{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1074"},{"groupId":"OG001","value":"1090"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1084"},{"groupId":"OG001","value":"1093"}],"units":"Participants"}],"description":"An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs are reported based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.","groups":[{"description":"Participants were administered paclitaxel, 80 mg/m\\^2, IV infusion QW for maximum of 36 weeks followed by dose-dense doxorubicin, 60 mg/m\\^2 or dose-dense epirubicin, 90 mg/m\\^2 IV (investigator's choice) plus cyclophosphamide, 600 mg/m\\^2, IV repeated every Q2W for a maximum of 20 weeks supported with G-CSF or GM-CSF treatment.","id":"OG000","title":"Chemotherapy"},{"description":"Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m\\^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m\\^2 or dose-dense epirubicin, 90 mg/m\\^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m\\^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose.","id":"OG001","title":"Atezolizumab and Chemotherapy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Evaluable Population included all participants who received any amount of any study drug.","reportingStatus":"POSTED","timeFrame":"Up to 5 years","title":"Number of Participants With Adverse Events (AE)","type":"SECONDARY","unitOfMeasure":"Participants"}