{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"93.3"},{"groupId":"OG001","value":"98.8"}]}],"title":"AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8.1"},{"groupId":"OG001","value":"12.7"}]}],"title":"SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"720"},{"groupId":"OG001","value":"740"}],"units":"Participants"}],"description":"AE=any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. AE can therefore be any unfavorable \\& unintended sign (including abnormal laboratory finding), symptom/disease temporally associated with use of a medicinal product, whether or not considered related to medicinal product. SAE=any AE that met any given criteria: fatal (i.e. AE causes/leads to death); life-threatening (i.e. AE, in view of investigator, placed the participant at immediate risk of death); required/prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity (i.e. AE results in substantial disruption of participant's ability to conduct normal life functions); congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug; significant medical event in investigator's judgment. Percentages have been rounded off.","groups":[{"description":"Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.","id":"OG000","title":"Trastuzumab"},{"description":"Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.","id":"OG001","title":"Trastuzumab Emtansine"}],"paramType":"NUMBER","populationDescription":"SE population included all randomized participants who received any amount of study treatment.","reportingStatus":"POSTED","timeFrame":"From signing of informed consent till end of follow up (up to approximately 131 months)","title":"Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}