CDE Detailed Report

Disease: Sport Related Concussion
Sub-Domain: General Health History
CRF: Migraine History

Displaying 1 - 23 of 23
CDE ID CDE Name Variable Name Definition Short Description 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
C17024 Migraine Disability Assessment (MIDAS) - Household work not done past three months day count MIDASHshldNotDoneP3MDayCt Number of days in the last three months the participant/subject has not done household work because of their headaches, as part of the Migraine Disability Assessment (MIDAS) Test form. Number of days in the last three months the participant/subject has not done household work because of their headaches, as part of the Migraine Disability Assessment (MIDAS) Test form. On how many days in the last 3 months did you not do household work because of your headaches? Numeric Values

INSTRUCTIONS: Please answer the following questions about ALL your headaches you have
had over the last 3 months. Write your answer in the box next to each question. Write 0 if you
did not do the activity in the last 3 months. Please provide numbers; example: everyday
headache = 90

Innovative Medical Research, 1997 2007, AstraZeneca Pharmaceuticals, LP. All Rights reserved. Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Migraine History General Health History Participant History and Family History

Free-Form Entry

day
C54376 Brain abnormality indicator BrainAbnormalInd The indicator related to brain abnormalities The indicator related to brain abnormalities Do you have any brain abnormalities? No;Yes No;Yes Alphanumeric

(unrelated to concussion)

Adult;Pediatric Supplemental 1.00 2016-12-04 23:35:32.0 Migraine History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17025 Migraine Disability Assessment (MIDAS) - Household work productivity half reduction past three months day count MIDASHshldWrkProHReP3MCt Number of days in the last three months the participant/subject has experienced productivity reduction by half or more while doing household work because of their headaches, as part of the Migraine Disability Assessment (MIDAS) Test form. Number of days in the last three months the participant/subject has experienced productivity reduction by half or more while doing household work because of their headaches, as part of the Migraine Disability Assessment (MIDAS) Test form. How many days in the last 3 months was your productivity in household work reduced by hald or more because of your headaches? Numeric Values

Do not include days you counted in question 3 where you did not do household work).
INSTRUCTIONS: Please answer the following questions about ALL your headaches you have
had over the last 3 months. Write your answer in the box next to each question. Write 0 if you
did not do the activity in the last 3 months. Please provide numbers; example: everyday
headache = 90

Innovative Medical Research, 1997 2007, AstraZeneca Pharmaceuticals, LP. All Rights reserved. Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Migraine History General Health History Participant History and Family History

Free-Form Entry

day
C54379 Headache daily occurrence indicator HdacheDailyOccurInd The indicator related to whether the participant/subject has a headache every day The indicator related to whether the participant/subject has a headache every day Do you have a headache every day? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2016-12-04 23:35:32.0 Migraine History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17026 Migraine Disability Assessment (MIDAS) - Activity missed past three months day count MIDASActMissP3MDayCt Number of days in the last three months the participant/subject has missed family, social, or leisure activities because of their headaches, as part of the Migraine Disability Assessment (MIDAS) Test form. Number of days in the last three months the participant/subject has missed family, social, or leisure activities because of their headaches, as part of the Migraine Disability Assessment (MIDAS) Test form. On how many days in the last 3 months did you miss family, social or leisure activities because of your headaches? Numeric Values

INSTRUCTIONS: Please answer the following questions about ALL your headaches you have
had over the last 3 months. Write your answer in the box next to each question. Write 0 if you
did not do the activity in the last 3 months. Please provide numbers; example: everyday
headache = 90

Innovative Medical Research, 1997 2007, AstraZeneca Pharmaceuticals, LP. All Rights reserved. Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Migraine History General Health History Participant History and Family History

Free-Form Entry

day
C54381 Headache pain medication more than four days week indicator HdachPainMedMoreFourDysWkInd Indicator for whether the participant/subject takes headache pain medication more than four days per week Indicator for whether the participant/subject takes headache pain medication more than four days per week Do you take over the counter or pescription pain or headache medication more than 4 days per week? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Migraine History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17028 Migraine Disability Assessment (MIDAS) - Headache past three months day count MIDASHdacheP3MDayCt Count the total number of days in the past three months the participant/subject had headache, as part of the Migraine Disability Assessment (MIDAS) Test form. Count the total number of days in the past three months the participant/subject had headache, as part of the Migraine Disability Assessment (MIDAS) Test form. On how many days in the last 3 months did you have a headache? Numeric Values

If a headache lasted more than 1 day, count each day.
INSTRUCTIONS: Please answer the following questions about ALL your headaches you have
had over the last 3 months. Write your answer in the box next to each question. Write 0 if you
did not do the activity in the last 3 months. Please provide numbers; example: everyday
headache = 90

Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Migraine History General Health History Participant History and Family History

Free-Form Entry

day
C54382 Headache chronicity type HeadacheChronicityTyp The type as related to headache chronicity. The type as related to headache chronicity. Do you have intermittent or constant headache? Intermittent;Chronic Intermittent;Chronic Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-02 15:04:05.0 Migraine History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17029 Migraine Disability Assessment (MIDAS) - Headache average pain intensity scale MIDASHdcheAvePainIntenScl Average pain scale of the headache experienced by the participant/subject, as part of the Migraine Disability Assessment (MIDAS) Test form. Average pain scale of the headache experienced by the participant/subject, as part of the Migraine Disability Assessment (MIDAS) Test form. On a scale of 0-10, on average how painful were these headaches? Numeric Values

(Where 0 = no pain at all and 10 = pain as bad as it can be).
INSTRUCTIONS: Please answer the following questions about ALL your headaches you have
had over the last 3 months. Write your answer in the box next to each question. Write 0 if you
did not do the activity in the last 3 months. Please provide numbers; example: everyday
headache = 90

Innovative Medical Research, 1997 2007, AstraZeneca Pharmaceuticals, LP. All Rights reserved. Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Migraine History General Health History Participant History and Family History

Free-Form Entry

0 10
C54383 Headache episode duration HdacheEpisdDur The element related to the duration of a headache episode The element related to the duration of a headache episode How long does each headache episode last? Greater than 2 hours;Less than 2 hours Greater than 2 hours;Less than 2 hours Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-06 08:20:12.0 Migraine History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17402 Site name SiteName The name of the site for the study The name of the site for the study Site Name Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Migraine History General Health History Participant History and Family History 255

Free-Form Entry

C54384 Headache neurological symptom before during type HdacheNeuroSympBefDurTyp The element related to the type of neurological symptoms before and/or during headache The element related to the type of neurological symptoms before and/or during headache Do you have neurological symptoms immediately before and/or during your headache? Visual scotoma;Visual hallucination;Weakness or numbness on one side of the body Visual scotoma (blind or black spots);Visual hallucination (zig zag or wavy lines, colored lights or balls, shimmering patterns);Weakness or numbness on one side of the body Alphanumeric Adult;Pediatric Supplemental 1.00 2016-06-06 08:20:12.0 Migraine History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19247 Subject ID SubIDNam Subject identification ID Subject identification ID Site Name Alphanumeric Adult;Pediatric Supplemental 1.00 2014-06-05 13:10:49.0 Migraine History General Health History Participant History and Family History 255

Free-Form Entry

C54385 Migraine headache pain symptom type MigrHeadachePainSymptmTyp The element related to the type of pain symptoms the participant/subject experiences with migraine headaches The element related to the type of pain symptoms the participant/subject experiences with migraine headaches Do you have any of these symptoms with headache? Pain on one side of head only;Pain made worse by routine activity;Pain limits or restricts routine activities;Throbbing or pulsing pain sensation Pain on one side of head only;Pain made worse by routine activity;Pain limits or restricts routine activities;Throbbing or pulsing pain sensation Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Migraine History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C19256 Study protocol name StudyProtocolName Name of study protocol Name of study protocol Study Name/ID pre-filled Alphanumeric Adult;Pediatric Supplemental 1.00 2014-06-05 16:38:14.0 Migraine History General Health History Participant History and Family History 4000

Free-Form Entry

C54386 Migraine headache symptom type MigrHeadacheSymptmTyp The element related to the type of pain symptoms the participant/subject experiences with migraine headaches The element related to the type of pain symptoms the participant/subject experiences with migraine headaches Do you have any of these symptoms with your headache? Nausea/vomiting;Increased sensitivity to normal light AND sound;Pain on one side of head only;Throbbing or pulsing pain sensation;Pain limits or restricts routine activities;Pain made worse by routine activity Nausea/vomiting;Increased sensitivity to normal light AND sound;Pain on one side of head only;Throbbing or pulsing pain sensation;Pain limits or restricts routine activities;Pain made worse by routine activity Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Migraine History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C53072 Migraine headache indicator MigraineHeadacheInd Indicator as to whether the participant/subject has a medical history of migraine headache Indicator as to whether the participant/subject has a medical history of migraine headache Personal history of migraine headache Yes;No Yes;No Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Migraine History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C54387 Headache prior treatment indicator HeadachPriorTxInd Indicator related to prior treatment for headache Indicator related to prior treatment for headache Prior treatment for headache? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Migraine History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17022 Migraine Disability Assessment (MIDAS) - School work absent past three month day count MIDASSchoWorkAbsPast3MDayCt Number of days in the last three months the participant/subject has missed work or school because of their headaches, as part of the Migraine Disability Assessment (MIDAS) Test form. Number of days in the last three months the participant/subject has missed work or school because of their headaches, as part of the Migraine Disability Assessment (MIDAS) Test form. On how many days in the last 3 months did you miss work or school because of your headaches? Numeric Values

If you're not working or going to school, just enter 0.
INSTRUCTIONS: Please answer the following questions about ALL your headaches you have
had over the last 3 months. Write your answer in the box next to each question. Write 0 if you
did not do the activity in the last 3 months. Please provide numbers; example: everyday
headache = 90

Innovative Medical Research, 1997 2007, AstraZeneca Pharmaceuticals, LP. All Rights reserved. Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Migraine History General Health History Participant History and Family History

Free-Form Entry

day
C54373 Headache past three month alcohol substance use unrelated indicator HdachePstThrMoAlcSubUseUnrlInd Indicator for whether the participant/subject has had a headache in the past three months that is unrelated to alcohol/substance use Indicator whether participant/subject has had a headache in the past three months that is unrelated to alcohol/substance use Have you had one or more headaches in the past 3 months, unrelated to alcohol/substance use? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2017-02-03 15:56:09.0 Migraine History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C54388 Migraine headache family history indicator MigrHeadacheFamHisInd Indicator as to whether the participant/subject has a family history of migraine headache Indicator as to whether the participant/subject has a family history of migraine headache Any family history of migraine headaches Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Migraine History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17023 Migraine Disability Assessment (MIDAS) - School work productivity reduction past three months day count MIDASSchlWrkProRedP3MDayCt Number of days in the last three months the participant/subject has experienced productivity reduction by half or more while at work or school because of their headaches, as part of the Migraine Disability Assessment (MIDAS) Test form. Number of days in the last three months the participant/subject has experienced productivity reduction by half or more while at work or school because of their headaches, as part of the Migraine Disability Assessment (MIDAS) Test form. How many days in the last 3 months was your productivity at work or school reduced by half or more because of your headaches? Numeric Values

If you're not working or going to school. Just enter 0. (Do not include days you counted in question 1 where you missed work or school).
INSTRUCTIONS: Please answer the following questions about ALL your headaches you have
had over the last 3 months. Write your answer in the box next to each question. Write 0 if you
did not do the activity in the last 3 months. Please provide numbers; example: everyday
headache = 90

Innovative Medical Research, 1997 2007, AstraZeneca Pharmaceuticals, LP. All Rights reserved. Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Migraine History General Health History Participant History and Family History

Free-Form Entry

day
C54374 Headache start within two week concussion indicator HdacheStrtWithnTwoWkConcussInd Indicator for whether the participant/subject has had headaches that started within two weeks of concussion Indicator for whether the participant/subject has had headaches that started within two weeks of concussion Did headaches start within 2 weeks of concussion? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2017-02-03 15:56:09.0 Migraine History General Health History Participant History and Family History

Single Pre-Defined Value Selected

CSV