{"analyses":[{"ciLowerLimit":"-0.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.9","estimateComment":"The difference in percentage of participants with a primary cardiac event between the pertuzumab and placebo arms. The 95% confidence interval (CI) was estimated using Hauck-Anderson correction.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Treatment Difference","paramValue":"0.4"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.9"},{"groupId":"OG001","value":"0.5"}]}],"title":"Primary Cardiac Event (Composite)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.8"},{"groupId":"OG001","value":"0.3"}]}],"title":"Heart Failure and LVEF Decline"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.1"},{"groupId":"OG001","value":"0.2"}]}],"title":"Cardiac Death (Definite or Probable)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"2364"},{"groupId":"OG001","value":"2405"}],"units":"Participants"}],"description":"Primary cardiac event was defined as either: Heart Failure (New York Heart Association \\[NYHA\\] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology.","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 included participants who received any amount of study medication (chemotherapy, pertuzumab/placebo, or trastuzumab), according to the treatment actually received.","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 Primary Cardiac Event, Final Analysis","type":"SECONDARY","unitOfMeasure":"percentage of participants"}