CDE Detailed Report

Disease: Friedreich's Ataxia
Sub-Domain: Clinical Event End Points
CRF: Cardiac End Points

Displaying 1 - 12 of 12
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
C58685 Patient ambulatory status PtAmbStat Status indicating whether the patient is ambulatory or not. Status indicating whether the patient is ambulatory or not. Indicate the ambulatory status of patient Ambulatory;Non-ambulatory Ambulatory;Non-ambulatory Alphanumeric Adult;Pediatric Supplemental 1.00 2020-04-21 15:28:04.0 Cardiac End Points Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C58686 Heart palpitation history indicator HrtPalpHistInd Indicator of whether the patient has a history of heart palpitations. Indicator of whether the patient has a history of heart palpitations. Is there a history of palpitations? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2020-04-21 16:09:42.0 Cardiac End Points Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C58687 Heart symptomatic arrhythmias atrial origin history indicator HrtSymtpmArthmAtrOrigHistInd Indicator of whether the patient has a history of symptomatic arryhtmias documented to be of atrial origin. Indicator of whether the patient has a history of symptomatic arryhtmias documented to be of atrial origin. Is there a history of symptomatic arrhythmias documented to be of atrial origin? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2020-04-21 17:06:32.0 Cardiac End Points Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C58688 Heart symptomatic arrhythmias ventricular origin history indicator HrtSymtpmArthmVentOrigHistInd Indicator of whether the patient has a history of symptomatic arryhtmias documented to be of ventricular origin. Indicator of whether the patient has a history of symptomatic arryhtmias documented to be of ventricular origin. Is there a history of symptomatic arrhythmias documented of ventricular origin? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2020-04-21 17:08:29.0 Cardiac End Points Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C58689 Chest discomfort cardiac cause history indicator ChstDscmftCrdcCauseHistInd Indicator of whether the patient has a history of chest discomfort that is suggestive of a cardiac cause. Indicator of whether the patient has a history of chest discomfort that is suggestive of a cardiac cause. Is there a history of chest discomfort suggestive of a cardiac cause? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2020-04-21 17:10:31.0 Cardiac End Points Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C58690 Syncope history indicator SyncopeHistInd Indicator of whether the patient has a history of syncope. Indicator of whether the patient has a history of syncope. Is there a history of syncope? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2020-04-21 17:12:19.0 Cardiac End Points Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C58691 Dizziness near syncope history indicator DizzyNearSyncopeHistInd Indicator of whether the patient has a history of dizziness or of near syncope Indicator of whether the patient has a history of dizziness or of near syncope Is there a history of dizziness or near syncope? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2020-04-21 17:13:27.0 Cardiac End Points Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C18805 Hospitalization other text HospitOTH The free-text field related to 'Hospitalization reason' specifying other text. Reason why the participant/subject was hospitalized, excluding all surgeries The free-text field related to 'Hospitalization reason' specifying other text. Reason why the participant/subject was hospitalized, excluding all surgeries Other, specify Alphanumeric

Record the reason for each hospitalization within the past year

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Cardiac End Points Clinical Event End Points Outcomes and End Points 4000

Free-Form Entry

C05408 Hospital admission date and time HospitlAdmissDateTime Date (and time, if applicable and known) the participant/subject was admitted to the hospital Date (and time, if applicable and known) the participant/subject was admitted to the hospital Indicate the start date of participant's hospitalization. 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 Cardiac End Points Clinical Event End Points Outcomes and End Points

Free-Form Entry

C10606 American College of Cardiology and the American Heart Association heart failure stage ACCAHAHeartFailStage Stage of the participant/subject's heart failure according to the American College of Cardiology (ACC) and the American Heart Association (AHA) Stage of Heart Failure Stage of the participant/subject's heart failure according to the American College of Cardiology (ACC) and the American Heart Association (AHA) Stage of Heart Failure Classify the subject using the ACC/AHA Stage of Heart Failure. A;B;C;D A - Patients at high risk of developing HF because of the presence of conditions that are strongly associated with the development of HF, such patients have no identified structural or functional abnormalities of the pericardium, myocardium, or cardiac valves and have never shown signs or symptoms of HF;B - Patients who have developed structural heart disease that is strongly associated with the development of HF but who have never shown signs or symptoms of HF;C - Patients who have current or prior symptoms of HF associated with underlying structural heart disease;D - Patients with advanced structural heart disease and marked symptoms of HF at rest despite maximal medical therapy and who require specialized interventions Alphanumeric

Choose only one.

Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, et al. (2005) ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). Circulation, 112,e154-e235. Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 Cardiac End Points Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C10607 Hospitalization past year count HospitPastYrCt Count of all hospitalizations the participant had within the past year for any reason Count of all hospitalizations the participant had within the past year for any reason Indicate the number of hospitalizations the participant had in the past year. Numeric Values

Record the total number of hospitalizations for the past year.

No references available. Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 Cardiac End Points Clinical Event End Points Outcomes and End Points

Free-Form Entry

C10609 Hospitalization reason HospitRsn Reason why the participant/subject was hospitalized, excluding all surgeries Reason why the participant/subject was hospitalized, excluding all surgeries Indicate cause for hospitalization. Cardiovascular;Other, specify Cardiovascular;Other, specify Alphanumeric

Record the reason for each hospitalization within the past year.

No references available. Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Cardiac End Points Clinical Event End Points Outcomes and End Points

Multiple Pre-Defined Values Selected

CSV