{"analyses":[{"ciLowerLimit":"0.52","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.72","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.61","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"47.5","upperLimit":"58.7","value":"52.8"},{"comment":"The upper limit of the Confidence Interval is not estimable due to insufficient number of participants with events.","groupId":"OG001","lowerLimit":"70.2","upperLimit":"NA","value":"83.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"542"},{"groupId":"OG001","value":"543"}],"units":"Participants"}],"description":"Progression Free Survival (PFS) is defined as the duration from the date of first randomization to either progressive disease (according to the IMWG criteria specified in the protocol), or death, whichever occurs first (=all these considered as events) at the end of the study","dispersionType":"95% Confidence Interval","groups":[{"description":"All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (whether they subsequently had rando 2 or not) even those who didn't receive any treatment dose.","id":"OG000","title":"Arm A - Part 1 up to End of Study"},{"description":"All patients randomized to the DVTd group (Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (whether they subsequently had rando 2 or not) even those who didn't receive any treatment dose.","id":"OG001","title":"Arm B - Part 1 up to End of Study"}],"paramType":"MEDIAN","populationDescription":"All participants randomized in the first randomization even if they did not receive any study treatment dose.","reportingStatus":"POSTED","timeFrame":"From the date of first randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 80.1 months at the end of the study","title":"Progression Free Survival (PFS) From First Randomization up to the End of the Study","type":"SECONDARY","unitOfMeasure":"Months"}