{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"429"},{"groupId":"OG001","value":"397"}]}],"title":"TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"67"}]}],"title":"TESAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"434"},{"groupId":"OG001","value":"417"}],"units":"Participants"}],"description":"An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant administered a medicinal product and which did not necessarily had a causal relationship with this treatment. A serious adverse event (SAE) was an AE occurring during any study phase, that fulfilled 1 or more of following criteria: resulted in death, was immediately life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, was congenital abnormality or birth defect, and was an important medical event that jeopardized participant or required medical treatment to prevent 1 of outcomes listed above. TEAE was any AE that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after initiation of the study drug until the 40-day (+7 days) safety follow-up visit.","groups":[{"description":"Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.","id":"OG000","title":"T-DXd"},{"description":"Participants received Investigator's choice single-agent chemotherapy (capecitabine 1000 or 1250 mg/m\\^2 orally twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles, paclitaxel 80 mg/m\\^2 via IV infusion qw in 3-week cycles or nab-paclitaxel 100 mg/m\\^2 via IV infusion qw for 3 weeks followed by 1-week rest period in 4-week cycles) until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.","id":"OG001","title":"Chemotherapy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The Safety population included all participants who received at least 1 dose of study drug.","reportingStatus":"POSTED","timeFrame":"From first dose of study drug (Day 1) up to PCD of 18 March 2024 (maximum of approximately 43.85 months)","title":"Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}