{"classes":[{"categories":[{"measurements":[{"comment":"The median and upper and lower 95% CIs could not be estimated due to too few events.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The median and upper 95% CI could not be estimated due to too few events.","groupId":"OG001","lowerLimit":"2.7","upperLimit":"NA","value":"NA"},{"comment":"Due to the low numbers of participants (3) there are too few events (1) that impacted the estimate of survival function to no variation, hence the 95% CIs could not be estimated.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"14.24"},{"comment":"The median and upper and lower 95% CIs could not be estimated due to too few events.","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The median and upper and lower 95% CIs could not be estimated due to too few events.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The median and upper 95% CI could not be estimated due to too few events.","groupId":"OG005","lowerLimit":"1.5","upperLimit":"NA","value":"NA"},{"comment":"The upper 95% CI could not be estimated due to too few events.","groupId":"OG006","lowerLimit":"5.6","upperLimit":"NA","value":"17.50"},{"comment":"The median and upper 95% CI could not be estimated due to too few events.","groupId":"OG007","lowerLimit":"29.5","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"7"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"10"},{"groupId":"OG007","value":"8"}],"units":"Participants"}],"description":"PFS was defined as the number of months from a participant's first dose of study treatment to the earlier of disease progression or death due to any cause. Median PFS was estimated using the Kaplan-Meier method. 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. PFS data was censored: participants alive and no documented disease progression at time of analysis were censored at date of last disease assessment; participants alive with no disease assessment were censored at the first study dose date; participants alive without documented disease progression, with withdrawn consent were censored at date of last disease assessment before consent withdrawal; and for participants who started anti-cancer therapy other than study treatment prior to documentation of disease progression were censored at date of last disease assessment prior to starting new therapy.","dispersionType":"95% Confidence Interval","groups":[{"description":"In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.","id":"OG000","title":"Oprozomib IR 150 mg/Day + Dexamethsone"},{"description":"In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.","id":"OG001","title":"Oprozomib GR 150 mg/Day + Dexamethasone"},{"description":"In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.","id":"OG002","title":"Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone"},{"description":"In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.","id":"OG003","title":"Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone"},{"description":"In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.","id":"OG004","title":"Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone"},{"description":"In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.","id":"OG005","title":"Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone"},{"description":"In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.","id":"OG006","title":"Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone"},{"description":"In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.","id":"OG007","title":"Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone"}],"paramType":"MEDIAN","populationDescription":"The efficacy analysis set included all participants, excluding roll-over participants, who were included in the safety analysis set, and had a baseline disease assessment and at least 1 post-baseline disease assessment.","reportingStatus":"POSTED","timeFrame":"Day 1 of cycle 1 up to the end of study visit (where each cycle was 28 days); median treatment duration in Part 1 was 11.43 weeks and in Part 2 was 28 weeks","title":"Kaplan-Meier Estimate of PFS","type":"SECONDARY","unitOfMeasure":"months"}