{"analyses":[{"ciLowerLimit":"0.563","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.138","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.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1070","pValueComment":"Progression-free survival, overall response, 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":"0.800","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":"0.578","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.164","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":"0.1326","paramType":"Hazard Ratio (HR)","paramValue":"0.820","statisticalComment":"One-sided unstratified log-rank test","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Could not be estimated due to the low number of events","groupId":"OG000","lowerLimit":"18.1","upperLimit":"NA","value":"NA"},{"comment":"Could not be estimated due to the low number of events","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"238"},{"groupId":"OG001","value":"240"}],"units":"Participants"}],"description":"Overall Survival (OS) was defined as the time from randomization to death due to any cause.\n\nMedian overall survival was derived using the Kaplan-Meier method; participants still alive were censored at the date last known to be alive.","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 OS was 12.6 (0, 20) and 13.2 (0, 19) months in each treatment group respectively.","title":"Overall Survival","type":"SECONDARY","unitOfMeasure":"months"}