{"analyses":[{"ciLowerLimit":"0.261","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.698","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.3919","paramType":"Hazard Ratio (HR)","paramValue":"0.666","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"comment":"The number of events were not sufficient to calculate the upper limit of the confidence interval.","groupId":"OG000","lowerLimit":"14.8","upperLimit":"NA","value":"24.7"},{"comment":"The number of events were not sufficient to calculate the upper limit of the confidence interval.","groupId":"OG001","lowerLimit":"23.3","upperLimit":"NA","value":"36.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"description":"Time from date of randomization to the date of first anti-tumor therapy since end of study treatment. In case a concomitant or concurrent procedure was identified as anti-tumor therapy during the medical review process, the start date of that anti-tumor therapy was used instead. Participants in the survival follow-up phase without subsequent anti-tumor therapy at the time of the analysis were censored at the latest available follow-up date. Participants without anti-tumor therapy and still on treatment at the time of analysis were censored at the data cut-off date if any trial treatment administration was recorded after the data cut-off date. In case no such record exists, the subject was censored at the last available administration date prior or equal to the data cut-off date. Participants dying before start of subsequent anti-tumor therapy 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 Anti-tumor Therapy","type":"SECONDARY","unitOfMeasure":"months"}