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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:
Sub-Domain: Drugs
CRF: Prior and Current Medications
Item count: 19 (19 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
C12691
Medication prior or concomitant response text
MedctnPriorConcmtntRespnsTxt
Description of the response to the medication
Response?
  
Alphanumeric
Record the response to each treatment. If no response, record none
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Prior and Current Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant response text
255
Free-Form Entry
       
C18301
Steroid treatment Duchenne or Becker Muscular Dystrophy indicator
StrdTreatmntDMDBMDInd
Indicator for whether the participant/subject has ever taken steroids for the treatment of Duchenne (DMD) or Becker (BMD) Muscular Dystrophy
Has the participant/subject ever taken steroids for the treatment of the Duchenne or Becker Muscular Dystrophy?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Yes (Complete Table #1 - add additional lines as needed. Use a separate line when the dose or frequency of a treatment has changed.). No (Do not complete Table #1, Skip to Question #2)
No references available
Adult;Pediatric
Supplemental
3.0
7/21/2013
Aliases for variable name not defined
Prior and Current Medications
Drugs
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
C02014
Medication prior or concomitant name
MedctnPriorConcomName
Name of the prior/concomitant agent or drug administered.
Treatment Name
  
Alphanumeric
Record the verbatim name (generic or trade name) of the medication the participant/subject reports taking. See the data dictionary for additional information on coding the medication name using RXNorm.
RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/)
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Prior and Current Medications
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.
Treatment Name
  
Alphanumeric
Record the verbatim name (generic or trade name) of the medication the participant/subject reports taking. See the data dictionary for additional information on coding the medication name using RXNorm.
RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/)
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Prior and Current Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant RXNorm code
255
Free-Form Entry
     
3162728
 
C18294
Steroid treatment dose
StrdTreatmtDose
Dose of the steroid treatment that the participant/subject is taking per administration
Dose
  
Numeric Values
Record the strength and units of the medication the participant/subject is taking
Supplemental - Highly Recommended
No references available
Adult;Pediatric
Supplemental
3.0
7/21/2013
Aliases for variable name not defined
Prior and Current Medications
Drugs
Treatment/Intervention Data
  
Free-Form Entry
       
C02022
Medication prior or concomitant dose unit of measure
MedctnPriorConcomDoseUo
Dosage unit of measure of the prior or concomitant medication administered.
Dose Units
g;mcg;mcL;mg;mL;oz;Other, specify;Unknown;NA;
gram;microgram;microliter;milligram;milliliter;ounce;Other, specify;Unknown;Not applicable;
Alphanumeric
Supplemental - Highly Recommended
Record the units of the medication the participant/subject is taking. See the data dictionary for additional information on coding the dosage unit of measure using Unified Code for Units of Measure (UCUM).
Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Prior and Current Medications
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 of the medication the participant/subject is taking. See the data dictionary for additional information on coding the dosage unit of measure using Unified Code for Units of Measure (UCUM).
Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/
Adult;Pediatric
Supplemental
2.0
3/13/2018
Aliases for variable name not defined
Prior and Current Medications
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).
Dose Units
  
Alphanumeric
Record the units of the medication the participant/subject is taking. See the data dictionary for additional information on coding the dosage unit of measure using Unified Code for Units of Measure (UCUM).
Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Prior and Current Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose unit of measure UCUM code
255
Free-Form Entry
       
C02011
Medication prior or concomitant dose frequency
MedctnPriorConcmtntDoseFreq
Frequency of use of a prior/concomitant medication.
Dose Frequency
BID;TID;QID;q2h;q4h;q6h;q8h;QAM;QPM;QD;AD;HS;PRN;OTH;UNK;NA;
twice daily;three times a day;four times a day;every 2 hours;every 4 hours;every 6 hours;every 8 hours;one dose in morning;one dose in evening;once daily;alternating day (every other day);at bedtime;as needed;Other, specify;unknown;Not applicable;
Alphanumeric
Supplemental - Highly Recommended
Record how often the medication is being taken. See the data dictionary for additional information on coding the frequency using CDISC SDTM Frequency Terminology.
CDISC SDTM Frequency Terminology (Code C71113) - http://evs.nci.nih.gov/ftp1/CDISC/SDTM/
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Prior and Current Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose frequency
 
Single Pre-Defined Value Selected
     
3162733
 
C17972
Medication prior concomitant dose frequency Clinical Data Interchange Standards Consortium Standard Data Tabulation Model code
MedPriConDoseFreqCDISCSDTMCode
Code that represents the frequency of the dosage of the prior or concomitant medication administered. Clinical Data Interchange Standards Consortium Standard Data Tabulation Model (CDISC SDTM)
Dose Frequency
  
Alphanumeric
Record how often the medication is being taken. See the data dictionary for additional information on coding the frequency using CDISC SDTM Frequency Terminology.
CDISC SDTM Frequency Terminology (Code C71113) - http://evs.nci.nih.gov/ftp1/CDISC/SDTM/
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Prior and Current Medications
Drugs
Treatment/Intervention Data
 
255
Free-Form Entry
       
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.
Start Date
  
Date or Date & Time
Supplemental - Highly Recommended
Record the date (and time if applicable to the study) 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. Studies that need to collect Start Time will need to add fields for time to the form template.
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
8/28/2013
Aliases for variable name not defined
Prior and Current Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant start date and time
 
Free-Form Entry
     
3162752
 
C18290
Steroid treatment start age value
StrdTreatmtStartAgeVal
Age when the steroid treatments began
Age (to the nearest 1/2 year)
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/21/2013
Aliases for variable name not defined
Prior and Current Medications
Drugs
Treatment/Intervention Data
  
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.
End Date
  
Date or Date & Time
Supplemental - Highly Recommended
Record the date (and time if applicable to the study) 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. End Date should be recorded if Continuing Medication is answered NO. Conversely, End Date should remain blank if Continuing Medication is answered YES. Studies that need to collect End Time will need to add fields for time to the form template.
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
8/28/2013
Aliases for variable name not defined
Prior and Current Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant end date and time
 
Free-Form Entry
     
3162753
 
C18291
Steroid treatment stop age value
StrdTreatmtStopAgeVal
Age when the steroid treatments ended
Age (to the nearest 1/2 year)
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/21/2013
Aliases for variable name not defined
Prior and Current Medications
Drugs
Treatment/Intervention Data
  
Free-Form Entry
       
C18307
Steroid treatment stop change reason
StrdTreatmtStopChngRsn
Reason the steroid treatment was stopped or changed
Reason(s) Stopped/Changed
Hypertension;Excessive Weight Gain;Adjustment for growth;Loss of ambulation;Fractures;Behavior Disorder;Growth Failure;Delayed Puberty;
Hypertension;Excessive Weight Gain;Adjustment for growth;Loss of ambulation;Fractures;Behavior Disorder;Growth Failure;Delayed Puberty;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/21/2013
Aliases for variable name not defined
Prior and Current Medications
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.
Ongoing?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one. Answer YES if the participant/subject is still taking the treatment or NO if the participant/subject has stopped taking the treatment.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Prior and Current Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant ongoing indicator
 
Single Pre-Defined Value Selected
     
2321822
 
C18300
Medication supplement use indicator
MedctnSupplUseInd
Indicator of whether the participant/subject has ever taken physician prescribed medications, investigational medications or supplements
Has the participant/ subject ever taken physician prescribed medications, investigational medications, or supplements?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one. If this question is answered YES then at least one prior/current medication record needs to be recorded. Do NOT record study medications taken (if study has a drug intervention) on this form. Refer to the Study Drug Dosing form to record study medications.If Yes, complete Table #2 - add additional lines as needed. Use a separate line when the dose or frequency of a treatment has changed. If No, stop completing the form
No references available
Adult;Pediatric
Supplemental
3.0
7/21/2013
Aliases for variable name not defined
Prior and Current Medications
Drugs
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
C18364
Medication supplement name
MedctnSupplName
Name of the medication or supplement administered
Medication/Supplement Name
  
Alphanumeric
No instructions available
RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/)
Adult;Pediatric
Supplemental
3.0
7/21/2013
Aliases for variable name not defined
Prior and Current Medications
Drugs
Treatment/Intervention Data
 
255
Free-Form Entry
     
3162728
 
C18302
Medication supplement indication text
MedctnSupplementIndTxt
Text describing the indication or reason the participant/subject is taking the medication or supplement
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
3.0
7/21/2013
Aliases for variable name not defined
Prior and Current Medications
Drugs
Treatment/Intervention Data
 
255
Free-Form Entry
       
07-15-2019
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