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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: Laboratory Tests and Biospecimens/Biomarkers
CRF: Biospecimens Collection and Processing
Item count: 84 (84 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
C56053
Sample obtain with headache indicator
SampObtWithHeadacheInd
The indicator relating to the sample being obtained while the participant was having a headache.
Was sample obtained while the participant was having a headache?
Yes;No;
Yes;No;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C56056
Sample collection headache diagnosis text
SampCollHeadDiagnosTxt
Text describing the headache diagnosis at the time of sample collection
What was the headache diagnosis at the time of sample collection?
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
 
255
Free-Form Entry
       
C56057
Headache ictal indicator
HeadacheIctalInd
The indicator relating to whether the headache was ictal.
Was headache ictal?
Yes;No;
Yes;No;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C15604
Headache severity prior sample collection score
HeadachSevrPriorSampCollctnScr
The score rating of the severity of the participant/subject's last headache prior to sample collection
Record severity of last headache prior to sample collection on a scale of 0-10
0;1;2;3;4;5;6;7;8;9;10;
0 (Least severe);1;2;3;4;5;6;7;8;9;10 (Most severe);
Numeric Values
0 = least severe; 10 = most severe
No references available
Adult;Pediatric
Supplemental
3.0
7/16/2013
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Headache severity prior to sample collection
 
Single Pre-Defined Value Selected
       
C56059
Headache 28 day prior to sample collection frequency
Headache28DayPriSampCollFreq
The frequency of the participant's headaches during the 28 days prior to sample collection
Record 28-day headache days frequency prior to sample collection
No headaches in the past 28 days;<1 day per month in the past 28 days;1-4 days in the past 28 days;5-9 days in the past 28 days;10-14 days in the past 28 days;15 or more days in the past 28 days;
No headaches in the past 28 days;<1 day per month in the past 28 days;1-4 days in the past 28 days;5-9 days in the past 28 days;10-14 days in the past 28 days;15 or more days in the past 28 days;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Core
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C15607
Medication history change indicator
MedctnHistChngInd
Whether or not the participant/subject had a change in his or her medication around the time of specimen collection.
Indicate whether any medication changes have recently occurred prior to the sample?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
These elements should be captured on other study specific source documents (e.g. Headache Diary, and Prior and Concomitant Medications) and should be pre-populated if initially collected elsewhere to avoud redundant data points.
No references available
Adult;Pediatric
Supplemental
3.0
7/16/2013
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Medication history change indicator
 
Single Pre-Defined Value Selected
       
C56060
Timeframe window between medication change specimen collection duration
TimeWindBtwnMedChngSpecCollDur
The timeframe window between medication changes and specimen collection.
If yes, specify timeframe window between medication changes and specimen collection
Less than 1 week;1-2 weeks;3-4 weeks;1-3 months;>3 months;
Less than 1 week;1-2 weeks;3-4 weeks;1-3 months;>3 months;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C56063
Blood sample last acute abortive time
BldSampLastAcuteAbortTime
The time the last acute abortive was taken in relationship to the blood sample.
In relationship to the blood sample, what time was the last acute abortive was taken?
  
Date or Date & Time
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
C56064
Medication adjustment 5 half life text
MedAdjust5HalfLifeTxt
Text describing any medications that have been adjusted or taken within 5 half lives of the biomarkers being assessed.
Indicate any medications that have been adjusted or taken within 5 half lives of the biomarkers being assessed
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
 
255
Free-Form Entry
       
C56067
Participant current smoker indicator
ParticCurrentSmokeInd
The indicator relating to whether the participant is a current smoker.
Is participant a current smoker?
Yes;No;
Yes;No;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C56071
Cigarette smoked past week count
CigSmokePastWkCt
The number of cigarettes the participant has smoked in the past week.
If yes, specify how many cigarettes were smoked in the past week
  
Numeric Values
Include units
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
C56072
Cigarette smoked past week unit of measure
CigSmokePastWkUnitMeasr
The unit of measure pertaining to the amount of cigarettes the participant has smoked in the past week.
If yes, specify how many cigarettes were smoked in the past week
Individual;Pack;Carton;
Individual;Pack;Carton;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Single Pre-Defined Value Selected
       
C56151
Last cigarette smoked before sample collection time
LastCigSmokeBefSampCollTime
The time since the participant last smoked a cigarette before sample collection.
Provide time since last cigarette was smoked before smaple collection
  
Date or Date & Time
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
C56075
Alcoholic drink consume past week count
AlcDrinkConsPastWkCt
The number of alcoholic drinks that were consumed within the past week.
Specify how man alcoholic drinks were consumed in the past week
  
Numeric Values
In units
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
C55382
Medication prescription type text
MedicationPrescriptionTypTxt
The free-text field related to type of prescription medication participant/subject.
Name
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
5/2/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
 
255
Free-Form Entry
       
C56077
Prescription medication dose
PrescripMedDose
The dose of the participant's prescription medication.
Dose
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
C56079
Prescription medication quantity value
PrescripMedQuanVal
The value representing the quantity of the participant's prescription medication.
Quantity
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
C56080
Over the counter medication supplement name
OTCMedSuppName
The name of the participant's over-the-counter medication and/or supplements.
Name
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
C56081
Over the counter medication supplement dose
OTCMedSuppDose
The dose of the participant's over-the-counter medication and/or supplements.
Dose
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
C56082
Over the counter medication supplement quantity value
OTCMedSuppQuanVal
The value representing the quantity of the participant's over-the-counter medication and/or supplements.
Quantity
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
C56086
Recreational substance name
RecSubstanceName
The name of the recreational substance the participant uses.
Name
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
C56087
Recreational substance dose
RecSubstanceDose
The dose of the recreational substance the participant uses.
Dose
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
C56088
Recreational substance quantity value
RecSubstanceQuanVal
The value representing the quantity of the recreational substance the participant uses.
Quantity
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
6/6/2017
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
  
Free-Form Entry
       
C15618
Premenopausal indicator
PremenpausInd
Whether or not the participant/subject is currently in her premenopausal phase.
Is the participant/subject currently premenopausal?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
To be answered for women only
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
7/16/2013
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Premenopausal indicator
 
Single Pre-Defined Value Selected
       
C16174
Menopause indicator
MenopauseInd
Indicates whether participant/subject is currently menopausal.
Is the participant/subject perimenopausal?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
To be answered for women only
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
6/11/2013
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Menopause indicator
 
Single Pre-Defined Value Selected
       
C16177
Post-menopausal indicator
PostMnpslInd
Indicates whether participant/subject is post-menopausal
Is the participant/subject currently postmenopausal?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
To be answered for women only
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
6/11/2013
Aliases for variable name not defined
Biospecimens Collection and Processing
Laboratory Tests and Biospecimens/Biomarkers
Assessments and Examinations
Post-menopausal indicator
 
Single Pre-Defined Value Selected
       
06-16-2019
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