{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.01","upperLimit":"0.16","value":"0.160"},{"groupId":"OG002","lowerLimit":"-0.01","upperLimit":"0.16","value":"0.160"},{"groupId":"OG003","lowerLimit":"-0.40","upperLimit":"0.33","value":"0.050"},{"groupId":"OG004","lowerLimit":"-0.40","upperLimit":"0.33","value":"0.050"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"20"},{"groupId":"OG004","value":"20"}],"units":"Participants"}],"title":"The change from baseline in FEV1: 6 weeks"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.03","upperLimit":"0.18","value":"0.070"},{"groupId":"OG002","lowerLimit":"0.03","upperLimit":"0.18","value":"0.070"},{"groupId":"OG003","lowerLimit":"-0.33","upperLimit":"0.52","value":"-0.130"},{"groupId":"OG004","lowerLimit":"-0.33","upperLimit":"0.52","value":"-0.130"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"17"},{"groupId":"OG004","value":"17"}],"units":"Participants"}],"title":"The change from baseline in FEV1: 12 weeks"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.13","upperLimit":"0.16","value":"0.000"},{"groupId":"OG002","lowerLimit":"-0.13","upperLimit":"0.16","value":"0.000"},{"groupId":"OG003","lowerLimit":"-0.56","upperLimit":"0.63","value":"-0.110"},{"groupId":"OG004","lowerLimit":"-0.56","upperLimit":"0.63","value":"-0.110"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"13"},{"groupId":"OG004","value":"13"}],"units":"Participants"}],"title":"The change from baseline in FEV1: 18 weeks"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.16","upperLimit":"0.14","value":"-0.010"},{"groupId":"OG002","lowerLimit":"-0.16","upperLimit":"0.14","value":"-0.010"},{"groupId":"OG003","lowerLimit":"-0.45","upperLimit":"0.78","value":"-0.040"},{"groupId":"OG004","lowerLimit":"-0.45","upperLimit":"0.78","value":"-0.040"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"10"}],"units":"Participants"}],"title":"The change from baseline in FEV1: 24 weeks"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.23","upperLimit":"0.12","value":"-0.055"},{"groupId":"OG002","lowerLimit":"-0.23","upperLimit":"0.12","value":"-0.055"},{"groupId":"OG003","lowerLimit":"-0.29","upperLimit":"0.71","value":"-0.030"},{"groupId":"OG004","lowerLimit":"-0.29","upperLimit":"0.71","value":"-0.030"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"7"},{"groupId":"OG004","value":"7"}],"units":"Participants"}],"title":"The change from baseline in FEV1: 30 weeks"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.28","upperLimit":"0.00","value":"-0.140"},{"groupId":"OG002","lowerLimit":"-0.28","upperLimit":"0.00","value":"-0.140"},{"groupId":"OG003","lowerLimit":"-0.37","upperLimit":"0.26","value":"-0.050"},{"groupId":"OG004","lowerLimit":"-0.37","upperLimit":"0.26","value":"-0.050"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"6"}],"units":"Participants"}],"title":"The change from baseline in FEV1: 39 weeks"},{"categories":[{"measurements":[{"comment":"because of 1 participant data only","groupId":"OG000","lowerLimit":"-0.060","upperLimit":"-0.060","value":"NA"},{"comment":"because of 1 participant data only","groupId":"OG002","lowerLimit":"-0.060","upperLimit":"-0.060","value":"NA"},{"groupId":"OG003","lowerLimit":"-0.12","upperLimit":"0.39","value":"0.115"},{"groupId":"OG004","lowerLimit":"-0.12","upperLimit":"0.39","value":"0.115"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"4"}],"units":"Participants"}],"title":"The change from baseline in FEV1: 48 weeks"},{"categories":[{"measurements":[{"comment":"because of 1 participant data only","groupId":"OG000","lowerLimit":"-0.460","upperLimit":"-0.460","value":"NA"},{"comment":"because of 1 participant data only","groupId":"OG002","lowerLimit":"-0.460","upperLimit":"-0.460","value":"NA"},{"groupId":"OG003","lowerLimit":"-0.07","upperLimit":"0.31","value":"0.010"},{"groupId":"OG004","lowerLimit":"-0.07","upperLimit":"0.31","value":"0.010"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"}],"units":"Participants"}],"title":"The change from baseline in FEV1: 57 weeks"},{"categories":[{"measurements":[{"comment":"because of 1 participant data only","groupId":"OG000","lowerLimit":"-0.570","upperLimit":"-0.570","value":"NA"},{"comment":"because of 1 participant data only","groupId":"OG002","lowerLimit":"-0.570","upperLimit":"-0.570","value":"NA"},{"groupId":"OG003","lowerLimit":"-0.16","upperLimit":"0.33","value":"0.085"},{"groupId":"OG004","lowerLimit":"-0.16","upperLimit":"0.33","value":"0.085"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"2"}],"units":"Participants"}],"title":"The change from baseline in FEV1: 66 weeks"},{"categories":[{"measurements":[{"groupId":"OG003","lowerLimit":"-0.42","upperLimit":"0.33","value":"-0.045"},{"groupId":"OG004","lowerLimit":"-0.42","upperLimit":"0.33","value":"-0.045"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"2"}],"units":"Participants"}],"title":"The change from baseline in FEV1: 75 weeks"},{"categories":[{"measurements":[{"groupId":"OG003","lowerLimit":"-0.44","upperLimit":"0.18","value":"-0.130"},{"groupId":"OG004","lowerLimit":"-0.44","upperLimit":"0.18","value":"-0.130"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"2"}],"units":"Participants"}],"title":"The change from baseline in FEV1: 84 weeks"},{"categories":[{"measurements":[{"groupId":"OG003","lowerLimit":"-0.66","upperLimit":"0.23","value":"-0.215"},{"groupId":"OG004","lowerLimit":"-0.66","upperLimit":"0.23","value":"-0.215"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"2"}],"units":"Participants"}],"title":"The change from baseline in FEV1: 93 weeks"},{"categories":[{"measurements":[{"comment":"because of 1 participant data only","groupId":"OG003","lowerLimit":"0.150","upperLimit":"0.150","value":"NA"},{"comment":"because of 1 participant data only","groupId":"OG004","lowerLimit":"0.150","upperLimit":"0.150","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"The change from baseline in FEV1: 102 weeks"},{"categories":[{"measurements":[{"comment":"because of 1 participant data only","groupId":"OG003","lowerLimit":"0.080","upperLimit":"0.080","value":"NA"},{"comment":"because of 1 participant data only","groupId":"OG004","lowerLimit":"0.080","upperLimit":"0.080","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"The change from baseline in FEV1: 111 weeks"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"24"},{"groupId":"OG004","value":"25"}],"units":"Participants"}],"dispersionType":"Full Range","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":"NSCLC: BBI608 + Pem + CDDP (Phase 1 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 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":"OG001","title":"MPM: BBI608 + Pem +CDDP (Phase 1 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 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":"OG002","title":"MPM or NSCLC: BBI608 + Pem + CDDP (Phase 1 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 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":"OG003","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 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":"OG004","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). In respiratory function tests, data from 1 participant with MPM in Phase 1 part were not collected.","reportingStatus":"POSTED","timeFrame":"Every 6 weeks from the first dose of BBI608 until Week 30, and then every 9 weeks from Week 31 [Actually up to Week 111]","title":"Respiratory Function Tests (Forced Expiratory Volume in the First Second [FEV1])","type":"SECONDARY","unitOfMeasure":"L"}