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Severity described the intensity of an event and was graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening consequences; urgent intervention indicated; and Grade 5: Death related to AE. Serious TEAEs were defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires inpatient hospitalization, or causes prolongation of existing hospitalization.","groups":[{"description":"T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.","id":"OG000","title":"Part 1: DS-8201a Low Dose"},{"description":"T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.","id":"OG001","title":"Part 1: DS-8201a Medium Dose"},{"description":"T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.","id":"OG002","title":"Part 1: DS-8201a High Dose"},{"description":"All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in the continuation phase.","id":"OG003","title":"Part 2a: DS-8201a Low Dose"},{"description":"All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in the continuation phase.","id":"OG004","title":"Part 2b (Exploratory): DS-8201a Low Dose"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Adverse event data were assessed in the Safety Analysis Set t data cut-off date of 21 March 2019.","reportingStatus":"POSTED","timeFrame":"Day 0 to Day 47 post last dose","title":"Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)","type":"SECONDARY","unitOfMeasure":"Participants"}