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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: Headache
Sub-Domain: Drugs
CRF: Concomitant Medications
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 participant subject take any medications within days prior study participation or during the study?
Yes;No;
Yes;No;
Alphanumeric
If Yes, please complete below table for each concomitant medication. Including all prescription medications, vitamins, herbal supplements, and over the counter (OTCs).
No references available
Adult;Pediatric
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant use indicator
 
Single Pre-Defined Value Selected
     
2220500
 
C02014
Medication prior or concomitant name
MedctnPriorConcomName
Name of the prior/concomitant agent or drug administered.
Medication Name
  
Alphanumeric
Verbatim name (generic or trade name) of the medication, including vitamins and herbal supplements the participant/subject reports taking.;Verbatim name (generic or trade name) of the rescue medication or treatment the participant/subject has received.
RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/)
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Concomitant 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.
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
3.0
8/28/2013
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant RXNorm code
255
Free-Form Entry
     
3162728
 
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.
Indication
  
Alphanumeric
If given for AE, enter exact term from AE CRF Record the reason the participant/subject gives for taking the medication.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant indication text
4000
Free-Form Entry
     
3158920
 
C02006
Medication prior or concomitant dose
MedctnPriorConcomDose
Dose of prior/concomitant medication taken per administration.
Dose per Administration
  
Numeric Values
Record the strength of the medication the participant/subject is taking.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose
 
Free-Form Entry
     
3162729
 
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 per Administration
  
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
3.0
8/28/2013
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose unit of measure UCUM code
255
Free-Form Entry
       
C02022
Medication prior or concomitant dose unit of measure
MedctnPriorConcomDoseUo
Dosage unit of measure of the prior or concomitant medication administered.
Units of Dose
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 of the medication the participant/subject is taking. The code list displays the most common dose unit options.
Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Concomitant 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. The code list displays the most common dose unit options.
Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/
Adult;Pediatric
Supplemental
2.0
3/13/2018
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
 
4000
Free-Form Entry
     
3162730
 
C02011
Medication prior or concomitant dose frequency
MedctnPriorConcmtntDoseFreq
Frequency of use of a prior/concomitant medication.
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
Record how often the medication is being taken. The code list displays the most common options.
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
Concomitant Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose frequency
 
Single Pre-Defined Value Selected
     
3162733
 
C02015
Medication prior or concomitant route type
MedctnPriorConcomRteTy
Type of access route for the administration of the prior/concomitant medication.
Route
Buccal;Inhaled;Intramuscular;Intravenous;Nasal;Oral;Rectal;By ear;Topical;Subcutaneous;Sublingual;Transdermal;Unknown;Other, specify;
Buccal;Inhaled;Intramuscular;Intravenous;Nasal;Oral;Rectal;By Ear;Topical;Subcutaneous;Sublingual;Transdermal;Unknown;Other, specify;
Alphanumeric
Record the route of administration. The code list displays the most common options.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant route type
 
Single Pre-Defined Value Selected
     
3162743
 
C18737
Medication prior or concomitant route other text
MedctnPriorConcomRteOTH
The free-text field related to 'Medication prior or concomitant route type' specifying other text. Type of access route for the administration of the prior/concomitant medication.
Other, specify
  
Alphanumeric
Record the route of administration. The code list displays the most common options.
No references available
Adult;Pediatric
Supplemental
1.0
5/27/2014
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
 
4000
Free-Form Entry
     
3162743
 
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
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). 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.).
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant start date and time
 
Free-Form Entry
     
3162752
 
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
Record the day, month, and year the participant/subject stopped taking the medication. Stop Date should be recorded if Ongoing? is answered No. Conversely, Stop Date should remain blank if Ongoing? is answered Yes. This field should be completed to the best of the Investigator’s knowledge.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant end date and time
 
Free-Form Entry
     
3162753
 
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
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
Concomitant Medications
Drugs
Treatment/Intervention Data
Medication prior or concomitant ongoing indicator
 
Single Pre-Defined Value Selected
     
2321822
 
07-22-2019
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