{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.01","upperLimit":"7.37","value":"5.48"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"* PFS is defined as the time from on study to the first occurrence of progression or death, whichever occurs first.\n* If no event exists, the PFS will be censored at the last follow-up.\n* Progressive disease - At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"Participants enrolled in Arm 2 are not evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Up to 5 years","title":"Progression-free Survival (PFS) (Arm 1 Only)","type":"PRIMARY","unitOfMeasure":"months"}