{"classes":[{"categories":[{"measurements":[{"comment":"The median, 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, upper and lower 95% CIs could not be estimated due to too few events.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The median, upper and lower 95% CIs could not be estimated due to too few events.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The median, 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, upper and lower 95% CIs could not be estimated due to too few events.","groupId":"OG005","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The upper 95% CI could not be estimated due to too few events.","groupId":"OG006","lowerLimit":"3.7","upperLimit":"NA","value":"16.6"},{"comment":"The median could not be estimated due to too few events. The lower bound 95% CI was estimated from observed data that were available (25% percentile).","groupId":"OG007","lowerLimit":"28.6","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"6"},{"groupId":"OG007","value":"7"}],"units":"Participants"}],"description":"DOR, presented in months, was defined as the number of days between the date of the first tumor assessment indicating an objective response (PR or better) through to the subsequent date of progression or death due to any cause, or where applicable date of censoring (date of first progressive disease assessment or death or date of censoring - date of the first objective response result + 1/30.4). Median PFS was estimated using the Kaplan-Meier method. 95% confidence intervals were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.","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. Participants who did not achieve an objective response were excluded from the analysis of DOR. Participants who responded and had not progressed while on study were censored at the date of assessment of the last evaluable tumor 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 Duration of Response (DOR)","type":"SECONDARY","unitOfMeasure":"months"}