{"analyses":[{"ciLowerLimit":"0.544","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.883","estimateComment":"Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using a Cox proportional hazards model stratified by the randomization stratification factors.","groupDescription":"To ensure proper control of type I error, analysis of PFS was performed under a group sequential design framework with the stopping boundaries constructed using the Lan-DeMets spending function with an O'Brien-Fleming approach. The inferential comparison between the 2 treatment groups for PFS used the 1-sided log-rank test stratified by the randomization stratification factors. A 1-sided p-value was compared against the prespecified adjusted alpha value of 0.011 to determine significance.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0014","pValueComment":"Progression-free survival, overall response rate, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.","paramType":"Hazard Ratio (HR)","paramValue":"0.693","statisticalComment":"One-sided stratified log-rank test, stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.567","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.913","estimateComment":"Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using an unstratified Cox proportional hazards model.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0033","paramType":"Hazard Ratio (HR)","paramValue":"0.720","statisticalComment":"One-sided unstratified log-rank test","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.8","upperLimit":"9.2","value":"7.6"},{"groupId":"OG001","lowerLimit":"8.6","upperLimit":"13.0","value":"11.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"238"},{"groupId":"OG001","value":"240"}],"units":"Participants"}],"description":"Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause.\n\nDisease status was assessed at a central laboratory with serum and urine protein electrophoresis, immunofixation, serum-free light chain (SFLC) assay, bone marrow sample evaluation, serum calcium, plasmacytoma evaluation, and skeletal survey. Response and disease progression were determined using a validated computer algorithm based on the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC).\n\nMedian PFS was derived using the Kaplan-Meier method; participants still alive with no disease progression were censored at the time of their last disease assessment.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter).\n\nParticipants 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":"Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone"},{"description":"Participants received carfilzomib administered by IV infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter).\n\nParticipants 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":"Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat population","reportingStatus":"POSTED","timeFrame":"From randomization until the data cut-off date of 15 June 2017; median (minimum, maximum) follow-up time for PFS was 12.0 (0, 20) and 12.6 (0, 19) months in each treatment group respectively.","title":"Progression Free Survival","type":"PRIMARY","unitOfMeasure":"months"}