{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}],"title":"Early dysfunction noted on 2D GLS"},{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}],"title":"No early dysfunction noted on 2D GLS"}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"Patients with moderate CTRCD by 2D echo"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"}],"title":"Early dysfunction noted on 2D GLS"},{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"8"}],"title":"No early dysfunction noted on 2D GLS"}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"10"}],"units":"Participants"}],"title":"Patients without moderate CTRCD by 2D echo"}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"10"}],"units":"Participants"}],"description":"* Cardiac dysfunction for this outcome measure is defined as moderate cancer therapy related cardiac dysfunction (CTRCD) by 2D Echocardiogram Modified Simpson's Biplane Method of LVEF. Moderate CTRCD is defined as \\>10% ejection fraction drop to \\<50%.\n* Patients were assessed for early evidence of dysfunction by strain defined as a relative drop in global longitudinal strain (GLS) by 15% and GLS \\> -17%.","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":"Participants were not included in this outcome measure if they did not have GLS.","reportingStatus":"POSTED","timeFrame":"Baseline and day 1 of each odd numbered cycle (each cycle is 21 days) up to 1 year","title":"Early Detection of Cardiac Dysfunction by 2D Echocardiography Ventricular Strain Compared to 2D Echocardiography Ejection Fraction","type":"SECONDARY","unitOfMeasure":"Participants"}