{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"9"},{"groupId":"OG006","value":"9"}],"units":"Participants"}],"description":"SAE was defined as any untoward medical occurrence at any dose if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect.","groups":[{"description":"Participants received eribulin mesilate 1.4 mg/m\\^2 intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 20 mg/m\\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.","id":"OG000","title":"Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2"},{"description":"Participants received eribulin mesilate 1.4 mg/m\\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.","id":"OG001","title":"Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2"},{"description":"Participants received eribulin mesilate 1.4 mg/m\\^2 and irinotecan hydrochloride 100 mg/m\\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.","id":"OG002","title":"Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2"},{"description":"Participants received eribulin mesilate 1.4 mg/m\\^2 and irinotecan hydrochloride 125 mg/m\\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.","id":"OG003","title":"Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2"},{"description":"Participants with RMS received eribulin mesilate 1.4 mg/m\\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.","id":"OG004","title":"Phase 2: RMS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2"},{"description":"Participants with NRSTS received eribulin mesilate 1.4 mg/m\\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.","id":"OG005","title":"Phase 2: NRSTS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2"},{"description":"Participants with EWS received eribulin mesilate 1.4 mg/m\\^2, intravenous infusion on Days 1 and 8 and Irinotecan hydrochloride 40 mg/m\\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.","id":"OG006","title":"Phase 2: EWS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety analysis set included all participants who received at least 1 dose of either study drug.","reportingStatus":"POSTED","timeFrame":"Up to approximately 2 years and 4 months","title":"Number of Participants With Serious Adverse Event (SAE)","type":"SECONDARY","unitOfMeasure":"Participants"}