{"classes":[{"categories":[{"measurements":[{"comment":"Not reached","groupId":"OG000","lowerLimit":"2.89","upperLimit":"NA","value":"5.59"},{"comment":"Not reached","groupId":"OG001","lowerLimit":"2.89","upperLimit":"NA","value":"5.59"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"25"}],"units":"Participants"}],"description":"PFS was defined as the time from BBI608 administration to documented PD (as assessed according to the mRECIST or RECIST 1.1) or death, whichever is earlier. The result of imaging assessment by the imaging assessment committee was used for phase 2 part.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants orally received BBI608 (480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days 1 in Cycles 2 and subsequent cycles.\n\nPremeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.","id":"OG000","title":"MPM: BBI608 + Pem + CDDP (Phase 2 Part)"},{"description":"Participants orally received BBI608(480 mg) twice daily plus intravenously received Pem (500 mg/m2) and CDDP (75 mg/m2) on Day 3 in only Cycles 1 and on Days1 in Cycles 2 and subsequent cycles.\n\nPremeditation with folic acid and vitamin B12 was given to reduce occurrence of serious adverse drug reactions, with reference to the package insert for Pem. Each cycle was defined as 21 days.","id":"OG001","title":"MPM: BBI608 + Pem + CDDP (Phase 2 Part Including 1 Participant With MPM in Phase 1 Part)"}],"paramType":"MEDIAN","populationDescription":"modified ITT population. Efficacy was analyzed using the efficacy analysis population (i.e., modified ITT population; mITT), separately for Phase 1 part (n=4), Phase 2 part (n=24) and Phase 2 part including 1 participant with MPM in Phase 1 part (n=25).","reportingStatus":"POSTED","timeFrame":"From BBI608 administration to documented PD or death, whichever is earlier, about 17 months","title":"Phase 2 Part: Progression-free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"month"}