{"analyses":[{"ciLowerLimit":"0.243","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.586","estimateComment":"Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort. Hierarchical testing: HRD+ subset tested first. If HRD+ subset demonstrated statistical significance, overall non-gBRCA cohort was then tested","paramType":"Hazard Ratio (HR)","paramValue":"0.38","statisticalComment":"Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.1","upperLimit":"15.9","value":"12.9"},{"groupId":"OG001","lowerLimit":"3.5","upperLimit":"5.7","value":"3.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"106"},{"groupId":"OG001","value":"56"}],"units":"Participants"}],"description":"PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.","dispersionType":"95% Confidence Interval","groups":[{"description":"Niraparib (300 mg) once daily in 28-day cycles until disease progression in participants with homologous recombination deficiency-positive (HRD+) tumors Niraparib vs. Placebo 2:1 ratio","id":"OG000","title":"Non-gBRCAmut HRD+ Niraparib"},{"description":"Placebo once daily in 28-day cycles until disease progression patients with homologous recombination deficiency-positive (HRD+) tumors Niraparib vs. Placebo 2:1 ratio","id":"OG001","title":"Non-gBRCAmut HRD+ Placebo"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat Population. Only those participants with data available at the indicated time points were analyzed.","reportingStatus":"POSTED","timeFrame":"From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days","title":"Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+)","type":"PRIMARY","unitOfMeasure":"months"}