{"analyses":[{"ciLowerLimit":"-1.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.9","estimateComment":"95% CI was estimated using Hauck-Anderson correction.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Treatment Difference","paramValue":"-0.1"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.9"},{"groupId":"OG001","value":"3.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2364"},{"groupId":"OG001","value":"2405"}],"units":"Participants"}],"description":"Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB).","groups":[{"description":"Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\\^2 + epirubicin 90-120 mg/m\\^2 or doxorubicin 50 mg/m\\^2 + cyclophosphamide 500-600 mg/m\\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\\^2 for 3 cycles, 75 mg/m\\^2 in first cycle and 100 mg/m\\^2 in subsequent cycles, or 75 mg/m\\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\\^2 or epirubicin 90-120 mg/m\\^2 + cyclophosphamide 500-600 mg/m\\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).","id":"OG000","title":"Pertuzumab + Trastuzumab + Chemotherapy"},{"description":"Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\\^2 + epirubicin 90-120 mg/m\\^2 or doxorubicin 50 mg/m\\^2 + cyclophosphamide 500-600 mg/m\\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\\^2 for 3 cycles, 75 mg/m\\^2 in first cycle and 100 mg/m\\^2 in subsequent cycles, or 75 mg/m\\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\\^2 or epirubicin 90-120 mg/m\\^2 + cyclophosphamide 500-600 mg/m\\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\\^2 + carboplatin AUC 6 (up to 900 mg).","id":"OG001","title":"Placebo + Trastuzumab + Chemotherapy"}],"paramType":"NUMBER","populationDescription":"Safety population","reportingStatus":"POSTED","timeFrame":"Baseline until the end of follow-up (median [range] follow-up: 11.3 [0.1-12.9] years)","title":"Percentage of Participants With Secondary Cardiac Event, Final Analysis","type":"SECONDARY","unitOfMeasure":"percentage of participants"}