{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.4","upperLimit":"20.7","value":"13.6"},{"comment":"Could not be estimated due to the low number of events","groupId":"OG001","lowerLimit":"41.7","upperLimit":"NA","value":"NA"},{"comment":"Could not be estimated due to the low number of events","groupId":"OG002","lowerLimit":"4.2","upperLimit":"NA","value":"21.0"},{"groupId":"OG003","lowerLimit":"3.9","upperLimit":"20.0","value":"12.9"},{"groupId":"OG004","lowerLimit":"10.0","upperLimit":"20.2","value":"15.3"},{"groupId":"OG005","lowerLimit":"10.2","upperLimit":"21.0","value":"16.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"89"},{"groupId":"OG005","value":"104"}],"units":"Participants"}],"description":"Progression-free survival (PFS) was defined as the time from first dose to the earlier of disease progression or death due to any cause. The duration of PFS was calculated using Kaplan-Meier methods; participants with no baseline and/or post-baseline disease assessments, who started a new anticancer therapy before documentation of disease progression or death, died or had disease progression immediately after more than 1 consecutively missed disease assessment visit or who were alive without documentation of disease progression before the data cutoff date were censored.\n\nParticipants were evaluated for disease response and progression by the investigator according to the IMWG-URC.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.","id":"OG000","title":"Phase 1: Carfilzomib 45 mg/m²"},{"description":"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.","id":"OG001","title":"Phase 1: Carfilzomib 56 mg/m²"},{"description":"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.","id":"OG002","title":"Phase 1: Carfilzomib 70 mg/m²"},{"description":"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.","id":"OG003","title":"Phase 1: Carfilzomib 88 mg/m²"},{"description":"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.","id":"OG004","title":"Phase 2: Carfilzomib 70 mg/m²"},{"description":"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.","id":"OG005","title":"Phase 1+2: Carfilzomib 70 mg/m²"}],"paramType":"MEDIAN","populationDescription":"Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).","reportingStatus":"POSTED","timeFrame":"From randomization until the data cut-off date of 22 July 2016; median follow-up time for PFS was 13.8 months","title":"Progression-free Survival","type":"SECONDARY","unitOfMeasure":"months"}