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CDE Detailed Report
This report contains detailed information about the selected CDEs.
Disease: Headache
CRF: Concomitant Medications
Item count: 14 (14 distinct CDEs)
CDE ID
CDE Name
Definition / Description
Code List / Permissible Values
Definitions for Codes / Permissible Values
Data Type
Instructions
Additional Notes
References
Classification (e.g., Core)
Version #
Version Date
Variable Name
Aliases for Variable Name
CRF Module / Guideline
Sub-Domain
Domain
C02002
Medication prior or concomitant use indicator
Indicator of whether the participant/subject reported taking any medications during the time period relevant to the study protocol
  
Alphanumeric
If Yes, please complete below table for each concomitant medication. Including all prescription medications, vitamins, herbal supplements, and over the counter (OTCs).
Did the participant subject take any medications within days prior study participation or during the study?
No references available
Supplemental
3.0
7/22/2013
MedctnPriorConcomUseInd
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
C02014
Medication prior or concomitant name
Name of the prior/concomitant agent or drug administered.
  
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.
Medication Name
RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/)
Supplemental
3.0
8/28/2013
MedctnPriorConcomName
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
C02025
Medication prior or concomitant RXNorm code
Code for name of the prior/concomitant agent or drug administered.
  
Alphanumeric
Code the verbatim name (generic or trade name) of the medication using RXNorm.
Medication Name
RXNorm (http://www.nlm.nih.gov/research/umls/rxnorm/)
Supplemental
3.0
8/28/2013
MedctnPriorConcomRxNormCode
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
C02024
Medication prior or concomitant indication text
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.
  
Alphanumeric
If given for AE, enter exact term from AE CRF Record the reason the participant/subject gives for taking the medication.
Indication
No references available
Supplemental
3.0
8/28/2013
MedctnPriorConcomIndTxt
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
C02006
Medication prior or concomitant dose
Dose of prior/concomitant medication taken per administration.
  
Numeric Values
Record the strength of the medication the participant/subject is taking.
Dose per Administration
No references available
Supplemental
3.0
8/28/2013
MedctnPriorConcomDose
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
C02013
Medication prior or concomitant dose unit of measure UCUM code
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).
Dose per Administration
Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/
Supplemental
3.0
8/28/2013
MedctnPriorConcomDoseUOMUCUMCd
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
C02022
Medication prior or concomitant dose unit of measure
Dosage unit of measure of the prior or concomitant medication administered.
  
Alphanumeric
Record the units of the medication the participant/subject is taking. The code list displays the most common dose unit options.
Units of Dose
Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/
Supplemental
3.0
8/28/2013
MedctnPriorConcomDoseUo
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
C18736
Medication prior or concomitant dose unit of measure other text
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.
  
Alphanumeric
Record the units of the medication the participant/subject is taking. The code list displays the most common dose unit options.
Other, specify
Unified Code for Units of Measure (UCUM) - http://unitsofmeasure.org/
Supplemental
2.0
3/13/2018
MedctnPriorConcomDoseUoMOTH
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
C02011
Medication prior or concomitant dose frequency
Frequency of use of a prior/concomitant medication.
  
Alphanumeric
Record how often the medication is being taken. The code list displays the most common options.
Frequency
CDISC SDTM Frequency Terminology (Code C71113) - http://evs.nci.nih.gov/ftp1/CDISC/SDTM/
Supplemental
3.0
7/24/2013
MedctnPriorConcmtntDoseFreq
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
C02015
Medication prior or concomitant route type
Type of access route for the administration of the prior/concomitant medication.
  
Alphanumeric
Record the route of administration. The code list displays the most common options.
Route
No references available
Supplemental
3.0
8/28/2013
MedctnPriorConcomRteTy
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
C18737
Medication prior or concomitant route other text
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.
  
Alphanumeric
Record the route of administration. The code list displays the most common options.
Other, specify
No references available
Supplemental
1.0
5/27/2014
MedctnPriorConcomRteOTH
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
C02016
Medication prior or concomitant start date and time
The date (and time, if applicable and known) on which the prior/concomitant medication usage began.
  
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.).
Start Date
No references available
Supplemental
3.0
8/28/2013
MedctnPriorConcomStrtDateTime
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
C02008
Medication prior or concomitant end date and time
The date (and time, if applicable and known) the administration of the prior/concomitant medication ended.
  
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.
End Date
No references available
Supplemental
3.0
8/28/2013
MedctnPriorConcomEndDateTime
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
C02003
Medication prior or concomitant ongoing indicator
Indicator of or description that the prior/concomitant medication usage is ongoing.
  
Alphanumeric
Answer Yes if the participant/subject is still taking the medication or No if the participant/subject has stopped taking the medication
Ongoing?
No references available
Supplemental
3.0
8/28/2013
MedctPrConcomOngoingInd
Aliases for variable name not defined
Concomitant Medications
Drugs
Treatment/Intervention Data
06-16-2019
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