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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: Patient Reported Outcomes
CRF: Headache Calendar
Item count: 7 (7 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
C10626
Condition diary date and time
CondDiaryDateTime
Date (and time, if applicable and known) the diary data are recorded
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.).
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study.
Adult;Pediatric
Supplemental–Highly Recommended
3.0
8/28/2013
Aliases for variable name not defined
Headache Calendar
Patient Reported Outcomes
Outcomes and End Points
Diary date and time
 
Free-Form Entry
       
C15966
Diary day headache indicator
DiaryDayHeadachInd
Indicator of whether the participant/subject experienced a headache on a particular day.
Headache
Yes;No;
Yes;No;
Alphanumeric
If ‘Yes’ answered, the appropriate Headache Record CRF (Acute or Preventive) must be completed for each yes capturing additional information about the headache.
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study.
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/16/2013
Aliases for variable name not defined
Headache Calendar
Patient Reported Outcomes
Outcomes and End Points
Diary day headache indicator
 
Single Pre-Defined Value Selected
       
C15967
Diary day migraine indicator
DiaryDayMigrnInd
Indicator of whether the participant/subject thought the headache was a migraine.
Migraine
Yes;No;
Yes;No;
Alphanumeric
A migraine is defined as pain in the head that includes at least 2 or more of the following features (1. throbbing; 2. pain in front, side, or back of head; 3. moderate or severe pain; 4. worsens with activity) AND 1 or more of the following 2 associated symptoms (1. nausea and/or vomiting; 2. light/sound sensitivity). If yes is answered for Headache or Migraine, complete the appropriate Headache Record CRF (Acute or Preventive) for EACH headache/migraine day.
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study.
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/16/2013
Aliases for variable name not defined
Headache Calendar
Patient Reported Outcomes
Outcomes and End Points
Diary day migraine indicator
 
Single Pre-Defined Value Selected
       
C56043
Headache migraine onset time
HeadMigOnsetTime
The time that the subject's headache started.
Time Onset
  
Date or Date & Time
Record the start and end time according to the ISO 8601, the International Standard for the representation of dates and times. 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.).
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study.
Adult;Pediatric
Supplemental–Highly Recommended
1.0
6/5/2017
Aliases for variable name not defined
Headache Calendar
Patient Reported Outcomes
Outcomes and End Points
  
Free-Form Entry
       
C56044
Headache migraine end time
HeadMigEndTime
The time that the subject's headache ended.
Time End
  
Date or Date & Time
Record the start and end time according to the ISO 8601, the International Standard for the representation of dates and times. 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.).
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study.
Adult;Pediatric
Supplemental–Highly Recommended
1.0
6/5/2017
Aliases for variable name not defined
Headache Calendar
Patient Reported Outcomes
Outcomes and End Points
  
Free-Form Entry
       
C22804
Pain present eleven point intensity scale
PainPrsnt11IntensityScl
Scale for the participant's current pain intensity based on an a scale of 0-10.
Severity
0;1;2;3;4;5;6;7;8;9;10;
0;1;2;3;4;5;6;7;8;9;10;
Alphanumeric
On a scale from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, how bad is your headache right now?
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study.
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/17/2013
Aliases for variable name not defined
Headache Calendar
Patient Reported Outcomes
Outcomes and End Points
  
Single Pre-Defined Value Selected
       
C56042
Headache severity scale
HeadacheSeverityScale
The scale of the amount of headache the participant/subject is experiencing.
Severity
Mild;Moderate;Severe;None;
Mild;Moderate;Severe;None;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental–Highly Recommended
1.0
6/5/2017
Aliases for variable name not defined
Headache Calendar
Patient Reported Outcomes
Outcomes and End Points
  
Single Pre-Defined Value Selected
       
07-20-2019
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