CDE Detailed Report

Disease: Headache
Sub-Domain: Patient Reported Outcomes
CRF: Headache Calendar

Displaying 1 - 7 of 7
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C56043 Headache migraine onset time HeadMigOnsetTime The time that the subject's headache started. 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 1.00 2017-06-05 14:58:03.0 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. 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 1.00 2017-06-05 14:58:03.0 Headache Calendar Patient Reported Outcomes Outcomes and End Points

Free-Form Entry

C10626 Condition diary date and time CondDiaryDateTime Date (and time, if applicable and known) the diary data are recorded 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 3.00 2013-08-28 16:08:00.453 Headache Calendar Patient Reported Outcomes Outcomes and End Points

Free-Form Entry

C15966 Diary day headache indicator DiaryDayHeadachInd Indicator of whether the participant/subject experienced a headache on a particular day. 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 3.00 2013-07-16 14:01:43.01 Headache Calendar Patient Reported Outcomes Outcomes and End Points

Single Pre-Defined Value Selected

C15967 Diary day migraine indicator DiaryDayMigrnInd Indicator of whether the participant/subject thought the headache was a migraine. 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 3.00 2013-07-16 14:01:43.01 Headache Calendar Patient Reported Outcomes Outcomes and End Points

Single Pre-Defined Value Selected

C22804 Pain present eleven point intensity scale PainPrsnt11IntensityScl Scale for the participant's current pain intensity based on an a scale of 0-10. Scale for the participant's current pain intensity based on an a scale of 0-10. Severity 0;1;10;2;3;4;5;6;7;8;9 0;1;10;2;3;4;5;6;7;8;9 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 3.00 2013-07-17 09:26:36.973 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. The scale of the amount of headache the participant/subject is experiencing. Severity Mild;Moderate;Severe;None Mild;Moderate;Severe;None Alphanumeric Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-06-05 14:46:52.0 Headache Calendar Patient Reported Outcomes Outcomes and End Points

Single Pre-Defined Value Selected

CSV