{"classes":[{"categories":[{"measurements":[{"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"}]}]}],"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":"A TEAE was defined as an AE that emerged during treatment, having been absent at pretreatment, or reemerged during treatment, having been present at pre-treatment (baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.","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":"From first dose of study drug up to approximately 2 years 4 months","title":"Number of Participants With Treatment-Emergent Adverse Events (TEAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}