{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"37.0","upperLimit":"68.0","value":"52.5"},{"groupId":"OG001","lowerLimit":"30.5","upperLimit":"61.8","value":"46.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"39"}],"units":"Participants"}],"description":"Overall response rate was defined as the percentage of participants with the best confirmed response of complete response (CR) or partial response (PR) based on RECIST v1.1. CR was defined as complete disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline summed longest diameters.","dispersionType":"95% Confidence Interval","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":"NUMBER","populationDescription":"MITT analysis set included all participants who were randomized and received at least one dose of study medication without major protocol eligibility violations.","reportingStatus":"POSTED","timeFrame":"From the date of randomization until CR or PR (Up to approximately 6 years 3 months)","title":"Phase 2: Percentage of Participants With Overall Response","type":"SECONDARY","unitOfMeasure":"percentage of participants"}