CDE Detailed Report

Disease: Friedreich's Ataxia
Sub-Domain: General Health History
CRF: Medical History

Displaying 1 - 47 of 47
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
C10539 Diabetes first diagnosis age value DiabetFrstDiagnosisAgeVal Value representing the age, in years, at which the participant/subject was first diagnosed with diabetes mellitus Value representing the age, in years, at which the participant/subject was first diagnosed with diabetes mellitus Indicate age when diabetes was first diagnosed Numeric Values

Answer should be recorded in years.

No references available 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

year
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 No references available 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

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 No references available 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

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 Constitutional symptoms (e.g., fever, weight loss);Eyes;Ears, Nose, Mouth, Throat;Cardiovascular;Respiratory;Gastrointestinal;Genitourinary;Musculoskeletal;Integumentary (skin and/or breast);Psychiatric;Endocrine;Hematologic/Lymphatic;Allergic/Immunologic;Hepatobiliary Constitutional symptoms (e.g., fever, weight loss);Eyes;Ears, Nose, Mouth, Throat;Cardiovascular;Respiratory;Gastrointestinal;Genitourinary;Musculoskeletal;Integumentary (skin and/or breast);Psychiatric;Endocrine;Hematologic/Lymphatic;Allergic/Immunologic;Hepatobiliary Alphanumeric

Enter all significant medical history items, including surgeries, EXCEPT the problem/condition that is the focus of this study. Use only one line per description.;Each body system is pre-populated on the case report form. Record the physical exam results for each.

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 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
C17478 Cardiovascular history heart failure indicator CardioHistHeartFailureInd Indicator as to whether the participant/subject has ever experienced heart failure Indicator as to whether the participant/subject has ever experienced heart failure Heart failure Yes;No;Unknown Yes;No;Unknown Alphanumeric No references available 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

C10541 Diabetes treatment type DiabetTreatTyp Type of treatment the participant/subject is receiving or has received for diabetes mellitus Type of treatment the participant/subject is receiving or has received for diabetes mellitus Indicate the treatments taken for diabetes Diet;Oral medication;Insulin;None Diet;Oral medication;Insulin;None Alphanumeric

Choose all that apply

No references available 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

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

Enter all significant medical history items, including surgeries, EXCEPT the problem/condition that is the focus of this study. Use only one line per description.;Each body system is pre-populated on the case report form. Record the physical exam results for each.

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
C17468 Cardiovascular history arrhythmia bradycardia indicator CardioHistArrhythBradycardInd Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of bradycardia Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of bradycardia Bradycardia Yes;No;Unknown Yes;No;Unknown Alphanumeric No references available 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

C17479 Cardiovascular history ischemia heart disease indicator CardioHistIschHeartDiseaseInd Indicator as to whether the participant/subject has or had ischemia heart disease Indicator as to whether the participant/subject has or had ischemia heart disease Ischemia heart disease Yes;No;Unknown Yes;No;Unknown Alphanumeric No references available 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

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. If Yes, treated with head or neck radiation? Yes;No/Not documented;Unknown Yes;No/Not documented;Unknown Alphanumeric

History can also be obtained from a family member, friend, or chart/ medical record. If the informant is unable to answer the question or is deemed unreliable (e.g., the participant/ subject has dementia) the history should be obtained from the medical record. Unknown includes the scenario where information in not documented in the medical record.

No references available 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

C19057 Diabetes mellitus complications other text EndocrineHistDiabMellCompliOTH The free-text field related to 'Diabetes mellitus complications type' specifying other text. Type(s) of complications related to diabetes mellitus the participant/subject has experienced or is experiencing The free-text field related to 'Diabetes mellitus complications type' specifying other text. Type(s) of complications related to diabetes mellitus the participant/subject has experienced or is experiencing Other, specify Alphanumeric

Choose all that apply

No references available 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

C17469 Cardiovascular history arrhythmia indicator CardioHistArrhythInd Indicator as to whether the participant/subject has or had a cardiac arrhythmia Indicator as to whether the participant/subject has or had a cardiac arrhythmia Arrhythmia Yes;No;Unknown Yes;No;Unknown Alphanumeric No references available 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

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.).

No references available 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
C17480 Diabetes mellitus complications type EndocrineHistDiabMellCompliTyp Type(s) of complications related to diabetes mellitus the participant/subject has experienced or is experiencing Type(s) of complications related to diabetes mellitus the participant/subject has experienced or is experiencing Indicate the complications of diabetes Nephropathy;Neuropathy;Retinopathy;Other, specify;None Nephropathy;Neuropathy;Retinopathy;Other, specify;None Alphanumeric

Choose all that apply

No references available 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

C10546 Depression first episode diagnosed age value DepressFrstEpisodDiagAgeVale Value representing the age, in years, at which the participant/subject experienced her or his first depressive episode or was first diagnosed with depression, whichever is earlier Value representing the age, in years, at which the participant/subject experienced her or his first depressive episode or was first diagnosed with depression, whichever is earlier Age at which participant/subject experienced first depressive episode or was first diagnosed with depression, whichever is earlier Numeric Values

Answer should be recorded in years.

No references available 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

year
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

Choose all that apply

No references available 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

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 No references available 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

C00315 Medical history global assessment indicator MedclHistGlobalAssmtInd Indicator of whether the participant/subject has a history of any medical problems/conditions Indicator of whether the participant/subject has a history of any medical problems/conditions Documented medical history: Yes;No;Unknown Yes;No;Unknown Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

3145578
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 No references available 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

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 No references available 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

Choose all that apply

No references available 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

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 No references available 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

C00316 Medical history condition end date and time MedclHistCondEndDateTime Date (and time, if applicable and known) for the end of an event in the participant's/subject's medical history Date (and time, if applicable and known) for the end of an event in the participant's/subject's medical history End Date 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.).

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Free-Form Entry

3145557
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 No references available 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

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. If Yes, type of cancer diagnosed with Alphanumeric No references available 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

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 No references available 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

C00317 Medical history condition start date and time MedclHistCondStrtDateTime Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history Start Date 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.).

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History General Health History Participant History and Family History

Free-Form Entry

2543596
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 No references available 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

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 No references available 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

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

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.).

No references available 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

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 Yes;No Alphanumeric

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

No references available 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

2736881
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 No references available 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

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 No references available 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

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 No references available 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

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.

No references available 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

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 No references available 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

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 No references available 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

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 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

Choose all that apply

No references available 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

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 Term Alphanumeric

Enter all significant medical history items, including surgeries, EXCEPT the problem/condition that is the focus of this study. Use only one line per description.

No references available 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
C17487 Psychiatric history psychotic diagnosis text PsychHistPsychoticDiagnosTxt Text identification of any psychotic disorder diagnosis made for the participant/patient. Text identification of any psychotic disorder diagnosis made for the participant/patient. Psychotic disorder diagnosis description Alphanumeric No references available 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

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 No references available 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

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 No references available 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

C06358 Diabetes mellitus type DiabetesMellitusTyp Type of diabetes mellitus Type of diabetes mellitus Indicate type Type 1;Type 2 Type 1;Type 2 Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Medical History General Health History Participant History and Family History

Single Pre-Defined Value Selected

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

Choose all that apply

No references available 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

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 No references available 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

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 No references available 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

CSV