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
C55989 Regular aerobic exercise indicator RegularAerobicExerciseInd Indicator related to whether or not the participant/subject participates in regular aerobic exercise Indicator related to whether or not the participant/subject participates in regular aerobic exercise Regular aerobic exercise No;Yes;Unknown No;Yes;Unknown Alphanumeric Adult;Pediatric Supplemental-Highly Recommended 1.00 2017-06-05 10:05:06.0 Behavioral History [php] [php_1]

Single Pre-Defined Value Selected

C55993 Regular aerobic exercise days week number RglrArbcExrcsDysWkNum Number of days per typical week that the participant/subject engages in aerobic exercises Number of days per typical week that the participant/subject engages in aerobic exercises How many times/week do you get regular aerobic exercise? 0;1-2;3-5;6-7 0;1-2;3-5;6-7 Alphanumeric Adult;Pediatric Exploratory 1.00 2017-06-05 10:17:15.0 Behavioral History [php] [php_1]

Single Pre-Defined Value Selected

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 3.00 2013-07-18 16:35:19.49 Behavioral History [php] [php_1]

Single Pre-Defined Value Selected

3171659
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 Behavioral History [php] [php_1] 4000

Free-Form Entry

3170860
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? (e.g., esophageal varices, delirium tremens (DTs), cirrhosis, etc.) 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 Supplemental 3.00 2013-07-18 14:26:06.9 Behavioral History [php] [php_1]

Single Pre-Defined Value Selected

3171677
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

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 Behavioral History [php] [php_1]

Single Pre-Defined Value Selected

3170853
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 Behavioral History [php] [php_1]

Single Pre-Defined Value Selected

3170060
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 Behavioral History [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 2013-07-20 10:21:25.65 Behavioral History [php] [php_1]

Single Pre-Defined Value Selected

3170080
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 Supplemental 3.00 2013-07-18 14:26:06.9 Behavioral History [php] [php_1]

Free-Form Entry

0 120 year 2524471
C00712 Subscribed drug or substance illicitly used category SbscrbdDrgSubIllctUseCat Category of illegal drugs, prescription, or over-the-counter drugs subscribed by the participant/subject, and used for purposes other than those for which they are meant to be used, or in large amounts Category of illegal drugs, prescription, or over-the-counter drugs subscribed by the participant/subject, and used for purposes other than those for which they are meant to be used, or in large amounts If YES, specify illicit drug type(s) used Sedatives (e.g., sleeping pills, barbiturates, Seconal, Quaaludes, or Chloral Hydrate);Tranquilizers or anti-anxiety drugs (e.g., Valium, Librium, muscle relaxants, or Xanax);Painkillers (e.g., Codeine, Darvon, Percodan, Dilaudid, or Demerol);Stimulants (e.g., Preludin, Benzedrine, Methadrine, uppers, or speed);Marijuana, hash, THC, or grass;Cocaine or crack;Hallucinogens (e.g., Ecstasy, LSD, mescaline, psilocybin, PCP, angel dust, or peyote);Inhalants or Solvents (e.g., amyl nitrate, nitrous oxide, glue, toluene, or gasoline;Heroin;Other, specify (e.g., Methadone, Elavil, steroids, Thorazine, or Haldol) Sedatives (e.g., sleeping pills, barbiturates, Seconal, Quaaludes, or Chloral Hydrate);Tranquilizers or anti-anxiety drugs (e.g., Valium, Librium, muscle relaxants, or Xanax);Painkillers (e.g., Codeine, Darvon, Percodan, Dilaudid, or Demerol);Stimulants (e.g., Preludin, Benzedrine, Methadrine, uppers, or speed);Marijuana, hash, THC, or grass;Cocaine or crack;Hallucinogens (e.g., Ecstasy, LSD, mescaline, psilocybin, PCP, angel dust, or peyote);Inhalants or Solvents (e.g., amyl nitrate, nitrous oxide, glue, toluene, or gasoline;Heroin;Other, specify (e.g., Methadone, Elavil, steroids, Thorazine, or Haldol) Alphanumeric

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

PhenX Toolkit - Substances - Lifetime Use Protocol #031100: https://www.phenxtoolkit.org/index.php Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Behavioral History [php] [php_1]

Multiple Pre-Defined Values Selected

3171797
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 Behavioral History [php] [php_1]

Free-Form Entry

0 120 year 2008447
C00713 Drug or substance current illicit use indicator DrgSubstCurrntIllicitUseInd Indicator of participant's/subject's use of illegal drugs, prescription or over-the-counter drugs in the past year for purposes other than those for which they are meant to be used, or in large amounts Indicator of participant's/subject's use of illegal drugs, prescription or over-the-counter drugs in the past year for purposes other than those for which they are meant to be used, or in large amounts Current drug user? (Use of any illicit drug within the past year) 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 Supplemental-Highly Recommended 3.00 2013-07-20 10:21:25.65 Behavioral History [php] [php_1]

Single Pre-Defined Value Selected

3171724
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 Supplemental 3.00 2013-07-18 14:26:06.9 Behavioral History [php] [php_1]

Free-Form Entry

0 120 year 2178045
C00714 Behavioral history assessment date and time BehavrlHistAssmtDateTime Date (and time, if applicable and known) the participant/subject behavioral history was taken Date (and time, if applicable and known) the participant/subject behavioral history was take Date behavioral history taken 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.).
Supplemental - Highly Recommended based on study type, disease stage and disease type.

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

Free-Form Entry

3170040
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 3.00 2013-07-18 16:35:19.49 Behavioral History [php] [php_1]

Single Pre-Defined Value Selected

3171647
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

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

No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-20 10:21:25.65 Behavioral History [php] [php_1]

Multiple Pre-Defined Values Selected

3179449v1
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-Highly Recommended 3.00 2013-07-18 14:26:06.9 Behavioral History [php] [php_1]

Single Pre-Defined Value Selected

3171540
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

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 Behavioral History [php] [php_1]

Single Pre-Defined Value Selected

3171627
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

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

No references available Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-20 10:21:25.65 Behavioral History [php] [php_1]

Single Pre-Defined Value Selected

3171578
C18670 Subscribed drug or substance illicitly used category other text SbscrbdDrgSubIllctUseCatOTH The free-text field related to 'Subscribed drug or substance illicitly used category' specifying other text. Category of illegal drugs, prescription, or over-the-counter drugs the participant/subject used for purposes other than those for which they are meant to be used, or in large amounts Subscribed drug substance illicitly used category specifying other text. Category of illegal drugs, prescription, or over-the-counter drugs the participant/subject used for purposes other than those for which they are meant to be used, or in large amounts Other, specify Alphanumeric

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

PhenX Toolkit - Substances - Lifetime Use Protocol #031100: https://www.phenxtoolkit.org/index.php Adult;Pediatric Supplemental 1.10 2022-06-24 11:33:13.0 Behavioral History [php] [php_1] 4000

Free-Form Entry

3171797
CSV