{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"title":"Early dysfunction noted on 3D Echo"},{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}],"title":"No early dysfunction noted on 3D echo"}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Patients with moderate CTRCD by 2D echo"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"0"}],"title":"Early dysfunction noted on 3D Echo"},{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"9"}],"title":"No early dysfunction noted on 3D echo"}],"denoms":[{"counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"Patients without moderate CTRCD by 2D echo"}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"description":"* Cardiac dysfunction for this outcome measure is defined as moderate cancer therapy related cardiac dysfunction (CTRCD) as assessed by 2D Echocardiogram Modified Simpson's Biplane Method of LVEF. Moderate CTRCD is defined as \\>10% ejection fraction drop to \\<50%.\n* 3D echocardiograms were reviewed for evidence of cardiac dysfunction prior to onset of Moderate CTRCD by 2D echocardiogram. Dysfunction on 3D Echo was defined as \\>10% ejection fraction drop to \\<50%.","groups":[{"description":"* Dexrazoxane will be given intravenously on an outpatient basis over 15 minutes on each day that doxorubicin is given.\n* Dexrazoxane should be given no more than 30 minutes prior to administration of doxorubicin, which is typically given on Day 1 of a 21-day cycle.\n* Dosing is a 10:1 ratio of dexrazoxane to doxorubicin; doxorubicin is typically given at 75 mg/m2, so dexrazoxane dosing would be 750 mg/m2.\n* In the event of a national shortage of dexrazoxane, 72-hour infusional doxorubicin can be used instead of dexrazoxane and bolus doxorubicin..","id":"OG000","title":"Arm 1: Doxorubicin and Upfront Dexrazoxane"},{"description":"* Doxorubicin is given as standard of care. Doxorubicin is typically given at 75 mg/m2 on Day 1 of a 21-day cycle.\n* Starting with cycle 5, standard of care dexrazoxane (75 mg/m2) will be given for 4 cycles.\n* The last 10 patients enrolled after completion of enrollment to Arm 1 will be enrolled to Arm 2.","id":"OG001","title":"Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"13 participants were removed due to lack of analyzable 3D echo prior to onset of Moderate CTRCD or end of study.","reportingStatus":"POSTED","timeFrame":"Baseline and day 1 of each odd numbered cycle (each cycle is 21 days) up to 1 year","title":"Ability of 3D Echocardiogram to Serve as an Early Marker of Cardiac Dysfunction Compared to 2D Echocardiogram Modified Simpson's Biplane Method of LVEF","type":"SECONDARY","unitOfMeasure":"Participants"}