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 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
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;Ginkgo;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;Ginkgo;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
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

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

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

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

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

C13520 Dysphagia indicator DysphagiaInd Did the participant/subject have dysphagia (difficulty swallowing) identified at bedside assessment? The dysphagia screening should utilize a validated tool that incorporates a swallow assessment and an assessment of level of consciousness and neurological function. The indicator of dysphagia (difficulty swallowing) identified at bedside assessment; the dysphagia screening should utilize a validated tool that incorporates a swallow assessment and an assessment of level of consciousness and neurological function. Dysphagia indicator Yes;No;Unknown Yes;No;Unknown Alphanumeric

The dysphagia screening should utilize a validated tool that incorporates a swallow assessment and an assessment of level of consciousness and neurological function.

Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17464 Cardiovascular history abnormal echocardiogram left ventricular hypertrophy indicator CardioHistAbnrmlECGLVHInd Indicator as to whether the participant/subject has or had an abnormal echocardiogram (ECG) specifically exhibiting left ventricular hypertrophy (LVH) Indicator as to whether the participant/subject has or had an abnormal echocardiogram (EKG) specifically exhibiting left ventricular hypertrophy (LVH) LVH 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

C19769 Medical history pulmonary aspiration diagnosis indicator MedHistPlmnryAspirDiagInd Indicator of history of aspiration Indicator of history of aspiration Pulmonary aspiration diagnosis indicator 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

C00328 Prior traumatic injury type PriorTraumInjryType General location of traumatic injury, if evidence of prior traumatic injury General location of traumatic injury, if evidence of prior traumatic injury Prior traumatic injury type Brain Injury;Spine Injury;Other Extracranial Injury Brain Injury;Spine Injury;Other Extracranial Injury Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-19 21:21:51.533 Medical History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C22673 Medical history autism indicator MedHistAutInd Indicator of whether participant/subject has Autism Indicator of whether participant/subject has Autism Autism Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:40:25.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17475 Cardiovascular history cardiac surgery type CardioHistCardSurgTyp Type of cardiac surgery or mechanical intervention the participant/subject underwent Type of cardiac surgery or mechanical intervention the participant/subject underwent If yes, indicate type (choose all that apply) Coronary artery bypass graft;Cardiac valve surgery, including non-open surgery;Pacemaker;Implantable cardiac defibrillator;Other, specify Coronary artery bypass graft (CABG);Cardiac valve surgery, including non-open surgery (i.e. percutaneous valvuloplasty);Pacemaker;Implantable cardiac defibrillator;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

Multiple Pre-Defined Values Selected

C22652 Medical history recurrent ear infection indicator MedHistReccEarInfInd Indicator of whether the participant/subject has been affected by recurrent ear infections Indicator of whether the participant/subject has been affected by recurrent ear infections Recurrent ear infections Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:25:54.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C10516 Scoliosis maximum spine curvature measurement ScolMaxSpnCrvtrMsrmnt The maximum curvature of the spine in degrees for a participant/subject who has been diagnosed with scoliosis. The maximum curvature of the spine in degrees for a participant/subject who has been diagnosed with scoliosis. Scoliosis maximum spine curvature measurement Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 Medical History General Health History Participant History and Family History

Free-Form Entry

C17488 Psychiatric history psychotic diagnosis type PsychHistPsychoticDiagnosTyp Type of psychotic disorder the participant/subject has been diagnosed with, if any Type of psychotic disorder the participant/subject has been diagnosed with, if any If yes, choose all disorders that apply Schizophrenia;Bipolar disorder;Depression with psychotic features;Dementia with psychotic ideation;Other, specify Schizophrenia;Bipolar disorder;Depression with psychotic features;Dementia with psychotic ideation;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

Multiple Pre-Defined Values Selected

C00312 Body system category BodySysCat Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems. Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems. Body System Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify: Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify: Alphanumeric

Record the appropriate body system for each line of medical history.

Review of Symptoms from Centers for Medicare and Medicaid Services https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

2002895
C22663 Medical history gastroesophageal reflux disease (GERD) indicator MedHistGERDInd Indicator of whether the participant/subject has/had gastroesophageal reflux disease Indicator of whether the participant/subject has/had gastroesophageal reflux disease Gastroesophageal reflux disease Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:33:08.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C14126 Seizure classification type SeizClassTyp The type of seizures present by classification. The type of seizures present by classification. Seizure classification type Generalized;Focal;Unclassified Generalized;Focal;Unclassified seizures are considered unidentifiable due to lack of data and do not fit in to the aforementioned categories for Generalized and Focal Seizures Alphanumeric Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Medical History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C17465 Cardiovascular history abnormal echocardiogram other text CardioHistAbnrmlECGOtherTxt Text description of any abnormal characteristics other than left ventricular hypertrophy (LVH), or decreased left ventricular (LV) function that the participant/subject has ever exhibited on an echocardiogram (ECG) Text description of any abnormal characteristics other than left ventricular hypertrophy (LVH), or decreased left ventricular (LV) function that the participant/subject has ever exhibited on an echocardiogram (EKG) 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

C19835 Pain indicator PainInd Indicator of pain present Indicator of pain present Pain indicator 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

C05460 Seizure indicator SeizInd Indicator of seizure activity Indicator of seizure activity Seizures/Epilepsy Yes;No;Suspected;Unknown Yes;No;Suspected;Unknown Alphanumeric McHugh GS, Engel DC, Butcher I, et al. Prognostic value of secondary insults in traumatic brain injury: results from the IMPACT study. J Neurotrauma. 2007;24(2):287–293. Signorini DF, Andrews PJ, Jones PA, et al. Adding insult to injury: the prognostic value of early secondary insults for survival after traumatic brain injury. J Neurol Neurosurg Psychiatry. 1999;66(1):26–31. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22674 Medical history obsessive compulsive disorder indicator MedHistOCDInd Indicator of whether participant/subject has Obsessive Compulsive Disorder (OCD) Indicator of whether participant/subject has Obsessive Compulsive Disorder (OCD) Obsessive Compulsive Disorder (OCD) Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:40:50.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17476 Cardiovascular history condition indicator CardioHistCondInd Indicator as to whether the participant/subject has or had a cardiac condition or complication Indicator as to whether the participant/subject has or had a cardiac condition or complication Cardiac condition 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

C22653 Medical history respiratory support indicator MedHistRespSuppInd Indicator of whether the participant/subject utilizes respiratory support/ventilation assist Indicator of whether the participant/subject utilizes respiratory support/ventilation assist Respiratory support/ventilation assist Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:26:36.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C10520 Vision affected by disease indicator VisAffectDisInd The indicator of whether the disease/disorder has affected the participant's/subject's vision The indicator of whether the disease/disorder has affected the participant's/subject's vision Is vision affected 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

C17489 Psychotic disorder indicator PsychoDisorderInd Indicator as to whether the participant/subject has had a psychotic disorder diagnosis. Indicator as to whether the participant/subject has had a psychotic disorder diagnosis. Psychotic 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

C00313 Medical history condition SNOMED CT code MedclHistCondSNOMEDCTCode Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject Medical History Term Alphanumeric

Code each of the medical history conditions using SNOMED CT

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 255

Free-Form Entry

C22664 Medical history delayed gastric empty indicator MedHistDlyGasEmpInd Indicator of whether the participant/subject has/had delayed gastric emptying Indicator of whether the participant/subject has/had delayed gastric emptying Delayed gastric emptying Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:33:37.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C14127 Seizure generalized classification type SeizGenClassTyp The type of generalized epileptic seizures, considered to originate at some point within, and rapidly engage, bilaterally distributed networks and may include such bilateral networks as ortical and subcortical structures, but do not necessarily include the entire cortex, experienced by the participant/subject. The type of generalized epileptic seizures, considered to originate at some point within, and rapidly engage, bilaterally distributed networks, experienced by the participant/subject. Seizure generalized classification type Tonic clonic;Absence;Typical;Atypical;Myoclonic absence;Eyelid myoclonia;Myoclonic;Myoclonic atonic;Myoclonic tonic;Clonic;Tonic;Atonic;Epileptic spasms, focal or generalized Tonic clonic (in any combination);Absence;Absence-Typical;Absence-Atypical;Absence-Myoclonic absence;Absence-Eyelid myoclonia;Myoclonic (not otherwise specified);Myoclonic-Myoclonic atonic;Myoclonic-Myoclonic tonic;Clonic;Tonic;Atonic;Epileptic spasms, focal or generalized Alphanumeric Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17466 Cardiovascular history arrhythmia atrial fibrillation indicator CardioHistArrhythAtrialFibInd Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of atrial fibrillation Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of atrial fibrillation Atrial Fibrillation 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

C19836 Pain anatomic site text PainAntmicSiteTxt Anatomic Site of body pain Anatomic Site of body pain If yes, where Alphanumeric Adult;Pediatric Supplemental 1.00 2015-02-05 00:00:00.0 Medical History General Health History Participant History and Family History 255

Free-Form Entry

C06020 Urinary incontinence past three months indicator UrinIncntPstThreeMoInd Indicator of involuntary urine leakage (incontinence) within the last three months. Urinary incontinence is defined by International Continence Society (Abrams et al. 2002) as the complaint of any involuntary leakage of urine. Indicator of involuntary urine leakage (incontinence) within the last three months. Urinary incontinence is defined by International Continence Society (Abrams et al. 2002) as the complaint of any involuntary leakage of urine. Urinary incontinence past three months frequency No;Yes;Not applicable;Unknown No;Yes;Not applicable;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C22675 Medical history oppositional defiance indicator MedHIstOppDefInd Indicator of whether participant/subject displays oppositional defiance Indicator of whether participant/subject displays oppositional defiance Oppositional defiance Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:41:22.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C17477 Cardiovascular history congenital heart disease indicator CardioHistCongHeartDiseaseInd Indicator as to whether the participant/subject has or had a congenital heart disease Indicator as to whether the participant/subject has or had a congenital heart disease Congenital heart disease 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

C22654 Medical history respiratory support type MedHistRespSuppTyp Type of respiratory support utilized by a participant/subject Type of respiratory support utilized by a participant/subject If yes, indicate type Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:27:42.0 Medical History General Health History Participant History and Family History 500

Free-Form Entry

C10521 Hearing affected by disease indicator HearAffectDisInd The indicator of whether the disease/disorder has affected the participant's/subject's hearing The indicator of whether the disease/disorder has affected the participant's/subject's hearing Is hearing affected 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

C18666 Body system other text BodySysOTH The free-text field related to 'Body system category' specifying other text. Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured Free-text category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems. Other, specify Alphanumeric Review of Symptoms from Centers for Medicare and Medicaid Services https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Medical History General Health History Participant History and Family History 4000

Free-Form Entry

2002895
C00314 Medical history taken date and time MedclHistTakenDateTime Date (and time, if applicable and known) the participant/subject's medical history was taken Date (and time, if applicable and known) the participant/subject's medical history was taken Date Medical 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.).

Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Free-Form Entry

2179659
C22665 Medical history chronic constipation indicator MedHIstChrnConsInd Indicator of whether the participant/subject has/had chronic constipation Indicator of whether the participant/subject has/had chronic constipation Chronic constipation Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 1.00 2016-07-27 11:34:16.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C14130 Seizure focal classification type SeizFocClassTyp The type of focal epileptic seizures, considered to originate within networks limited to one hemisphere, which may be discretely localized or more widely distributed, and may originate in subcortical structures, experience by the participant/subject. The type of focal epileptic seizures, considered to originate within networks limited to one hemisphere, which may be discretely localized or more widely distributed, and may originate in subcortical structures, experience by the participant/subject. Seizure focal classification type Without impairment of consciousness or responsiveness;With observable motor or autonomic components;Involving subjective sensory or psychic phenomena only;With impairment of consciousness or responsiveness;Evolving to a bilateral, convulsive seizure Without impairment of consciousness or responsiveness;Without impairment of consciousness or responsiveness-With observable motor or autonomic components (roughly corresponds to the concept of "simple partial seizure");Without impairment of consciousness or responsiveness-Involving subjective sensory or psychic phenomena only (corresponds to the concept of "aura");With impairment of consciousness or responsiveness (roughly corresponds to the concept of "complex partial seizure");Evolving to a bilateral, convulsive seizure (involving tonic, clonic, or tonic and clonic components replaces the term "secondarily generalized seizure") Alphanumeric Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Medical History General Health History Participant History and Family History

Multiple Pre-Defined Values Selected

C17467 Cardiovascular history arrhythmia atrial flutter indicator CardioHistArrhythAtrialFlutInd Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of atrial flutter Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of atrial flutter Atrial Flutter 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

C19856 Medical history gastrostomy tube since last visit indicator MedHistGtubeSLVInd Indicator of Gtube placed since last study visit Indicator of Gtube placed since last study visit Gastrostomy tube No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

C06192 Fecal incontinence past three month average frequency FclInctPstThrMoAvgFreq Average frequency of incontinence to solid or liquid stools within the last three months. Fecal incontinence is defined as involuntary passage of stools. Average frequency of incontinence to solid or liquid stools within the last three months. Fecal incontinence is defined as involuntary passage of stools. Fecal incontinence past three month average frequency Never;Not applicable;Less than once per month;Not every day but at least once per week;Not every week but at least once per month;Once every month;One episode per day;Two or more episodes per day;Unknown Never;Not applicable;Less than once per month;Not every day but at least once per week;Not every week but at least once per month;Once every month;One episode per day;Two or more episodes per day;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

CSV