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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: Rescue Treatments
Item count: 15 (15 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
C16211
Headache pain medication after study drug indicator
HdachPainMedctnAftrStdyDrugInd
Indicator whether the subject has received any additional pain or headache medications after the study drug was administered
Did the participant/subject receive any additional pain or headache medication(s) after the study drugs were administered?
Yes;No;Unknown;
Yes;No(STOP);Unknown(STOP);
Alphanumeric
If Yes, complete the rescue medication(s) that the particpant/subject received.
No references available
Adult;Pediatric
Supplemental
3.0
7/16/2013
Aliases for variable name not defined
Rescue Treatments
Drugs
Treatment/Intervention Data
Headache or pain medication administered after study drug indicator
 
Single Pre-Defined Value Selected
       
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
Rescue Treatments
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 rescue 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
Rescue Treatments
Drugs
Treatment/Intervention Data
Medication prior or concomitant RXNorm code
255
Free-Form Entry
     
3162728
 
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.
Time Rescue Drug Adminstered (24 hour clock)
  
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
Rescue Treatments
Drugs
Treatment/Intervention Data
Medication prior or concomitant start date and time
 
Free-Form Entry
     
3162752
 
C05122
Study therapy administered date and time
StdyTherpyAdminstrdDateTime
Date (and time, if applicable and known) the study therapy was administered to the participant/subject
Time Study Drug Administered (24 hour clock)
  
Date or Date & Time
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
STDY_THERAPY_DT
Rescue Treatments
Drugs
Treatment/Intervention Data
Study therapy administered date and time
 
Free-Form Entry
     
3160681
 
C22804
Pain present eleven point intensity scale
PainPrsnt11IntensityScl
Scale for the participant's current pain intensity based on an a scale of 0-10.
Pain Severity (complete one of the following scales)
0;1;2;3;4;5;6;7;8;9;10;
0;1;2;3;4;5;6;7;8;9;10;
Alphanumeric
Complete one of the following scales
No references available
Adult;Pediatric
Supplemental
3.0
7/17/2013
Aliases for variable name not defined
Rescue Treatments
Drugs
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
C56042
Headache severity scale
HeadacheSeverityScale
The scale of the amount of headache the participant/subject is experiencing.
Pain Severity (complete one of the following scales)
Mild;Moderate;Severe;None;
Mild;Moderate;Severe;None;
Alphanumeric
Complete one of the following scales.
No references available
Adult;Pediatric
Supplemental
1.0
6/5/2017
Aliases for variable name not defined
Rescue Treatments
Drugs
Treatment/Intervention Data
  
Single Pre-Defined Value Selected
       
C02006
Medication prior or concomitant dose
MedctnPriorConcomDose
Dose of prior/concomitant medication taken per administration.
Dose
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Rescue Treatments
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).
Unit Administered
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Rescue Treatments
Drugs
Treatment/Intervention Data
Medication prior or concomitant dose unit of measure UCUM code
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.
Other, specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
2.0
3/13/2018
Aliases for variable name not defined
Rescue Treatments
Drugs
Treatment/Intervention Data
 
4000
Free-Form Entry
     
3162730
 
C02015
Medication prior or concomitant route type
MedctnPriorConcomRteTy
Type of access route for the administration of the prior/concomitant medication.
Route of Administration
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
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Rescue Treatments
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
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
5/27/2014
Aliases for variable name not defined
Rescue Treatments
Drugs
Treatment/Intervention Data
 
4000
Free-Form Entry
     
3162743
 
C56039
Headache migraine rescue device used name
HeadMigRescueDeviceUsedName
The name of the rescue device used in the treatment of headache or migraine.
Device Name
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/5/2017
Aliases for variable name not defined
Rescue Treatments
Drugs
Treatment/Intervention Data
 
255
Free-Form Entry
       
C56040
Headache migraine rescue device used start date
HeadMigRescDevUsedStartDate
The start date on which the rescue device was used in the treatment of headache or migraine.
Start Date
  
Date or Date & Time
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/5/2017
Aliases for variable name not defined
Rescue Treatments
Drugs
Treatment/Intervention Data
  
Free-Form Entry
       
C56041
Headache migraine rescue device used end date
HeadMigRescDevUsedEndDate
The end date on which the rescue device was used in the treatment of headache or migraine.
End Date
  
Date or Date & Time
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/5/2017
Aliases for variable name not defined
Rescue Treatments
Drugs
Treatment/Intervention Data
  
Free-Form Entry
       
06-16-2019
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