{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"description":"DLTs were clinically significant adverse events within 21 days of treatment judged by investigator at least possibly related to treatment. This included greater than or equal to (\\>=) Grade 3 (G3) peripheral neuropathy, \\>=G3 nausea and vomiting despite optimal anti-emetic treatment, any other non-hematologic toxicity of \\>=G3 (except alopecia, single abnormal laboratory values the Investigator judged unlikely related to study therapy, had no clinical correlate, and resolved within 7 days, and hypersensitivity reaction to any of the compounds), Grade 4 neutropenia lasting over 7 days, febrile neutropenia (defined as fever \\>=38.5 degrees Celsius with absolute neutrophil count below 1.0\\*10\\^9 per liter, G3 thrombocytopenia with nontraumatic bleeding (without therapeutic systemic anticoagulation) requiring platelet transfusion, Grade 4 thrombocytopenia (with or without nontraumatic bleeding), any study drug-related death, any other toxicity the dose escalation committee believed to be DLT.","groups":[{"description":"Participants received Eribulin Mesylate 0.7 mg/m\\^2, 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 a 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 1b: Eribulin Mesylate 0.7 mg/m^2 + Gemcitabine 1000 mg/m^2 + Cisplatin 70 mg/m^2"},{"description":"Participants received Eribulin Mesylate 1.0 mg/m\\^2, 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 a 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 1b: Eribulin Mesylate 1.0 mg/m^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 1b of this study.","reportingStatus":"POSTED","timeFrame":"Cycle 1 (Cycle length=21 days)","title":"Phase 1b: Number of Participants With Dose-limiting Toxicity (DLT) as Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0","type":"PRIMARY","unitOfMeasure":"Participants"}