{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"38"}]}],"title":"TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"14"}]}],"title":"SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"39"}],"units":"Participants"}],"description":"TEAE was defined as an adverse event that had an onset date, or a worsening in severity on or after the first dose of study drug up to the end of the study. Number of participants with TEAEs were reported based on safety assessments of laboratory tests, physical examination, examining bowel movements, regular measurement of vital signs, eastern cooperative oncology group-performance status and electrocardiogram parameter values. SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening required inpatient hospitalization; resulted in persistent, significant disability; was congenital anomaly/birth defect or medically important due to other reasons than mentioned criteria. Number of participants with TEAEs and SAEs were reported.","groups":[{"description":"Participants received Eribulin Mesylate 1.0 mg/m\\^2 (Recommended Phase 2 dose), as an intravenous infusion on Days 1 and 8 in combination with Gemcitabine 1000 mg/m\\^2, as an intravenous infusion on Days 1 and 8 and Cisplatin 70 mg/m\\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.","id":"OG000","title":"Phase 2: Eribulin Mesylate 1.0 mg/m^2 + Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2"},{"description":"Participants received Gemcitabine 1000 mg/m\\^2, as an intravenous infusion on Days 1 and 8 and cisplatin 70 mg/m\\^2, as an intravenous infusion on Day 1 of each 21-day cycle until the occurrence of PD, unacceptable toxicity, withdrawal of consent, withdrawal by the investigator, lost to follow-up, death, or for a maximum of six cycles of gemcitabine plus cisplatin (18 weeks), whichever occurred first.","id":"OG001","title":"Phase 2: Gemcitabine 1000 mg/m^2+ Cisplatin 70 mg/m^2"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"SAS included all participants who were randomized and treated in Phase 2 of this study.","reportingStatus":"POSTED","timeFrame":"From the first dose of study drug up to approximately 6 years 3 months","title":"Phase 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)","type":"PRIMARY","unitOfMeasure":"Participants"}