CDE Detailed Report

Disease: Cerebral Palsy
Sub-Domain: General Health History
CRF: Medical History

Displaying 1 - 50 of 117
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (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
C22646 Medical history retinopathy of prematurity indicator MedHistRetinPremInd Indicator of whether the participant/subject has been affected by Retinopathy of prematurity Indicator of whether the participant/subject has been affected by Retinopathy of prematurity Retinopathy of prematurity Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:22:09.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C08177 Hemorrhage indicator HemrrhgInd Indicator of the presence of cerebral hemorrhages, regardless of size in any region of the brain Indicator of the presence of cerebral hemorrhages, regardless of size in any region of the brain Presence of cerebral hemorrhages, regardless of size in any region of the brain Yes;No;Unknown;Not assessed Yes;No;Unknown;Not assessed Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22679 Medical history first depressive episode diagnosis age value MedHistFrstDepEpDiagAgeVal Value of a participant's/subject's age when first depressive episode was diagnosed Value of a participant's/subject's age when first depressive episode was diagnosed Age at which participant/subject experienced first depressive episode or was first diagnosed with depression, whoever is earlier (years) Numeric Values Adult;Pediatric Supplemental 1.00 2016-07-27 11:43:54.0 Medical History General Health History Participant History and Family History

Free-Form Entry

year
C17470 Cardiovascular history arrhythmia other text CardioHistArrhythOtherTxt Text description of any cardiac arrhythmia the participant/subject has or had in a form other than atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia, or bradycardia Text description of any cardiac arrhythmia the participant/subject has or had in a form other than atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia, or bradycardia Other, specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History 255

Free-Form Entry

C22658 Medical history bronchiectasis indicator MedHistBronInd Indicator of whether the participant/subject has been diagnosed with brochiectasis Indicator of whether the participant/subject has been diagnosed with brochiectasis Bronchiectasis Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:30:05.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C10543 Cancer head or neck radiation treatment indicator CancerHeadNeckRadiatTreatInd Indicator as to whether the participant's/subject's cancer is or was treated with head or neck radiation Indicator as to whether the participant's/subject's cancer is or was treated with head or neck radiation. Treated with head or neck radiation Yes;No/Not documented;Unknown Yes;No/Not documented;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17482 Diabetes mellitus indicator EndocrineHistDiabetesMellInd Indicator as to whether the participant/subject has diabetes mellitus (type I or type II) Indicator as to whether the participant/subject has diabetes mellitus (type I or type II) Diabetes mellitus (type I or type II) Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19058 Psychiatric history psychotic diagnosis other text PsychHistPsychoticDiagnosOTH The free-text field related to 'Psychiatric history psychotic diagnosis type' specifying other text. Type of psychotic disorder the participant/subject has been diagnosed with, if any The free-text field related to 'Psychiatric history psychotic diagnosis type' specifying other text. Type of psychotic disorder the participant/subject has been diagnosed with, if any Other, specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

C00319 Medical history condition ongoing indicator MedclHistCondOngoingInd Indicator of whether a medical condition/disease experienced by the participant/subject is ongoing Indicator of whether a medical condition/disease experienced by the participant/subject is ongoing Ongoing? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose Yes or No to indicate if the medical condition/disease is still present.

Adult;Pediatric Core 3.00 2013-07-24 11:38:01.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

2736881
C22669 Medical history recurrent urinary tract infect MedHistRecUrnTrctInfInd Indicator of whether participant/subject has/had recurrent urinary tract infections Indicator of whether participant/subject has/had recurrent urinary tract infections Recurrent urinary tract infections Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:36:34.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17460 Cancer history indicator CancerHistInd Indicator as to whether the participant/subject has or had cancer Indicator as to whether the participant/subject has or had cancer. Cancer Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22647 Medical history high myopia indicator MedHistHghMyopInd Indicator of whether the participant/subject has been affected by high myopia Indicator of whether the participant/subject has been affected by high myopia High myopia Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:22:55.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C10506 Genetic diagnosis established indicator GeneticDiagnosEstablishedInd Whether a genetic diagnosis for the disease/disorder was established Whether a genetic diagnosis for the disease/disorder was established Genetic diagnoses established Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-14 03:55:23.71 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22680 Medical history checkup recommend interval complete indicator MedHistChckRecIntInd Indicator of whether or not checkups were completed at recommended intervals Indicator of whether or not checkups were completed at recommended intervals Checkups at recommended intervals Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:44:16.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17471 Cardiovascular history arrhythmia supraventricular tachycardia indicator CardioHistArrhythSupraTachInd Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of supraventricular tachycardia Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of supraventricular tachycardia Supraventricular tachycardia Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22659 Medical history restrictive airway disease indicator MedHistRestAirDsInd Indicator of whether the participant has been diagnosed with restrictive airway disease Indicator of whether the participant has been diagnosed with restrictive airway disease Restrictive airway disease Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:30:36.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C10556 Pregnant ever indicator PregEverInd Indicator as to whether or not the participant/subject has every been pregnant, both term and not to term Indicator as to whether or not the participant/subject has every been pregnant, both term and not to term Pregnant ever (female participants) Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17483 Psychiatric history clinical anxiety diagnosis indicator PsychHistClinAnxietyDiagnosInd Indicator as to whether the participant/subject has had an anxiety diagnosis Indicator as to whether the participant/subject has had an anxiety diagnosis. Anxiety disorder diagnosis Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C19078 Cardiovascular history cardiac surgery other text CardioHistCardSurgOTH The free-text field related to 'Cardiovascular history cardiac surgery type' specifying other text. Type of cardiac surgery or mechanical intervention the participant/subject underwent The free-text field related to 'Cardiovascular history cardiac surgery type' specifying other text. Type of cardiac surgery or mechanical intervention the participant/subject underwent Other, specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

C00321 Medical history for body system indicator MedclHistBodySysInd Indicator of whether the participant/subject has a history of medical problems/conditions for the specific body system. Indicator of whether the participant/subject has a history of medical problems/conditions for the specific body system. Does the participant/subject have a history of any medical problems/conditions in the following body systems? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one for each body system.

Adult;Pediatric Core 3.00 2013-07-22 16:57:17.79 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22670 Medical history Perinatal neurological event indicator MedHistPerNeurEvntInd Indicator of whether participant had a perinatal neurological event Indicator of whether participant had a perinatal neurological event Perinatal neurological event Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:37:58.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17461 Cancer history type text CancerHistTypTxt Text description of the type of cancer the participant/subject was or is diagnosed with Text description of the type of cancer the participant/subject was or is diagnosed with. Type of cancer diagnosed with Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History 255

Free-Form Entry

C22648 Medical history optic neuropathy indicator MedHistOptNeurInd Indicator of whether the participant/subject has been affected by optic neuropathy Indicator of whether the participant/subject has been affected by optic neuropathy Optic neuropathy Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:23:36.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C10507 Genetic diagnosis confirmation type GenDiagnosConfrmTyp Manner in which genetic diagnosis was confirmed Manner in which genetic diagnosis was confirmed Genetic diagnosis confirmation type Participant/subject report;Medical record;Commercial testing;Research testing Participant/subject report;Medical record;Commercial testing;Research testing Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 Medical History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C22681 Medical history difficulty schedule attend healthcare appointment indicator MedHistDiffSchHlthcrApptInd Indicator of whether or not there was difficulty scheduling/attending healthcare appointments Indicator of whether or not there was difficulty scheduling/attending healthcare appointments Difficulty scheduling/attending healthcare appointments Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Exploratory 1.00 2016-07-27 11:45:01.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17472 Cardiovascular history arrhythmia ventricular tachycardia indicator CardioHistArrhythVentTachInd Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of ventricular tachycardia Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of ventricular tachycardia Ventricular tachycardia Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22660 Medical history tracheomalcia indicator MedHistTrachInd Indicator of whether the participant has been diagnosed with tracheomalacia Indicator of whether the participant has been diagnosed with tracheomalacia Tracheomalacia Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:31:00.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C12207 Gastrointestinal therapy take nutrition supplement indicator GITherTakeNutritionSupplInd Indicator whether the participant/subject is taking nutritional supplements Indicator whether the participant/subject is taking nutritional supplements Nutritional supplements Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17484 Psychiatric history clinical anxiety past year indicator PsychHistClinAnxietyPastYrInd Indicator as to whether the participant/subject had clinical anxiety within the last year Indicator as to whether the participant/subject had clinical anxiety within the last year Clinical anxiety within the past year Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

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

Free-Form Entry

C00322 Medical history condition text MedclHistCondTxt Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history Medical history condition Alphanumeric

Record one Medical History term per line. Make sure to record if the following events are in the medical history which are Core items: Any stroke; Ischemic stroke; Hemorrhagic stroke; Hemorrhagic stroke type; 4) Transient ischemic attack (TIA); Carotid stenosis; Epilepsy/ Seizure disorder; Central nervous system infection; Dementia; Head trauma; Head trauma type; Atrial fibrillation (AF)/ flutter; Rheumatic heart disease

SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html) Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

2003874
C22671 Medical history abnormal sleep EEG indicator MedHistAbnSlpEEGInd Indicator of whether a participant/subject has/had an abnormal sleep EEG Indicator of whether a participant/subject has/had an abnormal sleep EEG Abnormal sleep EEG Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:38:48.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17462 Cardiovascular history abnormal echocardiogram decreased left ventricular function indicator CardioHistAbnrmlECGDecLVFnInd Indicator as to whether the participant/subject has or had an abnormal echocardiogram (ECG) specifically exhibiting decreased left ventricular (LV) function Indicator as to whether the participant/subject has or had an abnormal echocardiogram (EKG) specifically exhibiting decreased left ventricular (LV) function Decreased LV function Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22650 Medical history conductive impairment indicator MedHistCondImpInd Indicator of whether the participant/subject has been affected by conductive impairment Indicator of whether the participant/subject has been affected by conductive impairment Conductive impairment Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:24:49.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C10514 Genetic diagnosis point mutation result GenDiagnosPtMutReslt The result of the genetic testing revealed a point mutation describe the position and amino acid change The result of the genetic testing revealed a point mutation describe the position and amino acid change Genetic diagnosis point mutation Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 Medical History General Health History Participant History and Family History 255

Free-Form Entry

C52357 Percent body fat value PercentFatVal Percent body fat calculated value Percent body fat calculated value % Body fat Numeric Values

Percent body fat calculations: Slaughter equations based on the triceps and subscapular skinfolds can be adapted for cerebral palsy. See Table II, Original Slaugter equations and corrections for children with cerebral palsy, in Gurka MJ, Kuperminc MN, Busby MG, Bennis JA, Grossberg RI, Houlihan CM, et al. Assessment and correction of skinfold thickness equations in estimating body fat in children with cerebral palsy. Dev Med Child Neurol. 2010;52(2):e35–e41 equations and corrections.

Gurka MJ, Kuperminc MN, Busby MG, Bennis JA, Grossberg RI, Houlihan CM, et al. Assessment and correction of skinfold thickness equations in estimating body fat in children with cerebral palsy. Dev Med Child Neurol. 2010;52(2):e35–e41; Slaughter MH, Lohman TG, Boileau RA, Horswill CA, Stillman RJ, Van Loan MD, et al. Skinfold equations for estimation of body fatness in children and youth. Hum Biol. 1988;60(5):709–723. Adult;Pediatric Supplemental 1.00 2017-01-12 10:42:26.0 Medical History General Health History Participant History and Family History

Free-Form Entry

0 100
C17473 Cardiovascular history cardiac surgery date CardioHistCardSurgDate Date of most recent cardiac surgery or mechanical intervention performed on the participant/subject Date of most recent cardiac surgery or mechanical intervention performed on the participant/subject Date of most recent surgery Date or Date & Time Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Free-Form Entry

C17485 Psychiatric history clinical depression past year indicator PsychHistClinDepressPastYrInd Indicator as to whether the participant/subject has had clinical depression within the last year Indicator as to whether the participant/subject has had clinical depression within the last year Clinical depression within the past year Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22661 Medical history laryngomalacia indicator MedHistLarInd Indicator of whether the participant has been diagnosed with layrngomalacia Indicator of whether the participant has been diagnosed with layrngomalacia Laryngomalacia Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:31:34.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C12208 Gastrointestinal therapy nutrition supplement type GITherpyNutritionSupplementTyp Type(s) of nutritional supplement(s) being taken by the participant/subject Type(s) of nutritional supplement(s) being taken by the participant/subject If yes, indicate type Beta Carotene;Calcium;Dehydroepiandrosterone (DHEA);Echinacea;Flax Seed Oil;Folic Acid;Ginko;Ginseng;Saw Palmetto;Soy Protein Powder;Soy Supplements;St. John's Wort;Vitamin A;Vitamin C;Vitamin E;Weight Loss Supplements;Wheat Germ;Turmeric;Fiber;Creatine;CoQ10;Other, specify Beta Carotene;Calcium;Dehydroepiandrosterone (DHEA);Echinacea;Flax Seed Oil;Folic Acid;Ginko;Ginseng;Saw Palmetto;Soy Protein Powder;Soy Supplements;St. John's Wort;Vitamin A;Vitamin C;Vitamin E;Weight Loss Supplements;Wheat Germ;Turmeric;Fiber;Creatine;CoQ10;Other, specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Medical History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

2183828
C19760 Medical history strabismus diagnosis indicator MedHistStrbsmsDiagInd Indicator of medical history of strabismus Indicator of medical history of strabismus Strabismus No;Yes;Unknown No;Yes;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2015-02-05 00:00:00.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C00327 Prior traumatic injury indicator PriorTraumInjryInd Indicator of prior traumatic injury found either historically, previous emergency department visits, radiographic findings, or signs or symptoms at time of presentation. Indicator of prior traumatic injury found either historically, previous emergency department visits, radiographic findings, or signs or symptoms at time of presentation. Prior traumatic event Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-19 21:21:51.533 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22672 Medical history behavior difficulty indicator MedHIstBhvDiffInd Indicator of whether participant/subject has/had behavior difficulties Indicator of whether participant/subject has/had behavior difficulties Behavior difficulties Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:39:26.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17463 Cardiovascular history abnormal echocardiogram indicator CardioHistAbnrmlECGInd Indicator as to whether the participant/subject has or had an abnormal echocardiogram (ECG) Indicator as to whether the participant/subject has or had an abnormal echocardiogram (EKG) Abnormal echocardiogram Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22651 Medical history sensori-neural indicator MedHistSensNrlInd Indicator of whether the participant/subject has been affected by sensori-neural impairment Indicator of whether the participant/subject has been affected by sensori-neural impairment Sensori-neural impairment Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:25:24.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C10515 Scoliosis diagnosis indicator ScolDiagnosInd The indicator of whether the participant/subject has been diagnosed with scoliosis The indicator of whether the participant/subject has been diagnosed with scoliosis Scoliosis Yes;No;Unknown History reported and/or confirmed in medical record;History NOT reported and NOT confirmed in medical record;History reported as unknown or could not be collected Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C52358 Epilepsy type EpilepsyTyp Type of epilepsy Type of epilepsy Epilepsy type Medically intractable;Well controlled Medically intractable;Well controlled Alphanumeric

Choose one.

Adult;Pediatric Supplemental 1.00 2017-01-12 11:32:55.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17474 Cardiovascular history cardiac surgery indicator CardioHistCardSurgInd Indicator as to whether the participant/subject has had cardiac surgery or mechanical intervention Indicator as to whether the participant/subject has had cardiac surgery or mechanical intervention Cardiac surgery/mechanical intervention Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17486 Psychiatric history clinical depressive diagnosis indicator PsychHistClinDepressDiagnosInd Indicator as to whether the participant/subject had a depressive disorder diagnosis Indicator as to whether the participant/subject had a depressive disorder diagnosis Depressive disorder diagnosis Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22662 Medical history recurrent lower respiratory tract infection indicator MedHistRecLwRespTrInfInd Indicator of whether the participant/subject has been diagnosed with recurrent lower respiratory tract infections Indicator of whether the participant/subject has been diagnosed with recurrent lower respiratory tract infections Recurrent lower respiratory tract infections Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:32:03.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

CSV