{"analyses":[{"ciLowerLimit":"0.157","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.185","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0940","paramType":"Hazard Ratio (HR)","paramValue":"0.431","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"14.5","upperLimit":"20.8","value":"15.2"},{"comment":"The number of events were not sufficient to calculate the upper limit of the confidence interval.","groupId":"OG001","lowerLimit":"17.3","upperLimit":"NA","value":"38.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"description":"Progression was defined as follows per Blade criteria: The disease was considered to be progressive if it met 1 or more of the following: \\>25% increase in the level of serum monoclonal paraprotein (M-protein);\\>25% increase in the 24 h urinary light chain excretion; \\>25% increase in plasma cells in the bone marrow- definite increase in the size of existing bone lesions or soft tissues plasmacytomas (STP); Development of new bone lesions or STP, or development of hypercalcemia. TTP was defined as time from randomization to disease progression. Participants without events were censored on the date of last tumor assessment. Participants without PD at time of treatment discontinuation were censored at the date of discontinuation. Participants without PD at the time of the analysis but still on treatment were censored at the date of the latest available multiple myeloma status assessment. Participants dying from causes other than PD were treated as censored observations at time of death.","dispersionType":"95% Confidence Interval","groups":[{"description":"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide \\[L-BLP25\\]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.\n\nSingle low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m\\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.","id":"OG000","title":"Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide"},{"description":"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.\n\nMultiple low dose cyclophosphamide: An IV infusion of 300 mg/m\\^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m\\^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.","id":"OG001","title":"Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide"}],"paramType":"MEDIAN","populationDescription":"Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.","reportingStatus":"POSTED","timeFrame":"From the date of randomization up to Month 48","title":"Time to Progression (TTP)","type":"SECONDARY","unitOfMeasure":"months"}