CDE Detailed Report

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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 / Guidance) Subdomain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C00700 Alcohol use stopped age value AlcUseStopAgeVal Age in years when participant/subject stopped ingesting alcoholic beverages, including social drinking Age in years when participant/subject stopped ingesting alcoholic beverages, including social drinking Age quit drinking Numeric Values

History can be obtained from participant/ subject, family member, friend, or chart/ medical record. The age in years should be collected or N/A (Not applicable if subject never smoked) should be selected.

No references available Adult;Pediatric Supplemental 3.00 2013-07-18 14:26:06.9 Risk Factors [php] [php_1]

Free-Form Entry

0 120 year 2008448
C00711 Tobacco prior use indicator TobcoPriorUseInd Indicator of the participant's/subject's past regular tobacco (e.g., cigarettes, cigars, chewing tobacco or pipe) use prior to the past 12 months Indicator of the participant's/subject's past regular tobacco (e.g., cigarettes, cigars, chewing tobacco or pipe) use prior to the past 12 months Past tobacco use? Yes;No;Unknown Yes;No;Unknown Alphanumeric

History can be obtained from participant/ subject, family member, friend, or chart/ medical record.

No references available Adult;Pediatric Core 3.00 7/20/2013 10:21:26 AM Risk Factors [php] [php_1]

Single Pre-Defined Value Selected

3170080
C52532 Family history subarachnoid hemorrhage family member other type FamHisSAHFamMemberOthTyp Specify whether the family member with a history of subarachnoid hemorrhage is male or female Specify whether the family member with a history of subarachnoid hemorrhage is male or femal Other Male;Female Male;Female Alphanumeric Adult;Pediatric Supplemental 1.00 2017-01-20 10:47:32.0 Risk Factors [php] [php_1]

Multiple Pre-Defined Values Selected

C00701 Tobacco use stopped age value TobcoUseStopAgeVal Age in years when participant/subject stopped using tobacco products (e.g., cigarettes, cigars, chewing tobacco or pipe) Age in years when participant/subject stopped using tobacco products (e.g., cigarettes, cigars, chewing tobacco or pipe) Age stopped tobacco use Numeric Values

History can be obtained from participant/ subject, family member, friend, or chart/ medical record. The age in years should be collected or N/A (Not applicable if subject never smoked) should be selected.

No references available Adult;Pediatric Core 3.00 2013-07-18 14:26:06.9 Risk Factors [php] [php_1]

Free-Form Entry

0 120 year 2524471
C00719 Tobacco product used type TobcoProdctUsedTyp Type of tobacco product (e.g., cigarettes, cigars, chewing tobacco or pipe) used by the participant/subject Type of tobacco product (e.g., cigarettes, cigars, chewing tobacco or pipe) used by the participant/subject Type(s) of tobacco used Filtered cigarettes;Non-filtered cigarettes;Low tar cigarettes;Cigars;Pipes;Chewing tobacco;Other, specify Filtered cigarettes;Non-filtered cigarettes;Low tar cigarettes;Cigars;Pipes;Chewing tobacco;Other, specify Alphanumeric

Choose all that apply. History can be obtained from participant/ subject, family member, friend, or chart/ medical record.

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Risk Factors [php] [php_1]

Multiple Pre-Defined Values Selected

3179449v1
C52533 History previous subarachnoid hemorrhage unruptured intracranial aneurysm indicator HisPrevSAHUIAInd Indicator for whether the participant/subject has a history of subarachnoid hemorrhage due to unruptured intracranial aneurysm Indicator for whether the participant/subject has a history of subarachnoid hemorrhage due to unruptured intracranial aneurys Do you have a history of a previous SAH due to UIA No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental-Highly Recommended 1.00 2015-02-18 00:00:00.0 Risk Factors [php] [php_1]

Single Pre-Defined Value Selected

C00702 Alcohol use started age value AlcUseStrtAgeVal Age in years when participant/subject started ingesting alcoholic beverages, including social drinking Age in years when participant/subject started ingesting alcoholic beverages, including social drinking Age started drinking Numeric Values

History can be obtained from participant/ subject, family member, friend, or chart/ medical record. The age in years should be collected or N/A (Not applicable if subject never smoked) should be selected.

No references available Adult;Pediatric Supplemental 3.00 2013-07-18 14:26:06.9 Risk Factors [php] [php_1]

Free-Form Entry

0 120 year 2008447
C00730 Alcohol use frequency AlcUseFreq The frequency of consumption of alcohol by the participant The frequency of consumption of alcohol by the participan How often do you have a drink containing alcohol? Monthly or less;2 to 4 times a month;2 to 3 times a week;4 or more times a week;Unknown;Never Monthly or less;2 to 4 times a month;2 to 3 times a week;4 or more times a week;Unknown;Never Alphanumeric

Choose one. History can be obtained from participant/ subject, family member, friend, or chart/ medical record.

Question is from the Alcohol Use Disorders Identification Test (AUDIT) - http://www.who.int/substance_abuse/activities/sbi/en/ Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Risk Factors [php] [php_1]

Single Pre-Defined Value Selected

3171627
C52534 Autosomal dominant polycystic kidney disease indicator ADPKDInd Whether or not the participant/subject has autosomal-dominant polycystic kidney disease Whether or not the participant/subject has autosomal-dominant polycystic kidney diseas Do you have a history of autosomal-dominant polycystic idney diease No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-22 09:34:41.527 Risk Factors [php] [php_1]

Single Pre-Defined Value Selected

C00703 Tobacco use started age value TobcoUseStrtAgeVal Age in years when participant/subject started using tobacco products (e.g., cigarettes, cigars, chewing tobacco or pipe) Age in years when participant/subject started using tobacco products (e.g., cigarettes, cigars, chewing tobacco or pipe) Age started tobacco use Numeric Values

History can be obtained from participant/ subject, family member, friend, or chart/ medical record. The age in years should be collected or N/A (Not applicable if subject never smoked) should be selected.

No references available Adult;Pediatric Core 3.00 2013-07-18 14:26:06.9 Risk Factors [php] [php_1]

Free-Form Entry

0 120 year 2178045
C01507 Blood pressure diastolic measurement BldPressrDiastlMeasr Measurement of pressure of the participant's blood against the artery walls during diastole (the relaxation phase) in millimeters of mercury (mmHg) Measurement of pressure of the participant's blood against the artery walls during diastole (the relaxation phase) in millimeters of mercury (mmHg) Blood pressure Numeric Values

Systolic/diastolic (mmHg)

Adult;Pediatric Supplemental-Highly Recommended 3.10 2024-03-11 10:40:54.0 Risk Factors [php] [php_1]

Free-Form Entry

0 300 millimeter of mercury 2004291
C52535 Ethnicity pertinent intracranial aneurysm type EthnPertinentUIAtype Ethnicity type pertinent to unruptured intracranial aneurysms the participant/subject most closely identifies with Ethnicity type pertinent to unruptured intracranial aneurysms the participant/subject most closely identifies with Ethnicity pertinent to intracranial aneurysm: Japanese;Finnish;Eastern Asian;European;Persian;Arabic;Southeast Asian;South Asian;Pacific Islander;American Indian Japanese;Finnish;Eastern Asian;European;Persian;Arabic (ara);Southeast Asian;South Asian (Indian subcontinent) (for OMB purposes, this value is considered to be part of Asian);Pacific Islander (for OMB purposes, this value is considered to be part of Native Hawaiian or Other Pacific Islander);American Indian Alphanumeric Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-08-28 16:08:00.453 Risk Factors [php] [php_1]

Single Pre-Defined Value Selected

2192217
C00704 Alcohol drinking day average drinks consumed range AlcDrinkingDayAvgDrinksCnsmRng The counted number of drinks containing alcohol consumed by the participant/subject on a typical day when he/she is drinking. It is noted that the meaning of "drinks consumed" differs from one nation and culture to another, so the most common alcoholic beverages likely to be consumed will be defined as well as quantity of each that constitutes a drink (approximately 10 grams of pure ethanol). For example, one bottle of beer (330 ml at 5% ethanol), a glass of wine (140 ml at 12% ethanol), and a shot of spirits (40 ml at 40% ethanol) represent a standard drink of about 13 g of ethanol The counted number of drinks containing alcohol consumed by the participant/subject on a typical day when he/she is drinking. It is noted that the meaning of "drinks consumed" differs from one nation and culture to another How many alcoholic drinks do you have on a typical day when you are drinking 1 or 2;3 or 4;5 or 6;7, 8, or 9;10 or more;Unknown 1 or 2;3 or 4;5 or 6;7, 8, or 9;10 or more;Unknown Alphanumeric

History can be obtained from participant/ subject, family member, friend, or chart/ medical record.

Question is from the Alcohol Use Disorders Identification Test (AUDIT) - http://www.who.int/substance_abuse/activities/sbi/en/ Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-18 16:35:19.49 Risk Factors [php] [php_1]

Single Pre-Defined Value Selected

3171647
C01565 Blood pressure systolic measurement BldPressrSystMeasr Measurement of pressure of the participant's blood against the artery walls during systole (the contraction phase) in millimeters of mercury (mmHg) Measurement of pressure of the participant's blood against the artery walls during systole (the contraction phase) in millimeters of mercury (mmHg) Blood pressure Numeric Values

Systolic/diastolic (mmHg)

Adult;Pediatric Supplemental-Highly Recommended 3.10 2024-03-11 10:40:09.0 Risk Factors [php] [php_1]

Free-Form Entry

0 300 millimeter of mercury 2004289 C25298
C00705 Alcohol current use indicator AlcCurntUseInd Indicator of whether the participant/subject consumed at least one alcoholic drink within the past 12 months Indicator of whether the participant/subject consumed at least one alcoholic drink within the past 12 months Current drinker? Yes;No;Unknown Yes;No;Unknown Alphanumeric

History can be obtained from participant/ subject, family member, friend, or chart/ medical record. In the U.S., a single drink serving contains about 14 grams of ethanol or "pure" alcohol. Although the drinks below are different sizes, each one contains the same amount of pure alcohol and counts as a single drink: 12 oz. of beer (about %% alcohol) = 8-9 oz. of malt liquor (about 7% alcohol) = 5 oz. of wine (about 12% alcohol) = 1.5 oz. of hard liquor (about 40% alcohol)

No references available Adult;Pediatric Supplemental 3.00 2013-07-18 14:26:06.9 Risk Factors [php] [php_1]

Single Pre-Defined Value Selected

3171540
C05454 Hypertension indicator HypertensInd Indicator of hypertension. In adults, hypertension is defined as a systolic pressure >= 140 and a diastolic >= 90. In children, it is defined as systolic blood pressure >95th percentile for age Indicator of hypertension. In adults, hypertension is defined as a systolic pressure >= 140 and a diastolic >= 90. In children, it is defined as systolic blood pressure >95th percentile for ag Do you have a history of hypertension? Yes;No;Unknown;Suspected Yes;No;Unknown;Suspected Alphanumeric

In adults, hypertension is defined as a systolic pressure = 140 and a diastolic pressure = 90. In children, it is defined as systolic blood pressure > 95th percentile for age.

Adult;Pediatric Core 3.00 2013-07-20 10:21:25.65 Risk Factors [php] [php_1]

Single Pre-Defined Value Selected

C00706 Alcohol prior use indicator AlcPriorUseInd Indicator of the participant's/subject's alcohol consumption prior to the past 12 months Indicator of the participant's/subject's alcohol consumption prior to the past 12 months Past drinker Yes;No;Unknown Yes;No;Unknown Alphanumeric

Consumed at least one drink prior to the past year. History can be obtained from participant/ subject, family member, friend, or chart/ medical record.

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Risk Factors [php] [php_1]

Single Pre-Defined Value Selected

3171578
C06108 Tobacco smoke pack-year value TobccoSmkePckYrVal If participant is a former or current cigarette smoker, documents the number of pack-years of smoking [(average number smoked daily)/20] x (number of years smoked) = pack-years] If participant is a former or current cigarette smoker, documents the number of pack-years of smoking [(average number smoked daily)/20] x (number of years smoked) = pack-years] For former or current cigarette smokers only, the number of pack-years of smoking Numeric Values

[(average number of cigarettes smokes daily)/20] x (number of years smoked)

Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-17 09:26:36.973 Risk Factors [php] [php_1]

Free-Form Entry

pack-years
C00707 Alcohol consume six or more drinks frequency AlcConsume6MoreDrinkFreq The rate of occurrence for when the participant/subject consumes six or more drinks containing alcohol on one occasion. It is noted that the meaning of "drinks consumed" differs from one nation and culture to another, so the most common alcoholic beverages likely to be consumed will be defined as well as quantity of each that constitutes a drink (approximately 10 grams of pure ethanol). For example, one bottle of beer (330 ml at 5% ethanol), a glass of wine (140 ml at 12% ethanol), and a shot of spirits (40 ml at 40% ethanol) represent a standard drink of about 13 g of ethanol The rate of occurrence for when the participant/subject consumes six or more drinks containing alcohol on one occasion. It is noted that the meaning of "drinks consumed" differs from one nation and culture to another How often do you have six or more drinks on one occasion? Never;Less than monthly;Monthly;Weekly;Daily or almost daily;Unknown Never;Less than monthly;Monthly;Weekly;Daily or almost daily;Unknown Alphanumeric

History can be obtained from participant/ subject, family member, friend, or chart/ medical record.

Question is from the Alcohol Use Disorders Identification Test (AUDIT) - http://www.who.int/substance_abuse/activities/sbi/en/ Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-18 16:35:19.49 Risk Factors [php] [php_1]

Single Pre-Defined Value Selected

3171659
C11131 Body mass index value BMIVal Value of the participant's body mass index, calculated from height and weight Value of the participant's body mass index, calculated from height and weight BMI Numeric Values

Body mass index (kg/m2)

Adult;Pediatric Exploratory 3.10 2024-02-29 15:58:55.0 Risk Factors [php] [php_1]

Free-Form Entry

0 99
C00708 Alcohol use related to hospitalization indicator AlcUseRelatedHospInd Indicator of whether the participant/subject has been hospitalized for an alcohol-related problem (i.e., esophageal varices, delirium tremens (DTs), cirrhosis and others) Indicator of whether the participant/subject has been hospitalized for an alcohol-related problem (i.e., esophageal varices, delirium tremens (DTs), cirrhosis and others) Have you ever been hospitalized for an alcohol-related problem Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. History can be obtained from participant/ subject, family member, friend, or chart/ medical record.

No references available Adult;Pediatric Supplemental 3.00 2013-07-18 14:26:06.9 Risk Factors [php] [php_1]

Single Pre-Defined Value Selected

3171677
C18770 Tobacco product used other text TobcoProdctUsedOTH The free-text field related to 'Tobacco product used type' specifying other text. Type of tobacco product (e.g. cigarettes, cigars, chewing tobacco or pipe) used by the participant/subject The free-text field related to 'Tobacco product used type' specifying other text. Type of tobacco product (e.g. cigarettes, cigars, chewing tobacco or pipe) used by the participant/subject Other, specify Alphanumeric

History can be obtained from participant/ subject, family member, friend, or chart/ medical record.

No references available Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Risk Factors [php] [php_1] 4000

Free-Form Entry

3170860
C00709 Tobacco cigarettes smoked daily average number TobcoCigaretSmokedDlyAvgNum Average number of cigarettes the participant/subject smokes daily (On the days you smoked cigarettes during the past 30 days, how many cigarettes did you smoke per day, on average?) Average number of cigarettes the participant/subject smokes daily (On the days you smoked cigarettes during the past 30 days, how many cigarettes did you smoke per day, on average?) Average number of cigarettes smoked per day Less than one cigarette per day;1 cigarette per day;2 to 5 cigarettes per day;6 to 15 cigarettes per day (about 1/2 pack);16 to 25 cigarettes per day (about 1 pack);26 to 35 cigarettes per day (about 1 1/2 packs);More than 35 cigarettes per day (about 2 packs or more);Unknown Less than one cigarette per day;1 cigarette per day;2 to 5 cigarettes per day;6 to 15 cigarettes per day (about ½ pack);16 to 25 cigarettes per day (about 1 pack);26 to 35 cigarettes per day (about 1 ½ packs);More than 35 cigarettes per day (about 2 packs or more);Unknown Alphanumeric

Choose Skip if cigarettes an answer in previous question. History can be obtained from participant/ subject, family member, friend, or chart/ medical record.

PhenX Toolkit: https://www.phenxtoolkit.org/index.php - Protocol 1: Tobacco - 30-Day Quantity and Frequency (Adolescent Protocol) #030801 Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-18 14:26:06.9 Risk Factors [php] [php_1]

Single Pre-Defined Value Selected

3170853
C52529 Family history unruptured intracranial aneurysm subarachnoid hemorrhage indicator FamHisUIASAHInd Indicator for whether the participant/subject has a family history of unruptured intracranial aneurysm or subarachnoid hemorrhage Indicator for whether the participant/subject has a family history of unruptured intracranial aneurysm or subarachnoid hemorrhag Is there a family history of unruptured intracranial aneurysm (UIA) or subarachnoid hemorrhage (SAH)? No;Yes No;Yes Alphanumeric

Familial history of 2 or more first degree relatives with unruptured intracranial aneurysms or with history of subarachnoid hemorrhage due to an intracranial aneurysm

Adult;Pediatric Supplemental-Highly Recommended 1.00 2015-02-18 00:00:00.0 Risk Factors [php] [php_1]

Single Pre-Defined Value Selected

C00710 Tobacco current use indicator TobcoUseCurntInd Indicator for whether the participant/subject regularly uses tobacco products (e.g., cigarettes, cigars, chewing tobacco or pipe) at the present time Indicator for whether the participant/subject regularly uses tobacco products (e.g., cigarettes, cigars, chewing tobacco or pipe) at the present tim Current tobacco use? Yes;No;Unknown Yes;No;Unknown Alphanumeric

History can be obtained from participant/ subject, family member, friend, or chart/ medical record.

No references available Adult;Pediatric Core 3.00 2013-07-20 10:21:25.65 Risk Factors [php] [php_1]

Single Pre-Defined Value Selected

3170060
C52531 Family history subarachnoid hemorrhage family member type FamHisSAHFamMemberTyp Specify which family member has a history of subarachnoid hemorrhage Specify which family member has a history of subarachnoid hemorrhag Specify family member with history of SAH Brother;Daughter;Father;Mother;Other;Sister;Son Brother;Daughter;Father;Mother;Other;Sister;Son Alphanumeric Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-01-20 10:47:32.0 Risk Factors [php] [php_1]

Multiple Pre-Defined Values Selected

CSV