code on this form. Specifics of the side effect (i.e., Severity, Relatedness, Outcome, etc) should be recorded on the General Adverse Events form if they occur during the study. Common Side Effects Chart:AA=Motor offs (including wearing off and sudden off); BB=Dyskinesia;CC=Hallucination/psychosis; DD=Cognitive impairment – not dementia; EE=Non-motor offs, specify; FF=Behavioral disturbances, specify; GG=Autonomic dysfunction; HH=Daytime sleep abnormalities;II= Nighttime sleep abnormalities; JJ=ICD (including Gambling, Hypersexuality, Binge eating, Shopping);KK=Punding;LL=Dopadysregulation syndrome;MM=Dopamine agonist withdrawal;OT=Other important side effects, specify

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

Single Pre-Defined Value Selected

2321822
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 No references available Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Parkinson's Disease Medication Log Drugs Treatment/Intervention Data 4000

Free-Form Entry

C02013 Medication prior or concomitant dose unit of measure UCUM code MedctnPriorConcomDoseUOMUCUMCd 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). UCUM code Alphanumeric Unified Code for Units of Measure (UCUM): http://unitsofmeasure.org/ Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Parkinson's Disease Medication Log Drugs Treatment/Intervention Data 255

Free-Form Entry

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 Parkinson's Disease Medication Log Drugs Treatment/Intervention Data 4000

Free-Form Entry

3162730
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) Alphanumeric

Please refer to the following PD Medication Name Reference: 1 Alpha-Dihydroergocryptine; Budipine; L-Dopa Methylester; Lisuride; Pramipexole; Selegiine standard oral;Amantadine; Cabergoline; L-Dopa Slow Release; Mematine; Rasagiline; Selegiline patch;Apomorphine; Entacapone; L-Dopa Soluble; Pergolide; Ropinirole; Selegiline sublingual;Bromocriptine; L-Dopa Duel Release; L-Dopa Standard; Piribedil; Rotigotine; Tolcapone

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

Free-Form Entry

3162728
C02022 Medication prior or concomitant dose unit of measure MedctnPriorConcomDoseUo 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 Parkinson's Disease Medication Log Drugs Treatment/Intervention Data

Single Pre-Defined Value Selected

3162730
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

Please refer to the PD Medication Name Reference Chart. Additionally, please include the genric name or trade name of the medication

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

Free-Form Entry

3162728
C08218 Parkinson's Disease medication class category PDMedClassCat Category of the class of the anti-Parkinson's Disease medication ever taken by the participant/subject Category of the class of the anti-Parkinson's Disease medication ever taken by the participant/subject Medication Class Alphanumeric

Please refer to the following PD Medication Class Reference: Levodopa;Dopamine agonists;MAO-B inhibitors;COMT inhibitors;Antiglutamat agents;Anticholinergics;Other, specify

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Parkinson's Disease Medication Log Drugs Treatment/Intervention Data 255

Free-Form Entry

C08219 Parkinson's Disease medication maximum dose PDMedMaxDose Maximum dose of the anti-Parkinson's Disease medication taken by the participant/subject Maximum dose of the anti-Parkinson's Disease medication taken by the participant/subject Maximum Dose Numeric Values

Record the highest strength of the medication the participant/subject has ever taken.

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

Free-Form Entry

3162729
CSV