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death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"1"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"2"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"2"}]}],"title":"Drug-related TEAEs associated with death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"7"},{"groupId":"OG007","value":"22"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"11"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"4"},{"groupId":"OG012","value":"5"}]}],"title":"TEAEs associated with discontinuation of drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"5"},{"groupId":"OG007","value":"21"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"11"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"3"},{"groupId":"OG012","value":"5"}]}],"title":"Related TEAEs associated with drug discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"5"},{"groupId":"OG007","value":"18"},{"groupId":"OG008","value":"3"},{"groupId":"OG009","value":"9"},{"groupId":"OG010","value":"5"},{"groupId":"OG011","value":"9"},{"groupId":"OG012","value":"14"}]}],"title":"TEAEs associated with dose reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"18"},{"groupId":"OG008","value":"2"},{"groupId":"OG009","value":"9"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"9"},{"groupId":"OG012","value":"13"}]}],"title":"Drug-related TEAEs associated with dose reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"21"},{"groupId":"OG007","value":"36"},{"groupId":"OG008","value":"8"},{"groupId":"OG009","value":"13"},{"groupId":"OG010","value":"9"},{"groupId":"OG011","value":"13"},{"groupId":"OG012","value":"22"}]}],"title":"TEAEs associated with dose interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"15"},{"groupId":"OG007","value":"28"},{"groupId":"OG008","value":"7"},{"groupId":"OG009","value":"11"},{"groupId":"OG010","value":"5"},{"groupId":"OG011","value":"11"},{"groupId":"OG012","value":"17"}]}],"title":"Related TEAEs associated with dose interruption"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"50"},{"groupId":"OG007","value":"66"},{"groupId":"OG008","value":"21"},{"groupId":"OG009","value":"33"},{"groupId":"OG010","value":"19"},{"groupId":"OG011","value":"25"},{"groupId":"OG012","value":"59"}],"units":"Participants"}],"description":"Treatment-emergent adverse events were graded by Common Terminology Criteria for Adverse Events, v4.03.","groups":[{"description":"Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).","id":"OG000","title":"Dose Escalation: Cohort 1, 0.8 mg/kg"},{"description":"Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).","id":"OG001","title":"Dose Escalation: Cohort 2, 1.6 mg/kg"},{"description":"Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).","id":"OG002","title":"Dose Escalation: Cohort 3, 3.2 mg/kg"},{"description":"Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG003","title":"Dose Escalation: Cohort 4, 5.4 mg/kg"},{"description":"Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG004","title":"Dose Escalation: Cohort 5, 6.4 mg/kg"},{"description":"Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).","id":"OG005","title":"Dose Escalation: Cohort 6, 8.0 mg/kg"},{"description":"Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG006","title":"Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg"},{"description":"Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG007","title":"Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg"},{"description":"Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG008","title":"Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg"},{"description":"Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG009","title":"Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg"},{"description":"Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG010","title":"Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg"},{"description":"Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG011","title":"Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg"},{"description":"Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG012","title":"Dose Expansion: HER2-expressing Other Solid Tumors"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety events were assessed in the Safety Analysis Set. It was prespecified in the protocol that single patients with unique tumor types would be combined into 1 group for the safety analysis. For the safety overview, TEAEs for HER2-expressing NSCLC, Colorectal, and Other Solid Tumors (excluding 1 HER2-low gastric cancer subject who received 5.4 mg/kg) were combined and reported together.","reportingStatus":"POSTED","timeFrame":"Baseline up to 28 days after the last dose of study drug, up to 3 years 5 months","title":"Overview of Treatment-emergent Adverse Events","type":"SECONDARY","unitOfMeasure":"Participants"}