{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"720"},{"groupId":"OG001","value":"740"}],"units":"Participants"}],"description":"An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was any AE that met any of the following criteria: fatal (i.e., the AE actually causes or leads to death); life-threatening (i.e., the AE, in the view of the investigator, placed the participant at immediate risk of death); required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity (i.e., the AE results in substantial disruption of the 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 the investigator's judgment.","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":"COUNT_OF_PARTICIPANTS","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":"Number of Participants With AEs and SAEs Leading to Death","type":"SECONDARY","unitOfMeasure":"Participants"}