{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.6","upperLimit":"24.4","value":"10.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"}],"units":"Participants"}],"description":"The event-free survival time is defined as the time from registration to disease progression while receiving LCL161 and cyclophosphamide, death due to any cause, or subsequent treatment for multiple myeloma. Date of progression will be defined as the date that the criteria for progressive disease were first met after initiation of cyclophosphamide. If a patient goes off study treatment and never received cyclophosphamide, they will be censored on the date they went off study treatment. If a patient initiates cyclophosphamide but later discontinues cyclophosphamide due to toxicity and continues LCL161 alone, disease progression on LCL161 alone will be considered an event in this case. The distribution of event-free survival will be estimated using the method of Kaplan-Meier.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)"}],"paramType":"MEDIAN","populationDescription":"Patients treated with combination of LCL161 and cyclophosphamide were included in this analysis.","reportingStatus":"POSTED","timeFrame":"From registration to disease progression while receiving SMAC mimetic LCL161 and cyclophosphamide, death due to any cause, or subsequent treatment for multiple myeloma, assessed up to 1 year","title":"Event-free Survival","type":"SECONDARY","unitOfMeasure":"months"}