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CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease: Parkinson's Disease
Sub-Domain: Drugs
CRF: Parkinson's Disease Medication Log
Item count: 14 (14 distinct CDEs)
CDE ID
CDE Name
Variable Name
Definition / Description
Question Text
Permissible Value
Description
Data Type
Instructions
References
Population
Classification (e.g., Core)
Version #
Version Date
Aliases for Variable Name
CRF Module / Guideline
© or TM
Sub-Domain
Domain
Previous Title
Size
Input Restrictions
Min Value
Max Value
Measurement Type
LOINC ID
SNOMED
caDSR ID
CDISC ID
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
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
3.0
7/22/2013
Aliases for variable name not defined
Parkinson's Disease Medication Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant use indicator
 
Single Pre-Defined Value Selected
     
2220500
 
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
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
3.0
7/22/2013
Aliases for variable name not defined
Parkinson's Disease Medication Log
Drugs
Treatment/Intervention Data
Medication anti-Parkinsonian prior or concomitant drug class name
255
Free-Form Entry
       
C02014
Medication prior or concomitant name
MedctnPriorConcomName
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
3.0
8/28/2013
Aliases for variable name not defined
Parkinson's Disease Medication Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant name
4000
Free-Form Entry
     
3162728
 
C02025
Medication prior or concomitant RXNorm code
MedctnPriorConcomRxNormCode
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
3.0
8/28/2013
Aliases for variable name not defined
Parkinson's Disease Medication Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant RXNorm code
255
Free-Form Entry
     
3162728
 
C08219
Parkinson's Disease medication maximum dose
PDMedMaxDose
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
3.0
7/22/2013
Aliases for variable name not defined
Parkinson's Disease Medication Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant maximum dose
 
Free-Form Entry
     
3162729
 
C02022
Medication prior or concomitant dose unit of measure
MedctnPriorConcomDoseUo
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
3.0
8/28/2013
Aliases for variable name not defined
Parkinson's Disease Medication Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose unit of measure
 
Single Pre-Defined Value Selected
     
3162730
 
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.
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
2.0
3/13/2018
Aliases for variable name not defined
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
MedctnPriorConcomDoseUOMUCUMCd
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
No instructions available
Unified Code for Units of Measure (UCUM): http://unitsofmeasure.org/
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Parkinson's Disease Medication Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose unit of measure UCUM code
255
Free-Form Entry
       
C08221
Parkinson's Disease medication exposure duration
PDMedExposDur
Estimated total duration of exposure to the prior or concomitant medication
Estimated Total Duration of Exposure
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Parkinson's Disease Medication Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant exposure duration
 
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
Days;Weeks;Months;years;
Days;Weeks;Months;years;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Parkinson's Disease Medication Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant exposure duration unit of measure
 
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.
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
3.0
8/28/2013
Aliases for variable name not defined
Parkinson's Disease Medication Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant ongoing indicator
 
Single Pre-Defined Value Selected
     
2321822
 
C08223
Medication prior or concomitant discontinuation reason
MedPriorConcDiscontRsn
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 instructions available
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Parkinson's Disease Medication Log
Drugs
Treatment/Intervention Data
Medication prior or concomitant discontinuation reason
 
Multiple Pre-Defined Values Selected
       
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
Other, specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
5/27/2014
Aliases for variable name not defined
Parkinson's Disease Medication Log
Drugs
Treatment/Intervention Data
 
4000
Free-Form Entry
       
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
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
3.0
7/22/2013
Aliases for variable name not defined
Parkinson's Disease Medication Log
Drugs
Treatment/Intervention Data
Medication Parkinsonian prior or concomitant side effect type
255
Free-Form Entry
       
07-20-2019
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