{"analyses":[{"ciNumSides":"TWO_SIDED","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"1.0000","statisticalMethod":"Fisher Exact","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"description":"The overall immune response was achieved at least for 2 timepoints; that is at least 1 parameter in at least 1 assay (Lymphoproliferation assay, enzyme-linked immunospot (ELISPOT) for interferon \\[IFN\\] gamma, and intracellular IFN gamma cytokine assay in peripheral blood mononuclear cell \\[PBMC\\]) with ratio to background \\>=2, and ratio of background-corrected value to baseline \\>=2;Specific immune response at a given timepoint 't' was considered as differences of log-scale values under stimulation (X vax,t ) to those of the respective unstimulated controls (Xneg,t, background values)were computed after certain assay-specific pre-processing steps: Yt = Xvax,t - Xneg,t; A participant was considered to show positive stimulation-induced immune response at timepoint 't' (POS\\[t\\]=1), upon fulfilling the following criteria: Yt =\\>1 (That is at least a 2-fold higher value under stimulation than without stimulation). AVvax,t-1SEM vax,t \\> AVneg,t+1SEMneg,t (ELISPOT and proliferation assay only).","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 in Weeks 1 and 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":"NUMBER","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 Week 104","title":"Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response","type":"PRIMARY","unitOfMeasure":"participants"}