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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 Diary - Preventive Therapies
Item count: 34 (34 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
C15966
Diary day headache indicator
DiaryDayHeadachInd
Indicator of whether the participant/subject experienced a headache on a particular day.
Did you experience a headache today?
Yes;No;
Yes;No;
Alphanumeric
No instructions available
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 Diary - Preventive Therapies
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.
Did you experience a migraine today?
Yes;No;
Yes;No;
Alphanumeric
No instructions available
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 Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
Diary day migraine indicator
 
Single Pre-Defined Value Selected
       
C56777
Headache start date and time
HeadacheStartDateTime
The time at which the participant/subject's headache started.
What time did your headache start?
  
Date or Date & Time
No instructions available
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study.
Adult;Pediatric
Supplemental–Highly Recommended
1.0
7/14/2017
Aliases for variable name not defined
Headache Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
  
Free-Form Entry
       
C15977
Headache end date and time
HdchEndDateTime
The time of the day the headache ended
What time did your headache end?
  
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
7/16/2013
Aliases for variable name not defined
Headache Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
Headache end date and time
 
Free-Form Entry
       
C15969
Headache or migraine medication taken type
HdachMigMedctnTyp
Type of pain medication(s) taken by participant/subject
What pain medication(s) other than the study drug did you take?
Acetaminophen;Almotriptan;Aspirin;Dihydroergotamine (DHE);Eletriptan;Ergotamine tartrate (ET);Frovatriptan;Ibuprofen;Naproxen;Naratriptan;Rizatriptan;Sumatriptan;Zolmitriptan;Other, specify;
Acetaminophen;Almotriptan;Aspirin;Dihydroergotamine (DHE);Eletriptan;Ergotamine tartrate (ET);Frovatriptan;Ibuprofen;Naproxen;Naratriptan;Rizatriptan;Sumatriptan;Zolmitriptan;Other, specify;
Alphanumeric
Choose all that apply
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 Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
Headache or migraine medication taken type
 
Multiple Pre-Defined Values Selected
       
C19034
Headache or migraine medication taken other text
HdchMigMedctnOTH
The free-text field related to 'Headache or migraine medication taken type' specifying other text. Type of pain medication(s) taken by participant/subject
Other, specify
  
Alphanumeric
Choose all that apply including study drug Only answer if Yes was answered for "Did you take any pain medications?"
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 Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
 
4000
Free-Form Entry
       
C15937
Headache typical severity type
HeadachTypclSevertyTyp
The participant's/subject's typical headache pain severity
Which word describes the severity of your headache?
Mild;Moderate;Severe;None;
Most of the time I can ignore my headache and continue what I'm doing;My headache makes concentration difficult, but I can perform undemanding tasks;I cannot concentrate nor do much of anything;None;
Alphanumeric
For assessing headache pain everity, we have included two scales, (NRS) 0-10, and (ordinal 4-point scale) none, mild, moderate, severe.
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 Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
Headache typical severity type
 
Single Pre-Defined Value Selected
       
C15917
Headache typical pain intensity scale
HeadacheTypPainIntstyRateScale
Rating scale for the pain of this headache on a scale of 0 -10
Rate your overall pain for this headache on a scale of 0-10
0;1;2;3;4;5;6;7;8;9;10;
0;1;2;3;4;5;6;7;8;9;10;
Numeric Values
For assessing headache pain everity, we have included two scales, (NRS) 0-10, and (ordinal 4-point scale) none, mild, moderate, severe.
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 Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
Headache typical pain intensity rating scale
 
Single Pre-Defined Value Selected
       
C15950
Headache typical pain type
HdchTypcPainTyp
Type of pain the participant/subject experiences with the headache
Which of the following describes the pain you feel?
Throbbing;Pounding;Stabbing;Constant;Sharp;Pressure;Pulsating;Squeezing;Other, specify;
Throbbing;Pounding;Stabbing;Constant;Sharp;Pressure;Pulsating;Squeezing;Other, specify;
Alphanumeric
Choose all that apply
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 Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
Headache typical pain type
 
Multiple Pre-Defined Values Selected
       
C19032
Headache typical pain other text
HdchTypcPainOTH
The free-text field related to 'Headache typical pain type' specifying other text. Type of pain the participant/subject experiences with the headache
Other, specify
  
Alphanumeric
Choose all that apply
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 Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
 
4000
Free-Form Entry
       
C02411
Laterality type
LatTyp
Laterality type relative to the anatomic site of the body examined or affected
Where is the location of your headache pain?
Right;Left;Bilateral;
Right;Left;Bilateral;
Alphanumeric
Choose only one
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 Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
Laterality type
 
Single Pre-Defined Value Selected
       
C15899
Headache worst pain anatomic site
HdchPainWrstAntmicSite
Location of worst headache pain
Where is the location of your headache pain that hurts the most?
Right temple;Top;One eye;Around eyes;Behind eyes;Left temple;Front;Back;All over;Other, specify;
Right temple;Top;One eye;Around eyes;Behind eyes;Left temple;Front;Back;All over;Other, specify;
Alphanumeric
Choose all that apply
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 Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
Headache worst pain anatomic site
 
Multiple Pre-Defined Values Selected
       
C56778
Headache pain hurt most eye type
HeadPainHurtMostEyeTyp
The eye that hurts the most due to headache pain.
One Eye (specify)
Left;Right;
Left;Right;
Alphanumeric
No instructions available
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study.
Adult;Pediatric
Supplemental–Highly Recommended
1.0
7/14/2017
Aliases for variable name not defined
Headache Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
  
Single Pre-Defined Value Selected
       
C19027
Headache worst pain anatomic other text
HdchPainWrstAntmicOTH
The free-text field related to 'Headache worst pain anatomic site' specifying other text. Location of worst headache pain
Other, specify
  
Alphanumeric
Choose all that apply
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 Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
 
4000
Free-Form Entry
       
C56779
Headache sound aggravate indicator
HeadSoundAggInd
The indicator relating to whether sound aggravates the participant/subject or makes his/her headache worse.
Does sound aggravate or make your headache worse?
Yes;No;
Yes;No;
Alphanumeric
No instructions available
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study.
Adult;Pediatric
Supplemental–Highly Recommended
1.0
7/14/2017
Aliases for variable name not defined
Headache Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
  
Single Pre-Defined Value Selected
       
C53077
Migraine headache light indicator
MigraineHeadacheLightInd
Indicator as to whether light bothers participant/subject when experiencing a migraine headache
Does light aggravate or make your headache worse?
Yes;No;
Yes;No;
Alphanumeric
No instructions available
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study.
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/15/2013
Aliases for variable name not defined
Headache Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
  
Single Pre-Defined Value Selected
       
C15961
Headache worse during activity indicator
HeadachWorsDurngActvtyInd
Indicates whether activity or playing makes headache worse
Does activity or playing make this headache worse?
Yes;No;Not applicable;
Yes;No;Not applicable;
Alphanumeric
No additional instructions
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 Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
Headache worse during activity indicator
 
Single Pre-Defined Value Selected
       
C15971
Headache warning symptom indicator
HdchWarnSymInd
Indicator for any auras (warnings) that the headache was going to start
Did you have any warnings that this headache was going to start?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No additional instructions
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 Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
Headache warning symptom indicator
 
Single Pre-Defined Value Selected
       
C56785
Headache premonitory symptom type
HdachPreSymptmTyp
The type of premonitory symptom(s) (symptoms that come before headache) that the participant/subject experienced.
If premonitory symptoms (symptoms that come before headache), which of the following did you experience?
Fatigue;Difficulty concentrating;Irritability;Mood Changes;Food Cravings;Nausea;Yawning;Neck stiffness / pain;Blurred vision;Sensitivity to light;Sensitivity to noise;
Fatigue;Difficulty concentrating;Irritability;Mood Changes;Food Cravings;Nausea;Yawning;Neck stiffness / pain;Blurred vision;Sensitivity to light;Sensitivity to noise;
Alphanumeric
Choose all that apply
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study.
Adult;Pediatric
Supplemental–Highly Recommended
1.0
7/14/2017
Aliases for variable name not defined
Headache Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
  
Multiple Pre-Defined Values Selected
       
C15972
Headache aura symptom type
HdchWarnAurasSymTyp
Type of aura (warning) that a headache was going to start
If aura symptoms (neurological symptoms that occur before and during headache), which type of aura did you have?
Visual;Sensory;Speech;Motor;Brainstem;
Visual;Sensory;Speech;Motor;Brainstem;
Alphanumeric
Choose all that apply
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 Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
Headache aura symptom type
 
Multiple Pre-Defined Values Selected
       
C56780
Headache reduce activity level indicator
HeadRedAcLvlInd
The indicator relating to whether the participant/subject's headache reduced his/her activity level.
Did this headache reduce your activity level?
Yes;No;
Yes;No;
Alphanumeric
No instructions available
Hershey AD, Powers S 2011. Amitriptyline and Topiramate in the Prevention of Childhood Migraine Study.
Adult;Pediatric
Supplemental–Highly Recommended
1.0
7/14/2017
Aliases for variable name not defined
Headache Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
  
Single Pre-Defined Value Selected
       
C15939
Headache typical level activities affected result
HeadachTypclLvlActvtyAffctRslt
Result of onset of headache in usually daily activities
How would you describe your abilities to perform your usual daily activities at the onset of this headache
Able to work/function normally;Working ability or activity impaired to some degree;Working ability or activity severely impaired;Bed rest required;
Able to work/function normally;Working ability or activity impaired to some degree;Working ability or activity severely impaired;Bed rest required;
Alphanumeric
Should be capture at onset of headache and after taking medication
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 Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
Headache typical level activities affected type
 
Single Pre-Defined Value Selected
       
C15975
Headache post initial study medication time interval
HdchPstInStMedctnTimeIntrvl
The time interval after taking initial study medication for headache
Time AFTER taking initial study medication
2 hours;24 hours;48 hours;
2 hours;24 hours;48 hours;
Alphanumeric
Complete table only if you have taken study medication
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 Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
Headache post initial study medication time interval value
 
Single Pre-Defined Value Selected
       
C15976
Headache post initial study medication date and time
HdchPostInStMedctnDateTime
The actual time (24 hr clock) after taking initial study medication for headache
Time (24 hr clock) AFTER taking initial study medication
  
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
7/16/2013
Aliases for variable name not defined
Headache Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
Headache post initial study medication date and time
 
Free-Form Entry
       
C15897
Headache associated symptom type
HdchAssocSymptmTyp
The associated symptoms the participant/subject experienced with headache
Associated Symptoms
Sensitive to light;Sensitive to noise;Nausea;Vomiting;Aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs);
Sensitive to light;Sensitive to noise;Nausea;Vomiting;Aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs);
Alphanumeric
Choose all that apply
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 Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
Headache associated symptom type
 
Multiple Pre-Defined Values Selected
       
C15893
Headache retire bed indicator
HdchRetireBedInd
Indicates whether the participant/subject went to bed with the headache
Went to bed with this headache?
Yes;No;
Yes;No;
Alphanumeric
Answer headache end time or whether participant/subject went to bed with a headache, not both.
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 Diary - Preventive Therapies
Patient Reported Outcomes
Outcomes and End Points
Headache went to bed with indicator
 
Single Pre-Defined Value Selected
       
06-25-2019
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